▶ 0:06:30Chair Scott: The U.S. senate on the aging will now come to order. This country has a big drug problem. America's drug supply is not secured and american patients are in danger result. -- as a result. 91% of prescriptions in the united states are for generic drugs and many older americans rely on one or more medications.
▶ 0:06:56Chair Scott: This congress has worked closely with ranking member gillibrand to do everything it can to ensure older americans have access to healthy and quality drugs. We've sent a letter to the f.d.a. Asking took foreign inspections and the quality of drugs coming into our country.
▶ 0:07:21Chair Scott: We wrote letters to groups purchasing organizations and distributors and farm issues asking where they source their drugs and information about low will have quality generics. First we held a hearing on the quality problems with foreign generics on communist china and india for drugs. We fooled that up with solutions on how to bring drug manufacturing back to the united states threaten we heard from american drug manufacturers on the problems they face.
▶ 0:07:52Chair Scott: This january we held a hearing where I was proud to announce no clear members act with ranking member gillibrand, a bipartisan bill that would require many manufacturers to disclose where they're manufactures. You know where your car is made, where the food too of today in you eat is from but not where your drugs come from. That doesn't make any sense.
▶ 0:08:19Chair Scott: I encourage all members of this committee to co-sponsor this bill. Last year we brought fromsters of experts from communist china to show how our overreliance on foreign drugs was no accident but by washington, D.C. officials chewing profits over patients. Today we want to focus on the harm these low will have quality drugs are harming.
▶ 0:08:47Chair Scott: Generic drugs made in india have 54% more adverse effects than equivalent drugs made in the U.S. that means americans and their family members are ending up in the hospital, potentially even dying. This should never happen in our country.
▶ 0:09:10Chair Scott: In 2008, contaminated hem religion from common cyst china killed nearly 100 americans. This was life-saving place these people needed and it till killed them. How aboutly was killed because reliance on communist china.
▶ 0:09:36Chair Scott: Those drugs never should have made it into our country but there are sadly too many stories like this. In 2003 contaminated eyedrops from india injured dozens and blinded some. This should never have happened. Under the current framework.
▶ 0:10:05Chair Scott: We cannot rely on drugs from independenca to be the same quality. The bottom line is foreign matchererrings are not being head to the same standards as domestic mastererers. This lets bad actors cut corners. Parents' leavings are on the line. Here in the U.S., the f.d.a.
▶ 0:10:33Chair Scott: Doesn't announce when it goes to a manufacturerring facility but overseas the majority are preannounced so they can clean up any problems they have. Inspections alone can't solve this problem. The f.d.a relies on masterererring to submit data on an honor system. They know this and are taking advantage of the oversight. We saw this in 2018.
▶ 0:11:06Chair Scott: Sued the department for $500,000 falsifying katya. The f.d.a cannot trust manufacturers to be honest brokenners. Brokers. Congress needs to look at solutions to conduct oversight of foreign mastererers. The katya shows us the equivalent are not the case. This is why testing drugs for quality is so, so important.
▶ 0:11:34Chair Scott: Here in march, rose mayor gibson talked about the department of war's drugs. Of 13 medicines tested. 15% were found to have serious manufacturing defects including containing toxins, core sin generals and not dissolving property. These are not isolated incidence from communist china. This problem is systemic.
▶ 0:12:04Chair Scott: Congress needs to do everything we can to bring manufacturing back here. Simply, a country that cannot provide for itself cannot protect itself and it cannot remain safe. America is too great a country to be as vulnerable as we are on this matter.
▶ 0:12:23Chair Scott: When american manufacturing has an option, we must turn to proven manufactureerers. Not adversaries and bad actors. I hope today we can bring attention to this. We have a great witness panel here today. They can speak to these long-standing quality issues with foreign generics.
▶ 0:12:50Chair Scott: I'd like to turn it over to ranking member gillibrand for her opening state.
▶ 0:12:57Sen. Gillibrand: Thank you, chairman scott. Thank you if all our witnesses. I'm looking forward to continuing this conversation on how we can continue the reliability of our medication supply chains. These are vulnerable who disruption and we are putting ourselves in an increasingly perilous position.
▶ 0:13:22Sen. Gillibrand: Underlying market factors in the united states have led to a royce to the bottom where insent activitieses for mastererers are solely based on cost, not quality. Congress must empower the f.d.a to conduct rigorous oversight to make sure foreign mastererers comply with all safety standards and move woo from cost being the only incentives in purchasing.
▶ 0:13:52Sen. Gillibrand: We must expand testing of these drugs and ingredients. There have been many recommendations made before this committee on how to ensure the drugs that enter the U.S. market are high quality. This includes legislation like our bipartisan clear labels agent or proposals to expand supply chain mapping.
▶ 0:14:16Sen. Gillibrand: I'm thrill that there's so much bipartisan interest on this and I look forward to working with chairman scott and other members to solve these problems. Thank you.
▶ 0:14:30Chair Scott: I want to thank senator gillibrand. The low quality general rigs ricks are harming everyday americans. I'd like to thank them for being here today to discuss their experiences and how we can stop sub standard foreign drugs from greg our market. Lisa salberg knows firsthand what is at stake when drug quality fails.
▶ 0:15:01Chair Scott: Living with a transplanted heart she depends on her medication to survive. When she was switched to a sub standard generic that was ineffective, it nearly cost alberto herrera life. Thankfully she was able to figure out it was the medication causing her problems before it was studio late. She an she is an advocate for transparency and quality.
▶ 0:15:28Chair Scott: I want to thank you for being here and please tell your story.
