Hearings to examine the human cost of dangerous foreign drugs.

The US Senate Senate Special Committee on the Age of will now come to order. This country has a big drug problem, and it's not the one most people are thinking about when they say it. America's drug supply is not secured, and American patients are in danger as a result. Car- Congress needs to do everyth- everything it can to change that. Ninety-one percent of prescriptions in the United States are for generic drugs. And many older Americans rely on one or more medications to lead healthy and happy lives. This Congress, I've worked closely with ranking member Gillibrand to push the federal government to do everything it can to ensure older Americans have access to safe, and health, high-quality drugs. We sent letters to the secretaries of HHS, the Department of War, and the VA about our reliance on Communist China and India for generic drugs. We've sent a letter to the FTA asking about foreign inspections and the quality of drugs coming into our country. Also wrote letters to groups, purchase group, purchasing organization, distributors and pharmacies, asking where they source their drugs and the information they have about low quality foreign generics. Last year, this committee held three hearings on the quality of the medication seniors rely on. First, we held a hearing on the quality problems with foreign generics and our reliance on Communist China and India for drugs. We followed that up with a hearing on solutions on how to bring drug manufacturing back to the United States. Then we heard from American drug manufacturers on the problems they face and what the federal government can do to help them. This January we held a hearing where I was proud to announce the Clear Labels Act with the ranking members of the brand, a bipartisan bill that would require manufacturers to disclose where the drug and drug ingredients or API are manufactured. You know where your car is made, where the food you eat is from, but you don't know where the medications you or a loved one uh takes comes from. That doesn't make any sense. I encourage all members of this committee to cosponsor this bill so that all Americans can know where their medications are manufactured. At our last hearing on generic drugs in March, we brought in experts on communist China to discuss how our over-reliance on foreign drugs was no accident, but a very deliberate policy by the CCP and also Washington politicians choosing profits over patients. But today, we wanna focus on the real Americans that these low quality foreign drugs are harming. A researcher from Indiana University testified before this committee that generic drugs made in India have fifty-four percent more serious adverse events than equivalent drugs made in the US, including hospitalization, disability and death. That means American patients and their family members taking medications to manage health conditions or recover from illnesses or procedures are ending up in the hospital, potentially even dying. This should never happen in our country, but it's been going on for decades. In two thousand OU two thousand eight contaminated heparin from communist China killed nearly one hundred Americans. This was a life-saving blood thinner medication that these people needed and it killed them. Leroy Hubley lost his wife of forty-eight years, Bonnie, and his son, Randy, because of contaminated heparin from Communist China. They relied on this medication for their dialysis treatment they were go- undergoing due to a genetic kidney disease and it killed them. Those drugs never should have been made into our country, but these are sadly too many such, there are sadly too many such stories. In two thousand twenty-three contaminated eyedrops from India killed four people and blinded fourteen others. This cannot keep happening. But as long as we are not regularly testing drugs coming from communist China and India, and lagging behind in forward inspections, poor quality drugs from these countries will keep coming into America. Under the current framework, we simply cannot rely on the drugs coming from communist China and India to be the same quality as drugs made right here in America. It's been almost two decades since the Heparin incident. and we're even more reliant on Communist China and India for our medications than we were then. The bottom line is, foreign manufacture are not being held to the same standards as domestic manufacturers. This lets bad actors cut corners. And when it comes to patient safety, patients' lives are on the line. Here in the US, the FDA doesn't announce when it goes to inspect a m- a ma- manufacturing facility, but overseas, in Communist China and India, the majority inspections are pre-announced, so they can clean up any problems they've got. While I support the FDA's efforts to increase unannounced foreign inspections, inspections alone can't solve this problem. The problem is, the FDA relies on manufacturers to submit data on an honor system. Foreign manufacturers know this, and bad actors are taking advantage of gaps in the FDA's oversight. We saw this in twenty thirteen, when Rand Ba- Baxey settled with the Department of Justice for five hundred million dollars for falsifying data and systemic violations of FDA, good manufacturing practices. The FDA cannot trust foreign manufacturers that have a financial incentive to cut corners on quality to be honest brokers. Congress needs a look at solutions to systemic gaps in the FDA's ability to conduct oversight of foreign manufacturers. The FDA considers all approved generics to be equivalent, but data shows us this is not the case. This is why testing drugs for quality is so, so important. In her hearing in March, China Rx author Rosemary Gibson testified about the Department of War's testing of generic drugs. What they have found so far is shocking. Of thirteen medicines tested, fifteen percent were found to have serious manufacturing defects, including containing toxins, carcinogens, and not dissolving properly. These stories of bad quality drugs coming from communist China and India are an isolated instance. The problem is systemic. The federal government needs to do everything we can to make the drugs that Americans and seniors rely on here in America and bring manufacturing back here. Put simply, a country that cannot provide itself, uh, cannot provide for itself, cannot protect itself, and it cannot remain safe, strong and prosperous in the long run. America is too great a country to be a, to be as vulnerable as we are on this matter. When American manufacturing is not an option, we must turn to our affiliate, uh, to our allied nations with proven testing standards, not adversaries and bad actors who cut corners at the expense of American lives. I hope that today's hearing we can, we can draw attention to the people and their family members, who have been affected by these poor quality foreign drugs. We have a great witness panel here today, who are advocates for transparency and patient safety, and can speak to these longstanding quality issues with foreign generics. I'd like to turn over to the ranking member, Gillibrand, for her opening statement.

