▶ 0:01:30Okay, we're we're going to start. You good? All right. This hearing of the Committee on Oversight and Government Reform will come to order. I want to welcome everyone here today. Without objection, the chair may declare a recess at any time. I apologize for my laryngitis. We're going to try to fight our way through this. So, I'll recognize myself for the purpose of making an opening statement. Again, welcome to the Committee on Oversight and Government Reform.
▶ 0:02:00Today, we will examine solutions to ensure the Food and Drug Administration keeps our nation's food and drug supply safe for all Americans. There might not be another federal agency that more profoundly impacts every American's daily life than the FDA. The FDA oversees the safety of the food, drugs, and medical devices we rely on. These responsibilities make it a key pillar of public health in the United States.
▶ 0:02:28But Americans are not getting healthier. Americans life expectancy is four years less than other developed countries despite spending more than any other country on healthcare. Six in 10 Americans suffer from chronic disease. One in five Americans live with a mental illness. Nearly 20% of America's childrens are considered obese. 20% of children.
▶ 0:02:56So you would think the FDA under the Biden administration would have prioritized making Americans Wrong. President Biden's FDA pushed burdensome gender identity requirements on clinical trials that made compliance more expensive. They turned a blind eye to the Chinese Communist Party targeting our children by flooding our streets with illicit tobaca and nicotine products.
▶ 0:03:21They neglected infant formula facility inspections that led to mothers and fathers across the country being unable to buy the formula their children needed. And they failed to work handinhand with the US Customs and Border Protection to root out illicit pharmaceuticals, food, tobacco, and CBD. We are facing a national epidemic of chronic disease, mental health, and obesity. And the FDA under the previous administration sat on its hands.
▶ 0:03:50Thankfully, President Trump and Secretary Kennedy are taking action to make America healthy again. Soon after his return to office, President Trump signed an executive order removing uh pseudocience compliance burdens for clinical trials. The FDA recently restarted approvals of safer alternatives to traditional tobacco products, and I'm hopeful more will come soon to bring greater clarity to the market.
▶ 0:04:18Secretary Kennedy announced Operation Stor, which will provide families with access to safe infant formula for their babies and prevent shortages going forward. And President Trump's efforts to resecure the southern border have returned law enforcement's ability to stop the influx of illicit pharmaceuticals, food, tobacco, and CBD coming into our country. This committee has spent years investigating failures at FDA, and our findings are clear.
▶ 0:04:44The Biden administration stifled innovation with red tape and put bureaucrats before health of the nation. Reform is essential. The FDA must prioritize innovation, safety, and the health of all Americans. The FDA needs better systems to identify and address drug shortages. Quick approval of innovative medicines and techniques identified with AI and support of President Trump's promise to cure cancer is a necessity.
▶ 0:05:14The FDA must work with food producers to make our food healthier while not upending supply chains. Incentivizing domestic manufacturing of pharmaceuticals is essential to improving the safety of prescription drugs and will enable more research. Clearly and effectively regulating hemp products, will reduce confusion and prevent intoxicants and poisonous contaminants from infiltrating the market.
▶ 0:05:41These examples are just scratching the surface of the dysfunction and failures within the FDA. Today, I'm hopeful we can take a deep dive to better understand how we can improve the FDA to make Americans healthier. I now yield to the ranking member for his opening statement. Uh, thank you, Mr. Chair. Uh, today's hearing comes at a critical moment for public health and safety. All Americans should be able to trust that our government is working to ensure their food and medicine will be safe and affordable.
▶ 0:06:09But over the past two months, the Trump administration has purged thousands of FDA workers, putting this essential mission and American lives at risk. Last week, the administration purged 10,000 people at HHS, including 3,500 FDA employees. This was on top of a purge of approximately 1,000 FDA workers in February, and Secretary Kennedy subsequently admitted that 20% of last week's purges should not have happened.
▶ 0:06:34tried to brush it off, saying, quote, "We'll make mistakes, but how long will it take them to realize the full extent of the mistakes that they've made? How long will it take for them to try and very possibly fail to undo them? And how many Americans will get sick or die in that time?" The FDA is supposed to make sure that our children have the vaccines they need to survive outbreaks of preventable diseases like measles, which has killed at least two children in the US since February and sickened more Americans in two months than the entirety of 2024.
▶ 0:07:01The FDA is supposed to protect us from counterfeit drugs and contaminated infant formula, which are serious bipartisan concerns. But how is the agency supposed to stop dangerous elicit products from entering American homes and threatening American lives when underfunded food and drug inspection teams are are being cut even more? 170 employees from the FDA's Office of Inspections and Investigations were reportedly let go last week. And let me tell you some of the expertise we're losing because of the administration's actions.
▶ 0:07:28Besides that, they fired people responsible for regulating ecigarettes and ensuring that predatory companies cannot market vapes to children. They fired people responsible for monitoring drugs for side effects and updating warning labels. They fired the scientists monitoring bird flu and taking steps to prevent it from killing people. They fired the scientists with expertise in fighting heavy metals, toxins, and additives in our food supply. and and they fired the people who monitor prescription drug shortages and ensure that Americans have access to affordable prescription medications.
▶ 0:07:58How is this making Americans healthier? We all know the answer to that question. It's not. People are going to die. And as a dad, I'm especially concerned by the administration undoing the progress we've made to protect babies from contaminated infant formula and formula shortages. And we should all be concerned by the risk posed by contaminated meat and produce. This chaos will keep us in the dark about looming shortages for essential drugs like antibiotics and chemotherapy drugs.
▶ 0:08:22And it will leave people no choice but to pay for pricey brandame drugs because there are no FDA employees to approve generic versions. In the name of efficiency, this administration even fired employees who were critical in approving new medications, meaning Americans will have to wait longer for new treatments, if they get them at all. And on top of that, we just heard last night from the president that pharmaceutical tariffs will be next, making the drugs we all rely on even more expensive.
▶ 0:08:47One of the Americans impacted by these cuts is one of my constituents, a former teacher who spent 35 years working at the Department of Education. She has idiopathic pulmonary fibrosis, a terminal lung condition that took her aunt's life and is slowly taking hers. It's a rare disease that doesn't get much funding, but she had hope. a drug to slow down the disease received the FDA's breakthrough therapy designation in 2022 and the trial show that it might actually stop the progression of her disease.
▶ 0:09:12Her doctor anticipated FDA approval this year, but the FDA's funding cuts and the firing of researchers and staff who sit on the approval committees have made this impossible. This administration is stripping both hope and life-saving medications out of the hands of Americans who need it most. The FDA can and must do more for Americans.
▶ 0:09:30Addressing our country's chronic disease epidemic, ensuring our children are set up to live long and healthy lives, getting more life-saving medications to those who need them, and ensuring that food on our shelves is safe and wholesome should be at the top of that list of things to do. But rather than making it better, more efficient, this FDA is left ransacked and reeling from the chaos and destruction of the Trump administration. It's unclear whether the agency can even perform some of its most basic functions anymore. I don't know how much clearer I can be. These health cuts will kill people.
▶ 0:09:59They will make us less safe and less healthy. I was not elected to watch people suffer from diseases awaiting new treatments while this administration dismantles the offices that offer that hope. It's the responsibility of this committee to conduct meaningful oversight. If we are not talking about this and doing something about these cuts, we're not doing our jobs. I yield back. Gentleman yields back. Without objection, Representative Moscowitz is waved onto the committee for the purpose of asking questions at today's hearing.
▶ 0:10:27I'm now pleased to introduce today's witnesses. Mr. Guy Bentley is the director of consumer freedom at the Reason Foundation focusing on taxation and regulation of nicotine, tobacco, alcohol, and food. Mr. Jonathan Miller is the general counsel of the hemp round table and partner at FR Tide attorneys. Jonathan is known for being a leading advocate for hemp and CBD legislation, has continually worked to promote policies that benefit the hemp industry.
▶ 0:10:58And just so my colleagues on the other side of the aisle know, my friend Jonathan Miller is a former chairman of the Kentucky Democrat party. So we try to be bipartisan in this committee despite what you read in the paper. Mr. Miller. So, uh, Mr. Richard Williams is a senior affiliated scholar at the Mercada uh, at George Mason University.
▶ 0:11:23He's an expert in costbenefit analysis and risk analysis associated with food safety and nutrition. Mr. Shabir uh, Sofar is the executive director of the partnership for safe medicines. He leads a coalition representing much of the pharmaceutical supply chain. And Mr. Mr. David Kesler is a former commissioner of the US Food and Drug Administration under Presidents Bush and Clinton. Pursuant to committee rule 9G, the witnesses will please stand and raise a right hand.
▶ 0:11:52Do you solemnly swear or affirm that the testimony you are about to give is the truth, the whole truth, and nothing but the truth? So, help you God. Let the record show that the witnesses answered in the affirmative. Thank you all. You may take a seat. We appreciate you being here today and look forward to your testimony. Let me remind the witnesses that we have read your written statement. They will appear in full in the hearing record. Please limit your oral statements to five minutes. As a reminder, please press the button on the microphone in front of you so that it is on and the members can hear you.
▶ 0:12:23When you begin to speak, the light in front of you will turn green. After four minutes, the light will turn yellow. When the red light comes on, your five minutes have expired. We would ask that you please wrap it up. I now recognize Mr. Bentley for his opening statement. Chairman Comr, Ranking Member Subramanyam, and members of the committee. Thank you so much for the opportunity to testify today. My name is Guy Bentley, and I'm the director of consumer freedom at the Reason Foundation, a nonprofit public policy think tank.
▶ 0:12:50The Consumer Freedom Project analyzes and promotes policy solutions that improve public health while avoiding unintended consequences and protecting consumer choice. I would like to focus on three points. First, the current state of the tobacco market. Second, how we got here, and third, what can be done to reduce the illicit ecigarette market while ensuring adult smokers have legal access to a range of safer alternatives. The focus of this hearing is rightly on rooting out illicit products, including illegal ecigarettes.
▶ 0:13:21But there is some good news amid the disorder. Youth vaping has declined more than 70% since 2019 and is at its lowest level in 10 years. Youth smoking fell by 68% and is at its lowest level on record. These declines followed the decision to raise the age of purchase for tobacco products to 21 for which there was bipartisan support.
▶ 0:13:43Cigarettes remain the most widely used tobacco product with 28 million adult smokers and more than 400,000 deaths per year attributable to smoking. There are also 18 million adult vapors who are using ecigarettes to quit smoking. But thanks to the FDA's regulatory bottlenecks, since 2019, illicit products have flooded the market with almost 90% of ecigarettes being sold being sold illegally, mainly consisting of disposable products from China.
▶ 0:14:12Despite the huge demand for safer nicotine alternatives among adult smokers, the FDA has authorized just eight vaping devices for sale and 34 vaping products in total and only in tobacco and menthol flavors, which have little appeal to most ecigarette users. Ecigarette authorizations account for 0.2% of all tobacco product authorizations compared to 22% of combustible cigarettes.
▶ 0:14:39So, how did we arrive at a situation where it is easier to release a new cigarette onto the market than the safer products invented to displace cigarettes and the illicit products thrive? The answer is the FDA's approach to the pre-market tobacco product application pathway, which is how ecigarettes are evaluated and authorized for sale or not. The PMTA pathway established as part of the Tobacco Control Act was supposed to facilitate innovation for safer alternatives to cigarettes.
▶ 0:15:09In reality, it presents an almost insurmountable barrier. In 2022, an independent review of the FDA's performance as a tobacco regulator was published by the Reagan Udall Foundation, which criticized the FDA's lack of transparency and timeliness in authorizing ecigarettes into the legal market.
▶ 0:15:29It is unfortunate that in response to a report that emphasized the need for timeliness and transparency, the FDA issued a five-year plan of generalities with no substantive changes to the PMTA pathway. With a large elicit market now in place, the FDA has taken steps to ameliate the problem with the creation of a multi- agency task force last year, increases in seizures, injunctions, and civil money penalties.
▶ 0:15:56But the only way to sustainably resolve the problem of the illicit ecigarette market is to streamline the PMTA process to have regulated companies sell their company sell their ecigarettes in the United States and reduce death and disease from smoking. Reforming the PMTA process would lessen current burdens on FDA staff reviewing ecigarette applications, hasten the creation of a regulated marketplace, and restore public trust.
▶ 0:16:23The FDA insists its current approach to authorizing or denying ecigarette products is guided by science and is appropriate for the protection of public health. But despite the best of intentions, a regulatory regime that results in a de facto ban of almost all ecigarettes incentivizing the illicit market is not appropriate for the protection of public health.
▶ 0:16:47When it's easier to bring a cigarette onto the market than a vape or a nicotine pouch, both of which the FDA acknowledges are dramatically safer, that is not appropriate for the protection of public health. And an agency that fails to correct the misperceptions around ecigarettes. With the majority of Americans now believing that ecigarettes are just as or more dangerous than combustible cigarettes, that is not appropriate for the protection of public health.
▶ 0:17:14It is within FDA's current powers to change this dynamic and pursue a different path. Thank you and I look forward to your questions. Thank you, Chair and Mr. Miller. Mr. Chairman, uh, ranking member, I I'm grateful for the opportunity to testify before your committee today. Mr. Chairman, I'm especially grateful for your decades long leadership on behalf of Kentucky hemp farmers.
▶ 0:17:40You and I started on this journey in 2012 and worked across the aisle to secure hemp's legalization in the bluegrass state. Indeed, hemp's policy success has always been a bipartisan hallmark. And it's no wonder hemp products are made in the USA, harvested from crops grown by American farmers, manufactured by innovative US entrepreneurs, and sold by small businesses dotting the nation. Unfortunately, the US hemp industry continues to encounter avoidable bureaucratic headwinds in the marketplace.
▶ 0:18:09And this turmoil is due in large part to statements, actions, and indecisions of the FDA. When Congress passed the 2018 Farm Bill, it explicitly legalized the sale of hemp and its derivatives such as CBD. But just a few hours after the Farm Bill was signed into law, the FDA reasserted its opinion that it was illegal to market CBD as a dietary supplement. We've watched in bewilderment as FDA has jerked back and forth with contradictory opinions.
▶ 0:18:37First, the agency affirmed its ability to regulate CBD under current law. But then FDA stalled, even ignoring congressional appropriations report directives to take expedited action. Finally, in 2023, the agency stated that it cannot regulate CBD under existing regulatory pathways, essentially punting responsibility to Congress.
▶ 0:18:57This regulatory uncertainty resulted in a collapse of the CBD market as demonstrated on this chart behind me, denying economic opportunity that was promised to farmers. The FDA's inaction doesn't just threaten CBD. A new industry focused on the adult market has emerged to meet consumer demand for hemp derived can canabonoids like delta 8 and delta 9 THC. These products provide plant-based options for adults seeking functional health and wellness benefits.
▶ 0:19:26Furthermore, a promising new hemp beverage industry has soared into popularity, meeting adult consumer demand for non-alcoholic options through domestic inputs from our farmers. The only upward line on this chart represents the price of hemp flour, which recovered when it started being widely used for adult products, offering a lifeline to US farmers.
▶ 0:19:48Unfortunately, lack of uniform quality control standards for hemp products at the federal level has forced responsible farmers and small business owners to compete against unscrupulous actors who generate headlines by distributing poorly manufactured products that are sometimes inappropriately marketed to children. A political backlash has ensued. Language was added into the 2024 House Farm Bill that purported to crack down on the bad actors. Unfortunately, the language went much farther.
▶ 0:20:15It would have federally banned 90 to 95% of the hemp product marketplace, including most non- intoxicating CBD products and animal feed, which offers great promise to farmers, while undermining a decade of progress for hemp fiber production. I want to be very clear, the hemp industry is united behind an appropriate response to these challenges. Robust regulation of hemp products, not misguided prohibition. We support an approach that includes the four the following four pillars.
▶ 0:20:41restrict youth access, increase quality control standards, standardized labeling, and standardized packaging. FDA could act today on applying this four-pillar approach to hemp products. We are hopeful that new leadership of the FDA will reverse the past course of inaction and take deliberate steps to robustly regulate hemp. This approach is precisely in line with the new administration's focus on providing adult consumers the freedom to make their own health care choices with holistic solutions that are grown on American farms.
▶ 0:21:10If laws must be changed, we urge Congress to act now. There are two viable pathways. First, we hope we'll consider Senator Ron Weiden's effort in the last Congress, S5243, that would ensure that the FDA regulates applying the four-pillar approach. A parallel effort could be to invest more authority in the states to properly regulate their own markets. In the absence of federal regulation, many states, like our Kentucky home, Mr.
▶ 0:21:36chairman have filled the policy void by developing new laws and regulations that balance market access with consumer safety. We urge you to implement a federal framework that authorizes the sale of hemp products and develops uniform standards for labeling, packaging, and testing while allowing states flexibility on more complex issues.
▶ 0:21:56In the meantime, we've taken the additional step of establishing the US Hemp Authority, the industry's self-regulating organization, which sets rigorous standards for safety, quality, and transparency across the supply chain. The hemp industry may be unique in that we are coming to Congress to ask, please regulate us. Thank you for your consideration. Chair now recognize Mr. Williams for his opening statement. Dr. Williams. Thank you, Mr.
▶ 0:22:23Chairman, ranking member, and members of the committee, thank you for inviting me to testify about the FDA today. As I was nearing the end of my career at FDA, we were working on a rule governing how dietary supplements are made. After a year of looking, my staff could find virtually no benefits.
▶ 0:22:39When I suggested to the program office that maybe we shouldn't regulate, the response was, "But Richard, we have to get these guys somewhere." So, we ended up with a regulation, not because it would make supplements any safer, but because we could start exercising control over that industry. With approaches like that, is it any wonder the FDA has lost the trust of the American people? During the course of my career, one of my employees asked me, "Who do we work for?" I thought about it.