▶ 0:15:38Ms. Salberg: Thank you for the opportunity to be here today. Many many of this is my literal heart that has been transplanted. I bet that's a first. We think we're saving money but we may be harming more than helping.
▶ 0:16:06Ms. Salberg: I was lying thosed with hyper I was lying thosed with hy hypertrophic cardiomyopathy. My of it affected me and my sister passed away from it. In 2017 I got austrians plant. I sheaved a donor heart from a woman named brandy and we are a perfect match.
▶ 0:16:34Ms. Salberg: She has helped me regain nearly perfect health. In 1995 after I lost my sister I founded testament hypertrophic card omyopathy center. We've aided this drug discovery, advance diagnostics.
▶ 0:17:06Ms. Salberg: I've pucklished journals, written three books. I'm not a physician. M.I.a. Patient at have cat. My first experience with generic drugs, what I thought was a personal anomaly has revealed its to be a systematic failure were patients nationwide. First time was 1996. I was taking beta blockers to lower my heart rate.
▶ 0:17:38Ms. Salberg: After two doses it wasn't coming down. I went back to the name brand and thought this was a name brand. Later said, lisa, we need to talk. I think I know why there's a problem. It wasn't a me thing, it's a we think. In 2017 I got of.net my transplant. Prescribed a drug to prevent rejection. My insurance was not covering a name brand.
▶ 0:18:06Ms. Salberg: Forcing me to generics and some tricky territory. My condition is managed by managings your levels. My target is 6 1/2 to 7 1/2. I remained on one mastererer as best I could but shortages and eventually that one was taken off the market.
▶ 0:18:29Ms. Salberg: I take my fragile veins to at lot of draws of blood and a lot of expense for that. Sometimes it went too high. When it's too low and I'm open to rejection, there are no symptoms. So now I pay $120 per dose of my main brand because I can't trust generics.
▶ 0:18:57Ms. Salberg: My life literally depends upon it. Patients report to me daily emergency room visits, missed work, deteriorating health and we do the work and find that they've changed their manufacturer of a drug and let's go back to the other one. There is no accountability, no transparency and no recourse for patients in these situations.
▶ 0:19:22Ms. Salberg: 80% of our general rick drugs come into this country through three different providers or purchasers. What do we do to fix it? I'm going to urge all of you to pursue concrete codified reforms to modernize our drug system and to hold manufacturers and decision makers accountable. The basis is he said rexman. We have to make sure that they require disillusion rates.
▶ 0:19:52Ms. Salberg: That's been the problem in all ofmy bad drugs, theless disillusion rate is wrong. Weapon cannot send red-labeled drugs out to patients. We need to use independent laboratory testing. The red-yellow-green you've heard about. This system works and we should be doing this more trance parentsly.
▶ 0:20:18Ms. Salberg: And I would hope the f.d.a would publish a site where all of those results are made public. We do not allow anybody to take red medication. And we need to refuse low-quality drugs from greg the united states and hold bad actor responsible the first time, not after decades. I support the pharmaceutical act. I'll let my friends explain and I applaud you on the clear label act.
▶ 0:20:47Ms. Salberg: However, I think we need to pair it with payer level reform so patients can actually take arcs on the information on the label. Good actors, if they get green scores, they shouldn't be burp defend with extra views.
▶ 0:21:08Ms. Salberg: Poor quality manufacturers must be held accountable and lastly I agrees with doctors kellerman and absolutely moon when they said that the f.d.a should stop claiming that all generic duction sold in the united states are equally effective and safe. It cannot verify that without testing. Thank you.
▶ 0:21:38Sen. Gillibrand: Thank you. I want to introduce our next witness, Dr. adam clark-joseph. He's the founder of valisure, a technology company working to address a critical gap in the pharmaceutical supply chain. Dr.
▶ 0:21:56Sen. Gillibrand: Clark clark was driven to founding valisure by his personal experience with significant complications arising from batch variety in his anti-con as a rule isn't a medication. He utilizes his expertise as a digital chemist to employ big data and machine learning for enhance enhancing transparency in the pharmaceutical supply chain. You may begin.
▶ 0:22:29Dr. Clark-Joseph: Thank you for the honor of speaking to you today. I've taken medicine for depression for most of my adult life. I first encountered a bad batch when I was 25. At 27, it happened again. And then at 29, yet another incident.
▶ 0:22:55Dr. Clark-Joseph: I used my itemstary background and some equipment in my home to test the pistol myself. I found they were massively underdosed. That was last straw. I reached out to my long time friend, scientist david light and we dedicated to independencely testing and certifying on-market drug products.
▶ 0:23:22Dr. Clark-Joseph: Our findings led to the recalls of more than 25 million pharmacy products worst over $9 billion. We began testing the blockbuster drug zantac when my infant daughter was prescribed the liquid form. Our discover of the drug's instability sparkedth global withdrawal.
▶ 0:23:47Dr. Clark-Joseph: Why is this results in drugs underrecognized? Because the f.d.a drug leadership has claimed to everyone that all approved drugs are equivalent in quality. This false narrative created a market that competes only within price.
▶ 0:24:13Dr. Clark-Joseph: When you buy a car, do you just want the cheapest one in its class that claims to be legal to drive on the road? Of course not yet this is essentially how we're forced to buy drugs in america. Recent the new england journal of medicine Mr. you published an article about it and its first recommendation was that the f.d.a should stop claiming that all generic drugs sold in the united states are equally safe and effective.