Thank you, Chairman Scott. And thank you for calling today's hearing. Welcome to all our witnesses. I'm very grateful to meet you and excited to hear your testimony. I'm looking forward to continuing this conversation on how we improve the quality and reliability of our generic drug supply chain. As we've heard from our previous hearings, these supply chains are vulnerable to disruption. With decreased domestic manufacturing, we are putting ourselves in an increasingly perilous position. Underlying market factors in the United States have led to a race to the bottom, where incentives for manufacturers are solely based on cost, not quality. While almost all generic drugs that America ta- Americans takes are safe, Congress must empower the FDA to conduct rigorous oversight to make sure foreign manufacturers comply with our safety standards. Congress must also work with industry to move away from cost being the only factors in purchasing. We must incentivize manufacturers and purchasers to consider quality when they are sourcing active pharmaceutical ingredients and final dose foreign medicines. And we must expand testing of these drugs and ingredients, too. There have been many recommendations made before this committee on how to ensure the drugs that enter the US market are high quality. This includes legislation like our bipartisan Clear Labels Act or proposals to expand supply chain mapping. I'm thrilled that there is so much bipartisan excitement around strengthening our generic pharmaceutical supply, and I look forward to working with Chairman Scott and other members of this committee to solve these evergreen problems. Thank you.

I wanna thank our RANKING member, Jill Brand, for her bipartisan of efforts to change our drug supply chain in this country. Our witness panel has firsthand experience in their personal and professional lives with the low-quality genetics that are harming everyday Americans. I'd like to thank them for being here today to discuss their experiences and how we can stop substandard foreign drugs from entering the US market. Lisa Sauber is the founder of HCMA and has spent decades advocating for patients with her rare heart condition. She knows firsthand what is at stake when drug quality fails. Living with a transplanted heart, she depends on her medication to survive. When she was switched to a substandard generic that was ineffective, it nearly cost her her life. Thankfully, she was able to figure it out, figure out it was the medication causing her declining health before it was too late. Now she's an advocate, a strong advocate for drug quality and transparency. I wanna thank you for being here today, and please tell your story.

