Hearings to examine the human cost of dangerous foreign drugs.

1[Senate Hearing 119-483]2[From the U.S. Government Publishing Office]34                                                       S. Hrg. 119-48356                     POISONED PILLS: THE HUMAN COST7                       OF DANGEROUS FOREIGN DRUGS8=======================================================================910                                HEARING1112                               BEFORE THE1314                       SPECIAL COMMITTEE ON AGING1516                          UNITED STATES SENATE1718                    ONE HUNDRED NINETEENTH CONGRESS1920                             SECOND SESSION2122                               __________2324                             WASHINGTON, DC2526                               __________2728                              JUNE 3, 20262930                               __________3132                           Serial No. 119-313334         Printed for the use of the Special Committee on Aging3536[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]3738        Available via the World Wide Web: http://www.govinfo.gov3940                                __________4142                       U.S. GOVERNMENT PUBLISHING OFFICE4364-196 PDF                    WASHINGTON: 202644=======================================================================4546                       SPECIAL COMMITTEE ON AGING4748                     RICK SCOTT, Florida, Chairman4950DAVE McCORMICK, Pennsylvania         KIRSTEN E. GILLIBRAND, New York51JIM JUSTICE, West Virginia           ELIZABETH WARREN, Massachusetts52TOMMY TUBERVILLE, Alabama            MARK KELLY, Arizona53RON JOHNSON, Wisconsin               RAPHAEL WARNOCK, Georgia54ASHLEY MOODY, Florida                ANDY KIM, New Jersey55JON HUSTED, Ohio                     ANGELA ALSOBROOKS, Maryland56                              ----------57                McKinley Lewis, Majority Staff Director58                Claire Descamps, Minority Staff Director5960                         C  O  N  T  E  N  T  S6162                              ----------6364                                                                   Page6566Opening Statement of Senator Rick Scott, Chairman................     167Opening Statement of Senator Kirsten E. Gillibrand, Ranking68  Member.........................................................     36970                           PANEL OF WITNESSES7172Lisa Salberg, Founder and CEO, Hypertrophic Cardiomyopathy73  Association, Denville, New Jersey..............................     474Adam Clark-Joseph, Ph.D, Chief Analytics Officer and Co-Founder,75  Valisure, New Haven, Connecticut...............................     776Suzanne de La Monte, MD, MPH, Professor and Vice Chair of77  Pathology and Laboratory Medicine, Alpert Medical School of78  Brown University, Providence, Rhode Island.....................     979Dinesh Thakur, Public Health Activist, St. Petersburg, Florida...    108081                                APPENDIX82                      Prepared Witness Statements8384Lisa Salberg, Founder and CEO, Hypertrophic Cardiomyopathy85  Association, Denville, New Jersey..............................    2886Adam Clark-Joseph, Ph.D, Chief Analytics Officer and Co-Founder,87  Valisure, New Haven, Connecticut...............................    4088Suzanne de La Monte, MD, MPH, Professor and Vice Chair of89  Pathology and Laboratory Medicine, Alpert Medical School of90  Brown University, Providence, Rhode Island.....................    7791Dinesh Thakur, Public Health Activist, St. Petersburg, Florida...    829293                        Questions for the Record9495Adam Clark-Joseph, Ph.D, Chief Analytics Officer and Co-Founder,96  Valisure, New Haven, Connecticut...............................    9597Dinesh Thakur, Public Health Activist, St. Petersburg, Florida...    979899                       Statements for the Record100101Association for Accessible Medicines Statement...................   100102Peter C. Butler, M.D., Statement.................................   107103Taxpayers Protection Alliance Statement..........................   109104105                     POISONED PILLS: THE HUMAN COST106                       OF DANGEROUS FOREIGN DRUGS107108                              ----------109110                        Wednesday, June 3, 2026111112                                        U.S. Senate113                                 Special Committee on Aging114                                                    Washington, DC.115    The Committee met, pursuant to notice, at 3:29 p.m., Room116216, Hart Senate Office Building, Hon. Rick Scott, Chairman of117the Committee, presiding.118    Present: Senator Scott, McCormick, Tuberville, Gillibrand,119and Alsobrooks.120121                 OPENING STATEMENT OF SENATOR122                      RICK SCOTT, CHAIRMAN123124    The Chairman. Thank you. The U.S. Senate Special Committee125on Aging will now come to order. This country has a big drug126problem, and it is not the one most people are thinking about127when they say it. America's drug supply is not secured, and128American patients are in danger as a result.129    Congress needs to do everything it can to change that.130Ninety-one percent of prescriptions in the United States are131for generic drugs, and many older Americans will rely on one or132more medications to lead healthy and happy lives. This133Congress, I have worked closely with Ranking Member Gillibrand134to push the Federal Government to do everything it can to135ensure older Americans have access to safe and high-quality136drugs.137    We sent letters to the Secretaries of HHS, the Department138of War, and the VA about our reliance on Communist China and139India for generic drugs. We sent a letter to the FDA asking140about foreign inspections and the quality of drugs coming into141our country. We also wrote letters to group purchasing142organizations, distributors, and pharmacies asking where they143source their drugs and the information they have about low-144quality foreign generics.145    Last year, this Committee held three hearings on the146quality of the medication's seniors rely on. First, we held a147hearing on the quality problems with foreign generics and our148reliance on Communist China and India for drugs.149    We followed that up with a hearing on solutions on how to150bring drug manufacturing back to the United States. Then we151heard from American drug manufacturers on the problems they152face and what the Federal Government can do to help them. This153January, we held a hearing where I was proud to announce the154CLEAR LABELS Act with ranking member Gillibrand, a bipartisan155bill that would require manufacturers to disclose where the156drug and drug ingredients, or API, are manufactured.157    You know where your car is made, where the food you eat is158from, but you don't know where the medications you or a loved159one takes comes from. That doesn't make any sense. I encourage160all members of this Committee to co-sponsor this bill so that161all Americans can know where their medications are162manufactured.163    At our last hearing on generic drugs in March, we brought164in experts on Communist China to discuss how our over-reliance165on foreign drugs was no accident, but a very deliberate policy166by the CCP and also Washington politicians choosing profits167over patients. Today, we want to focus on the real Americans168that these low-quality foreign drugs are harming.169    A researcher from Indiana University testified before this170Committee that generic drugs made in India have 54 percent more171serious adverse events than equivalent drugs made the U.S.,172including hospitalization, disability, and death.173    That means American patients and their family members174taking medications to manage health conditions or recover from175illnesses or procedures are ending up in the hospital,176potentially even dying. This should never happen in our177country, but it has been going on for decades. In 2008,178contaminated heparin from Communist China killed nearly 100179Americans. This was a lifesaving blood thinner medication that180these people needed, and it killed them.181    Leroy Hubley lost his wife of 48 years, Bonnie, and his182son, Randy, because of contaminated heparin from Communist183China. They relied on this medication for their dialysis184treatment they were undergoing due to a genetic kidney disease,185and it killed them. Those drugs never should have been made186into our country, but these are sadly too many--there are sadly187too many such stories.188    In 2023 contaminated