▶ 0:24:43Dr. Clark-Joseph: Once weapon acknowledge that we can end the race to the bottom and begin a race to the top. The f.d.a hazy zero tolerance for contaminants like leads in baby food. Clearly the same should apply to all medications.
▶ 0:25:11Dr. Clark-Joseph: The military began a project with valisure a few years ago to independently test essential medicines and assign quality-risk scores red, yellow, or green. These can points out higher quality medications and point out lower qualities ones.
▶ 0:25:39Dr. Clark-Joseph: We found generics rated red because the pills dissolved too quickly. After 11 years it completed a chemical study and concluded a biogive lanes to the brand.
▶ 0:26:04Dr. Clark-Joseph: Testing has shown that 72% of suppliers scored green while 15% scored red. There was no correlation between price and quality. Also, on average, higher contaminant levels were found in certain drugs manufactured in india and china than in the same drugs made in the U.S. simply buying green and I I-avoiding red could save billions of dollars and thousands of lives. Kaiser permanente which, like both the military and the v.a.
▶ 0:26:37Dr. Clark-Joseph: Represents several percent of the U.S. pharmaceutical market, already requires independents testing of certain generic drugs and it has been doing if for years. He know it works and it works at scale.
▶ 0:27:01Dr. Clark-Joseph: Representatives rich mccormick and rosa delauro will be introducing the bipartisan transparency and quality in pharmaceuticals act. We encourage you to support this bill and act on it. Thank you again for your engagement on this critical issue and for allowing me to share my story.
▶ 0:27:26Chair Scott: Thank you. I'd like to introduce Dr. I'd like to introduce d Dr. suzanne de la monte. From brown's medical school. She has conducted extensive research on potential of food and medicine and pearls for patients.
▶ 0:27:47Chair Scott: Her work helps us understand what happens when americans take drugs with defects and carcinogens. Thank you and please begin your testimony. >> thank you for this opportunity. I study mechanisms of research.
▶ 0:28:23Chair Scott: I conduct the research, understand their impact and understand how they affect epidemics and affect seniors. In contrast to messaging designed to pin these problems on disease. The disease rates mirror the exposure rather than aging of genetics per se. What could be the culprit?
▶ 0:28:51Chair Scott: Convergent factors including several of the it's highlighting significant quality concerns about generic medications manufactured in foreign countries drew my attention to in committee. Prior to that I had already begun to investigate the potential cause of several insulin doeses. To a patient I'll refer to as sam. His only medical problem was hypertension.
▶ 0:29:18Chair Scott: However, after taking two years of a prescribed generic anti-hype tensive medication, he developed muscle weakness and metabolic problems. His symptoms worsened reynoldsering him chronically and I will virtually incapable of caring for himself and his disabled child. Deep dives led to evidence that he had been chronically exposed to chronic levels of notrosine.
▶ 0:29:55Chair Scott: We know that chronic low-dose exposures can cause insulin resistance diseases. Diabetes, obessity. Dementia. His exposures had occurred via contaminated lots of his medication.
▶ 0:30:16Chair Scott: Sam, now in a de billitating chronic disease state mirrors what we've seen. How many people were exposed and developed these serious side effects? We don't know.
▶ 0:30:36Chair Scott: Unfortunately, despite an f.d.a recall early in 2025, con tap nateed lots of the indexed medicine continues to be available in the united states. Sam took the medication as prescribed. Contamination of drugs is an old story but the problem is standard ised or eliminated with protocols and qualities control.
▶ 0:31:06Chair Scott: Contamination is just one example of how lax oversight over drug manufacturing can have unsheen problems in health. More than 40% of americans who are over 65 take five prescribed medications a day and between 5% and 20% make 10 or more per day.
▶ 0:31:36Chair Scott: The side effects from those drugs add more prescriptions. More drugs mean an increased risk for adverse offense.
▶ 0:31:52Chair Scott: Growing concern of generic drugs or ridge nateing in foreign countries, particularly in china or india stem from unacceptable manufacturing conditions and lax oversight quality, safety and efficacy. These problems threaten the health of consumers, particularly seniors.
▶ 0:32:15Chair Scott: Due to our extreme reliance on cheaper generic, the yearover year so farring prevalence rates of chronic disease, with poor generic drug manufacturing.
▶ 0:32:35Chair Scott: This is driven by financial gains yet makes no sense to spend lavish amounts of money on so many medicines that make so many seniors sicker and sicker with chronic diseases, thank you.
▶ 0:32:50Chair Scott: Thank you for your testimony. Next we have dinesh thakur. Putt everything on the line against indianaa manufacturers, resulting in a $4500 million settlement with the d.o.j. Now he advocates for drug qualitier, stronger f.d.a oversight. He is a proud floridian. Through for being here.
▶ 0:33:22Chair Scott: Please begin your testimony. >> thank you. I thank you for convening this hearing on a topic which impacts each one of us. I am a chemical engineer by training.
▶ 0:33:49Chair Scott: I obtained my behalf lore's degree in from osmania university in india. I beg your indulgence now to let me provide you a few concrete examples of my state. A whole stack of these investigation reports here that I'm more than happy to hand over to the committee today.
▶ 0:34:14Chair Scott: Let me give you an example of an independents generic manufacturer that makes and sells beta blocker and diuretic in our market here in the united states. Let me walk you through the conology of how we've held this company to account. In 2014, based on an inspections report of 1-483. U.S.
▶ 0:34:43Chair Scott: Inspectors said this -- the company was manipulating test results so that they could pass inspections by playing with instruments of their controls. The report states parameters are manipulated in order to get passing results. In objects of 2014, U.S. f.d.a inspectors had similar observation, in their inspection reports.