Thank you Chairman Scott, and Ranking Member Gillibrand, and distinguished members of the committee, for this opportunity to address you today. My name is Lisa Salberg, and I literally come to you with my heart in my hands. This is my literal physical heart that has been explanted. I bet that's a first. I'm asking for your help to protect lives of patients like me who depend on generic medication every day. We think we're saving money, but we may be adding to the financial health burden of our nation in ways yet unmeasured. I was born and raised in Rockaway Township, New Jersey, and I was diagnosed in middle school in nineteen eighty with hypertrophic cardiomyopathy, a genetic heart muscle disease that runs in my family and through generations. It has claimed many lives far too soon, including my sister. My personal medical history includes two pacemakers, five implantable defibrillators, a lifetime of cardiac medication. I had a stroke in nineteen ninety. I'm partially blind in one eye. I have had progressive heart failure and then in two thousand seventeen I got a transplant. It was on Groundhog's Day that I received a donor heart from a woman named Brandi, and we are a beautiful match. We are perfect together. She has helped me regain nearly perfect health, health I'm fighting now to protect. In nineteen ninety-five, after I lost my sister, I founded the Hypertrophic Cardiomyopathy Association, a non-profit that has served over twenty thousand families worldwide, and HCMA has developed sixty-two centers of excellence across the nation's most prestigious academic and health communities. in the country. We've aided in drug discovery, advanced diagnostics, and we've connected over half a million patients with the right doctors. I've published over twenty peer-reviewed journal articles, I've written three books. I'm not a physician, I'm a patient advocate. And I'm here because the system is failing people like me. So my first experience with generic drugs, we'll talk about in just a second. But what I thought was a personal anomaly has revealed itself to be a systematic failure with life-threatening consequences for patients nationwide. My experience isn't unique, it's a pattern. First time was nineteen ninety six. I was taking beta blockers to manage my heart rate. A generic beta blocker replaced my name brand, and after two doses, my heart rate wasn't coming down. I went back to the brand name and thought this was a me thing. Years later, my dear friend, doctor Harry Lever from the Cleveland clinic had heard a news report and said, " Lisa, we need to talk. I think I know why we're having these problems with our patients having erratic responses to their blood pressures." So guess what? It wasn't a me thing, it's a we thing. So two thousand seventeen I get my transplant. I'm gonna be prescribed Tacrolimus, brand name Prograph. It's to prevent rejection. My insurance was not covering a name brand, forcing me to generics and some tricky territory. Tacrolimus is managed by monitoring your levels. If you go too high, you burn out your kidneys and other things. If you go too low, you risk rejection. So my target's six and a half to seven and a half. I remained on one manufacturer as best I could, but shortages and eventually that one was taken off the market. Knowing the variables, I take my very fragile veins to a lot of draws for blood and a lot of expense in that as well. And sometimes I have to get more than one blood draw a month to make sure my levels are okay. Sometimes it was coming in too high, nine point nine. You shake when it goes too high. But when it came in at three point nine and it's too low and I'm open to rejection, there are no symptoms. You're just open to rejection. So now I pay a hundred and twenty dollars a month per dose of my name brand program because I can't trust generics my life literally depends upon it. Across the HCMA network and beyond, patients report to me daily emergency room visits, missed work, deteriorating health, and we do the work and we find that they've changed their manufacture of a drug, and let's go back to the other one and see how you're feeling. There is no accountability, no transparency and no recourse for patients in these situations. We should mention that eighty-five percent of our generic drugs come into this country through three different providers or purchasers. So what do we do to fix it? Well, I'm gonna urge all of you to per- pursue concrete codified reforms, not voluntary guidelines, to modernize our generic drug system, and to hold purchasers and manufacturers and decision makers accountable. The base of all this is hatchwaxman. We gotta go back and fix it. We need to make sure that ANDAs re- not only require meeting bioequivalence, but dissolution rates. That's been the problem in all of my drugs, the dissolution rate is wrong. And we need to inspect every batch of medication brought into the United States before it hits anybody's system. We cannot send red label drugs out to patients. We need to use independent laboratory testing, the red, yellow, green that you guys have heard a lot about over these past few meetings. The system works and we should be doing this more transparently. And I would hope that the FDA would publicly manage a web site where all those test results could be made public. Anything read goes back to the manufacturer or destroyed at their expense. And we do not allow anybody to take read medication. And we need to give the FDA control to refuse low quality drugs from entering the United States and hold bad actors accountable the first time, not after decades. I support bipartisan legislation like the Transparency and Quality Pharmaceutical Act, that may be coming from McCormick and uh DeLero, I'll let my friends explain that one. And I applaud you on the clear label act. However, I think we need to pair it with payer level reform so patients can actually take action on the information on the label, rather than just being stuck in the lowest formulary. Um, good actors should, if they get green scores, good actors shouldn't be burdened with extra extra reviews. Poor quality manufacturers must be held responsible for the financial burden. the product, the destruction, and the liability for downstream health expenses caused by their drugs. And lastly, I will state that I agree with Doctors Kellerman and Sherman uh uh Schulman, in their recent New E- New England Journal article when they said, quote, "The FDA should stop claiming that all generic drugs sold in the United States are equally safe and effective. It cannot verify that without product testing." Thank you very much for the time and I'm happy to take any questions.

Um, now I'll recognize ranking member Jill Rehm.