▶ 0:23:07Well, they're FDA managers, the Health and Human Services Secretary, and the president. But then I made up a person. She's a 30-year-old widow with two kids working in a diner in the Midwest. That's who we're working for. We should only be concerned about getting results, safer food, and helping people eat more nutritious diets. Again, when I look over my 27-year career, I was saddened by the fact that we hadn't made food any safer, and American diets have gone horribly wrong.
▶ 0:23:36But we justified our regulations to say we would prevent hundreds of thousands of cases of food born disease and people would use the food labels to change their diets, preventing cancer, heart disease, and diabetes. None of that happened. FDA justifies budget increases with the same information every year, coupled with new challenges. But increased funding for FDA means more regulations, more control over the economy, and higher prices.
▶ 0:24:03I don't think people care about giving FDA more money or seeing them exercise greater control. They just want safe and healthy food. FDA never talks about the those actual outcomes as they don't want to be held accountable for failures. In fact, they fight fiercely against any notion accountability. FDA has to get the science right.
▶ 0:24:25For example, FDA ignores the biological science of evolution that shows us that tiny amounts of exposures to substances, natural and synthetic, are not harming us. In fact, when we're exposed to tiny amounts, well, well over half of all chemicals and all radiation, they not only don't harm us, they're beneficial. In addition, given the massive testing of food and colored additives, it's unlikely that that's where the significant risk are.
▶ 0:24:53FDA needs to cut out ineffective programs and regulations and going forward needs to produce far fewer regulations. Ineffective programs include things like food standards. These are recipe standards from the 1930s that ensure manufacturers are producing foods just like mother used to make. If we cut out useless programs and we have far fewer regulations, resources will be freed up to meet new challenges.
▶ 0:25:21For example, a better use of FDA resources would be to produce information that helps food producers, particularly the small ones. A good example would be letting producers know the root causes of foodborne outbreaks. The challenges are real. We need to know whether chemicals like PAS and microplastics present health risk and if so, which ones of the many varieties are actually risky.
▶ 0:25:47We also need to address food coming into this country with intentionally added poisons from some of the most powerful enemies we have ever faced. FDA must embrace new science and technology. To start with, FDA must be fully committed to precision health, including nutrition. As we are now beginning to understand that individuals respond differently to foods, that means that some national advice and even some regulations, while it may help some, will harm others.
▶ 0:26:17New technologies include that will make food safer and healthier include smart packaging that will alert consumers to spoilage, blockchain enabled tracebacks which FDA has recently begun. I'm part glad to say robotics that can produce food more safely. There are new types of treatments for pathogens for manufacturers. Better foods can be produced through genetic modification and precision fermentation.
▶ 0:26:42And finally, for nutrition, there are new monitoring technologies that will give us real time advice on what to eat based on our characteristics. FDA needs to make sure that the new technologies are safe, but also that we do not inhibit innovations that will save lives. To restore trust, FDA should be working for consumers like that mythical waitness waitress who cares about results for her family. Thank you.
▶ 0:27:12Thank you. I now recognize Mr. Softar for his opening statement and I apologize for mispronouncing that. Maybe you can uh correct my It's fine. Uh Chairman Comr, Ranking Member Subramanyam, uh distinguished members of the House Oversight and Government Reform Committee, thank you for your leadership on this issue and for inviting me today. My name is Shabir Imber Saftar. I am the executive director of the Partnership for Safe Medicines, a coalition of all members of the supply chain dedicated to protecting Americans from counterfeit medicines.
▶ 0:27:42I would like to uh you you've read my written testimony and it's long and I apologize for that, but it's very thorough. We've been doing this for over 20 years. Uh but I want to just focus my comments on just three areas today which I think are of great concern and they they focus on the the current crop of crime and patient endangerment around GLP1s or weight loss injectables. First unlicensed vendors are selling unregulated GLP1s to patients without prescriptions.
▶ 0:28:11We see these sold on e-commerce websites like Etsy uh through med spas uh which are unlicensed to often distribute prescription drugs and also um through fake onlineies selling them as peptides. Um they're often labeled as research chemicals like this one and not for human consumption. And yet pe people are being sold them with instructions to inject them anyway and they often do. We're not the only group worried about this.
▶ 0:28:37In February, 38 states attorneys general wrote to the FDA asking them to take action on these and the FBI issued a similar alert, also raising concerns about compounders using illegal ingredients in their products and illegal compounding. Second, the FDA has cited patient safety issues even with legally compounded weight loss injectables. Now, compounded medicine fills a critical need in our drug supply and makes our drug supply more resilient.
▶ 0:29:05For example, consider a medicine that commercially comes in only an oral dosage form, like a pill, and the patient has swallowing issues, perhaps because they're a child or because their swallowing abilities are compromised. In that case, a compounding pharmacy can make a liquid form and allow that patient to take the treatment. That compounded treatment while unapproved drug by the FDA is still better than skipping the treatment altogether.
▶ 0:29:30However, the FDA has been clear that these are not FDA approved and pose uh safety risks because they are not clinically tested or for safety or efficacy. But if a patient must choose between taking a needed medicine or skipping treatment, obviously you do take the medicine. But what we're seeing in compounding of GLP1s is a different situation altogether.
▶ 0:29:52Opportunistic teleaalth companies are enticing people who don't plan on using weight loss injectables to start therapy on these compounded unapproved products and GLP1s are sterile injectables and compounding sterile products is very challenging something we've actually seen from reading inspection reports by state boards of pharmacy and the FDA. On top of that, legitimate and safe ingredients for compounded medications for these medications are actually difficult to come by.
▶ 0:30:21And in every case I've seen in my experience, when things are difficult to come by, criminals step in to fill the gap. PSM recently studied freight shipments of both simaglletide and tepatide, the active ingredients and major weight loss injectables coming in as freight using the FDA imports database. And most of these were coming in from China and India, in some cases Canada. and we found multiple entering shipments that should have been denied entry uh at our ports.
▶ 0:30:48By studying that database, we found one shipment of simaglletide that claimed to be manufactured at a JW Marriott in Canada. Now, not surprisingly, we did check the FDA's registered facilities database for facilities in Canada. And that JW Marriott is not in fact an approved manufacturing site that's ever been inspected. It was refused by inspectors, which I am grateful for. But the second one was a shipment that was stated to be manufactured at a health club in Toronto, Canada.
▶ 0:31:17That shipment did actually make it through. And so it came in and we don't know where it went. I'm sure the FDA's Office of Criminal Investigation probably does. Uh but it went somewhere in the US and is destined for US patients either by a legitimate or illegitimate uh dispenser. A third bucket of GLP1s that I would like to point out are these lookalike counterfeits.
▶ 0:31:39It looks exactly like an injector pen that would come from the branded manufacturer, but it does not in fact contain the active ingredient or the right ingredient. Sometimes it even contains needles that have been compromised uh with bacteria. This is an example of a unit of fake ompic that was is not in fact ompic. The the criminals actually peeled off the label of the real product and then printed up an ompic label and put it on it.
▶ 0:32:07A very alert pharmacist in Arkansas spotted this unit and quarantined it so that it would not be given to a patient and called the investigator at the board of pharmacy. The board ofy's investigator came over and used a new tool developed by by the National Association of Boards of Pharmacy called Pulse. It's a scanner app. It's on your phone and they used that tool to make an literally under a second determination that that product was counterfeit.
▶ 0:32:34Th that quick thinking by that pharmacist and that investigator almost certainly protected patients in Arkansas and around the country because the Arkansas State Board of Pharmacy then immediately moved to suspend the license of the Florida distributor uh who was shipping it into Arkansas. So they could no longer do business in Arkansas. I am very proud of the safety of the US prescription drug supply. It's the best in the world.
▶ 0:33:00And yet, it contends with an enormous, perhaps globally record-breaking amount of criminality. And despite that, none of us have to worry about walking into a bricks mortar pharmacy and getting a safe medicine. That is something that both keeps me up at night and actually also makes me very comfortable about living in the United States. I thank you for your time and I look forward to your questions. Chair to recognize Dr.
▶ 0:33:26Make make sure you got the microphone pulled right up to you so we can hear and C-SPAN can hear. Mr. Chairman, ranking member, members of the committee. My name is Dr. David Kesler. I have worked for both Republican and Democratic presidents. I was appointed by President George HW Bush and reappointed by President Bill Clinton as commissioner of the FDA.
▶ 0:33:52We were responsible for accelerated approval, user fees, the food label, and the regulation of tobacco products. The FDA is a national resource. In January 2021, I had the privilege of returning to federal service and co-leading Operation Warp Speed. Mr.
▶ 0:34:14Chairman, I am in full agreement with you and share significant concerns about the safety and efficacy of illicit and sometimes listenit drug products originating from overseas, particularly China. As you can see from the first graph, only 4% of active pharmaceutical ingredients, that's the key components of a drug, are produced in the United States.
▶ 0:34:4680% are produced in China and India. In my opinion, for example, we have been conducting a reckless national experiment with compounded new weight loss drugs, the GLP1s.
▶ 0:35:02Based on the information I've received from the FDA, it does not appear that there is routine FDA surveillance of the GLP1s that are being imported into the United States from China for compounding to assure what is in the product. We cannot have confidence in the safety of compounded GLP-1 drugs. But that is only the tip of the iceberg. The conventional wisdom is that illicit cheap copies are coming China.
▶ 0:35:33That has changed. The more significant threat, Mr. Chairman, is that China is attempting to surpass the United States in the sciences. As shown in the next figure, the highly respected Nature Global Index reveals that eight of the top universities in terms of impactful research in the natural sciences are located in China.
▶ 0:36:01Specifically in chemistry, all 10 of the highest ranked universities are in China and only in the health sciences does the US hold the lead. Do you want China to eat our lunch when it comes to science and innovation?
▶ 0:36:20We need to recognize that China is poised to surpass us in the sciences and we need to quickly act to make the necessary investments to shore up our competitiveness and avoid putting our nation at risk. I know there are limitations um in methodology. However, the US scientists that I have spoken with increasingly see much higher quality work coming out of China. Look at the last figure.
▶ 0:36:48China is increasing investment in research and development currently at approximately $500 billion as of last year. In contrast, our investment in the NIH increased only slightly from 2004 to 2016 and is now facing cuts. Whatever needs to be fixed, let's fix it. But we need to make a marked increase in our investment.
▶ 0:37:14I was a kid and went into the sciences after Russia launched Sputnik in 1957 as a result of our country's decision to be preeeminent in the sciences. We are facing Sputnik 2.0 today. But with China, the current cuts to scientific research at the NIH and universities needs to be reversed.
▶ 0:37:38Otherwise, we are seeding the scientific primacy that Congress over the last 75 years has worked on a bipartisan basis so hard to ensure. One of the reasons we've been able to lead the world in health sciences is due to a strong FDA and its rigorous standards.
▶ 0:37:59One of my goals as commissioner was to ensure that if you needed access to a lifesaving drug and you lived in the United States, you would have access to it before anywhere anyone else in the world. We saw that with CO 19, for example, with the antibodies. Those drugs appear to have saved President Trump's life back in October 2020. Dr.
▶ 0:38:25Peter Stein's office made that drug available to the president and thousands of others. Dr. Peter Stein was removed from office in the recent rounds of cuts, as were thousands of others. It is no way to restore trust in FDA when you cut the person who may have saved the president's life. These cuts appear to me as devastating, haphazard, thoughtless, and chaotic.
▶ 0:38:55Mr. Chairman, I agree with your priorities of increased enforcement against illicit imports and counterfeits. I agree with your priority of improving the safety of our food. The cuts will the current cuts will make achieving those priorities impossible. We need to be cleareyed about the threat that China poses to American exceptionalism, especially in the sciences.
▶ 0:39:20We can't afford to be haphazard in our support of American scientific enterprise. Not when China's commitment to the sciences is more real than it has been in the past. The competition, America's real competition in the sciences is China. The administration and Congress need to understand the nature of that competitive challenge and respond strategically, thoughtfully, and with appropriate strength. Thank you, Mr. Chairman. Thank you. We'll now begin our questions.
▶ 0:39:50Chair recognizes Miss Luna from Florida. Thank you, chairman. Um, good morning everyone. I want to thank you all for being here today. But what we're dealing with isn't just about counterfeit vape pens or elicit Chinese imports. This is how the FDA, the agency that's supposed to protect the American people, has utterly failed to keep toxic chemicals out of baby formula, sunscreen, and food products being sold in stores here in America. Let me be crystal clear.
▶ 0:40:16American parents have every reason to distrust the FDA when red 40, a known dye is in their child cereals, benzene is in sunscreen, also a known carcinogen, and Chinese-owned companies are allowed to dump trash on our shelves with made in the USA slapped on it. The FDA has become a rubber stamp for big pharmaceuticals, big agriculture, and the CCP instead of looking out for the best interests of the American people. Mr.
▶ 0:40:41Safar, is benzene a no carcin carcinogen safe in any quant quantity in consumer products like sunscreen or face wash? Congresswoman, thank you for the question. PSM focuses mostly on prescription medications and entirely prescription medications and so I don't have the expertise to answer your question about sunscreen. Okay. Um, I appreciate your honesty there.
▶ 0:41:01Um, for the American people watching, so you know, benzene is a known carcinogen and the FDA is allowing products with detectable levels of benzene to remain on the market if they are generally fighting for the best interest of the American people. My question would be why are they not saying anything about this? U Mr. Safar, would you also agree that the FDA can send armed agents into Amish dairy farms, but they are not keeping toxic Chinese-made face washes out of our stores?
▶ 0:41:32Congresswoman, thank you for the question. I I neither uh work on anything related to food products or face washes, so Got it. Does anyone on the panel have an answer to that? No. Okay. Um for the for just for context, here's an article that I'd like to enter into the record, Mr. Chairman. Okay. Without objection, it's ordered. The FDA was raiding Amish farms over raw milk, which to be honest with you is pretty absurd given that the FDA's dropped the ball on many other things that are actually causing causing cancer. Mr.
▶ 0:42:02Bentley, um you talk about consumer freedom, but isn't it true that freedom based is freedom is based on informed choices? And how can parents make informed choices when the FDA has allowed known neurotoxins like red 40 in kids food without warning labels? Congresswoman, thank you so much for the question. Um, food dies is I think Make sure you got the microphone in front of your face so everybody Yeah, there you go. I beg your pardon. Thank you so much, Congresswoman.
▶ 0:42:31I appreciate the question. Um, I think the issue of red dyes is a particularly important one and I think there does need to be further research into its relative safety and to whether the FDA has taken a relaxed attitude or or and whether that these products even if there isn't a known health risk at the moment whether a precautionary tu approach should be taken into removing them from the market.
▶ 0:42:54So I think that's very up uh up for discussion and I hope uh new leadership at the FDA can look at these perhaps underexamined questions in more detail. Yeah, we'll be making those suggestions. As I'm sure you know, products based and manufactured in the UK, even in other parts of the world, are way different than American products. And just to put it in perspective, I mean, um, aside from corporate lobbying and regulatory capture, do you think that there's a reason why red 40 would be still remain in American products when it's actively banned in the rest of the world? Just if you could yes or no. Uh, no.
▶ 0:43:24Okay. Um, I would say that because of the utter incompetence being displayed by the FDA, I I I understand that you are all not the head of the FDA, but I'm going to be choosing to reintroduce um, and I'm glad that you backed me up on this one, the Do or Die Act was what I introduced in the 119th Congress to remove some of those toxics uh, toxic chemicals and dyes from our food products. Dr. Williams, you're a former FDA economist. Can you please help me understand something?
▶ 0:43:51Um, why is the FDA moving faster to approve experimental drugs for billion-dollar pharmaceutical companies than it does to ban known toxins like Uh, well, first of all, I worked in First of all, I worked in the food section of FDA, not in the drug section. So, I really can't comment on that. I will say that just real quick, does anyone have a comment for that because we are 41 seconds? Pharmaceutical, nothing. Okay, sorry. Continue. Okay.
▶ 0:44:17I will say that uh in terms of of color additives uh there's some misinformation out there. They're not banned in Europe. Actually, Europe Europeans don't care that much about having color in their foods. The other thing is is that you really have to focus on the amount of exposure. Simply saying something is a toxin or a carcinogen doesn't mean a lot. What matters is the exposure. second and I and I appreciate your position, but what I will tell you is if you have something that's known to cause autism with children, you have a young child's brain that's developing. I don't think that that's misinformation.
▶ 0:44:48I think that the American people are trusting the FDA to ensure that they don't even have to worry about the levels of additive that has something that has a known uh detrimental effect on on a child. Um either which way, why are we adding fake stuff into product that should just be naturally made? I think that that would be the biggest argument. And I would say that big food wants it to be cheaper manufactured product because it's more of a net profit for them on the back end. Look, um I'm already over time.
▶ 0:45:10I appreciate you guys being here today, but if you have anything that you can provide my office with, I would appreciate it because I think that the FDA needs an entire overhaul and I think that the FDA currently is for sale. Thanks, guys. Chair recognized Mr. Suberman. Uh thank you, Mr. Chair. Uh M Dr. Kesler, I I was uh very interested in your testimony about how these cuts are affecting um you know our food safety and really just you know our ability to have a functioning FDA.
▶ 0:45:38And so um could you just tell me a little more you know this um these firings at HHS and FDA in particular um you know we're trying to find effective strategies to bring new drugs to the market in a safe manner but an expedient manner but how how do these cuts affect our ability to do Imagine, imagine uh ranking member that you were this, you know, there was an major airline
▶ 0:46:08and that major airline today that it was going to fire everyone except the co-pilots. And it was going to run that airline and it only had the co-pilots. No pilots. The senior people gone. People who fixed the planes were gone. People who got people on the plane gone. I think that's what we're facing with these cuts.
▶ 0:46:38Imagine if you try to run this Congress and there were only congressmen and congresswoman in the building. Right? That's what's going on at FDA today. I have major concerns. we are at risk. I think we are less safe today.
▶ 0:46:59I I've talked to um farmers who talked about the outbreak of aven flu and um you know we actually had the first mal case of bird flu in the state of Virginia, the commonwealth of Virginia and my district on Monday. How would these cuts uh impact the FDA's ability to deal with the bird flu epidemic? the experts on aven flu certainly at FDA and at NIH.