▶ 0:35:13Chair Scott: They spoke about attempts to hide results from review or writing raw data files, original results not being reported and partially shedding documents. The U.S. f.d.a went back to do follow-up inspections five years later.
▶ 0:35:32Chair Scott: The two in thors said in their report, which I have a copy here, a cascade of failures in the responsibilities. Missing raw data. Producing fresh samples when the original testing failed.
▶ 0:35:53Chair Scott: A the inspection in 2023 led by two other inspectors and they said in their report, the company engvall dated scientific results without a specific validated cause. The investigation kept over for 10 months. Last year another inspection was done.
▶ 0:36:20Chair Scott: It said in the report, for the U.S. market, they -- the facilities are not cleaned properly. To minimize con tap nation and failed to provide scientific data. In fact in january 2016, the U.S.
▶ 0:36:40Chair Scott: F.d.a manufacturer of manufacturing quality had this to say about this company -- your firm represented lie did samples without justification. Manipulating parameters to get passing results and here's the punch line. In 2017 in august, the U.S.
▶ 0:37:04Chair Scott: Office of criminal investigation closed the investigation of this company. In late 2022, the U.S. f.d.a inspectors -- this is one example. Another example is a drug that is used to treat cancer.
▶ 0:37:24Chair Scott: We had a shortage of this drug in this country back in 2022 and this company, the company that made this drug, was a single source for us, based in india and this -- the warning that was issued to this particular company by the director of manufacturing quality of the U.S. f.d.a, frances goodwin said I investigated observed bags filled with torn and discard orange documents.
▶ 0:37:54Chair Scott: They poured acidic acid in the trash bag can'ting ban slims. Changes were allowed to be made in manual entries. The point I'm trying to make here, imagine if in behavior was observed and documented in the financial services. That recalls demonstrating illegal behavior be destroyed by putting acidic acid into waste bins.
▶ 0:38:25Chair Scott: Would accept that? The facts we let them go by paying a fine and not holding them accountable? This is what we're doing. And I hear from my panel ests that we continue to have bad drugs allowed into this country. Isn't it time for you to call up the f.d.a and ask them very pointed lie why these investigations have been closed? I thank you for your time.
▶ 0:38:52Chair Scott: Thank you. We'll start with questions. Senator tubberville.
▶ 0:38:58Sen. Tubberville: Thank you, Mr. chairman. America has lost power in the pharmaceutical and generic drug market. It is a national security issue. This is not a partisan issue with talking points. There is real live parent harm and oversight that has fallen short.
▶ 0:39:28Sen. Tubberville: We heard excellent testimony from Ms. salberg about herb past and her problems and we thank her for being here today. Dr. de la monte, can you tell me how often unannounced inspections happen in foreign pharmaceutical facilities?
▶ 0:39:50Dr. De La Monte: I can't tell you how often but I know they're infrequent and they're often tipped so there's no way to actually hold them truly accountable.
▶ 0:40:05Sen. Tubberville: Thank you. Can you paint a picture about what you do when you go into a lab in india, what they're trying to hide, not trying to hide?
▶ 0:40:21Mr. Thakur: Sure, I can speak to my own experience working in india. Particularly in those days, the U.S. f.d.a gave specially a two U.S. f.d.a gave specially a tw two-month intimation saying we're coming to inspect your facilities. That changed. The U.S. established offices in china and india but they closed this emdo you and I don't know why. When the g.p.
▶ 0:40:51Mr. Thakur: Regulations happen, we have an honor system. We say this is how you told us that you make the drug. When we come inspect you, we want to make sure you follow what you told us when you asked us for approval of this drug. When they go there, we look over documentation.
▶ 0:41:14Mr. Thakur: We look at the processes and it's very easy to game that if people are given advance notice. In my case, the egregious example was in 2005 when an inspector came in and asked for certain documents which were not available, the inspector was told we'll give it to you tomorrow morning and overnight they fabricated the records and
▶ 0:41:48Mr. Thakur: Puts them in a steam room to make them look older. Is that acceptable to us? >> no. What do we do about that? >> sends anything about the quality that is not in the original n.d.a. Right where it came from. >> I've been intrigued by your ability to test your own drugs. Can you explain that?
▶ 0:42:22Dr. Clark-Joseph: Yes, I studied quite a bit of chemistry in college and I worked in my professor's laboratory one summer. Everybody's got to have a hobby. I'm a little bit on the nerdy side. >> you think? >> most a football coach. Do not listen to hem do not listen to h him.
▶ 0:42:45Dr. Clark-Joseph: >> so, so I had a number of free agents, microbalances and so on and I had been playing around with similar sorts of -- you know, I took lots of supplements. I tried breaking those down into their component pieces and so on. So I'd done similar tests before and yeah, the stars aligned to -- in this case.
▶ 0:43:12Dr. Clark-Joseph: >> and you brought up one point, we were talking about generic drugs. We have tense of billions spent every year in this country that are on the counter. That are supplements. They look pretty in the bottle. Most of us take supplements or whatever.
▶ 0:43:38Dr. Clark-Joseph: Do you have any thoughts on that?
▶ 0:43:43Mr. Thakur: Regulation for supplements is significantly below standards for us in terms of regulation of what really happens. The example that senator scott smoke about, about the eyedrops, these are over the counter eyedrops and we trusted that when we go to wall greens and cvs and buy these that they're supposed to work the way they're intended and we see con tame
▶ 0:44:15Mr. Thakur: Nation of bacteria causing people losing sight. The degradation of supplements is significantly lower compared to the regulation for medicines. >> thank you.