Thank you, Mister Chairman, I wanna introduce our next witness, Doctor Adam Clark-Joseph. Doctor Clark-Joseph is a Chief Analytics Officer and Co-Founder of Valissure, a technology company working to address a critical gap in the pharmaceutical supply chain through independent quality assurance. Doctor Clark-Joseph was driven to founding Valissure by his personal experience with significant complications arising from batch variability in his anti- Convulsant medication. Doctor Clark Joseph utilizes his exper expertise as a digital chemist chemist to employ big data and machine learning for enhancing transparency in the pharmaceutical supply chain. You may begin.

Uh, Ranking Member Gillibrand, Chairman Scott, members of the committee, uh, thank you for the honor of speaking before you today. So, I've taken medicine for depression for most of my adult life. I first encountered a bad batch of medicine when I was twenty-five. After refill, I suddenly fell ill. And after my doctor identified the problem, he told me that, you know, sometimes you just get a bad batch. At twenty-seven, it happened again, and I became ill for months. Then at twenty-nine, after yet another incident, I used my chemistry background and some equipment in my home to test my pills myself. And I discovered that they were just massively underdosed. So that was the last draw for me. I reached out to my longtime friend, scientist David Light. And together we founded Valisher, America's first laboratory dedicated to independently testing and certifying on-market drug products. We started Valisher to address drug quality problems, but we didn't initially realize the full scope and severity of these problems. Within a few years, our findings led to recalls of more than twenty-five million pharmacy products worth over nine billion dollars. We began testing the blockbuster drug Zantac because my infant daughter had just been s- prescribed the liquid form. Our discovery of the drug's instability sparked its global withdrawal. Our later work drove rolling recalls of sunscreens and hand sanitizers, as well as dozens of national recalls of multiple drugs due to the presence of various carcinogenic contaminants. So, why is this shocking problem of low-quality drugs in America so under-recognized? Bluntly, it's because for forty years, the former FDA drug leadership has claimed to everyone that all approved drugs are equivalent in quality. This demonstrably false narrative created a market that competes only on price, which incentivizes cost cutting, overseas manufacturing, and products being made just good enough to minimize regulatory scrutiny, all in the near complete absence of independent testing. So, 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. Now, recently, the New England Journal of Medicine published an article which, uh, Nils Selberg referenced, titled "Substandard Generic Drugs, Threats to Patient Safety and National Security". And its very first recommendation was that the FDA should stop claiming that all generic drugs sold in the United States are equally safe and effective. Once we acknowledge that not all generics are created equal, we can end the race to the bottom and begin fostering a race to the top. The FDA currently has a closer to zero program for contaminants like lead in baby food. Clearly, the same should apply to medications. If one manufacturer's product contains far lower contaminant level, than another's, then, all us being equal, shouldn't we prefer the objectively cleaner product? Uh, even if neither are so bad that they break the law? In pursuit of exactly this end, the military, via the Unis- Foreign Service University, began a project with Wallachia a few years ago, to independently test the ess- essential medicines and assign quality risk scores to classify suppliers as red, yellow, or green. By translating complex chemistry into these simple red-yellow-green quality risk designations, procurement decisions could easily favor objectively higher quality manufacturers and avoid lower quality ones. Incidentally, uh, tacrolimus, which you just heard about from the is on the military's essential medicines list, and we found generics that rated red because the pills dissolved too quickly. Notably, the FDA received so many complaints that after eleven years, it completed a clinical, uh, study and concluded a lack of bioequivalence to the brand. Our independent chemical testing effectively the same conclusion in weeks rather than years, and identified the root cause mechanism. More broadly, testing across twenty-five drugs and three hundred and fifty-nine suppliers has already shown that seventy-two percent of the suppliers scored green, while fifteen percent 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 US. Simply buying green and avoiding red could be transformational for incentivizing quality in American made medicine. Could also save billions of dollars and thousands of lives. This is not just a theoretical concept. Kaiser Permanente, which, like both the military and the VA, represents several percent of the US pharmaceutical market, already requires independent testing of certain generic drugs that it procures, and has been doing so for years. We know this works, and it works at scale. Uh, representatives Rich McCormick and Rosa DeLauro will be introducing the bipartisan Apparency and Quality in Pharmaceuticals Act to incorporate USU's chemical quality metrics and also independently derived manufacturing location metrics into military drug procurement. They're also working to include this bill in the NDAA and provide funding in the fiscal year twenty twenty-seven defense appropriations bill. We respectfully ask that this committee support this legislation. This is our one uh singular recommendation because after over a decade of researching the problem, we strongly believe that this is the most impactful solution available. Thank you again for your engagement on this critical issue and for allowing me to share my story.