▶ 0:47:30This is not just about FDA. Dr. Jeannie Morazza who was running NIA NIDA taught me everything about Aven and flu. She is no longer there. We are at risk from infectious diseases. Look, I can't tell you whether we're one mutation away or two mutations away, right? It's had devastating effects, I mean, on our animal livestock. And it gives me great concern.
▶ 0:48:00But that day is going to come and those people that we need are not there. And I'd like to enter into the record a Washington Post article entitled Worries Grow Over Risks to Americans as Trump cuts health safety agencies with without objection to order April 6th.
▶ 0:48:19And so how um would these firings at the FDA uh impact its ability to um make sure that infant formula is safe and that we we don't have another infant formula crisis? Absolutely. You're exactly right.
▶ 0:48:37what what what we heard I think from my panelists these are all complicated whether it's hemp whether um it's ecigarettes these are complicated decisions you have industries asking at this table please we need thoughtful regulations right that are balanced those people who are in charge of that policy at FDA to to be able to work through
▶ 0:49:08to get to the right answers with the Congress, even to answer your requests for information. They're not there. And you said recently, it's not too late to undo at least some of the damage that's been done. How much time do we have left before we can't fix what's been broken? And and what would you do to fix it? I always believed that things were fixable, right?
▶ 0:49:35I mean that was when I think we we we've seen that right you can always go in and fix the problem is especially in the sciences I've been the dean of two major medical schools this is about expertise this is pipeline if you we lose a generation of young people I mean young people got hit with COVID I think we can't underestimate the effect they couldn't go into their laboratories.
▶ 0:50:05They didn't they had to sacrifice their training. If we now have these cuts, right, at NIH and you know a second time they can't get jobs as postocs, we're going to lose a generation of scientists. They're going to set back this country and that's true at FDA. We've lost thousand person years of expertise in a few weeks.
▶ 0:50:29I don't think I mean if we let this go on for much longer I mean I think it's a matter of weeks I don't think I mean you know this may not be fixable this may affect us for decades thank you Dr. Kessler I yield back chair now recognizes the chairman of the uh general operations subcommittee uh Mr. Sessions from Texas Mr. Chairman thank you very much Dr. Castler, thank you for being here.
▶ 0:50:57We have had uh the former head uh of the FDA in before this committee several times. It was a purely political uh dance that he provided this committee not only on answering the people that were not going to work, the empty parking lots at FDA, people who chose to work from home, not collaborating, working with each other for four years. This happened all across government.
▶ 0:51:26And I find it uh interesting that now the argument is everybody wants to come back to work when you and I know that we disagree on that issue. Uh to the panel, I'd like to say to you, I had an opportunity this morning to look at WebMD and you may have your own ideas about the effectiveness or how WebMD works, but the bottom line is is that I'm looking at what
▶ 0:51:56might be delta 8, which is this unregulated form of hemp THC. It's called delta 8 THC. THC is an addictive product. Uh WebMD says that marijuana, which is what THC is, use over several years causes brain effects like lower IQ, slower processing speed, memory, and attention issues.
▶ 0:52:26I would direct you to this slide here where Delta 8 is involved and it's marketed in such a way that it appeals to not only adults but also to children.
▶ 0:52:43WebMD further says hemp's legality stems from the so-called federal farm bill, and I'm quoting this, the so-called farm bill, which removed hemp and its byproducts from the list of controlled substances. The reason hemp's low THC levels less than.3, which was on the bill, uh, but the bill doesn't mention delta 8 anywhere.
▶ 0:53:10And what's happened is chemists have come in and changed that viewpoint not only of the hemp which I was as the chairman of the rules committee very open to when the gentleman the young congressman former chairman uh former head of the agriculture committee in Kentucky came and asked me if I would allow this to be put into the law into the farm bill.
▶ 0:53:36And I went through a detailed explanation with him about what hemp stood for and how it might be used. I was told it was this ropes, things that are used by Americans every day, but to build the market. And he did not say anything that was wrong to me. He said what was right at the time.
▶ 0:53:58But now these so-called loopholes, chemistry, these are dangerous products that create in not only my congressional district, the sheriff in Mlinen County came to me and said, "Congressman Sessions, please go to our hospitals and look and see what is happening as a result of Delta 8.
▶ 0:54:22What's happening as a result of this hemp product that has become loaded with THC? I think what I would say to you is this. It is widely seen by many people as a dangerous product. It's dangerous not only to adults. It is very dangerous to children.
▶ 0:54:47children who don't recognize the difference between what might be a a small product, a gummy perhaps or something else and then turns into an emergency episode at an emergency room.
▶ 0:55:03I think one of the telling things is comes from a a guy whose name is Elton John, a well-known uh musician who has stated that of all the things that he's seen in his life, one of the worst things that he's seen is America and anybody else that legalizes marijuana. Marijuana is THC.
▶ 0:55:28And so, gentlemen, I will be watching you and I am interested in the hemp industry. The same reason why as chairman of the rules committee, I allowed it to be in the farm bill. But gentlemen, we've got to understand it is a dangerous product that causes IQ problems. It causes problems with slowness of adults and it causes problems that are harmful to children. Mr. Chairman, I yield back my time.
▶ 0:55:58Thank you. Uh, chair recognort from Thank you, Mr. Chair. Um, I want to show a visual here, Dr. Williams. According to the CDC, measles cases have skyrocketed during Donald Trump's time in office with 607 confirmed cases and two tragic deaths. You don't dispute that, right? You got to turn on your mic. Yep. Sorry. No, I don't dispute that. And Dr.
▶ 0:56:26Williams, you wrote that, quote, "This tragic measles outbreak is a direct consequence of spreading misleading information about vaccines, and unfortunately, Health Secretary Robert F. Kennedy Jr. has played a role in perpetuating these false claims." You wrote that, correct? No, I did not write that. That must be another Williams. Measel's outbreak. Um, RFK Jr.'s health agenda and surprising health wins. No, sir, I did not write that.
▶ 0:56:55Okay, let me let me mention this. On Sunday, Mr. Kennedy finally said the most effective way to prevent the spread of measles is the MMR vaccine, but he did not disavow false claims that many people have said were directly linked to the measles outbreak. And this obviously is something that must be addressed immediately. Correct. Yes, sir. Let me turn to my next topic.
▶ 0:57:24President Trump has put tariffs on just about everything, sending prices skyrocketing and unfortunately the stock market is plummeting right now. Mr. Bentley, you wrote that quote, "Tariffs of any kind are a direct tax on Correct. That's correct. And Mr. Safar in a February 18th Q&A at the White House, the following was asked and answered of the president. He said the question was asked of the president.
▶ 0:57:54And what about pharmaceutical tariffs? Answer. It'll be 25% and higher. You don't dispute he said that. Correct, Mr. Safar? I was not at the White House congressman, but I I'll take your word for it. Okay. Thank you. Well, look, today according to New York Times and many other periodicals, even common medicines like Tylenol and the active pharmaceutical ingredients in Advil are primarily made outside the US and are now subject to tariffs.
▶ 0:58:22Moreover, according to Forbes and ING, researchers have found that tariffs will increase the price of all generics by about $42 per drug per year. So, I come back to you, Mr. Bentley. Uh, you said tariffs in this article, tariffs aren't just a threat to the economy, they are a threat to public health. Correct. Correct, Congressman. I was talking about tariffs on ecigarettes, which would be a threat to public health because ecigarettes are a substitute for combustible cigarettes.
▶ 0:58:51And and of course, tariffs on generic drugs would also be a a threat to public health as well. Now, let me turn to you again, Mr. Bentley. Um, regarding ecigarettes. Mr. Mr. Bentley, by 2018 and 19, 20% of our kids were vaping, and the rate was doubling year-over-year, prompting Trump's then FDA commissioner, Scott Gotautle, to call it an epidemic. However, at this time in 2018, you call the situation quote, "an alleged Right.
▶ 0:59:22Correct. And today, there are over 1.6 million youth vapor. Yet, despite millions of underage users, you said recently that quote, "Claims of widespread youth vaping are disputable." You said that in this article. Correct. Correct. Because youth vaping has fallen dramatically since 2019. I assure you that the parents of the 1.6 million youth vapor don't believe that uh somehow claims of widespread youth vaping are somehow disputable.
▶ 0:59:52Now, let me turn to your other article, another article that you wrote here. You said, quote, "A question of taste, the public health case for ecigarette flavors." You believe, as the title suggests, that there is a public health case for flavored vapes, right? That's correct, Congressman. Let me just show you some of the American built, these are American sourced vapes that are on the currently.
▶ 1:00:21Strawberry Super Strudel. There's a public health case for that, right? There are 18 million adult vapors in the United States. There's a public health case for Strawberry Strudel. Yes, there is. Because most And how about how about this one? Rainbow Road. There's a public health case for Rainbow Road, right? They all need to go through FDA review to be evaluated on their public health merits, which I completely support.
▶ 1:00:43But flavors are the overwhelming choice of adults, 18 million of whom 13% of youth, according to you, 13% of youth, on page three of your statement, 13% of youth who vape site the availab availability of flavors as their reason for vaping. So hundreds of thousands of children who have never smoked are taking up vaping because of these flavors. This is sour Skittles. This is a sour Skittle vape.
▶ 1:01:10Sir, your defense of flavored vapes is completely unacceptable and endangering our youth today. Thank you and I yield back. Gentleman yields back. I'll recognize myself for for questions. Mr. Bentley, uh, tobacco is still huge crop in my congressional district. Uh, tobaca is still legal in the United States.
▶ 1:01:35The FDA collects 1.8 8 billion uh I'm actually they in 2014 the FDA collected 1.8 billion in user fees by the center for tobacco products. Uh today that number is $3.5 billion in user fees. Despite this increase FDA continues to put out unclear or incomplete guidance causing the people in the business that want to play by the rules uh to have uncertainty.
▶ 1:02:05Why can't FDA properly regulate tobacco despite charging the tobacco companies billions of dollars? Thank you for the question, Congressman, and you're exactly right. The Center for Tobacco Products, run by FDA, has collected billions of dollars in user fees, and yet we have a nicotine market that is in chaos with 90% of ecigarettes being bought on the illicit market. What can change at FDA to s resolve the problem of the illicit market is not more funding and staff but the process of approvals.
▶ 1:02:35And and just to touch on what my friend Mr. Christopher Morte said, it's my understanding that the FDA approved very few tobacco and nicotine products even though many of the products the PMTA process are safer than traditional cigarettes. Is that true? That's exactly true. So why is the FDA refusing to authorize safer products?
▶ 1:02:56Because the FDA interprets what's called the appropriate for protection of public health standard in a particularly opaque and we imagine strict way and that means fewer products by companies as you say congressman who want to play by the rules are getting to the market and I would argue with what to go along with what Mr. Christian Morte said the FDA's refusal to approve new tobacco products created a thriving market for illegal and unsafe products, the ones that uh Mr. Christian Morte was talking about from China.
▶ 1:03:26These products are targeted at children. Uh what should FDA be doing to prevent these illicit Chinese products targeting our children? FDA has set up a multi- agency task force particularly with partnership with DOJ and CBP to try and track and halt the importation of products from China. But at the end of the day, this will be nothing really more than a bandage unless its own internal processes can be reformed, which also fortunately don't require more staff or more funding.
▶ 1:03:55All right, Mr. Miller, we're going to shift gears to talk about uh hemp and hemp derivatives. so the uh Congress utilized the sale of hemp like Mr. uh Sessions was talking about and hemp derivatives are removing them from from being scheduled one substances. To what extent has FDA regulated hemp derived products like CBD? Uh they haven't.
▶ 1:04:23Uh and uh we as an industry um are are begging for that regulation. Why hasn't the FDA refused to regulate hemp and its derivatives despite having the authority to do so and despite the leading organization representing the the credible manufacturers and producers begging them to do that? Um I um uh they they've gone back and forth.
▶ 1:04:47They initially said that they were going to regulate products and then they have now claimed uh they need to have uh congressional authorization to allow them to regulate that. Uh we dispute that. Uh and uh I I do want to mention because Congressman Sessions raised that issue about youth uh youth use of of these products. We as an industry strongly oppose uh the sale of these products or the market these products to children and really are looking for the FDA's help to make sure that that doesn't happen.
▶ 1:05:16How long would it take the FDA to do something like this? I mean, what are we talking here? Well, we do we need a gazillion b bureaucrats that work from home or I mean, can can what's involved in FDA regulate this? Especially when you have the industry wanting to be regulated. So, there currently are a number of safeguards under current law that the FDA could use and has chosen not to use. They within the federal food, drug and cosmetic act.
▶ 1:05:43Uh for example, the law precludes manufacturers and distributors from selling mislabeled or adulterated products and it requires the manufacturer and sale of products consistent with good manufacturing practices. The law also requires reporting of serious adverse events and it mandates strict labeling including if FDA desires warning against the use of products by children. Finally, the FDA with the Consumer Product Safety Commission could require childproof packaging. So there's existing uh laws out there that they can take advantage of. All right, very good.
▶ 1:06:12My last question, Dr. Williams, we investigated the infant formula crisis extensively in this committee uh last Congress. Can you talk through uh quickly how the FDA failed to prevent the crisis and what needs to be done to improve competition and resilience to ensure an infam formula crisis never happens again? Yes. One of the main problems particularly with supply was that we would have manufacturers write to FDA and say we're thinking about getting into the infant formula business.
▶ 1:06:42FDA would respond with please don't. They wanted to keep the number of suppliers down to six. And they were they did that. So consequently when we had one plant that had a problem uh that actually had been uh investigated uh when it went when it had stopped production that's when we hit a huge supply problem.
▶ 1:07:01But there was one other problem and this stems from the infant formula act dating back I believe to the 80s where FDA produced a regulation that was manufact that was addressing manufacturing of infant formula good manufacturing practices. None of it in my estimation and my analysis would help infant formula at all. Nevertheless, the FDA was determined to go forward.
▶ 1:07:23The problem with that was when FDA passes regulations on infant formula that raises the price of infant formula for people who can't get it for free, what happens is less well-off consumers extend the infant formula with water. And there's nothing more dangerous than the primary source of nutrition being extended with water for infants. So that's another problem that I think FDA uh needs to be aware of. Very good. Chair recognizes Roana from California. Thank you, Mr.
▶ 1:07:54Chairman. Dr. Kesler, there's a dangerous anti-intellectualism that has become fashionable in our country today. Attack the scientist, attack the thinker, attack the academic. Vice President Vance says the universities are the enemy. He's calling an enemy the president the university where the president who appointed you went, Yale.
▶ 1:08:22Calling Harvard, where you were educated, the enemy. Calling the very university he or I studied it at, enemy. And I'm tired of politicians having this kind of false populism where they're attacking people who read, attacking people who think, attacking people who actually engage in intellectual excellence. What has been the alternative?
▶ 1:08:49Appointing people who didn't do the homework, who never read a book about economics or health sciences. We see what that's turning out to be. And I want to ask you, Dr. because because I was so concerned about the firing of Dr. Peter Marx, who has more qualifications than the entire cabinet put together, who actually did the one thing with Operation Warp Speed that was Donald Trump's contribution.
▶ 1:09:16Can you talk about how offensive it is that people far less qualified, far less knowledgeable fired this man? I don't think I could say it better, Congressman, than you just said it. I mean, go ahead. In fact, this does I mean, this feels a surreal just sitting here cuz everybody wants a stronger FDA.
▶ 1:09:46Everybody wants more regulation. Fix this. Make sure that infant formula is safe. Make sure uh that uh that drug is safe. Make sure that dietary supplement is safe. Do a better job. Go here. Go there. Make sure this import right doesn't contain any harmful products.
▶ 1:10:09But over the last several weeks, it this agency has been devastated. And Dr. Ker, I'm talking about something even deeper because I agree with you. these cuts are going to hurt people. The life-saving treatments aren't going to get uh approved. But I understand people are angry in this country. They're angry that jobs have gone offshore. They're angry that wages have stagnated.
▶ 1:10:38But what you have is politicians exploiting it in a false populism to blame anyone who thinks, to blame anyone who reads, to blame anyone who has ideas. They're attacking the smartest people in our country. and blaming them for problems that were caused by political failures. And we need politicians in this country who are going to say, "We're going to stand to defend intellectuals. We're not going to be afraid of that.
▶ 1:11:03We're going to stand to defend institutions that have led thought." You know, Lincoln called it mob rule. It's a story that goes all the way back to the to to the the Athenian mobs taking on Socrates. And I want people in our country, politicians, to stop with the false populism, to stop attacking the people who do their homework and who are leading inventions and who are leading science and leading thinking.
▶ 1:11:29Would President George Herbert Walker Bush, who actually sacrificed and fought in World War II, what would he have thought about this vice president attacking Yale? About this health secretary firing people of competence and exceptional talent? I was there sitting at graduation as a dean when President Bush came to give the commencement address. Right?
▶ 1:11:59These universities have contributed mightily to the in not only the intellectual life, right? not only to our freedoms but to our competitiveness and scientific advances have been generated by these universities. That was what this country this Congress back in the 50s and 60s set up this system.
▶ 1:12:27Van Bush right had a system that gave rise to the medicines uh that we have available today. Right? We have to be able to support that biomed infrastructure that is under attack. It needs to stop. I appreciate your service. Chair recognizes Mr. Groman from Thank you.
▶ 1:12:56I got to respond to a little bit of that. First of all, wages are stagnating. They're stagnating under the law of supply and demand. We just had a president who led 10 million people in this country. of course wages are stagnating and I I think a lot of times the business community is just fine with that. I've had businessmen complain to me, you know, uh I have to give give my workers another w uh raise here. Isn't that horrible? You know, can't we have more immigrants around here? So, we know why wages are stagnating.