▶ 0:44:32Chair Scott: Thank you, ranking member gillibrand?
▶ 0:44:37Sen. Gillibrand: Thank you, Mr. chairman. Independent testing for manufacturing, the global nature of generic supply chain means that 40% of finished drug products sold in the U.S. are produceeds abroad. The f.d.a routinely gives foreign manufacturers up to 1 weeks advance notice for inspections.
▶ 0:45:01Sen. Gillibrand: That allows bad actors three months to false fay data, clean up noncompliance. Compounding this issue when a foreign facility fates an audit, the f.d.a may wave enforcement to prevents shortages anxiety the qualities of the generic drug. That creates a race to the bottom and manufacturers have no financial insent active to care about quality or reliability.
▶ 0:45:35Sen. Gillibrand: Could independent third testing of generic drugs change the incentives and is it possible to scale enough testing to make an impact?
▶ 0:45:51Dr. Clark-Joseph: Yes, to both questions. One of the -- I believe the procurement reform of precisely the type included in representative mccormick and delauro's transparency and quality in pharmaceuticals acts woulds first of all, in addition
▶ 0:46:23Dr. Clark-Joseph: To the direct effects --
▶ 0:46:26Sen. Gillibrand: So you're saying start with just the military's acquisition, 7% and then you think testing that, making that the highest qualities would then create more incentives for the rest of the 33%?
▶ 0:46:42Dr. Clark-Joseph: Absolutely. Because once there is a kind of gold standard for examining quality and set by the government into law that will both create a precedents that these other large group purchasers can follow without fear of being a pioneer, though kudos to kaiser for their
▶ 0:47:13Dr. Clark-Joseph: Pioneering work in that area, but perhaps more importantly this will create at least the specter of financial liability and force, either in a legal sense or liability to their patients who might become aware of things and force decision makers at the purchasing level to take quality into account.
▶ 0:47:34Sen. Gillibrand: So create a certification standard. >> that would be wonderful.
▶ 0:47:47Sen. Gillibrand: Danker thakur?
▶ 0:47:54Mr. Thakur: Clearly there's a kostin occurred of letting bad medication into the country. We don't track the information.
▶ 0:48:07Mr. Thakur: In order to justify what is needed to create a testing program, you go back and say well we've gotten this far by doing this and mostly when patients go to their pharmacist and say my medicine isn't working they're usually told it's a psycho is amatic thing, it's all in your head. The challenge is that there is no liabilities to purchasers today.
▶ 0:48:32Mr. Thakur: They can -- what goes into form larrys. Most specially have two or three manufacturers but as a patients, if I go to by cvs and say, if my formulation is yellow or red, I really don't have the ability to influence that because the decision is made by the
▶ 0:49:03Mr. Thakur: Formulary at that time. Creating a liability at the formulation level will insentity vise buyers to be able to look at qualities as well. Right now every negotiation is about price, not about quality at all.
▶ 0:49:22Chair Scott: Thank you, ranking member. How did you figure out your drug wasn't working?
▶ 0:49:29Mrs. Salberg: The beta blocker, my heart rate didn't come down. The tacd, I found in the morning with my coffee my hand was shaking. This one over here is the one that sent it below normal. 3.9 and opened me for rejection. This has no symptoms.
▶ 0:49:52Mrs. Salberg: You just are open to rejection so you have to do a lot of blood testing and I've been through a lot of I.v.'s and blood draws in my life. I don't have good veins and at certain points they're going to have to start pumping my fingers for blood to get my levels. So I have challenged veins that I have to pay somebody to poke to go test the drugs again and sometimes it's twice a month.
▶ 0:50:19Mrs. Salberg: Now that I'm on name brand I'm down to my minnesotaly or every other month blood test.
▶ 0:50:28Chair Scott: You have insurance, I guess. >> I do have I think so.
▶ 0:50:31Chair Scott: If yo your generic doesn't work, you have to pay the higher co-pay of the brand? >> yep.
▶ 0:50:41Chair Scott: Even though it doesn't work? >> yep. It shocks me that I'm a patient advocate and we've let insurance companies put us in a really bad decisions, especially with a chronic illness.
▶ 0:50:55Chair Scott: That doesn't make sense. Dr. clark-joseph, the argument that some bears have is oh, it's going to cost more money. If you ever done an analysis that, when you end up back in the hospital or your conditions aren't treated, you actually end up back in the hospital. Even though it costs more for the american drug it's still still worst it?
▶ 0:51:23Dr. Clark Joseph: Absolutely. Me and my co-found earn david are co-authors on a working paper on precisely this issue. We estimated the cost from adverse events associated with low quality drugs and I'm happy to follow up with detailed calculations but we found it was
▶ 0:51:55Dr. Clark Joseph: A conservative cost of about $1 billion per year and the actual cost of testing every batch would be a tiny fraction of that. Generic drugs in the united states, although we do pay significantly more than the rest of the world for our branded duction.
▶ 0:52:13Dr. Clark Joseph: We pay something like 33% less on average for our generic drugs and we found with kaiser and others thattesting and certifying every batch would add about 1 becomes to 3% than about 1 becomes to 3% t to the cost. So we could still pay less than the les of the world and still have generic drugs that are high quality.
▶ 0:52:42Chair Scott: You talked about a drug that was recalled?
▶ 0:52:46Dr. De La Monte: Yes, the drug was recalled by the f.d.a and yet it remained on the market --
▶ 0:52:53Chair Scott: Pardon me. If my car is recalled I get a letter sent and they tell me I have to go and get something done. So that's not the way the f.d.a works?