eye drops from India killed four189people and blinded 14 others. This cannot keep happening. As190long as we are not regularly testing drugs coming from191Communist of China and India, and lag behind in foreign192inspections, poor quality drugs from these countries will keep193coming into America. Under the current framework, we simply194cannot rely on the drugs coming from Communist China and India195to be the same quality as drugs made right here in America.196    It has been almost two decades since the heparin incident,197and we are even more reliant on Communist China and India for198our medications than we were then. The bottom line is foreign199manufacturers are not being held to the same standards as200domestic manufacturers. This lets bad actors cut corners. When201it comes to patient safety, patients' lives are on the line.202    Here in the U.S., the FDA doesn't announce when it goes to203inspect a manufacturing facility, but overseas, in Communist204China and India, the majority of inspections are pre-announced205so they can cleanup any problems they have got. While I support206the FDA's efforts to increase unannounced foreign inspections,207inspections alone can't solve this problem.208    The problem is the FDA relies on manufacturers to submit209data on an honor system. Foreign manufacturers know this, and210bad actors are taking advantage of gaps in the FDA's oversight.211We saw this in 2013 when Ranbaxy settled with the Department of212Justice for $500 million for falsifying data and systemic213violations of FDA good manufacturing practices.214    The FDA cannot trust foreign manufacturers that have a215financial incentive to cut corners on quality to be honest216brokers. Congress needs to look at solutions to systemic gaps217in the FDA's ability to conduct oversight of foreign218manufacturers. The FDA considers all approved generics to be219equivalent, but data shows us this is not the case. This is why220testing drugs for quality is so, so important.221    In our hearing in March, ChinaRx author, Rosemary Gibson222testified about the Department of War's testing of generic223drugs. What they have found so far is shocking. Of 13 medicines224tested, 15 percent were found to have serious manufacturing225defects, including containing toxins and carcinogens, and not226dissolving properly. These stories of bad quality drugs coming227from Communist China and India aren't isolated incidents. The228problem is systemic.229    The Federal Government needs to do everything we can to230make the drugs that Americans and seniors rely on here in231America and bring manufacturing back here. Put simply, a232country that cannot provide itself--cannot provide for itself233cannot, protect itself, and it cannot remain safe, strong, and234prosperous in the long run. America is too great a country to235be as vulnerable as we are on this matter.236    When American manufacturing is not an option, we must turn237to our affiliate or to our allied nations with proven testing238standards, not adversaries and bad actors who cut corners at239the expense of American lives. I hope that in today's hearing240we can draw attention to the people and their family members241who have been affected by these poor quality foreign drugs.242    We have a great witness panel here today who are advocates243for transparency and patient safety and can speak to these244longstanding quality issues with foreign generics. Now, I would245like to turn it over to Ranking Member Gillibrand for her246opening statement.247248                 OPENING STATEMENT OF SENATOR249             KIRSTEN E. GILLIBRAND, RANKING MEMBER250251    Senator Gillibrand. Thank you, Chairman Scott. Thank you252for calling today's hearing. Welcome to all our witnesses. I am253very grateful to meet you and excited to hear your testimony. I254am looking forward to continuing this conversation on how we255can improve the quality and reliability of our generic drug256supply chain. As we have heard from our previous hearings,257these supply chains are vulnerable to disruption.258    With decreased domestic manufacturing, we are putting259ourselves in an increasingly perilous position. Underlying260market factors in the United States have led to a race to the261bottom where incentives for manufacturers are solely based on262cost, not quality.263    While almost all generic drugs that Americans take are264safe, Congress must empower the FDA to conduct rigorous265oversight to make sure foreign manufacturers comply with our266safety standards.267    Congress must also work with industry to move away from268costs being the only factors in purchasing. We must incentivize269manufacturers and purchasers to consider quality when they are270sourcing active pharmaceutical ingredients and final dose271foreign medicines. We must expand testing of these drugs and272ingredients too.273    There have been many recommendations made before this274Committee on how to ensure the drugs that enter the U.S. market275are high quality. This includes legislation, like our276bipartisan CLEAR LABELS Act, or proposals to expand supply277chain mapping.278    I am thrilled that there is so much bipartisan excitement279around strengthening our generic pharmaceutical supply, and I280look forward to working with Chairman Scott and other members281of this Committee to solve these evergreen problems. Thank you.282    The Chairman. I want to thank Ranking Member Gillibrand for283her bipartisan support of efforts to change our drug supply284chain in this country. Our witness panel has firsthand285experience in their personal and professional lives with the286low quality genetics that are harming everyday Americans.287    I would like to thank them for being here today to discuss288their experiences and how we can stop substandard foreign drugs289from entering the U.S. market. Lisa Salberg is the founder of290HCMA and has spent decades advocating for patients with her291rare heart condition. She knows firsthand what is at stake when292drug quality fails. Living with a transplanted heart, she293depends on her medication to survive.294    When she was switched to a substandard generic that was295ineffective, it nearly cost her her life. Thankfully she was296able to figure it out--figure out it was the medication causing297her decline in health before it was too late.298    Now she is an advocate, a strong advocate for drug quality299and transparency. I want to thank you for being here today, and300please tell your story.301302          STATEMENT OF LISA SALBERG, FOUNDER AND CEO,303304            HYPERTROPHIC CARDIOMYOPATHY ASSOCIATION,305306                      DENVILLE, NEW JERSEY307308    Ms. Salberg. Thank you, Chairman Scott, and Ranking Member309Gillibrand, and distinguished members of the Committee for this310opportunity to address you today. My name is Lisa Salberg, and311I literally come to you with my heart in my hands. This is my312literal physical heart that has been explanted.313    I bet that is a first. I am asking for your help to protect314lives of patients like me who depend on generic medication315every day. We think we are saving money, but we may be adding316to the financial health burden of our Nation in ways yet317unmeasured.318    I was born and raised in Rockaway Township, New Jersey, and319I was diagnosed in middle school in 1980 with hypertrophic320cardiomyopathy, a genetic heart muscle disease that runs in my321family and through generations. It has claimed many lives far322too soon, including my sister.323    My personal medical history includes two pacemakers, five324implantable defibrillators, and a lifetime of cardiac325medication. I had a stroke in 1990. I am partially blind in one326eye. I have had progressive heart failure, and then in 2017, I327got a transplant. It was on Groundhog's Day that I received a328donor heart from a woman named Brandy, and we are a beautiful329match.330    We are perfect together. She has helped me regain nearly331perfect health--health I am fighting now to protect. In 1995,332after I lost my sister, I founded the Hypotrophic333Cardiomyopathy Association, a non-profit that has served over33420,000 families worldwide, and HCMA has developed 62 centers of335excellence across the Nation's most prestigious academic and336health communities in the country.337    We have aided in drug discovery, advanced diagnostics, and338we have connected over half a million patients with the right339doctors. I have published over 20 peer-reviewed journal340articles, I have written three books. I am not a physician. I341am a patient advocate. I am here because the system is failing342people like