Thank you. Now I'd like to introduce Doctor Suzanne de Lamonte, Vice Chair of Pathology and Laboratory Medicine at Brown University's Albert Medical School. She has conducted extensive research on exposure to contaminants in food and medicine and potential health implications for patients. Her work helps us understand the real biological consequences of what happens on Americans' abnormally consumed drugs with manufacturing defects, toxins, and carcinogens. Thank you for being here. Please uh begin your testimony.

Chairman Scott, Ranking uh Member Gilbin, and committee members, thank you for this opportunity to participate in these hearings on drug safety, supply chains, and risk to aging Americans. I'm a physician scientist who studies mechanisms of aging-related chronic diseases, particularly those that damage the brain, and cause insulin resistance like diabetes, obesity, and dementia. My educational and academic backgrounds have equipped me to conduct such research, understand their societal impact, and experimentally demonstrate how the toxins' exposures cause chronic disease states that are currently epidemic and particularly afflict seniors. In contrast to messaging designed to pin these problems on genes, in fact the decade over decade increases in chronic disease rates mirror the effects of exposures rather than aging uh genetics per se. Well, what could possibly be the culprit? Convergent factors including several of the testimonies highlighting significant quality concerns about generic medications manufactured in foreign countries drew my attention to this committee. Prior to that, I had already begun to investigate the potential cause of several insulin-resistant diseases in a person I'll refer to as Sam. Sam was previously healthy, gainfully employed, and productive. His only medical problem was hypertension. However, after taking two years of an a prescribed generic antihypertensive medication, Sam developed type two diabetes, obesity, muscle weakness, and metabolic problems. His symptoms worsened, his cell status progressively deteriorated, rendering him chronically ill and virtually incapable of caring for himself or his disabled child. Deep dives into Sam's new unexpected complex illnesses led to evidence that he had been chronically exposed to toxic levels of nitrosamines present in his prescribed antihypertensive medication. My expertise includes research in non-cancer causing of causes of toxic effects of nitrosamines. We know that chronic low-dose exposures can cause insulin resistant diseases, diabetes, obesity, dementia, Sam's blood work and eventually records released from the pharmacy confirmed that his nitrosamine exposures had occurred via contaminated lots of his medication Sam now debil now debilitating chronic uh chronic disease state mirrors what we've observed in experimental models and in humans exposed to nitrosamine from various sources including dietary and medicinal. How many people were exposed and developed these serious side effects, we don't know. Unfortunately, despite an FDA recall, early in twenty twenty five, contaminated lots of the index medicine continued to be sold in the United States. Sam, unaware of the recall, took the medication as prescribed. Nitrosamine contamination of drugs is an old story in pharmaceutical industry, but the problem is managed or eliminated by standardized clean manufacturing protocols, extensive monitoring, and product testing, and quality control. Nitrosamine contamination is just one example of how lax regulatory oversight in generic drug manufacturing can have devastating effects on health. Problems concerning unsafe drug manufacture disproportionately impact seniors in part because they are victims of polypharmacy. More than forty percent of Americans who are over sixty-five take five prescribed medications a day and between ten percent and twenty percent take ten or more per day. Health care providers often prescribe additional drugs to combat the side effects of the targeted therapeutics. However, side effects from those drugs add even more prescriptions. Matters are worsened by many non-prescription generic medications used by seniors. More drugs mean increased risk for adverse events, like toxin contamination exposure. Growing concerns about generic drugs originating in foreign countries, particularly China and India. and that were widely sold at attractive possibly unrealistically low prices in united states stem from unacceptable manufacturing conditions and lax oversight on quality safety and efficacy these problems threaten the health and welfare of consumers particularly seniors circling back to our extreme extreme reliance on cheaper but concerning quality generics the year over year soaring prevalence rates of chronic diseases including diabetes and dementia parallel the rate shifts in overseas poor poorly regulated generic drug manufacturing coupled with polypharmacy. Sadly, this cascade 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.