▶ 0:53:06Dr. De La Monte: Not that I'm aware. First of all the physicians who prescribe the drug are not aware of the problem. The manufacturer it seems are responsible to just get away with it and to enable disease to go forward and again, it's clearly a pricing issue or they had it shelve and would they want to sell it. It's a big problem.
▶ 0:53:35Dr. De La Monte: I think lack of awareness on the clients, the physician and the people who are purchasing it just don't seem to be aware. Hospitals may also be involved in this. They just buy stuff up in large amounts, again price driven.
▶ 0:53:53Chair Scott: What kind of contaminants are found in medicines and what troats they pose to patients?
▶ 0:54:03Dr. De La Monte: -- is a big one and it's beautiful their link to chonnic diseases which is a current pandemic in the world. Just taking it causes obesity, diabetes, fatty liver disease and dementia. That's the gang of four causing problems in the united states and all the money being spent on trying to treat these people.
▶ 0:54:32Dr. De La Monte: Unfortunately these diseases that are drug induced are hard to treat in 9 1960's and 1970's, the rates of diabetes in people between 60 and 70 were far lower than today. The cost of treating them today is much higher so if you look at 60 to 70 year olds back then to now, the rates are so much higher and yet our medicine is supposed by better. What happened?
▶ 0:54:58Chair Scott: Mr. thakur. When you were a whistleblower did the f.d.a say thank you, thank god that you're here and why don't you come in and show us how you're going to improve this and can you brag about all the changes they mailed?
▶ 0:55:17Mr. Thakur: I wish it was true, I'm sorry it wasn't. I did offer to meet with the f.d.a enforcement and that never came to pass.
▶ 0:55:26Chair Scott: So they don't care?
▶ 0:55:30Mr. Thakur: I'm sure they must have a good reason for that. I can't comment why they wouldn't want to meet with someone like me who has something to offer.
▶ 0:55:43Chair Scott: Do you have any stories of other patients and a half gotten bad quality drugs or ineffective drugs?
▶ 0:55:54Ms. Salberg: Many. We were on a podcast talking about drug quality and a young man who was living by buffalo, new york called and said I'm taking myself to the hospital right now. I said what's going on? He's about 28 years old. He said my bata blocker is not working. I have to go to the hospital.
▶ 0:56:19Ms. Salberg: He went, got stabled, looked at the meds, went back to his old brand and that solved the problem. A thyroid patient had a battle keeping her thyroid levels stable and gave that up.
▶ 0:56:46Ms. Salberg: I had many people hospital I had many people hos hospitalized. We were lose we were losing transplants patients and nobody could figure out why. Why? They've been stable for 10 years and all of a sudden they're in rejection. You know how much it costs to put a hearts in a person, it's about a million bucks and this is like five bucks.
▶ 0:57:17Ms. Salberg: Why are we not supporting the amazing work we're doing with this high-expense, high-output procedure with a $5 drug?
▶ 0:57:27Chair Scott: Dr. clark-joseph, why aren't we testing? The department of war is starting to test now. Why isn't the f.d.a doing that? It seems pretty simple.
▶ 0:57:42Dr. Clark-Joseph: The f.d.a is mostly set up from a process perspective in their examination and inspection capacities. That is certainly an important part of the equation. Making sure that the production false and production lines are as they're supposed to be. It's important.
▶ 0:58:01Dr. Clark-Joseph: However, it doesn't, as we have seen, it doesn't catch everything and we are -- valisure are very much mission-aligned with the f.d.a but have a complementary set of expertise and capabilities and a don't have a full explanation beyond that of why the f.d.a hasn't gone this route but we look forward to any productive collaboration we can with them
▶ 0:58:31Dr. Clark-Joseph: Going forward.
▶ 0:58:34Chair Scott: Are there examples in the private sector that companies purchase on qualities first then price?
▶ 0:58:46Dr. Clark-Joseph: We have been running a program with kaiser for a number of years now wherein they -- in order for manufacturers to enter their bidding process for their next year's pro curement, they need to first get their medications tested and if they're selected and agreed to, ongoing certification.
▶ 0:59:09Dr. Clark-Joseph: So kaiser is therefore -- they're still asking them to compete on price but filtering down to the ones who are highest quality and then let them compete on price.
▶ 0:59:21Chair Scott: Dr. de la monte, the f.d.a relies heavily on self-testing data to meet standards. Do you feel if someone has an economic incentive to cut costs and the f.d.a just relies on their stuff? Does that make any sense to you?
▶ 0:59:42Dr. De La Monte: We have to go for quality and patient care and outcomes. We're in a profession that make people well. The small amount of money cited for girl additional testing and qualificationenings seems like we should be willing to pay that amount. Can't get everything for nothing. Right.
▶ 1:00:08Sen. Gillibrand: In both of your testimonys you discussed the impacts that low quality medication has on the health to have patients. However, many consumers don't have the background or expertise to discern whether a medication is safe or not. This could potentially lead to distrust of all generic drugs.
▶ 1:00:31Sen. Gillibrand: How should policy makers promote the need for strong oversight and increasing transparency while avoiding panic that could lead patients to stop paper or demand care? >> thank you for that question. Number one, we have to be honest. And we can start today by having the f.d.a update their website because it tells you generics are the same. That's a lie. We can't lie to the american people.
▶ 1:01:00Sen. Gillibrand: The good news is, 70-plus percent of generic drugs are great qualities and they work very well and we should lean into enforcing good actors to be prominent and we should also tell people if they are taking a medication that they've taken for a chronic illness for a long period of time and notice they're feeling different to immediately communicate with their physician.