me.343    My first experience with generic drugs, we will talk about344in just a second. What I thought was a personal anomaly has345revealed itself to be a systematic failure with life-346threatening consequences for patients nationwide. My experience347isn't unique. It is a pattern.348    First time was 1996. I was taking beta blockers to manage349my heart rate. A generic beta blocker replaced my name brand,350and after two doses, my heartrate wasn't coming down. I went351back to the brand name and thought this was a me thing. Years352later, my dear friend, Dr. Harry Lever from the Cleveland353Clinic had heard a news report and said, Lisa, we need to talk.354    I think I know why we are having these problems with our355patients having erratic responses to their blood pressures.356Guess what? It wasn't a me thing. It is a "we" thing. In 2017,357I get my transplant. I am going to be prescribed tacrolimus,358brand name PROGRAF. It is to prevent rejection.359    My insurance was not covering a name brand, forcing me to360generics and some tricky territory. Tacrolimus is managed by361monitoring your levels. If you go too high, you burn out your362kidneys and other things. If you got too low, you risk363rejection. My target is 6.5 to 7.5.364    I remained on one manufacturer as best I could, but365shortages, and eventually that one was taken off the market.366Knowing the variables, I take my very fragile veins through a367lot of draws for blood and a lot of expense in that as well,368and sometimes I have to get more than one blood draw a month to369make sure my levels are okay.370    Sometimes it was coming in too high, 9.9. You shake when it371goes too high. When it came in at 3.9 and it is too low and I372am open to rejection, there are no symptoms. You are just open373to rejection. Now I pay $120 a month per dose of my name brand374PROGRAF because I can't trust generics.375    My life literally depends upon it. Across the HCMA network376and beyond, patients report to me daily emergency room visits,377missed work, deteriorating health. We do the work, and we find378that they have changed their manufacturer of a drug and let's379go back to the other one and see how you are feeling. There is380no accountability, no transparency, and no recourse for381patients in these situations.382    We should mention that 85 percent of our generic drugs come383into this country through three different providers or384purchasers. What do we do to fix it? Well, I am going to urge385all of you to pursue concrete codified reforms, not voluntary386guidelines, to modernize our generic drug system, and to hold387purchasers and manufacturers and decisionmakers accountable.388    The base of all this is Hatch-Waxman. We got to go back and389fix it. We need to make sure that ANDAs not only require390meeting bio equivalents, but dissolution rates. That has been391the problem in all of my drugs, the dissolution rate is wrong.392We need to inspect every batch of medication brought into the393United States before it hits anybody's system.394    We cannot send red labeled drugs out to patients. We need395to use independent laboratory testing--the red, yellow, green396that you guys have heard a lot about over these past few397meetings. The system works and we should be doing this more398transparently. I would hope that the FDA would publicly manage399a website where all those test results could be made public.400    Anything red goes back to the manufacturer or destroyed at401their expense, and we do not allow anybody to take red402medication. We need to get the FDA control to refuse low-403quality drugs from entering the United States and hold bad404actors accountable the first time, not after decades.405    I support bipartisan legislation like the Transparency and406Quality Pharmaceutical Act that may be coming from McCormick407and DeLauro. I will let my friends explain that one. I applaud408you on the clear label act. However, I think we need to pair it409with payer level reform so patients can actually take action on410the information on the label rather than just being stuck in411the lowest formulary.412    Good actors should--if they get green scores, good actors413shouldn't be burdened with extra reviews. Poor quality414manufacturers must be held responsible for the financial415burden, the product, the destruction, and the liability for416downstream health expenses caused by their drugs.417    Last, I will state that I agree with Drs. Kellermann and418Schulman in their recent New England Journal article when they419said, "the FDA should stop claiming that all generic drugs sold420in the United States are equally safe and effective. It cannot421verify that without product testing." Thank you very much for422the time, and I am happy to take any questions.423    The Chairman. Now, I will recognize Ranking Member424Gillibrand for the next witness.425    Senator Gillibrand. Thank you, Mr. Chairman. I want to426introduce our next witness, Dr. Adam Clark-Joseph. Dr. Clark-427Joseph is a Chief Analytics Officer and Co-Founder of Valisure,428a technology company working to address a critical gap in the429pharmaceutical supply chain through independent quality430assurance.431    Dr. Clark-Joseph was driven to founding Valisure by his432personal experience with significant complications arising from433batch variability in his anticonvulsant medication. Dr. Clark-434Joseph utilizes his expertise as a digital chemist to employ435big data and machine learning for enhancing transparency in the436pharmaceutical supply chain. You may begin.437438           STATEMENT OF ADAM CLARK-JOSEPH, PHD, CHIEF439440          ANALYTICS OFFICER AND CO-FOUNDER, VALISURE,441442                     NEW HAVEN, CONNECTICUT443444    Dr. Clark-Joseph. Ranking Member Gillibrand, Chairman445Scott, members of the Committee, thank you for the honor of446speaking before you today.447    I have taken medicine for depression for most of my adult448life. I first encountered a bad batch of medicine when I was44925. After a refill, I suddenly fell ill, and after my doctor450identified the problem, he told me that sometimes you just get451a bad batch.452    At twenty-seven, it happened again, and I became ill for453months. Then at twenty-nine, after yet another incident, I used454my chemistry background and some equipment in my home to test455my pills myself, and I discovered that they were massively456underdosed, so that was the last straw for me.457    I reached out to my longtime friend and scientist, David458Light, and together we founded Valisure, America's first459laboratory dedicated to independently testing and certifying460on-market drug products.461    We started Valisure to address drug quality problems, but462we didn't initially realize the full scope and severity of463these problems. Within a few years, our findings led to recalls464of more than 25 million pharmacy products worth over nine465billion. We began testing the blockbuster drug Zantac because466my infant daughter had just been prescribed the liquid form.467Our discovery of the drug's instability sparked its global468withdrawal.469    Our later work drove rolling recalls of sunscreens and hand470sanitizers, as well as dozens of national recalls of multiple471drugs due to the presence of various carcinogenic contaminants.472Why is this shocking problem of low-quality drugs in America so473under-recognized? Bluntly, it is because for 40 years, the474former FDA drug leadership has claimed to everyone that all475approved drugs are equivalent in quality.476    This demonstrably false narrative created a market that477competes only on price, which incentivizes cost-cutting,478overseas manufacturing, and products being made just good479enough to minimize regulatory scrutiny, all in the near480complete absence of independent testing.481    When you buy a car, do you just want the cheapest one in482its class that claims to be legal to drive on the road? Of483course not, yet this is essentially how we are forced to buy484drugs in America. Recently, the New England Journal of Medicine485published an article, which Ms. Salberg referenced, titled,486"Substandard Generic Drugs, Threats to Patient Safety and487National Security."488    Its very first recommendation was that the FDA should stop489claiming that all generic drugs sold in the United States are490equally safe and effective. Once we acknowledge that not all491generics were created equal, we can end the race to the bottom492and begin fostering a race to the top.493    The FDA currently has a "closer to zero" program for494contaminants like lead in baby food. Clearly, the same should495apply