Thank you for your testimony. Next next is we have Dinesh Thakkar. um is a public health advocate who put everything on the line as a whistleblower against indian manufacturer rand boxie exposing systemic violations of fta manufacturing standards that resulted in a five hundred million dollar settlement with the doj now he advocates uh for drug quality stronger fta oversight and holding foreign manufacturers accountable who cut corners at the expense of american patients he is a proud floridian uh thank you for being here please begin your testimony

thank you um chairman scott ranking member jilabran and um distinguished members of this committee i thank you for convening this hearing on this topic that impacts all of us um my background and training had documented my statement i was a whistleblower in the prosecution of a generic drug company by the us doj in may of two thousand thirteen where that indian company pled guilty to seven counts of criminal felony and agreed to pay half a billion dollars in fines to us government while i have presented my analysis and made substantive recommendations in my written statement which i have submitted to this committee i beg your indulgence now let me provide you a few concrete examples of the issues that i referred to in my statement we intentionally pick these examples that are not technical i have the whole stack of these uh investigation reports here which i more than happy to hand it over to the to the committee today uh let me give an example of a company called ipka laboratories an indian genetic manufacturer that makes and sells metoprolol tartrate and furosemide, beta blocker and a diuretic in our market here in the United States. Let me walk through the chronology of how we have held this company to account for its fraudulent behavior over the last sixteen years. In two thousand fourteen, based on an inspection report of form four eighty-three, um USFD inspectors Peter Baker and Joanne King, this is what they said. The company was manipulating test results so that they could pass inspections by playing with instruments in their controls. Bad dating results. The report says integration parameters are manipulated in order to achieve passing results. Raw data files have been manipulated, deleted from the system. In October of two thousand fourteen, USFDA inspectors Peter Baker and Deepesh Shah had similar uh observations in their inspection reports. They spoke about attempts to hide results from review, overwriting raw data files, original reports uh results not being reported and partially shredding documents. The USFDA went back to do a follow-up inspections five years later, in August of two thousand nineteen. Inspectors Arjan Karapetyan and Patrik Gopadhyay said in their report, which I have a copy here, it says that a cascade of failures in your quality control responsibilities, missing raw data, repeat analysis by preparing fresh samples when the original testing failed. The USFDA conducted another inspection in two thousand twenty three led by investigator investigators Rajiv Shibhashthava and Kelly Hicks. And they said in their report, which I have a copy here, um the company invalidated outer specification results without a scientific valid cause. Investigation kept open for ten months without justification. The USFDA conducted another inspection two year uh last year uh led by investigator salim akhtar and it's it it said in the in this in this report here for the us market they um the the uh the the facilities are not cleaned properly to to minimize contamination and uh fail to provide scientific data in fact in and january two thousand sixteen the usfda director of manufacturing quality thomas had this to say about this company Your firm routinely retested samples without justification. We observed systematic manipulation of data, backdesting, backdating test data, manipulating parameters to obtain passing results. And here is a punch line. In two thousand si- seventeen in August, the USF Office of Criminal Investigation closed investigation of this firm. In late two thousand twenty two, the USFDA uh inspectors for uh you know, so so i- i- that this is one example. Another example is a drug called Cisplatin. This is a drug that is used to treat cancer. We had a shortage of this drug in this country back in two thousand twenty two. And this company, the company that made this drug, was a single source for us, based in India. And this this um the the the the warning letter issued to this particular company by the director of manufacturing quality at the USFDA, Francis Goodwin said in his warning letter, "I investigated observed plastic bags filled with torn and discarded original GMP documents." An analyst destroyed GMP records by pouring acetic acid in the trash bin containing analytical balance slips. Your electronic uh batch records allow changes to be made in in in manual entries. The point I'm trying to make here, uh uh chairman Scott and and I can remember Joel Brand, Imagine if this behavior was observed and documented in a financial services firm. The records uh demonstrating illegal behavior were destroyed by pouring acetic acid into waste bins. Would would we accept that? The fact that that, you know, uh would would we let and drawn go by paying a fine and not holding Mister Lay and Mister Skilling accountable? This is what we are doing right now. And then we hear from my my panelists here that we continue to have bad quality drugs in the country. Is this time for for you to to call up the USFTA office of criminal investigation, and ask them very pointedly why these investigations have been closed? I thank you for your time.

Well, thank each of you. Um, we'll start with questions, we'll start with uh Sunil Tuberville.