▶ 1:13:25They're stagnating because of excessive immigration. Uh as far as our universities, there's no diversity of thought there. Uh my one other comment, you talk about people who think and read. In my experience, people who are skeptical of our medical community or our pharmaceutical community are the most well- readad people in my district. That's why they're skeptical. They go beyond just the the the blather you get in the mainstream media. But okay, now we got to ask ask some questions here.
▶ 1:13:55Um uh I'll ask one of you folks. It seems to me that we am I correct here? We have more pharmaceuticals per person uh prescribed consumed or whatever in this country in the world or at least more than any other western countries. You don't know. Okay, we'll try to give you another question.
▶ 1:14:21Do we have more anti-depressants consumed in this country than other countries? We don't know. Stumped again. Okay. Um Okay. Uh we'll go for Mr. Williams. Americans have been grappling with I'll digress for a second.
▶ 1:14:43As far as bringing new pharmaceuticals on the market, do you believe the pharmaceutical industry itself has a disproportionate influence in determining which drugs come on the market and which off-brand drugs are not going to be researched? Uh my expertise is in food, food safety and nutrition, not in pharmaceuticals, Well, we'll we'll give you we'll give you a food question then.
▶ 1:15:13Americans have been grappling with high inflation, especially food inflation during the Biden administration. Uh grocery prices 22%. Um would you simplify the FDA's food regulatory structure to lower prices? Could you give me some examples of what could be done? Yeah, I I I believe that is exactly what I would do.
▶ 1:15:34I think a lot of the problem with FDA's food regulations from my expertise and it really is now going on over 40 years and I continue to look at it is that too many of FDA's regulations were not being made because it was going to keep food safer or because it was going to help nutrition. A lot of it is because uh of some firms controlling FDA saying we want regulations to put our competitors at a disadvantage.
▶ 1:15:58All those regulations have to be complied with and all of those all of the all of that compliance by those firms raises prices. They don't pay for they don't pay for the regulations. This is a big misunderstanding particularly in FDA. It's consumer. Can you give me a ballpark number on which you think food prices could drop if we didn't have what I'll refer to as unnecessary regulation? I wish I had that information. I don't.
▶ 1:16:23But I think um it would certainly help and it would certainly help FDA to focus their resources to target their inspections and focus their resources on risk. Okay. Um we'll give Mr. Bentley a question or Mr. Miller. America does spend a great deal on medicine and a lot of that is on on drugs.
▶ 1:16:49Nevertheless, our life expectancy seems to be less than other developed countries. Can you comment on that? Congressman, my expertise is mostly in tobacco policy, but I will say easy way that we could increase life expectancy and reduce cancer is have more authorized safer alternatives to cigarettes onto the market, which if FDA has been stying for the last five years. Okay. Mr. Miller, you got any comments?
▶ 1:17:18I I would just add that uh when it comes to holistic uh products, products made from uh American agriculture like hemp, uh uh these give alternatives to pharmaceuticals that uh a lot of uh Americans find tremendous relief in and we should be uh promoting them, but we should also, as I've been saying, regulate them strictly. Okay. I I Mr. Bentley and Williams and uh Mr. uh fourth one down the line. One more question or one more crack at it.
▶ 1:17:49It seems to me compared to other countries that we are overmedicated and I'm not sure that it's resulting in better health. Could you comment on that? Congressman, my expertise is is not in that area, but I will say that our drug supply, which is my expertise, is probably the safest in the world. In fact, the next time you go up and pick up a prescription, you probably should buy a $2 lottery ticket.
▶ 1:18:16You're more likely to hit that than to ever get a counterfeit medicine in a pharmacy. It's it's really the pride of the world. Thank you. I'll just add to that. In fact, I think medicine has been responsible for our longevity up till now, but I think it's time to focus on prevention. Uh and I'm very glad to see that there are a number of people entering government now that are focused on prevention more than medicalizing people who are already ill. Okay. Uh before I recognize Mr.
▶ 1:18:46Infume, Mr. Christian Morte has asked for recognition of unanimous consent. Yes. Uh Mr. Chairman, thank you so much for allowing me to enter into the record by or request unanimous consent u for this article by our witness, Mr. Richard Williams. entitled Measel's Outbreak, RFK Jr.'s health agenda and surprising health wins.
▶ 1:19:10Uh from his website um and I I' I'd give the witness a chance to remember that he wrote this, but it's from your website. This is your picture. This is your article and this is your quote that I had from earlier. Without objection, ordered. Would would you give him a chance to respond or if if he wants to respond, it's up it's up to the witness. I'll go back and take a look, but uh yeah, I don't recall that one.
▶ 1:19:38We'll give you a copy of this. Okay. It's serious to deny that you wrote this article. Uh chair recognizes Mr. Infume from Thank you very much, Mr. Chairman. My thanks to the witnesses who are here I want to uh just say a couple of things that are quite obvious and then turn the attention a bit to clinical trials. Dr.
▶ 1:20:05Kesler, I'm going to start by saying I'm going to end with you because I found your comments uh to be chilling and to be uh a real warning to where we are and where we are headed if we do not heed the fact that we are making big mistakes right now every day as we dismantle the Food and Drug Administration. Um, but before I do that, let me just state the obvious, and that is that everyone, I think, uh, wants to protect the health of all Americans.
▶ 1:20:35At least everybody should. And everybody wants to root out illicit products that always find their way into our markets. And that's why ensuring the health of the FDA is so vital to this country. It's got to have the resources to protect all of us, regardless of race, ethnicity, sex, or any other designation. It's critical to public health.
▶ 1:20:58Since the FDA commissioner Marqu was sworn, McCary was sworn into uh service on April 1st, Secretary Kennedy and he have pushed out and fired as has been stated over 4,000 federal employees at FDA. And just last week, more than 800 staff at FDA's Center for Drug Evaluation and Research were also fired.
▶ 1:21:24That center in particular is responsible for approving and monitoring new medications that come onto the market for side effects and for updating drug warning labels accordingly. Those fired workers, as has been stated earlier, are some of the nation's best and brightest scientists in charge of ensuring our supply of infant formula to make sure that it's safe.
▶ 1:21:48our medications for our family members and grandparents, food for all of us and many many ways the highest quality of food safety that we can expect in this country. So to have trust in the FDA, its decisions and its ability to ensure effectiveness of the drugs that are approved uh that requires research.
▶ 1:22:14It requires clinical trials and those trials must include all American groups that may have need for the treatment. So effectiveness and safety cannot be ensured to all without the inclusion of all Americans in those clinical trials.
▶ 1:22:29Which is why I'm particularly disturbed that these mass firings at our nation's health agencies, in addition to these anti-dei efforts and similar rhetoric across this administration, will make improving the overall health of Americans much, much more difficult.
▶ 1:22:49So, it was unfortunate to see that the FDA removed previously issued draft guidance on diversity in clinical trials from its website as if to suggest that disease is racially monolithic.
▶ 1:23:05Clinical trials refute that clinical trials when they are done correctly and with diverse participants give us the ability over and over again to produce the best medications and to chart out the best courses. In this Congress, we passed several years ago something known as the Henrietta Lax Enhancing Cancer Research Act in January of 2021.
▶ 1:23:32Many of you will remember this was initially led by the former chairman of this committee, the late Elijah Cummings. And this very committee listened to testimony about why it was important. And it was many of you on this committee that joined me and others on the floor to argue for its passage and it was indeed passed. Mrs.
▶ 1:23:53Henry at Alax and her extraordinary story of her hili cells which were alive many many years after her physical death have been very instructive in terms of finding a way to create cures for diseases. Jonas Sulk will tell you that before he was able to finalize the polio vaccine he had tested against her cells long after her death to make sure that it was in fact effective.
▶ 1:24:21It's been effective in HPC vaccines and it's been effective in helping the mapping of human genomes. So we don't want to go back to the days prior to Mrs. Lax when no one wanted to talk about diversity in clinical trials and we don't want to stay where we are where we're erasing any illusion to diversity in those trials from the website of the FDA. I just don't understand it at all.
▶ 1:24:51I want to, if I might, just get your opinion, those of you who are here right now, as to whether or not you think that removing diversity from clinical trials helps the American public or advances medical science. Dr. Kesler, it's absolutely essential that our trials be done in a diverse population. There is great variability of biological response.
▶ 1:25:20I'm humbled when I look at medicines and how variable they respond in different people. It's just the nature of biology. We work very hard pharmaceutical industry, FDA, the universities to make sure that clinical trials are increasingly representative and diverse.
▶ 1:25:44If we want to understand how medicines work, if we want safe and effective medicines, clinical trials require a representative and diverse population. Mr. Chairman, if I might have an additional 15 seconds, I'd like to ask unanimous consent that we enter into the record the GEO report to congressional committees two years ago entitled cancer clinical trials.
▶ 1:26:09Without objection to order, I'd like to ask unanimous consent that we enter into the record public law 116291, which many of the members of the committee voted in favor of that created this this whole notion of more diverse clinical trials, particularly in cancer research. Without objection to and I'd like to ask unanimous consent to enter into the record uh clinical research entitled genetic variant and cardiac remodeling injury and heart failure risk in black adults.
▶ 1:26:39Without objection to ordered. Thank you. I yield back. Chair recognize Mr. Perry from Pennsylvania. Thank you, Mr. Chairman. Gentlemen, thank you for being here. The average life expectancy for Americans is 78 years despite spending more than every other western developed country which has a life expectancy of 82 years. So we're not doing so well.
▶ 1:27:026 and 10 Americans have at least one chronic disease with more than 40% of children children suffering from at least one health condition. I just I think that's astounding. Uh, Mr. Safar, as of March 31st of this year, the American Society of Health System Pharmacists list 238 drugs and shortages in shortage.
▶ 1:27:29These shortages include pharmaceuticals used to treat infections, heart failure, psychiatric conditions and cancer and include drugs such as amoxicylin, penicellin, cis platin uh and active ingredients in most regimes. As you probably know, medications taken by Americans are manufactured largely overseas and their active ingredients are overwhelmingly made in India and China.
▶ 1:27:59Can you explain to us how our dependence on foreign pharmaceuticals markets has created manufacturing delays for critical medications across the USA? Thank you, Congressman, for the question. While I am not an expert in the inspection of foreign facilities, uh it is clear that our supply chain is global at this moment and medicines come and the ingredients come from all over the place.
▶ 1:28:24Um we we are usually very pleased to see efforts to secure the supply chain and to secure uh manufacturing facilities with inspectors from the FDA and it's part of what makes our supply chain most resilient. Does do you think it's a good plan for the United States to rely so heavily on other countries, including ones that consider us their enemy, which would be the Communist Party of China?
▶ 1:28:55Well, the national security implications of that are definitely outside my expert expertise, but I think that the doctor here is probably got a better Okay, Dr. Kesler, what do you got? I'm very I agree with you 100%. I mean I was in charge of you know with my colleagues operation warp speed of sourcing for the monoconal antibodies example there we are we we are at risk as a country we are not producing in
▶ 1:29:25this country essential medicines for life-saving conditions we need to do a better job so either one of you or anybody is it because the precursors or the drugs themselves are rare and unattainable in the United States of America. If you look at the top chem top universities for chemistry today, nature index have 10 out of 10 are in China.
▶ 1:29:54But but is that because they're unavailable in the United States? You need chemists make the drug, right? Where are they training the chemist? Where is that scientific expertise? Right. We're not investing in this country in the natural sciences. So, you're saying we have the material. We don't have the knowhow. Is that what you're saying? We don't have the knowhow. We don't have the plants. We don't have the commitment.
▶ 1:30:20Do these drug shortages then enhance the proliferation of illegal knockoff drugs? Is that is a is that a cause and effect relationship? We can't get them here. So there are knockoffs produced overseas, even in our country, that are often dangerous to people in our society that think they're taking a legitimate drug. They get it on the internet or get it over the through the mail and then take it and then overdose. Is that is that a part and parcel to this?
▶ 1:30:47It is much it's a much better strategy right to have the talent the expertise and the commitment and have this those chemicals uh come from a secure supply chain right than through a lot of different unregulated sources. I mean you want to lose sleep that's what you should lose sleep about where our medicines are coming from. Mr.
▶ 1:31:15Safar, does the presence of a strong domestic compounding industry contribute to supply chain resilience and patient access at any time, but certainly during national emergencies or supply chain disruptions? Um, Congressman, thank you for the question. Yes, as I said in my opening remarks, I think that there is a critical niche role that compounding plays in our drug supply. Uh, but as the FDA has said, compounded medications are not approved and they're not tested for safety or efficacy.
▶ 1:31:44So they should be used as a last resort. But as you pointed out, if there is a medicine you need for treatment that would be dangerous to your health to delay, you should definitely take the compounded version. If the if the normal product, the FDA approved product, what you say seems to imply that they're somehow danger. Are aren't they manufactured domestically and licensed facility with oversight of state boards?
▶ 1:32:05The FDA has actually been very clear that their safety is not the same as FDA approved drugs, which would be generics or the branded products that they take a a second tier to safety. They're they're not to be used as a first line of of treatment. And that's one of the problems we're seeing is that we're seeing upstart and unknown and somewhat shady tele.
▶ 1:32:27You're not you're not conflating compounded drugs made in a facility in a licensed facility under state monitoring or oversight with ill illicit uh counterfeit drugs are you're not conflating the two are you? That's a whole no that's a whole another problem. There's three types of danger that we've seen in the GLP1 space but even a medicine made in a state board of pharmacy or FDA inspected 503b for example outsourcing facility is not an FDA approved drug.
▶ 1:32:55The FDA has given it a status of being not approved and not tested for safety or efficacy. Now, would I take it if it was that or skip my cancer treatment? I would absolutely take it, but it's not supposed to be the first line product. You don't start treatment on it. I understand. Thank you, Mr. Chairman. I yield. Before I recognize Miss Brown, I have four UC requests.
▶ 1:33:16A letter from the Alliance for Pharmacy Compounding, a letter from the Council for Responsible Nutrition, a letter from the National Association of Convenience Stores, and a statement from Peter Pittz, the president of the Center for Medicine in Public Interest. Without objection, so ordered into the record. Chair now recognizes Miss Brown from Ohio. Thank you, Mr. Chairman. Um, the Food and Drug Administration exists to protect the public.
▶ 1:33:42It makes sure the foods we eat, the medicines we take, and the cosmetics we buy are safe and effective. Before any of these products reach store shelves, the FDA carefully reviews their development, testing, manufacturing, and labeling. And the agency keeps checking even after products are approved and available to make sure they remain safe and reliable. This work is vital.
▶ 1:34:07People need to trust that the FDA is making decisions based on science and facts. Unfortunately, from day one, the Trump administration has worked to undermine that trust. RFK pushes misinformation and lies. And just last week, President Trump recklessly fired thousands of workers across the FDA.
▶ 1:34:29These hard-working individuals, many of whom have been at the agency for decades and dedicated their lives to public service, were locked out of the building with no explanation. This isn't so-called government efficiency. It's playing petty politics with the health and well-being of the American people. These mass layoffs will delay reviews for new treatments and make it harder to ensure the safety of consumer products. Dr.
▶ 1:34:57Kesler, how will these staff cuts affect the agency's ability to oversee everyday consumer items like personal care products and cosmetics? And additionally, what is the typical review timeline for those products? And how might that change with less staff? I think it endangers uh the safety of all Americans.
▶ 1:35:19I mean I am told for example that no inspectors are cut but what I hear is now the inspectors have to do all their administrative work themselves right their travel cards are restricted laboratories can't purchase the the supplies that they need. So they're they're not being used efficiently.
▶ 1:35:50They can't do their jobs. And this just makes no sense to me. I don't understand, right, what the strategy is. Why would you take the entire infrastructure of the FDA and blow it up? There you go. Thank you. The FDA plays a role in our everyday lives, right? even if we don't see it.
▶ 1:36:16In 2023, after hearing troubling reports from around the country, Congresswoman Presley and I asked the FDA to investigate the link between chemical hair straighteners often used by women of color and uterine cancer. Shortly after the FDA proposed a ban on formaldahhide in those products, but when the agency missed the deadline to ask, we followed up late last August because our communities deserve answers and action.
▶ 1:36:42Black women have long faced discrimination and scrutiny for how we wear our hair, pressuring many of us to turn to certain hair products just to meet societal expectations. But here's the truth. Many of these products are poorly regulated and pose serious health risks. Studies have shown alarming results. Most recently, consumer reports revealed that several synthetic hair braiding products used predominantly by black women contain known carcinogens. This is not just about beauty. It's about public health.
▶ 1:37:12So, let me be absolutely clear. These hair products we rely on every day are putting our health at risk. Today, we sent another letter to the FDA urging them to move forward with the banning of formaldahhide and relaxers. With that being said, doc uh Dr. Kesler, given the historical underregulation of personal care products marketed towards black women, what should the FBA be doing right now to ensure these products are thoroughly tested and safe?
▶ 1:37:40And during your time as FDA commissioner, did you encounter any barriers when it came to addressing equity and product safety? Congresswoman, I just want to applaud you and your colleagues efforts. I think the issue you have raised is an enormously important one and I applaud you for that. Thank you.
▶ 1:38:07So, I'm assuming there were some challenges there and and by your response, I'm I'm grateful for your um accolades, but I want to say this. We can't let the new administration drop the ball on something this important. So, I plan to stay engaged and hold this administration accountable. Passing laws like the Crown Act to prohibit hairbased discrimination is critical, but we also need to crack down on products that impact women's health and well-being.
▶ 1:38:38By requiring safety testing and making sure that public health research reflects the diversity of the market, we can help build a safer, healthier, and more trusted America. So, with that, I want to say thank you, and I yield back the balance of my time. Chair, now recognize Mr. Biggs from Arizona. Thank Thank you, Mr. Chairman, and thank you uh witnesses for being here today.
▶ 1:39:00As Congress looks to restore trust in the FDA and crack down on dangerous elicit products in our drug supply, it's critical that we distinguish between true public health threats and legitimate medical practices such as pharmaceutical compounding. Compounded medications, when prepared by licensed USarmacies and FDA registered outsourcing facilities, are vital part of our health care system. These drugs aren't counterfeit. They're not knockoff. They're not illicit.