to medications. If one manufacturer's product contains496far lower contaminant levels than another's, then all else497being equal, shouldn't we prefer the objectively cleaner498product, even if neither are so bad that they break the law? In499pursuit of exactly this end, the military, via the Uniformed500Services University, began a project with Valisure a few years501ago to independently test essential medicines and assign502quality risk scores to classify suppliers as red, yellow, or503green.504    By translating complex chemistry into these simple red,505yellow, green quality risk designations, procurement decisions506can easily favor objectively higher quality manufacturers and507avoid lower quality ones. Incidentally, tacrolimus, which you508just heard about from Ms. Salberg, is on the military's509essential medicines list, and we found generics that rated red510because the pills dissolved too quickly.511    Notably, the FDA received so many complaints that after 11512years, it completed a clinical study and concluded a lack of513bioequivalence to the brand. Our independent chemical testing514effectively reached the same conclusion in weeks rather than515years and identified the root cause mechanism.516    More broadly, testing across 25 drugs and 359 suppliers has517already shown that 72 percent of suppliers scored green, while51815 percent scored red. There was no correlation between price519and quality. Also, on average, higher contaminant levels were520found in certain drugs manufactured in India and China than in521the same drugs made in the U.S. Simply buying green and522avoiding red could be transformational for incentivizing523quality and American made medicine.524    It could also save billions of dollars and thousands of525lives. This is not just a theoretical concept. Kaiser526Permanente, which like both the military and the VA, represents527several percent of the U.S. pharmaceutical market, already528requires independent testing of certain generic drugs that it529procures, and has been doing so for years. We know this works,530and it works at scale.531    Representatives Rich McCormick and Rosa DeLauro will be532introducing the Bipartisan Transparency and Quality in533Pharmaceuticals Act to incorporate the USU's chemical quality534metrics and also independently derived manufacturing location535metrics into military drug procurement. They are also working536to include this bill in the NDAA and provide funding in the537Fiscal Year 2027 Defense Appropriations Bill.538    We respectfully ask that this Committee support this539legislation. It is our one singular recommendation, because540after over a decade of researching the problem, we strongly541believe that this is the most impactful solution available.542Thank you again for your engagement on this critical issue and543for allowing me to share my story.544    The Chairman. Thank you. Now I would like to introduce Dr.545Suzanne de la Monte, Vice Chair of Pathology and Laboratory546Medicine at Brown University's Albert Medical School. She has547conducted extensive research on exposure to contaminants in548food and medicine, and potential health implications for549patients.550    Her work helps us understand the real biological551consequences of what happens when Americans unknowingly consume552drugs with manufacturing defects, toxins, and carcinogens.553Thank you for being here. Please begin your testimony.554555           STATEMENT OF SUZANNE DE LA MONTE, MD, MPH,556557             PROFESSOR AND VICE CHAIR OF PATHOLOGY558559            AND LABORATORY MEDICINE, ALPERT MEDICAL560561                  SCHOOL OF BROWN UNIVERSITY,562563                    PROVIDENCE, RHODE ISLAND564565    Dr. de La Monte. Chairman Scott, Ranking Member Gillibrand,566and committee members, thank you for this opportunity to567participate in these hearings on drugs safety, supply chains,568and risk to aging Americans. I am a physician scientist who569studies mechanisms of aging related chronic diseases,570particularly those that damage the brain and cause insulin571resistance like diabetes, obesity, and dementia.572    My educational and academic backgrounds have equipped me to573conduct such research, understand their societal impact, and574experimentally demonstrate how the toxins' exposures cause575chronic disease states that are currently epidemic and576particularly afflict seniors. In contrast to messaging designed577to pin these problems on genes, in fact, the decade over decade578increases in chronic disease rates mirror the effects of579exposures rather than aging genetics per se.580    What could possibly be the culprit? Convergent factors581including several of the testimoneys highlighting significant582quality concerns about generic medications manufactured in583foreign countries drew my attention to this Committee. Prior to584that, I had already begun to investigate the potential cause of585several insulin resistant diseases in a person I will refer to586as Sam.587    Sam was previously healthy, gainfully employed, and588productive. His only medical problem was hypertension. However,589after taking two years of a prescribed generic antihypertensive590medication, Sam developed type 2 diabetes, obesity, muscle591weakness, and metabolic problems.592    His symptoms worsened, his cell status progressively593deteriorated, rendering him chronically ill and virtually594incapable of caring for himself or his disabled child. Deep595dives into Sam's new unexpected complex illnesses led to596evidence that he had been chronically exposed to toxic levels597of nitrosamines present in his prescribed antihypertensive598medication.599    My expertise includes research in non-cancer causes of600toxic effects of nitrosamines. We know that chronic low dose601exposures can cause insulin resistant diseases, diabetes,602obesity, dementia. Sam's blood work, and eventually records603released from the pharmacy, confirmed that his nitrosamine604exposures had occurred via contaminated lots of his medication.605    Sam's now debilitating chronic disease state mirrors what606we have observed in experimental models and in humans exposed607to nitrosamines from various sources, including dietary and608medicinal. How many people were exposed and developed these609serious side effects, we don't know.610    Unfortunately, despite an FDA recall early in 2025,611contaminated lots of the index medicine continue to be sold in612the United States. Sam, unaware of the recall, took the613medication as prescribed.614    Nitrosamine contamination of drugs is an old story in615pharmaceutical industry, but the problem is managed or616eliminated by standardized clean manufacturing protocols,617extensive monitoring, end product testing, and quality control.618Nitrosamine contamination is just one example of how lax619regulatory oversight in generic drug manufacturing can have620devastating effects on health. Problems concerning unsafe drug621manufacturing disproportionately impact seniors in part because622they are victims of polypharmacy.623    More than 40 percent of Americans who are over 65 take five624prescribed medications a day, and between 10 percent and 20625percent take 10 or more per day. Healthcare providers often626prescribe additional drugs to combat the side effects of the627targeted therapeutics.628    However, side effects from those drugs add even more629prescriptions. Matters are worsened by many non-prescription630generic medications used by seniors. More drugs mean increased631risk for adverse events like toxin contamination exposure.632Growing concerns about generic drugs originating in foreign633countries, particularly China and India, and that were widely634sold at attractive, possibly unrealistically low prices in the635United States stem from unacceptable manufacturing conditions636and lax oversight on quality, safety, and efficacy.637    These problems threaten the health and welfare of638consumers, particularly seniors. Circling back to our extreme639reliance on cheaper, but concerning quality generics, the year640over year soaring prevalence rates of chronic diseases,641including diabetes and dementia, parallel the rate shifts in642overseas, poorly regulated generic drug manufacturing, coupled643with polypharmacy.644    Sadly, this cascade is driven by financial gains yet makes645no sense to spend lavish amounts of money on so many medicines646that make so many seniors sicker and sicker with chronic647diseases. Thank you.648    The Chairman. Thank you for your testimony. Next, we have649Dinesh Thakur, he is a public health advocate who put650everything on the line as a whistleblower against