Thank you, Mr. Chairman, uh, for holding this hearing. Today we're not discussing a new issue, as we all know. America has lost power in the generic drug and pharmaceutical ingredient market. We're relying on China for several drugs and it goes deeper than a trade issue, it is a national security issue. This is not a partisan issue with talking points. There is real life patient harm and oversight that has fallen short and we just heard a excellent testimony from Salzburg here about about her uh past and and her problems and we thank her for being here today. Uh I wanna start with uh Doctor Delamonte, uh, can you tell me how often unannounced inspections happen in foreign pharmaceutical uh facil- facilities?

I can't tell you how often, but I know they're infrequent and they're often chipped. Um, and so there's no way to actually hold them truly accountable uh for what's going on.

Thank you. Uh, Mister Thakur, can you paint a really good picture for us of a lab in India? And especially you, you know, worked on them, about what you see when you go in there, what they're trying to hide, not trying to hide. Can you paint a good picture for, for everybody here for that?

Sure. Um, I can speak to you from my own experience working in India. I had a misfortune of working in a company in India, uh, for eighteen months. Um, typically what happened in those days was that the USFDA gave a, uh, uh, an essentially a two month intimation saying that we're coming to inspect their facilities. Now that changed. after Anbaxi. Um, the USFDA establishes uh in offices in India and China, but they close them down, and I don't know why uh you have to ask them for that. But in that particular case, when the inspector comes in, the way that our regulations work, the GMP regulations work, is we have an honor system. What we do is we say, this is how you told us that you make the drug. When we come and inspect you, we wanna make sure that we we we see that you follow what you've told us, when you ask you uh when you asked us for approving this drug this is what market authorization in this country really means when we go there we look over documentation we look at the look at their processes and it's very easy to gain that if people are given a head notice in my case the greatest example that i i knew about was that in two thousand uh five when an inspector came in and asked for certain documents which were not available The inspector was told, " Well, we'll give it to you tomorrow morning." And overnight, the company fabricated those documents, put them in a steam room, to make them look like old documents. Now, is that acceptable to us?

No.

Thank you.

Um, Miss Sauberg, how can we have high quality near drugs? How do you think we can do that?

OK. Simply inspect every batch that comes into the United States, at the manufacturer or the purchaser's expense. and send anything that is not the quality that is in the original ANDA right on back where it came from.

Doctor Joseph, I'm intrigued with your ability to test your own drugs. Can you explain that?

Yes. So, I uh studied, although my degree wasn't in chemistry, I studied quite a bit of chemistry in college and I uh worked in my professor's laboratory one summer. Um everybody's gotta have a hobby, I am a little bit on the nerdy side.

You think?

Yes.

Being the football coach, do not listen to him. He doesn't know, he doesn't know.

Uh, but yes, so I had um, a number of uh, reagents, uh, glassware, uh, microbalances and so on. Um, 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 tasks before, and yeah, the stars aligned to uh, in this case.

Yeah. And you brought up one, one point there, we're talking about generic drugs. We have tens of billions of dollars spent in this country every year on supplements, that are on the counter, that don't have, that are not prescription drugs, and there's no telling what's in these things then, you know, they look pretty in the bottles, and most of us in here take a supplement, or whatever. Um, uh, you got any thoughts on that, uh, Mister Lec- Lecure?

What um Regulation for medicine actually is fairly extensive. Regulation for supplements is, is significantly below standards for us, um, in terms of regulation of what really happens. The example that uh Senator Scott uh uh spoke about about the the uh the deaths from eyedrops. Um these were over the counter eyedrops. And and so we trusted that when we go to CVS and Walgreens and actually buy these, that that you know they're supposed to work the the way that they're intended. And and we see you know issues of contamination of bacteria that you know people lost sight. And and and we had deaths you know with in in those cases so that's an egregious example, but the regulation of of supplements is significantly smaller, lower compared to the regulation for medicine.

Thank you. Thanks, Mister Chairman.

Thank you, Member Gillibrand.

Thank you, Mister Chairman. Um, Doctor uh Clark-Joseph and Mister Faker, independent testing for international manufacturing, the global nation like the global nature of generic drug supply chain means that forty percent of finished dose products sold in the US are produced abroad. When inspecting international facilities, the FDA routinely gives foreign manufacturers up to twelve weeks advance notice, which is a lot. This allows bad actors three months to falsify data, sanitize facilities, cover up noncompliance. The FDA also does not routinely perform independent random testing of generic drugs already on the market. Compounding this issue issue, when a foreign facility fails an audit, may waive enforcement to prevent shortages despite the quality of the generic drug. This creates a race to the bottom market incentive where purchasers have no financial incentive to um care about drug quality or reliability. So, Doctor Clark-Joseph, could independent third-party testing of generic drugs change the financial incentives to prioritize quality among companies operating in the US? And is it possible to scale enough testing to make an impact?