▶ 1:01:26Sen. Gillibrand: If you worked with aarp to put that on their website? >> they have not listened to may advice thus far but I would love if you guys could go ahead the f.d.a to actually tell the truth on their website.
▶ 1:01:49Sen. Gillibrand: We'll work on that. Dr. de la monte can you expand on the potentials if patients lose confidence in medicine or medications and how should we increase doctor and patient education on this issue?
▶ 1:02:06Dr. De La Monte: First I think there's a relatively low awareness in general among physicians about side affects effects due specifically to druggings. That's a big problem in medical education where we assume that the drug will work. Because it's f.d.a approved, it is for generics and I think that's a miss understanding.
▶ 1:02:32Dr. De La Monte: I like the idea of third-party testing and having a validation, a color code. I contacted a supplement company they use and I said by the way, how do I know this is not penny? They showed -- poison? They showed me all their testing and thirds-party validation. So it's there and you could tell people. I like the idea of having a website. But there's so much on the web. Right now people are using a.I. For medicine.
▶ 1:03:03Dr. De La Monte: You would think that some of those complications of a specific generic from company x is problem mattic and shouldn't be prescribed. Eventually we have to drill down to physicianings and health care workers telling people that we're going to keep to the safe ones and that is the way to go. There are safe ones. People are not dying every seconds but they're having comply craigs and I think because they're dying every seconds, we keep dismissing the ones that are bad.
▶ 1:03:33Dr. De La Monte: We need to keep up with the good groups and steel people for bad groups.
▶ 1:03:39Sen. Gillibrand: Agreed. It would be great to have a clearinghouse on the f.d.a website to track production of manufacturers who have that track record. Dr. clark-joseph, val sure is a leader in independent chemical testing. Filling a critical transparency gap in the global pharmaceutical supply chain.
▶ 1:04:07Sen. Gillibrand: You've partnered with the department of defense to chemically test and score generic medications. How is has this collaboration informed your abilities to scale, standards for a models for large purchasers and how can we use it to rewards safe manufacturers?
▶ 1:04:27Sen. Gillibrand: And along with that, when various pharmacy changes offer their own generics, do they have better qualities assurance because they themselves become brands names? Like cvs or walgreens?
▶ 1:04:47Dr. Clark-Joseph: Let me start and go in reverse order. With respect to large pharmacies as you mentioned, cvs and walgreens having their eastern brands, my impression is that they are still sourcing and procuring them in exactly the same way and they don't yet have any additional internal or independents quality verification or certification built in.
▶ 1:05:15Dr. Clark-Joseph: As for our product with the uniformed service, for the military, it's led to fleshing out an operational version of this red, yellow, green scoring system which has been guided by an expert review panel and we have further put in the kind of details to do this and we've gotten an excellent snapshot of the qualities risk profile of the manufacturers of the top
▶ 1:05:49Dr. Clark-Joseph: Essential medicines which also overlap with how you use medicines in general. That said, we also note that through our work with kaiser per meant through our work with kaiser per permente, with scale, the kind of snapshots that we've been generating for the uniform service university ideally would both be updated on a regular
▶ 1:06:21Dr. Clark-Joseph: Basis because manufacturers can change their procedures, things turn over and also perhaps pave the way for and paved the way for batch testing. This is why we are really, really excited and urge your support for the transparency and quality in pharmaceuticals act.
▶ 1:06:46Sen. Gillibrand: It makes sense because you could incentivize not only pharmaceutical chains to do it, you could incentivize hospital networks to do that like with kaiser permanente, the dod to do it. You could find large or group purchasing organizations to do it from a to mandate they have to have high quality done and they certify it saying we have been tested.
▶ 1:07:14Sen. Gillibrand: So my assumption is it creates large groups doing it, it creates a standard and everyone will ask for the standard. It will raise awareness that you can pay for a higher level quality of drug and everyone should have that choice to pay for a higher quality level of drug.
▶ 1:07:34Dr. Clark-Joseph: Absolutely. Two important points are that, we really believe beginning with military appropriation reform will start the ripple effect.
▶ 1:07:51Sen. Gillibrand: At hospital networks would be next and from there, the most successful pharmaceutical chains would be next. Cvs want to certify that the medicines on their label are tested.
▶ 1:08:04Dr. Clark-Joseph: Absolutely. And one point, although yes, there is some minimal additional cost to testing, it is important to note that we didn't find a correlation between price and quality in these drugs. It is not like purchasers would be forced, that the best ones are the most expensive.
▶ 1:08:30Dr. Clark-Joseph: There is actually a paper that, I think it was governor shulman and someone else not long ago who looked at the impact of the recalls of the angiotensin ii receptor blockers that, they were contaminated.
▶ 1:08:51Dr. Clark-Joseph: He compared the price and volume for those to the energy of statin -- angie of statin, the ace drugs that serve a similar purpose but weren't recalled. Despite the recalls of these objectively bad batches, the price did not increase, the price of the arb's did not increase relative to the control and the volume.
▶ 1:09:22Sen. Gillibrand: Even if they did slightly, people would be happy to pay. If you look at the generic of zyrtec and zyrtec, but say it is a $10 dosage bottle. The generic would be six dollars. If it has to be seven dollars you were still offering a lower price but guaranteeing the quality. There is a huge difference in price. If you are price sensitive, you are buying the generic and there is room between the brand name and the generic to add more value.
▶ 1:09:52Dr. Clark-Joseph: Absolutely.