▶ 1:39:25They're produced legally under rigorous oversight from state pharmacy boards and in many cases the FDA itself. These are personalized medications crafted to meet unique patient needs or to fill gaps in the drug supply such as when the FDA added semaglutide injection products OPImpic and Wiggoi to its drug shortest list drug shortage list back in March and August of 2022 prompting compoundingies to step and fill the gap. Mr. Safar told Mr.
▶ 1:39:52Perry, that compounded drugs are manufactured domestically in licensed facilities under the oversight of state boards of pharmacy and the FDA. But some narratives conflate compounded medications with counterfeit or unsafe knockoff drugs. It is true that manufacturing standards are the same for compounded outsourcing facilities in the US as those for branded pharmaceutical companies and both adhere to the good manufacturing practice system. Compounded drugs serve a critical role in maintaining access to care, particularly during times of FDA approved drug shortages.
▶ 1:40:23There was a company in my district that was able to step up dur during the FDA shortage of simaglutide injection products. The presence of a strong domestic compounding industry contributes to supply chain resilience and patient access during national emergencies or supply chain disruptions. Mr.
▶ 1:40:40Safar um your organization the partnership for safe medicines uh from 2007 to 2017 was uh was staffed or led by a guy named Scott Laganji. Is that correct? Uh I believe so. Yes. Did you follow him? I was the ex I'm the executive director that came after him. Yeah. So you when you say I believe so what you really meant to say yes of course I know that was Scott Laganja, right?
▶ 1:41:08You meant to say you knew that he was the guy that was leading your organization before you were right. I do not know the exact dates, but I know the end date was 2017 because that is when I started. So, so that's a that's a real cutesy response. And the reality is, you know, he was your immediate predecessor. I do. He is. He was. Right. And so I have a series of reports sitting right here. Before I go through with him, I just want to know, is your funding sources still the same as they were under him?
▶ 1:41:37We are funded by our members and dues from our members which is are listed on our website under right and I've I've gone to your website. I've read them. Do you get do you get money from um large pharmaceutical companies? No sir. We get money only from our members and our members are only trade associations or not forprofits. So um you're an actual company a for-profit company. You cannot uh give us money. You cannot give us provide us funding. All right. Very good. I have here now Mr.
▶ 1:42:05Chairman, I these these following items here. Uh, article called nonprofit linked to farmer lobby works to block drug imports. Nonprofit linked to farmer rolls out campaign to block drug imports without go ahead. Nonprofit linked to campaign against drug imports is deep ties to pharmaceutical research and manufacturers of America. And then, Mr. chairman. Uh I have now another one called a new report reveals it.
▶ 1:42:32It's it's a uh blowby-blow uh takedown of a report by this organization. Um it this is produced by the uh uh alliance for pharmacy compounding and it deals with uh report issued by uh Mr. Savvdar's company called new report reveals illegal ingredients for knockoff weight loss drugs flooding into US from foreign sources endangering patient safety without objection so ordered. Thank you.
▶ 1:43:01And then also I have a letter from the Alliance for Pharmacy Compounding dated April 8th, 2025 uh that was sent I believe to you Mr. Chairman. Without objection so ordered. Thank you Mr. Chairman. I do think that um attacks on compoundingarmacies by this particular organization when we're talking about whether something's a knockoff, illicit or illegal or counterfeit drug is in inapt and unfortunate.
▶ 1:43:32And Mr. Chairman, with that, I'm yield back the balance of my Chair now recognizes Miss Stanbury from New Mexico. Thank you, Mr. Chairman. I I just want to ask you a quick question. This is the oversight committee, correct? That's right. We're in the oversight committee.
▶ 1:43:52So, I I have to say I found this to be a very bizarre committee hearing because here we are in oversight and our job is to conduct oversight over the administration because of the separation of powers between Congress and the executive branch. And right now the administration is dismantling the Food and Drug Administration.
▶ 1:44:13And we are sitting here and members on both sides of the aisle are asking questions of industryfunded groups about how the FDA is going to protect public health from medicines and food. while the secretary is firing thousands of FDA employees. In fact, just this last week, they announced they were firing 3,500 members of FDA and RFK Jr.
▶ 1:44:41announced that he was going to fire 10,000 HHS employees across the entire agency. So my question is, if this is the oversight committee, why are we not conducting oversight over the administration and their mass firings and the actual deconstruction of the exact agency that's supposed to protect the public health? That is what we should be doing right now in this hearing room.
▶ 1:45:05So, I find it very bizarre that uh many of my friends across the aisle are asking uh you know how how these folks are going to protect the public health because they're not because they're dismantling and taking out the top experts who do this work. Now, some of my colleagues have already pointed out that one of the top vaccinologists not just in the United States but in the world, Dr. Peter Marx was forced to resign.
▶ 1:45:31And in a few moments, I'm going to enter his resignation letter into the record because it's instructive in his resignation. He says that for the last 13 years, he's tried to ensure the efficiency and effectiveness of the science and the public health.
▶ 1:45:47And he says it at the end of his letter, "However, it has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies. I have been trying to figure out for the last couple of weeks what exactly the end goal is inside of HHS. What exactly the end goal is inside of FDA.
▶ 1:46:16What exactly the GOP's theory of maja of make America healthy again is because today you want to take a vote on dismantling Medicaid. Your president is massfiring thousands of public health officials, including the people who make our drugs, our medications, our food, our cosmetic safety. Your president has announced yesterday that he wants to put tariffs pharmaceuticals.
▶ 1:46:46And you're going after Social Security and Medicaid by dismantling the offices and the services and programs through Doge that actually serve the people of this country. So, I don't understand it. I don't understand how this serves the public interest. Dr. Kesler, I am very grateful that you are here today. You are a legend. You are so well known across the public health space. And I know you're not currently serving in this administration.
▶ 1:47:13Uh, but help us understand the scope and the scale and why the American people need to be paying attention to what's happening inside the agency right now. 20 cents of every consumer dollar is spent on a product that FDA oversees. All our foods essentially, right, except meat in in poultry. USDA does that.
▶ 1:47:44all our drugs, oral cosmetics, our blood supply, our medical devices, our radiological uh many of our radiological uh devices, the agency is absolutely essential for safety of the American family, right?
▶ 1:48:08It's also absolutely key for our competitiveness, right? I mean, I am concerned, right, that that China's going to beat us scientifically, you know, if if we're not careful with all these cuts that are going on. But the reason I'm concerned about that, it's it's not about China, it's about the health of us. And Dr.
▶ 1:48:36Kesler, I just I want to end with this Uh as uh Vera Rosenthal was leaving uh the department after being fired by the secretary, she said people are going to die from these cuts. I am not being an alarmist. The day after they announced these mass firings and cuts, pharmaceutical prices tanked on the market. And that was before tariffs.
▶ 1:49:03And that's because the ability to get lifesaving drugs to market, the ability to save American lives, the ability to get gentle lady's time is expired to our people. Gentle lady's time is expired on having a functioning gentle lady's time is expired. I now recognize Mr. Higgins from Louisiana. The gentle lady's time is expired. The gentle lady's time is expired. But the American people, the gentle lady's time has expired.
▶ 1:49:32Miss Stanberry, Miss Stanberry, the gentle lady's time is expired. No, you're lying to the American people. I'm sorry, madam. You are lying to the American people. The American people need to understand their health is at risk and this is a emergency. Mr. Higgins from Louisiana is now recognized. It's always fascinating to witness to whailing and nashing of teeth. Is it not, gentlemen? Um, Mr.
▶ 1:50:00Williams, I'm going to be talking to you mostly, sir. Some questions and observations regarding FDA and food safety. Let's just talk about seafood for a second, please. About a year ago, we had a where members interacted mostly were not overspoken by other members.
▶ 1:50:23the members were interacted with u with our witnesses and it was it was confirmed broadly that only about one one tenth of 1% of seafood import into our country was inspected for for chemical and biological poisons. And we're talking about billions and billions of pounds of seafood coming into our country.
▶ 1:50:51It's consumed by Americans or else why is it coming here? And it and the only reason you don't get immediately sick in many cases because we cook it and it it it kills, you know, some of the some of the potential biological hazards and things, but the the chemicals and the long-term impact on cancer and neurological disorders and and serious problems can arise.
▶ 1:51:18You know, one might say, reasonable observer may say that if you're consuming billions of pounds of poisonous seafood imported into our country, somebody might get sick. Speaking to health.
▶ 1:51:34So, we believe there's been made in this arena of protecting Americans from from harmful biological and chemical elements that have been found broadly in imported seafood. Can you speak to how we're doing with that, Dr. Williams, in the past in since this year, 2025? Um, yeah.
▶ 1:51:59I I guess I could start briefly by just saying originally we had a rule on seafood called hazard analysis critical control points where we hoped that was going to make a big difference. Unfortunately the problems with seafood most of it is seafood consumed raw and I'm thinking raw oysters from the Gulf of wherever. Um uh and that's a problem because there's not much in the way you can do about that. They're taken right from the Gulf.
▶ 1:52:24they're already contaminated by the warm waters of the Gulf and when they go straight to people and eat them they are eating um in many cases dangerous pathogens. Uh there are I think one of the problems that we have with imported seafood again it's it's the problem that we have with everything is the resources that we devote to so many things at FDA that are not useful could be better uh used if we got rid of ineffective programs if we got rid of regulations that don't work so we could really focus target our inspections
▶ 1:52:54have have more resources to target our inspections on those products. Would you agree that there's that there's a high level of responsibility for the nations of origin uh to do proper inspections and their and their their procedures for farming and harvesting and packaging and shipping are in no way do they meet American standards that American producers
▶ 1:53:25are required to comply with. And yet there's they're act they're in violation of of agreements that they will perform at standards equivalent to American standards. Don't don't you believe we should enforce that? Yeah. And I think one of the problems is where are they actually coming from? So for example, I mean I can give an example in front of we've identified many many nations and they they bounce their product around.
▶ 1:53:53So exactly the question is and because I'm running out of time here, are we making progress regarding controlling poison seafood coming into our country? I really can't speak to whether or not we're actually making progress, but you're I want to agree with you. For example, if seafood says it's coming from Vietnam, for example, where I was, uh it may actually be coming from China. That's one of the things they do. They send their products through Vietnam to us.
▶ 1:54:19So I think it does make it difficult for our inspectors And it this administration, the Trump administration has been quite aggressive and I'm thankful to that to protect Americans from harmful seafood coming into our country. Um the the FDA's control over over other poisons that are that find their way into our food supply, the colored foods, etc.
▶ 1:54:45Can you just speak to that and I'll I'll allow you to answer if the chairwoman will allow. And that's the balance of my time. I don't I don't quite understand your question. Can you repeat it? The the the way the FDA will address poisons in our in our food uh to add like say brightness of color to children's cereal etc. Yeah. The the color additives these are tested particularly for carcinogens every single one of them before they come on the market.
▶ 1:55:13There still may be things that they didn't test for uh that might cause a problem but they're some of the most tested substances on earth. Um, so I think there are other issues concerned Chair now recognizes Mr. Garcia from Thank you, Mr. Chairman.
▶ 1:55:32And I want to first begin by uh thanking all of our witnesses uh for being here and for your testimony obviously for uh for all the comments that we've we've heard here um from from both sides of the aisle in the committee. Um, I do think that it's ironic that we're holding a hearing on restoring the trust in the FDA while we're ignoring the single biggest threat to public health today, which is, of course, is Donald Trump's health secretary, Robert F. Kennedy Jr.
▶ 1:56:00Now, together with Elon Musk, RFK Jr. is actively undermining the institutions that protect public health and the safety of all Americans. Now, we know that RFK Jr. already has a history of outrageous medical opinions and a dangerous antivax record. Now, let's just look at the measles alone. Before the measles vaccine, we know that measles would kill 400 to 500 American children annually. Now, after of course that vaccine was released, that number fell to almost nothing.
▶ 1:56:31But now with RFK's antivax movement growing and his dysfunction at HHS, we've seen over 600 confirmed measles cases across 22 jurisdictions. And that of course is not coincidence. We also know that this is also just the beginning.
▶ 1:56:50This committee is not serious about actually taking on the public health threat of measles, which by the way, their measles cases today is 50 times higher than we have trans athletes in college sports. Yet, they obsess about that every single day. The committee is obsessed with things that don't matter, but not the public health of actual Americans and children. By the way, children are now actually dying. And we know that, of course, that's just the beginning. RFK Jr.
▶ 1:57:17said that 5G and Wi-Fi can cause brain damage, ADHD, radiation sickness. He said that pesticides are actually turning people transgender. He's even questioned whether HIV causes AIDS. He's made comments, of course, that I'll kill nitrite, better known as poppers, the sum, is the actual cause of AIDS. He said during a campaign event that 100% of the people who died, the first thousand who had AIDS, were people who were addicted to poppers.
▶ 1:57:42In his 2021 book and 2023 interview with the New York Times and New York Magazine, he repeated claims that question the causes of AIDS despite overwhelming evidence to the contrary. In my opinion, RFK Jr. has been and will always be a tinfoil hat conspiracy theorist. He should be nowhere near anywhere near HHS medical opinion and our research in this country. Now, Dr. Dr. Kesler, I hate to have to even ask you this, but is there any serious medical evidence that HIV does not cause AIDS?
▶ 1:58:14No. Thank you. And that's exactly why these cuts by Doge and RFK Jr. to HIV research, treatment, prevention are so dangerous. Public health experts warned the actions will set us back decades. Now, despite Donald Trump's 2019 State of the Union promise to end the HIV epidemic, we've seen over 800 million in HIV research actually cut. HHS off the office of infectious disease and HIV policy has been shuttered. CDC surveillance efforts have been gutted.
▶ 1:58:42PEPAR the global fund all of course life-saving initiatives are being dismantled. Now Dr. Kesler now you led the effort to fasttrack approval for life-saving aid programs. Can you just briefly in a sentence or to explain how Doge is going after the work? I also chaired the board of the Elizabeth Glazer Pediatric AIDS you know, with uh President Bush, the son, right?
▶ 1:59:11That was I mean, the goal was to stop mother to child transmission throughout the world of HIV. It was the moral conscience of this nation, right? Global health is relies on America and that has been drastically cut. That's abs that's absolutely right, sir. And we and we also know that RFK Jr.
▶ 1:59:36while this is happening globally and here back home, he's fired 10,000 people from his agency and then claimed that that 2,000 of those was actually a mistake. So firing people, claiming they're a mistake, gutting the agency, taking away support from life-saving programs, spreading antivaccine conspiracy theories, that's what RFK Jr. right now is all about. All about these aren't just mistakes. either life or death decisions. Critical staff have been lost.
▶ 2:00:04Experts overseeing medicines, food safety, and medical devices, as we know, have been have been shut or let go. And we're incredibly concerned. I want to read this quote by former FDA Commissioner Robert Caiff. Quote, "The FDA, as we've known, is been is finished. With most of the leaders, institutional knowledge, and a deep un understanding of product development and safety no longer being employed, it is totally unacceptable that Congress is doing nothing to prevent, of course, his absolute destruction of our public health infrastructure. We need to stop this now.
▶ 2:00:34And with that, I yield back. Gentlemen, yield back. I I I just have to comment, Mr. Garcia, in all uh good faith. The the predecessor for the ranking member, Mr. uh Rascin said that uh those of us who wondered if COVID came from the lab at Wuhan, we were conspiracy theorists and that when we started suggesting that maybe former President Biden was in mental decline that uh we were conspiracy theorists and now,
▶ 2:01:04you know, there's just books coming out by all these Democratic journalists every day um saying what we we had wondered too. I'm not defending or uh trashing what you said about Robert F. Kennedy. It's just that that that you know conspiracy theories are are in the eyes of the beholder. Sir, sir, do do you think that that children should be getting the measles vaccine that children that children should be receiving the measles vaccine? I have my all my children are are And do you think they should be getting vaccinated for for COVID?
▶ 2:01:35Well, I don't I think there's a lot of questions about COVID that that we need answered, but but measles. Yes. He recognizes and again and again the the our current HHS secretary is a antivax conspiracy theorist and that is that is a fact. He caused a measles outbreak in another country that caused the the Absolutely. That that caused No, he did not. He absolutely did. RFK did not cause a measel outbreak. Green, you are an antivax.
▶ 2:02:05You're an antivax conspiracy theorist. I'm prepared. Number one choosing the fault. Mr. Chairman, am I recognized? Am I recognized? Our witnesses were snoozing, so I had to I had to spice it up a little bit. wake up. Chair recognizes Mr. Timonss from South Carolina. Thank you, Mr. Chairman.
▶ 2:02:25So, I realize that we're here to have a hearing about restoring trust in the FDA, rooting out illicit products, but I'm actually going to turn it upside down and I'm going to talk about how the FDA is not approving products that will help Americans. And so I guess normally it's good to be leaders in the world but not when it comes to obesity, not when it comes to chronic disease manage management, not when it comes to uh diabetes.
▶ 2:02:53And these are all things that I believe technology has the ability to help ameliate and and and really facilitate better outcomes. And so what I want to talk Dr. Williams is about continuous glucose monitors. I I have used them. I was in a a a test trial and it was one of the most enlightening experiences. It attached to my cell phone.
▶ 2:03:19I am not a diabetic but the information I got from um that piece of technology changed my life. It did. It changed my life. And uh the FDA has not um use of a continuous glucose monitor uh without a prescription. Well, it they just did, but you have to have type 2 diabetes who are not on insulin. Dr.
▶ 2:03:43Williams, do you believe that any American that wants to use a CGM to understand what the food that is putting in that they're putting into their body does to their to their blood glucose levels, do you think that's something that should be available to the general public? I do. I don't see any harm uh if they want that. These have been around for a very long time and the technology is uh used by millions of Americans unfortunately because they need it. They have diabetes of some kind.