Indian651manufacturer Ranbaxy, exposing systemic violations of FDA652manufacturing standards that resulted in a $500 million653settlement with the DOJ.654    Now he advocates for drug quality, stronger FDA oversight,655and holding foreign manufacturers accountable who cut corners656at the expense of American patients. He is a proud Floridian.657Thank you for being here. Please begin your testimony.658659           STATEMENT OF DINESH THAKUR, PUBLIC HEALTH660               ACTIVIST, ST. PETERSBURG, FLORIDA661662    Mr. Thakur. Thank you. Chairman Scott, Ranking Member663Gillibrand, and distinguished members of this Committee, I664thank you for convening this hearing on this topic that impacts665all of us.666    My background and training is documented in my statement. I667was a whistleblower in the prosecution of a generic drug668company by the U.S. DOJ in May 2013, where that Indian company669pled guilty to seven counts of criminal felony and agreed to670pay half a billion dollars in fines to the U.S. Government.671    While I have presented my analysis and made substantive672recommendations in my written statement, which I have submitted673to this Committee, I beg your indulgence now. Let me provide674you a few concrete examples of the issues that I referenced in675my statement. We intentionally picked these examples that are676not technical. I have a whole stack of these investigation677reports here which I am more than happy to hand it over to the678Committee today.679    Let me give an example of a company called IPCA680Laboratories, an Indian generic manufacturer that makes and681sells metoprolol tartrate and furosemide beta blocker, and a682diuretic in our market here in the United States. Let me walk683through the chronology of how we have held this company to684account for its fraudulent behavior over the last 16 years.685    In 2014, based on an inspection report on Form 483, USFDA686Inspectors Peter Baker and Joanne King, this is what they said,687the company was manipulating test results so that they could688pass the inspections by playing with instruments in their689controls. Backdating results. The report says integration690parameters are manipulated in order to achieve passing results.691Raw data files have been manipulated, deleted from the system.692In October 2014, USFDA Inspectors Peter Baker and Dipesh Shah693had similar observations in their inspection reports.694    They spoke about attempts to hide results from review,695overwriting raw data files, original reports--results not being696reported, and partially shredding documents. The USFDA went697back to do followup inspections five years later, in August6982019. Inspectors Arsen Karapetyan and Patrick Upadhyay said in699their report, which I have a copy here, it says that a cascade700of failures in your quality control responsibilities, missing701raw data. Repeat analysis by preparing fresh samples when the702original testing failed.703    The USFDA conducted another inspection in 2023, led by704Investigators Rajiv Srivastava and Kellia Hicks and they said705in their report, which I have a copy here, the company706invalidated outer specification results without a scientific707valid cause. The investigation kept open for 10 months without708justification.709    The USFDA conducted another inspection last year, led by710Investigator Salim Akhter. It said in his report here, for the711U.S. market, the facilities are not cleaned properly to712minimize contamination and fail to provide scientific data. In713fact, in January 2016, the USFDA Director of Manufacturing714Quality, Thomas Cosgrove had this to say about this company.715Your firm routinely retested samples without justification. We716observed systematic manipulation of data, backdating test data,717manipulating parameters to obtain passing results, and here is718the punchline.719    In 2017, in August, the USFDA Office of Criminal720investigation closed the investigation of this firm. In late7212022, the USFDA inspectors for--you know, so this is one722example. Another example is a drug called cisplatin. This is a723drugs that is used to treat cancer. We had a shortage of this724drug in this country back in 2022, and this company, the725company that made this drug, was a single source for us based726in India.727    The warning letter issued to this particular company by the728Director of Manufacturing Quality at the USFDA, Francis729Goodwin, said in his warning letter, I have investigated and730observed plastic bags filled with torn and discarded original731GMP documents. An analyst destroyed GMP records by pouring732acetic acid in the trash bin containing analytical balance733slips. He wrote, 20 batch records allowed changes to be made in734manual entries.735    The point I am trying to make here, Chairman Scott and736Ranking Member Gillibrand, imagine if this behavior was737observed and documented in a financial services firm. The738records demonstrating illegal behavior were destroyed by739pouring acidic acid into waste bins. Would we accept that? The740fact that, you know--would we let and draw and go by paying a741fine and not holding Mr. Lay and Mr. Skilling accountable?742    This is what we are doing right now. Then we hear from my743panelists here that we continue to have bad quality drugs in744the country. This is the time for you to call up the USFDA745Office of Criminal Investigation and ask them very pointedly746why these investigations have been closed. I thank you for your747time.748    The Chairman. I want to than each of you. We will start749with questions. We will start with Senator Tuberville.750    Senator Tuberville. Thank you, Mr. Chairman, for holding751this hearing. Today we are not discussing a new issue. As we752all know, America has lost power in the generic drug and753pharmaceutical ingredient market. We are relying on China for754several drugs, and it goes deeper than a trade issue. It is a755national security issue. This is not a partisan issue with756talking points.757    There is real life patient harm and oversight that has758fallen short. We just heard an excellent testimony from Ms.759Salberg here about her past and her problems, and we thank her760for being here today. I want to start with Dr. de La Monte. Can761you tell me how often unannounced inspections happen in foreign762pharmaceutical facilities?763    Dr. de La Monte. I can't tell you how often, but I know764they are infrequent, and they are often tipped. There is no way765to actually hold them truly accountable for what is going on.766    Senator Tuberville. Thank you. Mr. Thakur, can you paint a767really good picture for us of a lab in India, and especially768you, you know, worked in them, about what you see when you go769in there, what they are trying to hide and not trying to hide?770Can you paint good picture of everybody here for that?771    Mr. Thakur. Sure. I can speak to you from my own experience772working in India. I had a misfortune of working in a company in773India for 18 months. Typically what happened in those days was774that the USFDA gave essentially a 2-month intimation saying775that we are coming to inspect your facilities.776    Now, that changed after Ranbaxy. The USFDA established an777office in India and China, but they closed them down, and I778don't know why. You have to ask them for that, but in that779particular case, when the inspector comes in, the way that our780regulations work, the GMP regulations work is we have an honor781system.782    What we do is we say, this is how you told us that you make783the drug. When we come and inspect you, we want to make sure784that we see that you follow what you have told us when you785asked us for approving this drug.786    This is what market authorization in this country really787means. When we go there, we look over documentation. We look at788the processes and it is very easy to game that if people are789given ahead notice.790    In my case, the greatest example that I knew about was that791in 2005, when an inspector came in and asked for certain792documents which were not available, the inspector was told,793well, we will give it to you tomorrow morning, and overnight794the company fabricated those documents, put them in a steam795room to make them look like old documents. Now, is that796acceptable to us?797    Senator Tuberville. No. Ms. Salberg, how can we have high-798quality generic drugs? How do you think we can do that?799    Ms. Salberg. Simply inspect every batch that comes into the800United States at the manufacturer or the purchaser's expense801and send anything that is not the quality that is in the802original ANDA right