▶ 1:09:55Sen. Gillibrand: I have asked all my questions. I have to go pick up my son. Thank you all. I have a child arriving at an airport but thank you for your testimony today. I'm very grateful.
▶ 1:10:13Chair Scott: Thank you ranking member gillibrand. Dr. clark joseph, have any insurance companies or anybody listening to you, could they save money at all? It -- is there anybody?
▶ 1:10:29Dr. Clark-Joseph: We pitched it a number of times, but that was earlier on in our trajectory. At the time we didn't have well established data. It was just, it seems entirely rational that this would save money in the long term.
▶ 1:10:47Dr. Clark-Joseph: We hope that with the depreciation -- the appreciation of data pointing to the actual economic health costs of these things that insurance companies and health systems will be more interested.
▶ 1:11:01Chair Scott: Can you show me medicare would save money?
▶ 1:11:05Dr. Clark-Joseph: I would have to follow-up with you for detailed analysis. But I think it is overwhelmingly likely that medicare would ultimately save a lot of money.
▶ 1:11:20Chair Scott: Whenever you are ready, I can organize a meeting with cms to do that.
▶ 1:11:28Dr. Clark-Joseph: I would be delighted, thank you.
▶ 1:11:29Chair Scott: Right now you guys know the risks. How do you pick your drugs? You have some pill bottles there. Does it say where you got it?
▶ 1:11:39Ms. Salberg: I brought these three because this was the one that was under dosing me. This was the one that was overdosing me and this one came in the middle but it is a generic and then I went to namebrand and I'm not risking it anymore.
▶ 1:11:54Chair Scott: You know where those came from?
▶ 1:11:54Ms. Salberg: I didn't know. This is an interesting one. I'm from jersey. The company used to be down the street. It is made in india.
▶ 1:12:04Chair Scott: How did you find out?
▶ 1:12:06Ms. Salberg: I have smart friends who help me research and I'm a patient advocate who has resources.
▶ 1:12:11Chair Scott: It's not on the bottle?
▶ 1:12:12Ms. Salberg: No.
▶ 1:12:15Chair Scott: Your clothing all has country of origin.
▶ 1:12:18Ms. Salberg: My clothing, my shoes, everything.
▶ 1:12:21Chair Scott: That makes you feel good.
▶ 1:12:22Ms. Salberg: You don't know where it's coming from or who made it. There is another component that I want to bring up and that is temperature. When the drugs are imported we don't know that they are temperature controlled.
▶ 1:12:33Chair Scott: They are not. You know they are not.
▶ 1:12:37Ms. Salberg: We know they are not temperature regulated. They get very hot and that is not safe.
▶ 1:12:42Chair Scott: How about the rest of the? I guess you know. Are you pretty good about everything you or your family might take, or your friends?
▶ 1:12:53Dr. Clark-Joseph: I like to think so. I try very hard but even I sometimes, it is just something I worry about and have very little control over. In spite of my connections with valisure, I am ultimately forced to use basically the same pharmacies everyone else does.
▶ 1:13:16Dr. Clark-Joseph: If the ones in town have made what strike me as poor purchasing decisions that month, like with deluxe a teen -- diloxatine. It has been a life saver for me. There is a thing with drug specific nitro's means and that had me worried because yeah.
▶ 1:13:43Chair Scott: Anybody else? Do you know where your drugs come from?
▶ 1:13:48Dr. De La Monte: I wonder --
▶ 1:13:50Chair Scott: You should know this stuff, right? It is impossible, is not it?
▶ 1:13:55Dr. De La Monte: It is really tough. Somebody has to have skin in the game to get this to work. And I have asked people I know are at the higher levels of making drugs, whether they could make their own generics or whether they would supervise the generics because they are the source of the compound. They all claim it is impossible. I think they just want to push it aside and not do it.
▶ 1:14:23Chair Scott: So why do it?
▶ 1:14:24Dr. De La Monte: Right. This is extra work. But I think the push could come from consumers. If this concept were somehow popularized and made aware, you have a lot of pushback from people who are angry that this is what is happening. And there are some people out there who are on tv and the like who might be interested in sharing the information and making people aware. They are so good at drama.
▶ 1:14:56Dr. De La Monte: Showing the outrageous component of what we are getting, and realizing that things could be fixed. Sometimes you need a lot of pressure from people who are actually the victims, especially senior citizens.
▶ 1:15:09Chair Scott: That is how government is supposed to work, right?
▶ 1:15:13Dr. De La Monte: It is supposed to. But if people don't know, if you are getting food that comes from wherever you could read the label. But medicines?
▶ 1:15:23Dr. De La Monte: Chair scott: senator gillibrand and I have a bill that will have country of origin. That is a start. We are working on mapping where the ingredients come from. The federal government has unbelievable buying power. I used to run the largest hospital company. I can tell you, I was only 2% of the health care dollar but I could buy on volume so I could direct the markets. The federal government can do the same if they want to.
▶ 1:15:52Dr. De La Monte: They will say, it will cost more money or blah blah blah. It doesn't really matter if you are dead. It doesn't help you much. We will get this done. Thank each of you for being here. I think this was a great hearing. Problems with drug quality affect the american people, especially older americans. No american should have to wonder if a drug is safe or contains the medicine they need to stay healthy.
▶ 1:16:18Dr. De La Monte: I will continue to work with my colleagues to support policies that bring safe and high-quality drugs to patients and work with my members on this committee. If any senators have additional questions or statements, the hearing record will be open until next wednesday at 5 p.m.. Thank each of you for being here.