▶ 2:04:10And I I I don't understand why it has taken them this long. And it's interesting because a lot of companies are using CGMs. They're marketing them. They're selling them to Americans and they're it's technically illegal uh because they were not approved. They were approved, I guess, in March of last year. But why is the FDA not approving the use of of of technology that will help improve Americans lives? I think part of the issue uh lies in medical device laws.
▶ 2:04:37Um and they are really antiquated and I researched this uh years ago. The problem is when you go to invent something, you first have you have to get it approved. It cost a lot of money and a lot of time to get approved. a lot of inventions that actually would come from physicians, they don't do it because they look at the time and the expense and having to raise money and they don't want to do it. The second problem is once you get it approved, if you think about how inventions work, think of computers, you make a computer, you find bugs in it and then you change it and you change it repeatedly.
▶ 2:05:07Medical device laws do not allow for that. Every single change you make, you have to go back to the FDA. And so that is one of the reasons I think we the we're not seeing the innovation that we should particularly on these kind of monitoring devices. The ones you're talking about are just the beginning. We need to monitor what we eat, how much we eat. We need to know everything about our biomarkers, our uh our genes, our epigenetics and everything. Put all that together and give people real time advice on what to eat. It's doable.
▶ 2:05:37Well, and hold them accountable when they don't eat eat well, when they when they treat their body poorly. So I mean diet and exercise is the answer to 95 99% of health problems. And we have a pill for everything. We have a shot for this, shot for that, pill for this, pill for that. And I think that we can use technology to create an incentive structure and possibly a disincentive structure to facilitate decisions.
▶ 2:05:58And I mean, you know, if you take the technology in an Aura ring, in a Fitbit, in a CGM, and you put it all together and you have one device that's monitoring all of that, I mean, I think that you should I think it it could then communicate with your uh health insurance company, and you'll get a a benefit in your premium if you are not spiking your blood glucose level and if you're exercising every week. This technology exists. It just needs to be put into one.
▶ 2:06:22and the the incentive structures and disincentive structures need to be placed on the free market. I mean, does that make sense? It it does make sense. And one of the things that that we see particularly in the obesity sphere is everybody wants to blame food companies for selling foods that Americans want to buy. It is a positive sum game. You want to you don't buy foods un they don't make foods unless you want to buy them. The truth of the matter is we started gaining weight in 1980. Since 1980, we have increased our calorie consumption.
▶ 2:06:52This is individuals eating more by 400 calories a day. That can lead to a lot of weight. So part of it is we have to look at ourselves. We're we're eating too much and maybe some of that's because people are eating out more and the and the portion sizes are bigger. But that's one of the things that again these devices can help with that. They can tell us maybe what to eat and how much to eat. Again, I've had a scale for six years and it records my weight every morning. And that's another variable that we could put into the algorithm that determines the premium of your health insurance. If you're gaining weight, you need to pay more.
▶ 2:07:22If you're eating poorly and you're not sleeping, these are all things that factor into your health and uh can be used in underwriting. I'm out of time, Mr. Chairman. With that, I yield back. Thank you. Gentleman yields back. Chair recognized Mr. Frost from Florida. Thank you, Mr. Chair. This past month, the FDA reported 15 food and drug recalls. That's about a recall every 48 hours. It was even higher in January and February. And uh many of these recalls were very serious.
▶ 2:07:46They refer things like food crosscontamination, cancercausing arsenic, um, and lead, which can cause severe learning disabilities in children and miscarriages in adults. The past month also saw pet foods contaminated with bird flu. While these recalls save lives when folks are alerted in time, they also cost can cost working families time and money to replace recalled food. You know, this year tuna was recalled. That's about $3 per can down the drain.
▶ 2:08:15Prepared salads were recalled, another five bucks each. Frozen dinners were recalled, four, five, six bucks a serving. These numbers might seem small, but folks managing a family budget know how grocery costs add up um and what a waste it is to throw out food. Dr. Kesler, how does the work of the FDA's labs and inspectors help catch problems before bad food hits the grocery stores? The laboratories are absolutely essential at that detection.
▶ 2:08:44Four FDA laboratories, two food labs, two medical products labs have been shut. Those recalls that are absolutely essential, the people who communicate about those recalls, the communication shops have been gutted. the, you know, Trump and Musk claimed that the mass layoffs at the VA and the Social Security Administration wouldn't impact the services, but we're seeing that's not true.
▶ 2:09:15Um, services for veterans, seniors across the entire country are getting worse. Wait times are at all-time highs. Now, Trump and RFK Jr. are claiming that the mass layoffs at the FDA won't negatively impact food inspections. Dr. Kesler, how could mass layoffs at the FBA FDA impact food inspections? It will have a real in demonstrable effect.
▶ 2:09:39Yes, the the inspectors have not been touched as of today from what I can tell, but all their support, all their infrastructure is gone. So, all those inspectors can't get the supplies they need to inspect. They can't they have to do their own travel. They travel cards are not working. I'm not sure what the strategy is.
▶ 2:10:06And what does this mean for Americans vulnerability to serious food born I fear that we are less safe today. You know, I wish that were not the case, but you can't take thousands of people out of the FDA and not understand that you're putting the American people at risk. You know, I'm one of the 33 million Americans living with potentially life-threatening food allergies.
▶ 2:10:37Um, they I' I've almost died actually because of anaphylactic attack. Uh, Dr. Kesler, how could cuts to the FDA impact day-to-day safety of folks like me who live with serious food allergies? the the people who communicate, who share that information, who share that risk information, the people who write the policies that give the industry the guidance of what to put on the labels.
▶ 2:11:05They're not there anymore. Say we're lucky and these mass layoffs have no, you know, impact at the FDA um with undercovering uh potential foodborne disease outbreaks before they spread. How will cuts to FDA staff impact the people who are still there, their ability to alert the public to the threat of allergen crosscontamination or an E.oli outbreak?
▶ 2:11:30I think the effect of these cuts not only on the people who've left, you know, and and I'm hearing story repeat stories, I mean about, you know, how these were done, when they were done, right? I mean the the the real careless, almost mean aspects of how these this information was communicated.
▶ 2:12:00But people are getting up people who have enormous expertise, tens decades of expertise on those kind of questions, on those allergies. you know, they're they're not they're not staying at the energy and recruitment, getting the best and the brightest, something that we all believed in, that we dedicated our careers to be able to go into these agencies and and provide that kind of service.
▶ 2:12:29What signal is that sending? We're losing generations of future public servants, and that concerns me greatly. Thank you. I yield back. Chair recognizes Baron Donalds from Florida. Thank you, chairman. In 2019, President Trump warned of the horrible consequences of the Chinese Communist Party filling the void if Americans could not find federally approved tobacco products.
▶ 2:12:53To date, the Food and Drug Administration has only approved 34 vapor products despite millions of applications submitted to the Center for Tobacco Products. The disastrous Biden administration instead allowed illegal Chinese vape products to control more than half the market. This is one of the such products. This is lost Mary flavor is ginger beer. Mr.
▶ 2:13:19Bentley, does the American consumer know what the contents of this Chinese vape are? Congressman, thank you for the question. And obviously for that particular vape, I can't speak to its ingredients, but typically most vape products do have to register and register their ingredients if they are going to submit a pre-market tobacco application form in order to get FDA authorization.
▶ 2:13:43But you highlight the important point which is that millions of these products from American companies who manufacture for instance the e-liquids that smokers looking to switch away from deadly cigarettes want to use. Those American companies have been denied authorization for their products and instead elicit companies who often change their registration, can change their name, change the ingredients, are unaccountable to the FDA, have have managed to fill the void.
▶ 2:14:11So now 18 million adult vapors, exactly as you point out, do not know what they're getting, and the FDA has lost control of the market completely unnecessarily. Does the FDA even have a multi- agency task force to combat the sale of elicit vapes? The FDA last year did in collaboration with DOJ and CBP and other agencies set up a multi- agency task force to try and get a grip on the illicit market.
▶ 2:14:38But unfortunately, that's FDA passing the buck to other agencies already overstretched like DOJ and CBP when the solution for them, which wouldn't need any more staff, wouldn't require any more funding, is to change how they evaluate how to authorize these products in the first place.
▶ 2:14:56They can do it quicker and better as other countries such as the United Kingdom, Canada, New Zealand, Germany, France, all of these countries have tens of thousands of authorized ecigarette products with no problem with mass levels of, for instance, youth vaping that we all want to reduce. So, it is possible for FDA to change its practices and get the products that will save millions of Americans from smoking by switching it to a safer alternative. Let me ask you a let me ask you a follow-up question to that.
▶ 2:15:24Um, was the Biden administration aware of the numerous instances of illicit products that were showcased in the presence of FDA personnel at trade shows around the country? I cannot speak to what the Biden administration may or may not have been aware of, but it was widely known that this was a developing problem.
▶ 2:15:41Indeed, it was predictable and predicted that the minute you take off millions of products from the market for which there is high demand and that we must remember are dramatically safer than combustible cigarettes, then somebody is going to supply those 18 million adult consumers with those products. Well, listen, to be clear, I'm not against Americans who want to use uh vaping products or tobacco products.
▶ 2:16:06I think it is important for the American people to understand that the previous administration did not do the job of making sure that there were products on the shelf where they could clearly understand what they were consuming or ingesting. And then you have products like this that have hit the shelves in the United States primarily because the previous administration was derelct in their duty and making sure that they were make that they were approving applications of companies in America who could supply the demand from the American consumer. With that, Mr.
▶ 2:16:36Chairman, I yield back. Madam Chairman, I yield back. The the gentleman yields. I now recognize Miss Lee from Pennsylvania for five minutes. Thank you, Madam Chair. Um, I think it's insulting that Republicans have set this hearing on restoring trust to the FDA while they're wholeheartedly backing Trump and RFK Junior's efforts to dismantle the agency.
▶ 2:17:03We used to do bipartisan work with the FDA, so why are Republicans politicizing it now? None of the actions taken have done anything to improve the health or safety of Americans. If RK Jr. and Trump cared about things like protecting the public from unsafe medications. They wouldn't have illegally fired people responsible for making sure that the drugs that we actually that the drugs we take are actually safe and effective.
▶ 2:17:30They wouldn't have fired an estimated 170 people from FDA's Office of Inspections and Investigations, which inspects factories to make sure the pharmaceutical companies aren't cutting corners. They wouldn't have fired the people and closed the labs that make sure our medicines are safe from contamination. They wouldn't have fired the people in the offices that check to make sure that drug companies aren't making false claims in their ads. They wouldn't have forced out Dr.
▶ 2:17:58Peter Marx, FDA's top vaccine regulator, uh, while measles is killing kids. You know, the same disease we have a 97% effective vaccine for and damn near eradicated. Dr. Kesler, looking back at some of the very events members of both sides of this committee did work on, like the infant formula contamination and shortage, um how much worse could it have been if the FDA was short thousands of workers at that time?
▶ 2:18:26These are very challenging problems. It took a lot of dedicated people working with both sides of the aisle on any of these. I've been there in these kind of crisis moments. A and and I fear that that infrastructure, the ability to handle those challenging problems, we've now gutted the agency. Mr.
▶ 2:18:55Chairman, excuse me, Madam Chair, I'd like to enter into the record an article titled FDA planning for fewer food and drug inspections due to layoffs, officials say. Madam Chair, without objection. So ordered. Thank you. Dr. Kesler, what is the worst case scenario that could result from FDA's plan cuts to drug inspections? Is there anything that keeps you up at night around that? I think that's a yes. Then I mean people will die. Excuse me.
▶ 2:19:25You want to know the worst thing? Yes, please. Go back 1938. We forget the the founding of the agency, right? sulfanylamide the 38 act congress acted death there were deaths in children because adulterants ended up in those medicines because we didn't have the inspection system we didn't have the pre-approval system we have we've developed the most sophisticated system right so when you take a medicine today I mean what it says on the label
▶ 2:19:55is actually what's in the product that's taken an enormous effort by the congress over the last hundred years working with dedicated ated scientists and public servants. Why are we putting that at Yeah, I thank you for your cander.
▶ 2:20:12uh even as you you know hesitated to to start I think it's important that we speak frankly and and plainly while we are watching what can or will be a catastrophe if we do not change course before the mess we're currently in the FDA have been working with other agencies to prevent the spread of counterfeit and contaminated drugs coming in illegally are being made locally by people who would rather make a profit uh than make sure people have safe act uh safe medications. Dr.
▶ 2:20:38Are you at all confident that the FDA can continue to do important work like that with the thousands of firings uh that Trump and RFK have initiated? I am not confident that that can can continue. Congresswoman, just last week, Trump and RFK Jr. also fired more than 800 staff from FDA Center for Drug Evaluation and Research, which monitors medications for side effects and short and shortages, among other things. Dr.
▶ 2:21:02counselors, do these cuts raise the risk that people might suddenly find themselves without access to the medicines they need? I think that's a real risk. Thank you. My Republican colleagues want to sit here and pretend that everything is fine and that somehow the FDA is actually better under the Trump administration.
▶ 2:21:22But just look at the fact that none of the witnesses the Republicans invited here today represent patients, healthcare provide pro providers, scientists, parents, or any of the rest of us who stand to lose from these firings at the FDA. Nobody in this country should have to show up at a pharmacy wondering if their blood pressure medication or their insulin is going to be in stock today. It's truly ridiculous. and a tragedy that we have arrived at this point. To quote Dr.
▶ 2:21:47Markx in his resignation letter to the FDA, quote, "It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies." Thank you, and I yield back. The gentle lady yields. I now uh recognize Mr. Berles from Missouri for five minutes. Thank you, Madam Chair, and thank you to all of our witnesses for joining us today to confront the pressing crisis at the FDA.
▶ 2:22:13For too long, this agency has faltered, leaving hundreds of products approvals stalled. for years at times. While illicit vapes and counterfeit drugs from China flood our communities unchecked, the FDA's inaction has handed the Chinese Communist Party an open door to pedal dangerous knockoffs threatening our kids and our sick. All while safer options languish under red tape. It's not complicated. Fix the FDA.
▶ 2:22:44fix their sluggish process and ramp up enforcement and stop letting the Chinese Communist Party profit off of poisoning our Um, Mr. Safar, um, can you discuss the recent incidents of counterfeit drugs, particularly the GOP ones um that are that are flooding the market, the counterfeit ones?
▶ 2:23:07Yes, and thank you for the question, Congressman, a fellow We are seeing dangers to patients in three different areas that in the GLP-1 space that are very concerning. There's lookalike counterfeits. It's a pen that maybe was an insulin pen where a criminal has pulled off a label and rewrapped it with an ompic label, for example, and then sold it to an unsuspecting pharmacy. Just discovered one of those in Arkansas at the end of last year.
▶ 2:23:35Clever and attentive pharmacist caught it and quarantined it so that it wouldn't reach a patient. Second category is we're seeing enormous quantity because how did that get in the hands of the pharmacist? So surely they their supply chain is more reliable than that. The pharmacist was defrauded.
▶ 2:23:54Uh what happened was there is a distributor in Florida who had obtained uh units of these counterfeit uh products and had obtained a license to distribute some products in Arkansas. It's not clear exactly what kind of distribution license they had. and they shipped it into Arkansas. So, the pharmacist thought they were dealing with a licensed distributor who was licensed by their state board of pharmacy.
▶ 2:24:18And not until it showed up and the pharmacist had reason to suspect it was the pharmacist able to say, "Okay, I know they have a license, but let me set that aside and call the inspector." and the inspector from the Arkansas State Board of Pharmacy came over and used a new tool we have because of the Drug Supply Chain Security Act called Pulse made by the National Association of Boards of Pharmacy and scanned it and that barcode in under a second detected that OEMIC as counterfeit and the board of pharmacy then moved immediately to suspend
▶ 2:24:48the license of the Florida distributor. Okay, it's a real great story of patient Second category is we're seeing uh criminals selling illegal research grade pharmaceutical ingredients to Americans and they're doing it through illegal foreign fake onlineies and even sometimes on e-commerce sites like Etsy. We've captured images of research only Etsy on Etsy. People are buying Yes.
▶ 2:25:16Unfortunately, I can even show you an example ad of what this looks like. And they're often labeled not for human consumption, but when you get them, there are instructions to inject yourself with them. And people are in fact doing that. That's crazy. It is crazy. The third thing is one we just uh we just did a study about, which is freight shipments of simaglletide and trespide ingredients coming into the US that were not made in any FDA inspected facility.
▶ 2:25:42And because they're freight, they have to actually come with a bill of lighting that states the manufacturing location. And we found 179 shipments that were declared in in facilities that are not FDA inspected. Uh, for example, a a high school in Toronto, a gym in Toronto, uh, and JW Marriott in Vancouver. None of these, I checked, none of these are actually FDA inspected facilities. And yet, in some cases, they were let in.
▶ 2:26:09And so one of the improvements we would like to see uh from this next commissioner would be to actually refuse those based upon the bill of lighting to show because if you know that that's not a FDA inspected registered facility, there's no reason to even let it be shipped to the US. There's no reason to have to turn it around here when you know it's not going to be any better when it arrives. Yeah, I've limited time, but I want to talk about the FDA's process of approvals.
▶ 2:26:35It's reportedly holding approvals for numerous generic drugs uh even drugs that have shortages of about 238 drugs as of March of this year. How does this how is what's the impact of of this? So the drug approval process is actually not my specialty. I'm going to defer to my fellow witness Dr. Kesler. Mr.
▶ 2:27:01generic drugs are an absolutely essential part of what American families uh rely on. We need and FDA has a responsibility to make sure we have all have access to, you know, safe and effective generic drugs. But I'm concerned that that's got that requires The gentleman's out of time. Thank you. I yield back. I now recognize Miss Crockett from Texas for five minutes. Thank you so much, Madam Chair.
▶ 2:27:29Are we tired of winning yet? We are hugely winning. We have the best of the best. Right. Wrong. That was sarcasm if you didn't catch it. Um the fact is we should never have partisan politics playing a role when we're talking about something such as science.