on back where it came from.803    Senator Tuberville. Dr. Joseph, I am intrigued with your804ability to test your own drugs. Can you explain that?805    Dr. Clark-Joseph. Yes. Although my degree wasn't in806chemistry, I studied quite a bit of chemistry in college, and I807worked in my professor's laboratory one summer. Everybody has808got to have a hobby. I am a little bit on the nerdy side.809    Senator Tuberville. You think?810    Dr. Clark-Joseph. Yes.811    Senator Gillibrand. He is a football coach. Do not listen812to him. He doesn't know what he doesn't know.813    Dr. Clark-Joseph. Yes, so I had a number of reagents,814glassware, microbalances and so on, and I had been playing815around with similar sorts of--you know, I took lots of816supplements. I tried breaking those down into their component817pieces and so on, so I had done similar tasks before and, yes,818the stars aligned in this case.819    Senator Tuberville. Yes. You brought up one point there820when we are talking about generic drugs. We have tens of821billions of dollars spent in this country every year on822supplements that are on the counter that don't have--that are823not prescription drugs and there is no telling what is in these824things, and you know, they look pretty in the bottles and most825of us in here take a supplement or whatever. You got any826thoughts on that Mr. Thakur?827    Mr. Thakur. Regulation for medicine actually is fairly828extensive. Regulation of supplements is significantly below829standards for us in terms of regulation of what really happens.830    The example that Senator Scott spoke about, the deaths from831eye drops, these were over the counter eye drops and should832trusted, that when we go to CVS and Walgreens and actually buy833these, that, you know, they are supposed to work the way that834they are intended. We see issues of contamination of bacteria835that, you know, people lost sight.836    We had deaths, you know, in those cases. That is an837egregious example, but the regulation of supplements is838significantly smaller, lower, compared to the regulation for839medicine.840    Senator Tuberville. Thank you. Thank you, Mr. Chairman.841    The Chairman. Ranking Member Gillibrand.842    Senator Gillibrand. Thank you, Mr. Chairman. Dr. Clark-843Joseph and Mr. Thakur, independent testing for international844manufacturing, the global nature of generic drug supply chain845means that 40 percent of finished dose products sold in the846U.S. are produced abroad.847    When inspecting international facilities, the FDA routinely848gives foreign manufacturers up to 12 weeks advance notice,849which is a lot. This allows bad actors 3 months to falsify850data, sanitize facilities, cover up noncompliance. The FDA also851does not routinely perform independent random testing of852generic drugs already on the market. Compounding this issue853when a foreign facility fails an audit, the FDA may waive854enforcement to prevent shortages despite the quality of the855generic drug.856    This creates a race to the bottom market incentive where857purchasers have no financial incentive to care about drug858quality or reliability. Dr. Clark-Joseph, could independent859third party testing of generic drugs change the financial860incentives to prioritize quality among companies operating in861the U.S.? Is it possible to scale enough testing to make an862impact?863    Dr. Clark-Joseph. Yes, absolutely, to both questions. The864first point as to, could it change financial incentives, I865believe that procurement reform of precisely the type included866in Representative McCormick and DeLauro's Transparency and867Quality in Pharmaceuticals Act would. Introducing quality868metrics and independently derived drug manufacturing metrics869into the military drug procurement would, in addition to the870direct effects, have ripple effects throughout the private871sector.872    Senator Gillibrand. Are you saying start with just the873military's acquisition, seven percent, and then you think doing874that, testing that, making that the highest quality would then875create more incentives for the rest of the thirty-three876percent?877    Dr. Clark-Joseph. Absolutely, because once there is a kind878of gold standard for examining quality, one set by the879Government, ideally codified into law, that will both create a880precedent that these other large group purchasers can follow881without fear of being a pioneer.882    Though kudos to Kaiser for their pioneering work in that883manner. Perhaps more importantly, this will create at least the884specter of potential liability either in a legal sense or885liability to their patients who might become aware of things886and force decisionmakers at the purchasing level to take887quality into account.888    Senator Gillibrand. Create a certification standard so it889can be certified, inspected type thing.890    Dr. Clark-Joseph. That would be wonderful.891    Senator Gillibrand. Dr. Thakur--or Dinesh Thakur.892    Mr. Thakur. I think that clearly there is a cost involved893in testing everything that comes into the country. What we need894to understand is what is the consequence of not doing that895because we really don't have good data as to what is a896consequence of poor quality medicine in terms of897hospitalization, in terms of adverse events. We just don't898track that kind of information.899    In order to justify what is needed to create a testing900program, you always look back and say, well, we have gotten901over this far by doing this. Mostly when patients go to their902pharmacist and say, my medicine isn't working, they are usually903told that it is a psychosomatic thing. It is all in your head904because the drug looks different. Here is the challenge.905    The challenge is that there is no liability for purchases906today. They can determine what goes in the formulary. Like, for907example, most formularies essentially have manufacturers, two908or three manufacturers, and usually they are located overseas.909    As a patient, if I go to my CVS and say, look, if my910formulation is yellow or red, I really don't have the ability911to influence that because the purchasing decision is made by912the formulary at that point in time.913    Creating a liability at the procurement level that I was914talking about, that I think at least will change the equation a915little bit and incentivize buyers to be able to look at quality916as well. Right now, every negotiation is about price. It is not917about quality at all.918    Senator Gillibrand. Thank you, Mr. Chairman.919    The Chairman. Thank you, Ranking Member. Ms. Salberg, how920did you figure out your drug wasn't working?921    Ms. Salberg. My drug didn't work in a number of different922ways, at different points. The beta blocker, my heart rate923didn't come down. The tacrolimus, I found in the morning when I924had my coffee, and my hand was shaking. That is a telltale sign925of being high dosed on tacrolimus.926    This one over here is the one that sent it below normal,9273.9 and opened me for rejection. This has no symptoms. You just928are open to rejection. You have to do a lot of blood testing929and I have been through a lot of IVs and a lot of blood draws930in my life. I don't have good veins. At certain points, they931are going to have to literally start pumping my fingers for932blood to test my levels.933    They have had to do that in the past when you couldn't get934access to a vein. I have challenged veins that I have to pay935somebody to poke to go test the drugs again. Sometimes it is936twice a month to make sure my levels are proper. Now that I am937on name brand, I am down to my monthly to every other month938blood tests.939    The Chairman. You have insurance, I guess.940    Ms. Salberg. I do have insurance.941    The Chairman. If your generic doesn't work, do you have to942pay the higher co-pay because of the brand, even though it943doesn't work?944    Ms. Salberg. Yep.945    The Chairman. Even though you proved it doesn't work?946    Ms. Salberg. Yep.947    The Chairman. That surprised you, didn't it?948    Ms. Salberg. It's--I am sorry?949    The Chairman. Doesn't that surprise you?950    Ms. Salberg. Oh, it shocks me, but I am a patient advocate,951and I have watched how the health insurance companies put us in952a really bad position, especially those with chronic illness.953    The Chairman. Yeah, that doesn't make sense. Dr. Clark-954Joseph, so the argument that some buyers have is they say, oh,955it is going to cost more money. Have you ever done an analysis956that, because when you end up back in the hospital or your957condition is not treated, it actually