Uh, yes, absolutely, to both questions. Um, the first point as to could it change financial incentives, uh, one of the, uh, I believe that procurement reform of precisely the type, uh, included in, uh, uh, representative McCormick and Delora's, uh, transparency and quality in pharmaceuticals act would, uh, by changing, uh, introducing, uh, quality metrics and independently to write manufacturing metrics into the uh military drug procurement would uh first of all uh in addition to the direct effects would have ripple effects throughout the private sector, the uh

So so you're saying start with just the military's acquisition, seven percent, and then uh you think doing that, testing that, making that the highest quality would then create more incentives for the rest of the thirty three percent?

Absolutely. Um, because uh Um, the uh, once there is a uh, kind of gold standard for examining quality and, you know, set by the government, uh, ideally codified into law, uh, that will both uh, create a precedent that these other large group purchasers can follow, uh, without fear of, you know, being uh, a pioneer. Um, though kudos to Kaiser for their pioneering work in that manner, uh but perhaps more importantly this will create at least the specter of potential liability and force either in a legal sense or um liability to their patients who might become aware of things and force decision makers at the purchasing level to take quality into account.

So create a certification standard, so it can be certified inspected type thing.

The That would be wonderful.

Doctor Backer?

I think that um clearly there's a cost involved in testing everything that comes into the country. What we need to understand is what is the consequence of not doing that, because we really don't have good data as to what is the consequence of poor quality medicine in terms of hospitalization, in terms of adverse events. We just don't track that kind of information. So, in order to justify what is needed to to create a testing program um you always look back and say well we've gotten away this far um by you know through doing this and mostly when patients go to to their pharmacist and say my medicine isn't working they're usually told that it's a it's a psychosomatic thing it's all in your head because the drug looks different here's the challenge um the challenge is that there is no liability for for purchases today they can determine what goes in the formulary like for example um you know uh most formularies essentially have manufacturers two or three manufacturers and and usually they're located overseas but as a patient if i go to my cvs and say look if my uh um formulation is is yellow or red i really don't have the ability to influence that because the purchasing decision is made by the formulary at that point in time creating a liability at the procurement level that that he's adam's talking about that i think at least will it will change the equation a little bit and incentivize buyers to be able to look at quality as well. Right now, every uh negotiation is about price. It's not about quality at all.

Thank you, Mister Chairman.

Thank you, our anchor member. So um, Miss Holberg, how did you figure out your drug wasn't working?

My drug didn't work in a number of different ways at different points. So the beta blocker, my heart rate didn't come down. The tacrolimus I found in the morning when I had my coffee, my hand was shaking. And that is a telltale sign of being high dosed on tacrolimus. This one over here is the one that sent it below normal, three point nine, and opened me for rejection. This has no symptoms. You just are open to rejection. So you have to do a lot of blood testing. And I've been through a lot of IVs and a lot of blood draws in my life. I don't have good veins. And at certain points they're gonna have to literally start pumping my fingers for blood to test my levels. And they've had to do that in the past when you couldn't get access to a vein. 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 to make sure my levels are proper. Now that I'm on name brand, I'm down to my monthly to every other month blood tests.

So on your, uh, do you have insurance, I guess?

I do have insurance.

So if your generic doesn't work, Do you have to pay the the higher co-pay because of brand,

Yes.

even though it doesn't work?

Yep.

And even though you've proved it doesn't work?

Yep.

That surprises you, doesn't it?

It's, I'm sorry?

That does not surprise you.

Oh, it shocks me, but I'm a patient advocate and I've watched how the health insurance companies put us in a really bad position, especially those with chronic illness.

Yeah, that doesn't make sense. Doctor uh Clark Joseph, so so the argument that um some some buyers have is they say, oh it's gonna cost more money. Have you ever done an analysis that, uh, because when you end up back in the hospital, or your, your condition's not treated, it actually costs more money. Have you ever done an analysis that, says that's not actually, even though, you know, it costs a little bit more for the, you know, American drug, it's still worth it?