▶ 2:27:52But unfortunately in today's times, Democrats believe in scientists and experts and data and Republicans instead believe in conspiracy theorists. And right now, that is who we have leading one of the most important agencies in this country is a conspiracy theorist, not someone who has an actual resume to get the job done.
▶ 2:28:17So, why would anyone trust the Republicans on anything, let alone matters of public health and safety? It has taken Texas largest measles outbreak in 30 years with more than 500 confirmed cases and the death of two children for the Secretary of the Department of Health and Human Services to say what we already knew. The most effective way to prevent the spread of measles is the MMR vaccine.
▶ 2:28:44This is the same guy who chaired the antivax nonprofit Children's Health Defense. Just last month, during an interview with Fox News, he suggested that somehow being infected with measles could provide protection against cancer and heart disease. The Republicans are implementing the most dangerous public health agenda in modern American history, and people are literally dying as a result. This administration doesn't believe in science.
▶ 2:29:10They're firing thousands of scientists and public health officials who keep our food and medicine safe. Slashing funding for scientific agencies that help cities and states respond to public health emergencies, limiting public access to research and data that contradicts their misinformation. They're using financial threats to manipulate which studies the government will sponsor, and blocking researchers from diversifying clinical trials.
▶ 2:29:36This reckless and chaotic approach will make it more difficult for the FDA to achieve its mission of protecting the public health of Americans. But there are two issues that I want to address before my time expires. Staffing at FDA has long been a challenge. The Government Accountability Office has identified several challenges at FDA as high-risk issues. One of the bigger issues the GAO has identified as FDA's extensive workload.
▶ 2:30:03Last Congress, the Senate held a hearing on the sale of unauthorized and illegal vaping products and ecigarettes. During the hearing, Dr. Brian King, director of FDA's Center for Tobacco Products, testified that the volume of pre-market tobacco product applications is overwhelming. So FDA is instead prioritizing its enforcement responsibilities when it comes to ecigarettes products.
▶ 2:30:28But just last week, Trump not only fired the director of FDA's tobacco center, he closed two entire offices responsible for drafting new tobacco regulations and setting policies. Dr. Kesler in its 2025 high-risk report, GAO stated that quote, "Stable, senior FDA, and center leadership remains of vital importance to the agency.
▶ 2:30:52How will this vacuum of leadership impact the public health and safety of Americans?" will put Americans at risk. But you, Congresswoman, you raised a very, very point. I'm the only pediatrician on this panel today, right? And your constituents, please, the most important thing is what you said.
▶ 2:31:20If you want to prevent measles, please have your vaccinated against that very dangerous disease. Thank you so much for that, Doc. And I only got 56 seconds and I don't know if I'm going to go through my last question because you just I'm looking at Greg to see if he gonna make me do it. Listen, I I'm I'mma go off instead. Um, sorry.
▶ 2:31:46I appreciate the fact that you are an expert in this and here's the reality. Um the Republicans and definitely MAGA loves to troll me in so many ways. Um and the reality is that I trust and believe experts. I don't believe that I know everything. I believe that I was elected by my constituents to make sure that I could keep them safe in all ways.
▶ 2:32:11Making sure that they are not going to be victimized if they have say family members that are serving abroad because of signal gate because of that incompetence. Making sure that they have access to vaccines if they need it. Making sure that they can actually provide for their family because we have real economists that are the gentle lady's time is expired. We are inad tariff war. Gentle lady's time is expired. I now recognize Mr. Fallon from Texas for five minutes. Madam Chair, thank you very much.
▶ 2:32:41You know, a year ago, we held a hearing uh on the FDA and at that hearing I had the graphic behind me and I I I'm I'm perplexed as to why things haven't changed.
▶ 2:32:58So, I want I'm so glad that you all are here and I I really appreciate it because uh according to the law, there's supposed to be uh uh pre-marketed tobacco product applications supposed to be processed within 180 days. But unfortunately, the rolling average has been 3 years. And we bring this to light a year ago and it doesn't seem like anything has changed.
▶ 2:33:22This is a picture from uh a shop couple miles from where we are right now and it's littered with illegal smuggled Chinese vaping products. Uh and so my it I would ra I don't want anybody to vape and I don't want anybody to smoke, but it's their choice.
▶ 2:33:44And yet we I if if they're going to vape, I want them to vape with a product that's Americanmade, preferably that also went through a regulatory process. Not we don't know. This is the wild west. It doesn't make much sense. Mr. Bentley, what happens uh let's say if the FDA actually discovered because I want to focus more on enforcement because nothing has seemed to change. Uh what happens if the FDA becomes aware of this shop and they're selling uh illegal products?
▶ 2:34:13The FDA, thank you, Congressman, for the question. The FDA can issue warning letters distributors. It can also institute civil money penalties. What do they typically do when they find this? What's the first often there will be warning letters about a sharply worded rebuke? I agree, Congressman. It is absolutely nothing of a deterrent to selling elillicit products.
▶ 2:34:36And that is why the what how FDA has left the door open here by making its own regulatory processes so complicated that as you suggest that American companies who want to do their best to tell what is in the ingredients to sell products that are safer than cigarettes. Those smaller companies have not been able to get through FDA review. So other actors will jump into the um into the void to be because there's a demand. That's exactly correct. Prohibition did not work in this country in the 20s, did it? Absolutely not. No. Okay.
▶ 2:35:06So, they send a sharply worded letter, which no, everyone will ignore and not care about, and they're going to continue to sell. At what level do they typically at least confiscate? Now, I uh would not have the precise level of how much of the illicit market has been confiscated. I would assume it to be somewhere in the Dominous region as you demonstrate there.
▶ 2:35:29This is just a few miles from this building and um FDA and a few miles from FDA's White Oaks campus and the illicit market is still rampant. But so it's not typical that once they discover it, they don't even just take it. They they don't seize. No. What that that's amazing to me. Uh and I like that word dimminimus. I'm going to have to put that in my vocabulary particularly with a British accent. Sounds delicious. Uh Dr.
▶ 2:35:55Williams, when did the uh American food So, I don't know if you know this answer, but I'm curious. When did we switch from mainly sugar to fructose uh high fructose corn syrup? Well, interestingly, we haven't actually switched. For example, the uh the the colas um uh back when I was at FDA, what we found out was they would look at the relative prices of high fructose corn syrup and sugar, and depending on the relative prices, they might put more sugar and less HFC.
▶ 2:36:22Well, when did fruit when when did the corn syrup enter the food supply in large uh quantities? I'm not sure about that. I think it was in the 70s. I just think it's Do you know happen to know, Dr. Kesler? It was actually in the 40s and 50s, but you're right, Congressman. It didn't increase. Do you think, Dr. Kesler, that that was uh one of the contributing factors to Americans uh general problem with obesity? Yeah. Yeah.
▶ 2:36:45Um and it is just one of those things that uh I think we need to discuss more is preventative and not you know we spend more on healthcare than any country uh per capita in the world. I believe uh but if we're preventative you don't get sick in the first place. It's a heck of a lot better for the individual and for the country because you don't have that expense there is an enormous opportunity to make inroads in chronic disease.
▶ 2:37:09Congressman, as you're saying that, and I'd be I'd love to be able to spend time discussing that with you. Thank you. Uh thank you to the witnesses. Thank you, Madam Chair. I'll yield back. The gentleman yields. I now recognize Mr. Bell from Missouri for five minutes. Thank you, Madam Chair, and ranking member. And thank you to the witnesses for being here. When I came to Congress, I made a commitment that public health and public safety would be at the core of my work.
▶ 2:37:37That mission becomes harder when agencies like the a FDA face disruption, especially from actions like those recently taken by Doge. Last month, Doge abruptly announced it was cancelling leases for 30 FDA field offices, including a critical 52,000 square foot drug testing facility in my district of St. Louis.
▶ 2:38:04Described by former officials as the most important FDA drug testing lab in the country, this lab exposed cancer risks in the drug Zantac and just last month triggered a recall of acne treatments with dangerous levels of benzene. Though Doge and HHS reversed the decision days later, the damage was done.
▶ 2:38:30And so we must ask, are we putting the public at risk by undermining the FDA's ability to do its job? Are we creating conditions that allow unsafe or ineffective drugs into the US market? The FDA plays a vital role in protecting public health from food and medicines to medical devices. A key part of that is safeguarding the integrity of our drug supply.
▶ 2:38:59But right now, that work is under threat. Due to staffing cuts, the FDA has frozen the pilot program for foreign drug inspections and is planning to reduce both food and drug inspections. Just last week, 800 employees were cut from FDA's Center for Drug Evaluation and Research, or Cedar.
▶ 2:39:21Cutting Cedar staff will almost certainly slow the approval of new drugs and generic alternatives which working families defend depend on to afford prescriptions. Dr. Kesler, even if no food or drug inspectors were directly fired, how does a reduction in the Office of Inspections and Investigations impact FDA's ability to conduct inspections?
▶ 2:39:48It has a great uh impact and I just me congressman that laboratory in St. Louis it's one of the great laboratories in the world. It has enormous specialty expertise and can detect things that no one else can detect. But there are other laboratories that work more on a more routine basis that check on surveillance of imports. Four of those laboratories were closed. Right?
▶ 2:40:16That means more uh problematic problem products come into the United States. We need to have a robust uh laboratory system to detect illicit and harmful products. And Dr. Kesler, how will losing 800 staff affect Cedar's ability to approve new medications, especially timely affordable generics?
▶ 2:40:40Those uh those officials were the officials who communicated with the public who came up with creative solutions to the problems we've been discussing and those people they they support that's the infrastructure that supports the people who are looking at the applications. So what you're going to see is you're going to see increasing delays, right?
▶ 2:41:05things that we worked hard over the last 20 years to eliminate those delays are going to manifest. And Dr. Kesler, will fewer drug inspections make FDA better or worse at catching counterfeit or contaminated drugs? It's going to make people less safe. And and quickly, what is the time? What is the cost difference between brandame and generic prescriptions? And how would delays in generics affect working families?
▶ 2:41:34We all rely on generic drugs. I work very hard to make available life-saving medicines. But if people can't get access to them, if they can't afford them, right, what good is all that effort? Generic drugs are a very important part of the pharmaceutical armamentarium in this country. The Trump administration claims these cuts are to make America healthy again, but they will do the opposite.
▶ 2:42:01President Trump and Secretary Kennedy are slashing critical FDA functions, while Republicans in Congress aim to redirect taxpayer dollars into tax cuts for the wealthy. The result, Americans will wait longer for cheaper medications, and it will be harder to trust that our food and drugs are safe. That's the last thing working families need right now. Thank you, and I yield back. The gentleman yields. I now recognize Mr. Burchett from Tennessee for 5 minutes.
▶ 2:42:32Thank you, chair lady. Um, this is a question. These are some questions that I'm what I'm trying to do is separate hemp from marijuana. All right. And there seems to be a lot of confusion in that realm. Um, especially when I walk into one of our hemp stores in East Tennessee when they see me walk in there. Um, Mr. Miller. Now, do you support hemp products that contain intoxicating cannibids?
▶ 2:43:02Uh, we we support uh any product that has uh uh less than.3% delta 9 THC, which is the measurement. Some of those products do indeed uh cause impairment. Uh uh but at the same time, we feel very strongly that they need to be strictly regulated and most importantly kept out of the hands of children. Okay?
▶ 2:43:22because doctors at East Tennessee Children's Hospital where I spent a lot of quality time in my formative years during my evil conval phase as I called it um and and this is hospital in my district East Tennessee Children's Hospital they've reported that 56 newborns and over 30 kids have been exposed um or as they say poisoned by THC products. Is that ring is that sound right to you?
▶ 2:43:49I I don't know the numbers, but there certainly is is a real problem given the lack of of regulation and uh you know really the point of my testimony is that we need to get the FDA engaged particularly to get these products out of the hands of children. I guess I'm just worried because kids are ending up at the hospital and there just seems to be uh the public needs to be educated on this issue and I and I'm not seeing a lot of that. It just seems the rules and regulations are kind of all over the place. Yeah.
▶ 2:44:17know, I know Tennessee has been making a a strong effort to uh try to regulate these products. Uh my home state of Kentucky has as well. Uh again, we uh have uh we feel very strongly that uh um adult products are when when taken responsibly by adults are are a good uh health and wellness alternative. Uh but uh we have got to keep these out of the hands of kids and uh we need help. Uh uh we do our self-regulation as an industry.
▶ 2:44:44our our US hemp authority uh helps crack down uh internally, but only if we get uh the federal government uh working with the states will we ensure that this problem goes away. And I've talked to several people, some in this room actually, that um support the legalization of marijuana but do not support it in the hands of children.
▶ 2:45:04And I'm wondering um how are we expected to trust y'all if if you condone the sale of these things like Delta 8? Well, we we condone we do not condone the sale of products like that to kids. Uh that's uh 100%. Delta 8 uh uh is a product that many adults uh use and and swear by for their own health and wellness.
▶ 2:45:34And uh as long as the products are regulated and made sure there's uh no contaminants, make sure they're labeled properly and again make sure they're kept out of the hands of children, they can be a healthy alternative for for adults. But but you're absolutely right. Uh it is a real problem. These products are dangerous for kids and we're trying to do as much as we can as an industry, but we really need government regulation to crack down on it.
▶ 2:45:56Is it true that compounded drugs are manufactured domestically under the o oversight of the FDA or state boards? Does anybody care to answer that? Jump in there. Well, uh, thank you for the the question, Congressman. They are, but the FDA applies a a different safety label to them than they do the branded or generic drugs.
▶ 2:46:22They're marked as FDA unapproved drugs and they are not guaranteed for safety or efficacy. So while they provide an important niche part of our drug supply to make it resilient, they're to you they're only used as a last resort.
▶ 2:46:38But the one of the key questions is those compounding pharmacies may be mixing the final ingredients, but where are they getting their ingredients from and some of those ingredients that API what's a I know what API stands for know the rest of the committee does.
▶ 2:46:58So you you'll explain already pharmaceutical ingredient that first chart that I showed 80% of our API is coming from either China or India approximately. So that's my concern about the compounding. Where is the raw material coming from? Okay. Um well that was I guess the followup to that was um we've got some compounding pharmacies in our area as we do every other area.
▶ 2:47:28Um and I worry that some the vast majority of them are doing the right thing but I'm afraid some of them could be doing some folks some ill will. So thank y'all. I've run out of time. Thank you chair lady for your indulgence. Thank you ma'am. The gentleman's time is expired. I now recognize Miss Presley from Massachusetts. Thank you.
▶ 2:47:52For decades, a known carcinogen for meldahhide has been allowed to seep into chemical hair straighteners, especially those marketed uh to black women and girls. Uh these products are advertised as tools for beauty and self-expression. But uh to be clear, they are contributing uh to a public health crisis.
▶ 2:48:10This is not dissimilar from um the link that has been drawn between u talc and talcum powder uh baby powder Johnson and Johnson and uh a number of of black women who similarly suffered from um ovarian cancer um because of that link. Uh three in five black women use these products and according to the National Institutes of Health they face a 31% higher risk of breast cancer.
▶ 2:48:37These women are also twice at risk of developing uterine cancer compared to those who do not use these chemical straighteners. And it's not just impacting consumers. Salon workers are regularly subjected to the constant inhalation of these chemicals. They disproportionately face asthma, burns, and long-term illnesses. Despite this clear and present danger, the manufacturers of these products continue to sell them. This isn't a coincidence. This is exploitation. This is profits over people.
▶ 2:49:06In March 2023, I led a letter with Congresswoman Shantel Brown urging the FDA to ban fldahhide from chemical hair straighteners. The FDA proposed a ban that was scheduled for implementation under the Biden administration. Most recently, Trump froze all new regulations, leaving this rule in limbo. Dr. Kesler, the FDA's mission is to safeguard public health.
▶ 2:49:32Do you believe indefinitely delaying rules that have undergone rigorous research pose significant health risks to the public? Yes or no? I I believe that poses significant risks, Congresswoman. Okay. Um I agree. And the science has not changed and the harms are still real and everpresent. Dr.
▶ 2:49:55Kesler or public health rules that have been made that have made four public health rules that have made their way through the regulatory process in the previous administration. What should the current FDA commissioner be doing? One of the most dedicated public servants, the chief science officer took on the responsibility recently uh for cosmetics, right?
▶ 2:50:21because cosmetics was always the least resourced, the least regulated. And congressman, I applaud again your bringing this up. This has been a real issue. But Mji bumpers I mean left the agency because she didn't think it was a place she could work anymore and that concerns me. Concerns me as well. Thank you.
▶ 2:50:45In fact, just this morning, Congresswoman Shantel Brown and Nidia of Velasquez and I sent a letter urging Commissioner McCary to act. There have already been some states like Maryland, California, and Washington that have banned forldahhide from these products. But while these states have acted, they cannot solve the nationwide problem.
▶ 2:51:06It's clear that we need federal action to protect every woman, every worker, and every person who uses these products, regardless of where they live. In the courts, thousands of women have filed federal lawsuits against the manufacturers of these hair straighteners, alleging that their products have caused uterine cancer, breast cancer, and other devastating health outcomes.
▶ 2:51:32These lawsuits are not just legal are not just legal cases. They represent the lived experiences of women who have been harmed by this industry. They are mothers, daughters, sisters, and they deserve justice. It's well past time we take forldahhide off the market. We cannot wait another month, another year, or listen to another excuse. It's time to ban forldlahhide.
▶ 2:51:59Thank you, and I The gentle lady yields. I now recognize Mr. Magcguire from Virginia for five minutes. Thank you, Madam Chair, and thank you for our witnesses for being here today. You know, I was listening to the discussions going back and forth today, and many of you uh said that there were dangerous ingredients in not just cosmetics, but our foods and other places. And I believe I heard testimony that many of these dangerous chemicals are coming from China. Is that correct?
▶ 2:52:32Yes, Congressman. Yes. Correct. Agreed. So, if these dangerous chemicals are are harming the American people and they're coming from China, how do they get into our country, would it be the cartels?