costs more money? Have958you ever done an analysis that says that is not actually--even959if it costs a little bit more for the, you know, American drug,960it's still worth it?961    Dr. Clark-Joseph. Yes, absolutely. I am actually, both I962and my co-founder, David Light, are co-authors on a recent963working paper on precisely this issue. We estimated the cost964from adverse events associated with low quality drugs.965    I am very happy to followup with detailed calculations and966so on. We found a number that we feel is very conservative of967about $18 billion per year and the actual cost of testing every968batch would be a tiny fraction of that.969    Generic drugs in the United States, although we do pay970significantly more than the rest of the world for our branded971drugs, we pay something like 33 percent less on average for our972generic drugs. We found in our experience with Kaiser and973others that testing and certifying every batch would add about974one to three percent to the cost.975    We could still pay more than 30 percent less than the rest976of the world and have a fully certified generic drug supply977that would be of high quality.978    The Chairman. Dr. de La Monte, you talked about a drug that979was recalled?980    Dr. de La Monte. Yes, the drug was recalled by the FDA, and981yet it remained on the market, and, you know, one of the982pharmacies----983    The Chairman. If I have a--if my car is recalled, right, I984get a letter sent, right, and they tell me I have to go in and985get something done, so that is not the way the FDA works?986    Dr. de La Monte. Not that I am aware. First of all, the987physicians who prescribe the drug are usually unaware that988something has been recalled. The company, you know, one of989the--I don't want to name pharmacies, but specific pharmacies,990they should know that a drug has been recalled and not sell it991to the clients. It seems irresponsible to just get away with it992and not--and to enable disease to go forward.993    Again, it is clearly a pricing issue, or they had it994shelved and they want to sell it. It is a big problem because I995think lack of awareness on the client, the physician, and the996people who are purchasing it just don't seem to be aware.997Hospitals may also be involved in this. They just buy stuff up998in large amounts, again, price driven.999    The Chairman. What kind of contaminants are found in1000medicines, and what kind of risk do they pose to patients?1001    Dr. de La Monte. Well certainly nitrosamines are one of the1002big ones, and the reason I really pay a lot of attention to1003that is because they are linked to chronic diseases which are1004currently pandemic in the world. You know, we have--just taking1005low dose nitrosamine causes diabetes, obesity, fatty liver1006disease, and dementia.1007    You can just name the gang of four that is causing trouble1008in the United States and all the money we spend on trying to1009treat these people. Unfortunately, once you have these kinds of1010diseases that are drug induced, they are harder to treat. Now,1011I will give you a good example.1012    The 1960's and 70's, the rates of diabetes in people who1013were between 60 and 70 were far lower than they are today. The1014cost of treating them today is much higher. If you look at 601015to 70 year olds back then to those now, the rate is so much1016higher, and yet our medicine is supposedly better. What1017happened?1018    The Chairman. Mr. Thakur, so when you were a whistleblower,1019did the FDA say thank you? Thank God that you are here. You1020know, why won't you come in and show us how we are going to1021improve this, and then can you brag about all the changes they1022have made?1023    Mr. Thakur. I wish it was true. I am sorry it wasn't.1024    The Chairman. Oh, it is not true?1025    [Laughter.]1026    Mr. Thakur. I did offer to meet with the FDA.1027Unfortunately, that never came to pass.1028    The Chairman. They didn't--they don't care.1029    Mr. Thakur. I am sure they must have a good reason for1030that. I can't comment why, I mean, they wouldn't want to meet1031with somebody like me. I had something to offer.1032    The Chairman. Ms. Salberg, what do you hear from--do you1033have any stories of other patients that have gotten bad quality1034drugs or ineffective drugs?1035    Ms. Salberg. Many. Dr. Lever and I meet up on a podcast1036every couple of weeks, and we were talking about generic drug1037quality. About five days later, a young man from--who was at1038that time living up in--by Buffalo, New York, and he called and1039said, I am taking myself to the hospital right now.1040    I am like, what is going on, hon? He is like a 28-year-old1041guy. He said, my beta blocker is not working. My heart rate, I1042feel like I am going to die. I got to go to the hospitals. I1043am, like, go, go get it checked out. Then he got stabilized,1044looked at the meds, changed the generic.1045    He went back to his old drug, and he was fine again. That1046was just like a regular old Tuesday afternoon in the office1047with somebody calling saying they have got a problem. I have a1048board member who is on thyroid medication, and she had a battle1049trying to keep her thyroid levels even on generics and gave1050that up decades ago for name brand only because thyroid1051medications are very specific. I have had many people1052hospitalized, and Dr. Lever at the Cleveland Clinic was1053constantly dealing with this.1054    Not only with beta blockers, but the problems back in about10552017, or 1916, 1917, 1918, with tacrolimus. We were losing1056transplant patients, and nobody could figure out why. Why are1057they dying? They have been stable for 10 years and then all of1058a sudden they are in rejection. It is because they got inert1059drugs.1060    You know how much it costs to put a heart in a person? It1061is about a million bucks, and this is like five bucks. Why are1062we not supporting the amazing work that we are doing with this1063high expense, high output procedure with a five dollar drug?1064    The Chairman. Dr. Clark-Joseph, why aren't we testing? I1065mean, the FDA--I think the Department of War is starting to1066test now, right?1067    Dr. Clark-Joseph. That is correct.1068    The Chairman. Why isn't the FDA doing that? I mean, it1069seems pretty simple.1070    Dr. Clark-Joseph. Well, the FDA is mostly set up from a1071process perspective in their inspection and examination1072capacities and that is certainly an important part of the1073equation. Making sure that the production facilities and1074production lines are as they are supposed to be is important.1075    However, as we have seen, it doesn't catch everything. We,1076Valisure, are very much mission aligned with the FDA, but have1077a complementary set of expertise and capabilities. I don't have1078a full explanation beyond that of why the FDA has not gone this1079route. We look forward to any productive collaboration we can1080have with them going forward.1081    The Chairman. Are there examples that you know of in the1082private sector where, in contrast to Federal Government, where1083with drugs they purchase based on quality first, then price?1084    Dr. Clark-Joseph. I know we have been running a program1085with Kaiser for a number of years now, wherein in order for1086manufacturers to enter their bidding process for their next1087year's procurement, the manufacturers need to first get their1088medications tested and then if they are selected, agree to1089ongoing certification. Kaiser is therefore a private-sector1090example--they are still asking manufacturers to compete on1091price but filtering down to the ones who are highest quality1092and then letting them compete on the price.1093    The Chairman. Dr. de La Monte, the FDA relies heavily on1094self-attested manufacturing data to meet manufacturing1095standards. Do you feel comfortable that if somebody has an1096economic incentive to cut costs and the FDA just relies on1097their stuff, does that make any sense to you?1098    Dr. de La Monte. The economic incentives are unacceptable.1099We have to go for quality and patient care and outcomes. We are1100in a healthcare profession to make people well, not worry--I1101mean, the small amount of money that is cited for additional1102testing and third-party qualification, seems like we should be1103willing to pay that amount. You can't get everything for1104nothing, so, right.1105    The Chairman. Senator Gillibrand.1106    Senator Gillibrand. Thank you. Dr. de La Monte and Ms.1107Salzberg--or Salberg--in both of your testimoneys, you discuss1108the long term impacts that