▶ 2:52:49Congressman, in the case of illicit tobacco products and ecigarettes, whilst the market is um underregulated because FDA has choked off the supply of authorized legal ecigarettes, we do not know for some products what is contained in them. However, I would also make a caveat that might differ from from some other industries.
▶ 2:53:10Almost every ecigarette currently being sold or on the market, even if it is illicit, is probably still dramatically safer than a combustible cigarette and actually can provide a public health benefit. Is it getting here through the cartels? Uh, it can get in terms of ecigarettes, they're most mostly from China, not from uh the south of the border. I understand they're made in China, but they've got to come across the border somehow. How do they get across the border?
▶ 2:53:35They get they get across the border because these products can be sold by uh ecigarette distributors that can ship them in. They have tracking numbers that FDA can track so-called STMs. So that's how they get into the border through ports of entry. Some however are obviously not monitored and even outside of that regulatory system. Okay, Mr. Miller, what do you know on this? U I know I know very little. We we've heard uh reports that uh uh Chinese made uh purely synthetic canabonoids.
▶ 2:54:04So these are uh products that are made completely out of a lab and not uh come from nature at all. We hear that uh uh they may be coming through the country but uh again because there isn't this regulatory uh uh federal regulatory structure. We just don't have details and and and are unaware of of of the this the scope of their impact. All right. Uh Mr. Dr. Yeah, I'm I'm not aware of exactly how these things are coming in. One thing I am aware of though is fentanyl was just the start.
▶ 2:54:33They're creating things that are much, much more dangerous than fentanyl. That's right. And well, I got to tell you, fentanyl is the one we know about, but you're right. I've heard there are different color versions of these drugs that are even more dangerous. Congressman, we uh we have studied the routes by which illegal ingredients for knockoff weight loss medications have come into the country.
▶ 2:54:53And they come in both in freight and I testified before and my written testimony has some explanation of the report that we did where we studied uh these these ingredients that came in through freight and there's reforms that we could do to prevent that. But you're right, they primarily came from China and then India as a second uh and then these products also come in through back because of time. Dr. Kel, do you have any knowledge of how they get here?
▶ 2:55:18In December uh 2019, there was a decision unfortunately by the administration if you talk about ecigarettes not to regulate in the disposables and that opened the door. So what I would say is uh many of these drugs do come in from the cartels. Now this administration, thank God we got President Trump wanting to return manufacturer of drugs back to the US and the border has been shut down for the most part. I mean we still got a lot of work to do.
▶ 2:55:47There's still certainly a threat, but that means less fentanyl, for example, is coming in. You think a 100,000 people a year being killed or from fentanyl overdose, overdose epidemic, we should be jumping up and down and making a lot of noise. So, not only we stopping the fentanyl, we're stopping the flow of a lot of these other chemicals that are poisoning the American people. Now, earlier you guys talked about uh high fructose corn syrup being a danger to the obesity issue in our country. Mr. Williams, what about um what about trans fats?
▶ 2:56:16How big a deal is that? Well, it's interesting. Um, originally, um, trans fatty acids came on because there was a concern about animal fats. Nobody said, "What's the replacement? If we take, if we don't use animal fats, what are we going to use?" Nobody thought about the replacement as so h often happens in these decisions. They never think about the substitute. So, we got trans fatty acids, which were much more dangerous for heart disease than animal fats. Now, it seems like we're going back. The concern is seed oils.
▶ 2:56:43So, let's get rid of How do we have Crisco on the label says zero grams, zero trans fats per serving when it has trans fats in it? Yeah. I How does that make sense? I I don't know about Krisco. Oh, well, certainly an issue. But, but the issue is is that before you make these decisions, you to take something off the market, you have to know what's going to replace it. Definitely. Well, I'm glad we're bringing supply chains and drug manufacturing in America to save our people. Thank you.
▶ 2:57:10I yield Uh the gentleman yields. I I just want to clarify something that's been said. Uh there's an enormous difference between statelicicensed compoundingies compounding drugs on FDA's shortage list and illegal drug manufacturers making counterfeit drugs that they sell on Tik Tok. Uh we must root out illegal drug manufacturers while ensure pharmacies have the ability to respond to drug shortages. Just wanted to clear that up.
▶ 2:57:39Uh I now recognize myself uh for five minutes for for questioning and I'm going to speak on behalf of a community of people that here in America that largely get ignored on an extremely important issue and that's the issue of vaccines. And while we're talking about the FDA losing the trust of Americans, there's a very important reason why for that. And um I I have to recognize autism rates.
▶ 2:58:09Now, anytime you mess with people's children, this this is getting to the heart of a family. And you know, in the 1980s, one to four out of every 10,000 individuals had autism. 20 years ago it was 1 in 150 and just recently the rate has been said to be 1 in 36.
▶ 2:58:40But today there was a study um uh that just came out of 12 million children ages 5 to 8 and it has been released uh by the children's health defense that the autism rate is now 1 in 33. I mean we are talking about something that cannot be ignored anymore. This is a crisis and we are people are losing their children.
▶ 2:59:03They're watching their children go from being happy, active, babbling, growing, reaching milestones to completely disappearing. Completely disappearing. And parents over and over and over again point to vaccines and they are they are called conspiracy theorists. They're dismissed and they are completely ignored. And this cannot be ignored anymore. This is a crisis and we are losing our children and this cannot be allowed.
▶ 2:59:32Let's talk about another reason why the FDA has lost all trust from Americans and we can talk about the co vaccines. Emergency use authorization was given for these vaccines and the FDA took a pro approximately 21 days to give it for the Fiser Biioentech mRNA vaccine. Madna it the emergency youth author authorization was given in 18 days.
▶ 3:00:0218 days and then for Johnson and Johnson it was given in 23 days. Now this comes after typically vaccine development approval takes 10 to 15 years but for these vaccines for covid it was given the the emergency use was given in a matter of days and then full approval was given in months. Now what has been the result of that? Another thing and people that have been ignored. These are the these are the VE's reports.
▶ 3:00:32Now 1,662,426 VA's reports and it is listed here that there are 38,541 deaths, 156527,000 urgent care, 17,913 Bell's palsy, 5,175 miscarriages,
▶ 3:01:0422,247 heart attacks, 28,98 myocarditis, 77,311 permanently disabled. And these are people reporting themselves and no one seems to give a damn. And this is why the people do not trust the FDA along with the myriad of reasons that has been given today. And it's it's unbelievable.
▶ 3:01:33And at the time, medicines that have been trusted for years like Ivormectin, one of the safest drugs, was called horsepaste and has been one of the best effective treatments against COVID. Now, Mr. Kesler, did you object when Dr. Marx forced out the two top vaccine scientists at the FDA, Mr. Gruber and Dr. Dr. Gruber and Dr.
▶ 3:02:01Krauss due to their opposition of mandating booster shots. Did you object to that? I had enormous respect. Did you object? Yes or no? Yes or no? I have a little time left. Yes or no? No. But madam chairman, may I respect? You did not object. I had enormous respect for Dr. Marks.
▶ 3:02:25Well, I'm glad that you do, but you didn't object to him being removed when he said that booster shots should not be mandated and people that have been vaccinated with CO 19 are the people that keep getting COVID 19 and the people with the booster shots keep spreading and getting CO 19. No, this is my time where people like me with natural immunity don't get it and don't spread it around. Madam Chair, may I please? No, this is my time, Dr.
▶ 3:02:53Kesler and my time has expired. So I I now recognize uh the ranking me. Oh, Mr. Men has made it. I now recognize Mr. Men from California for 5 minutes. Um I'd like to hear Dr. Kesler's response to that last question. Thank you so much, M. Congressman.
▶ 3:03:12I I am a pediatrician here and it just is very important to state there is no scientific link between vaccines and autism respectfully on the issue on vees you know when you VAS is an open system and you have to look and ask the question you have to apply scientific principles selection bias things like that.
▶ 3:03:42Bradford Hill, you're there. Congressman, please. You facts are facts, data is data, and uh a a random website is not necessarily the best way to get any kind of real data. And we all understand, Dr. Kessle, the importance of peer review, don't we? Ex. Exactly. We have to we have to the the issue just because you see a reaction in a database, you have to ask whether there's causation. There are certain Bradford Hill principles that have to be applied and they were not being applied.
▶ 3:04:09And it's unfortunate right now that science is being rejected by people going on Google, going on, you know, websites of dubious origin to try to find their own information. We should all be concerned about that. So I want to address first I want to thank the chair and the ranking member for holding this hearing on the FDA. Um it is as we know the gold standard in the world for drug and medical product regulation. Its critical work has included the regulation and approval of a wide range of products ranging from the drugs we consume to the infant formulas that we feed our children.
▶ 3:04:39and of course plays a crucial role in cracking down on counterfeit med medical products and drugs. Uh that is why I believe the FDA should be fully funded and independent. It is absolutely essential particularly today to ensure a safe supply chain and that our products that we consume for our health have been properly reviewed for market.
▶ 3:04:58Now, under the leadership, quote unquote, of uh current HHS Secretary Kennedy and uh Donald Trump, the greater public health apparatus is in the process of firing thousands of workers at HHS, NIH, and the FDA. FDA has seen or proposals to slash 20% of its workforce, including 170 of those from the Office of Inspections and Investigations. And I just want to note that when we talk about efficiency, that's a word that gets thrown around a lot.
▶ 3:05:28We have to actually talk about what we mean when we talk about efficiency. What is the time frame we're looking at? What are the goals and parameters we want? If I want to lose weight, the fastest way to do that is maybe just cut off my leg. That is not an efficient way if you're thinking beyond the immediate term. And one can argue that the cuts to FDA are having a similar effect. In particular, I want to talk about the uh the effects on the drug approval pipeline. And so my understanding, Dr. Dr. Kessler, I think you're in a position to answer this.
▶ 3:05:56That uh I've been told by a lot of the life sciences companies that I represent in Orange County, California, that those many of those drug approval people are actually paid for by user fees. Is that your understanding? The Cedar has uh resources uh that are paid for by user fees, but that does not guarantee that the application of course will be approved. That's not the point. It just makes sure that there are people there who can re view them.
▶ 3:06:22And so I I think the point I would like to make here is that uh by cutting these people by uh terminating staff you are uh creating potentially a much longer pipeline for drug approval, product approval. Uh that is something that a lot of the companies I represent including uh companies like Edwards Life Sciences and Massimo. Uh some of the pharmaceutical companies I represent are very concerned that they're going to see much longer approval processes. And again, these are positions that are paid for out of the user fees. They actually don't cost the taxpayer anything.
▶ 3:06:51And so when we look at efficiency beyond the anything but the immediate term, these these cuts look very counterproductive, uh they look like they're going to have massive negative economic impacts on our communities, on the drug pipeline. And so I guess for you, Dr. Kesler, I just want to go back to you. How do you think drug approval times may be affected by cutting a blanket cut of 20% of the workforce? I think that drug approval times will increase, but most importantly, important medicines that we will depend on for our families. those.
▶ 3:07:21That's what I care about. That's right. Life-saving medications are not going to get approved now. Or it'll take longer to approve. I I hope not. There are still dedicated people, but I fear that those delays are going to happen. And when we talk about efficiency, I just want to note another thing that's happening right now. Uh the attacks on immigrants, particularly in higher education, uh the cuts to NIH are having massive impacts on universities around the country, including UC Irvine, which I represent. Uh they're very worried.
▶ 3:07:49I know that many of the immigrants that are researching potentially groundbreaking uh efforts in in new life sciences uh products and drugs uh that they many of them are going back to their countries of origin. They're going to other countries and other top research institutions. Uh I just want to ask them as my last question, Dr. Kesler, if you can speak about the administration's immigration actions and how you anticipate they might affect our our our life sciences industry here in the United States.
▶ 3:08:14Our competitiveness was enhanced by those people coming to universities in your district. They made America great. Exactly. And now we are the gentleman's time. Thank you. I yield In closing, I want to thank our witnesses once again for their testimony today. I now yield to ranking member Sue Brahman for his closing remarks. Thank you, Madam Chair. Uh, first I'd like to enter into the record some articles without objection. Without objection, so ordered.
▶ 3:08:43LA Times article February 13th, Trump assault on science will make Americans dumber and sicker. Washington Post article from April 2nd, veterinarians working on bird flu, pet safety are fired and HHS purge. Article from April 3rd in the New York Times, FDA layoffs could raise drug costs. An Axio article from April 3rd, drug industry worries about FDA delays. And Washington Post article from April 6, worries grow over risks to Americans as Trump cuts health safety agency.
▶ 3:09:10Finally, an Axius article from yesterday titled FDA cuts threaten medical product review programs. Without objection, so ordered. Thank you, Madam Chair. We've heard today about the need to make sure our infant formulas and drugs are safe and affordable, about the need to prevent youth vaping, the need to stop elicit products from getting to kids, and even the desire to have the FDA approved things faster. But as our experts here today said, we can't accomplish any of this without the scientists, researchers, and staff in place.
▶ 3:09:38And these are the people the administration has started firing thousands of people at the FDA. Uh someone said that running the FDA after these firings is like flying a plane with only a co-pilot. I think it's like flying a plane with only a flight attendant. Uh the it's such a difficult task already and now you're firing many of the people who make it happen. And the title of this hearing is rooting out elicit products, but the very offices in charge of keeping us safe and healthy have been gutted. And the foremost experts on rooting out elicit products are being fired. We're worried about products coming into our country across the border.
▶ 3:10:08But 170 people were fired at the Office of Inspections and Investigations. And because of that, now the agency will have to quote rep prioritize their workload for the rest of the year, which would mean less surveillance, less inspections, and more products that are illicit or bad for our health coming across the border. We actually need more inspectors, 16% more according to the GAO. And all this is going to do is make it harder for the inspectors who are still here to do their job. But it doesn't end there.
▶ 3:10:36The administration is also stopping the work of childhood lead poisoning prevention branch. This is those are the people who are making sure that our children don't get lead poisoning. And just earlier this year, lead paint was found in school buildings of a 68,000 student school district in Milwaukee. The school district called this lead poisoning prevention branch for advice. And they were getting advice up until last Tuesday. But now the people who are giving them advice have been fired.
▶ 3:11:02And as a dad of two girls, five and three, I can only imagine what's going through the minds of the parents in Milwaukee. And so, you know, this administration is also cutting food testing labs in California, one that tests for contaminants and baby food and for aven flu and other products. And so, America has to lead the world in science, innovation, scientific discovery, technological advancements.
▶ 3:11:26And the American people deserve to live in a country where we can trust what's in our food, what's in our medications and what's in our products. But cutting science funding and gutting the FDA, causing chaos throughout the agency is going to make every American man, woman, and child less safe, less healthy, and the administration, if they don't reverse course, people will die. I yield Uh the gentleman yields. I I now recognize myself for closing remarks.
▶ 3:11:54The good news, ladies and gentlemen, the American people are not going to die under President Trump and his great administration because the goal is to make America great again. And as uh our new administration is getting in place, we have to talk about things that previously happened under the Biden administration.
▶ 3:12:13things like the failures with infant formula where mothers were desperately seeking formula for their children and were blocked from ordering safe formulas from overseas. That was a complete failure. I can't believe that any time in our country mothers could not find infant formula um on the grocery store aisles and were blocked from getting formula that they much needed for their babies.
▶ 3:12:41We can also talk about how the FDA is is uh bans raw milk which is ridiculous. Raw milk is sold in countries all over the world. Countries like England, New Zealand, France, Italy, Germany, Norway, Sweden, Finland, and Denmark. Raw milk is uh has been here since the beginning of time. And many Americans not only produce raw milk, they'd also like to sell it.
▶ 3:13:07and many consumers would like to be able to buy it, but the FDA has declared war on anything natural and good and and while it allows many chemicals to be brought in into America, put in our foods and distributed all over the country, no wonder obesity is at all-time highs. No wonder Americans are sicker than most people around the world.
▶ 3:13:32The FDA's a failure to approve new nicotine products, which are safer than cigarettes, has spawned a massive and dangerous illegal market of Chinese vapes. No one trusts many of the products, especially anything laden with chemicals coming from China because China, after all, has been murdering Americans for years now. And Americans are dying every single day from fentanyl that comes in our country.
▶ 3:14:00And if China wants to be serious about tariffs and its treatment and unfair treatment against America, the first step they should do is stop sending fentanyl in our country and poisoning our people. The FDA has failed to effectively uh regulate hemp derived products which the industry themselves desperately wants to be regulated and we heard that in testimony today.
▶ 3:14:28The FDA has the authority to crack down on counterfeit drugs which come primarily from China and infiltrate our legitimate drug supply chain endangering American lives. And we heard our witnesses today talk about how we cannot trust China to give us lifesaving medications.
▶ 3:14:49President Trump's recent executive order ending the dimminious package exemption for low value imports will bolster bolster FDA's ability to restrict the flow of illicit products from China. And I think that's a great thing for every single American no matter how they vote and how they feel about the current president of the United States. The reality today is it is very sad that Americans don't trust the FDA.
▶ 3:15:18And I will reiterate again for the the many millions and millions of Americans who are still angry and want accountability and they deserve it for being forced to take a vaccine they should have never have been forced to take. And all the Americans that suffer from side effects and lost loved ones from a vaccine that should lose its FDA approval. And I'm saying that that is my own opinion.
▶ 3:15:44I believe that the FDA approval of COVID vaccines should be revoked and it they should be taken off the childhood vaccine schedule. Children don't need a COVID vaccine. Children were were one of the healthiest and had the lowest hospitalization rates and deaths during COVID. After all, our kids are resilient and they shouldn't be forced and be injected with manufactured vaccines that their parents disagree with.
▶ 3:16:14I thank everyone uh for for tuning into this hearing today. I thank our witnesses for being here and thank you for your testimony. With that and without objection, all members have five legislative days within which to submit materials and additional written questions for the witnesses which will be forwarded to the witnesses. If there is no further business, without objection, the committee stands adjourned. Thank you. Thank you. Thank you. Thank you. Thank you.