low quality medication has on the1109health of patients. However, many consumers do not have the1110background or expertise to discern whether a medication is safe1111or not. This could potentially lead to mistrust with all1112generic drugs.1113    Ms. Salberg, as a patient advocate, how should policymakers1114promote the need for oversight and increasing transparency,1115while avoiding panic that could lead patients to stop treatment1116or delay care if they are financially unable to pay for brand1117name drugs?1118    Ms. Salberg. Thank you for that question. I think, number1119one, we have to be honest. We have to tell the American people1120the honest truth, and we can start today by having the FDA1121update their website, because it tells you generics are the1122same. That is a lie. We can't lie to the American people.1123    We have to tell them the truth. The good news is 70-plus1124percent of generic drugs are great quality, and they work very1125well. We should lean into enforcing good actors to be1126prominent. We should also tell people if they are taking a1127medication that they have taken for a chronic illness for a1128long period of time, and they notice they are feeling1129different, to immediately communicate with their physician.1130    Senator Gillibrand. Make that a red flag. Do you have a--1131have you worked with the AARP to get them to notice that on1132their website, so like as a trusted source of information?1133    Ms. Salberg. The HCMA is much smaller than the AARP, and1134they have not listened to my advice thus far, so maybe this1135might change that, and I hope that they would do that. I would1136just really love if you guys could get the FDA to actually tell1137the truth on their website. That would be helpful.1138    Senator Gillibrand. We will work on that. Dr. de La Monte,1139can you expand on the potential public health consequences if1140patients lose confidence in FDA approved medicines and begin1141avoiding or discontinuing medically necessary therapies based1142on incomplete or misunderstood information? How should we1143increase doctor and patient education on this issue?1144    Dr. de La Monte. First, I think there is a relatively low1145awareness in general among physicians about side effects that1146are specifically due to the drugs. That is a big problem in1147medical education where we just assume that the drug will work.1148We think because it was FDA approved, it is FDA approved to buy1149the generics, and I think that is a misunderstanding.1150    Second, I like the idea of third party testing and then1151having a validation of color codes, so they know this has been1152third-party tested. I actually contacted a supplement company1153that I use, and I said, by the way, how do I know this is not1154poison? They actually showed me all their third party testing1155and validation.1156    I said oh, so it is out there, and you could actually tell1157people. I like the idea of having a website, but there is so1158much on the web, so you need to have a way for--I mean, right1159now, people are using AI for medicine. I mean you may just dial1160it in, whatever it is. You would think that some of those1161complications of a specific generic from company X is1162problematic and shouldn't be prescribed.1163    I mean eventually we have to drill down to physicians and1164health care workers telling people that we are going to keep to1165the safe ones. I think that is the way to go. There are safe1166ones, people are not dying every second, but they have these1167complications.1168    I think because they are not dying every second, we just1169keep dismissing the ones that are bad. We need to come up with1170the good group and tell people that there in fact are bad1171groups.1172    Senator Gillibrand. Yes, agreed. It would be great to have1173a clearinghouse of information on an FDA-approved website to1174actually track production and manufacturers that have bad track1175record.1176    Dr. de La Monte. I agree.1177    Senator Gillibrand. I would think. Dr. Clark-Joseph,1178Valisure is a leader in independent chemical testing for1179carcinogens and toxic impurities in generic drug manufacturing,1180filling a critical transparency gap in the global1181pharmaceutical supply chain. You have partnered with the1182Department of Defense on pharmaceutical quality assurance1183assessment studies to chemically test and score generic1184medications.1185    How has this collaboration informed your ability to scale,1186standardize for a model for large purchasers, and how can we1187use it to reward safe manufacturers? Along with that, when1188various pharmacy chains offer their own generics, do they have1189better quality assurance because they themselves become brand1190names like CVS or Walgreens?1191    Dr. Clark-Joseph. Let me go in reverse order. With respect1192to large pharmacies such as, as you mentioned, CVS or Walgreens1193having their own brand, my impression is that they are still1194sourcing them and procuring them in exactly the same way, and1195that they do not yet have any additional internal or1196independent quality verification or certification built in.1197    As to our project with the Uniformed Services University1198for the military, it has led to fleshing out an operational1199version of this red, yellow, green scoring system, which has1200been guided by an expert review panel, and we have further put1201in the details to do this. We have gotten an excellent snapshot1202of the quality risk profile of the extant manufacturers, of the1203top essential medicines, which also overlap with high use1204medicines in general.1205    That said, we also know through our work with Kaiser1206Permanente, that this absolutely can be done at scale. The kind1207of snapshots that we have been generating for the Uniformed1208Services University, ideally would both be updated on a regular1209basis because manufacturers can change their procedures if1210things turn over, and also perhaps pave the way for batch1211testing in kind of the Kaiser model nationwide.1212    Not to sound like a broken record but this is again why we1213are really, really excited and urge your support for the1214Transparency and Quality in Pharmaceuticals Act.1215    Senator Gillibrand. Yes. It makes sense because you could1216incentivize not only drug--pharmaceutical chains to do it. You1217could incentivize hospital networks to do like with Kaiser1218Permanente.1219    The DOD to do it. You can find the large purchasers or even1220group purchasing organizations to do it, to mandate that they1221have to have the high quality and testing done. Then they say1222we have been tested.1223    My assumption is if you create these large groups doing it,1224it will create a standard and then people will all be asking1225for that standard. It will also raise awareness that you can1226pay for a higher level quality of drug and that everyone should1227have that choice to pay for higher quality level of drug.1228    Dr. Clark-Joseph. Absolutely. Yes, we really believe that1229beginning with military appropriation reform will start that1230ripple effect exactly as you described.1231    Senator Gillibrand. Then the elite hospital networks will1232be next. Then from there, I think the most successful1233pharmaceutical chains will be next. I mean, CVS is going to1234want to certify that their drugs and their medicines that they1235are putting on their label are tested.1236    Dr. Clark-Joseph. Absolutely. One point--although, yes,1237there is some minimal additional cost to testing, it is1238important to note that we didn't find a correlation between1239price and quality in these drugs.1240    It is not like the greens are the most expensive ones.1241There is actually a paper by Kevin Schulman and someone else1242not too long ago that looked at the impact of the recalls of1243the angiotensin II receptor blockers (ARBs) that were recalled1244because they were contaminated with nitrosamines.1245    He compared the price and volumes for those to the1246angiotensin-converting enzyme inhibitors, the ACE drugs that1247serve a similar purpose but weren't recalled.1248    He found that despite the recalls of these objectively bad1249batches, the price of the ARBs did not increase relative to the1250control, and the volume, if anything, slightly increased.1251    Senator Gillibrand. Even if they did slightly, people would1252be happy to pay it. If you just look at a generic of Zyrtec and1253then you look at Zyrtec, the generic is--let's say it is a $101254dosage model. The generic might be $6. There is $4 in there you1255can play with. If it has to be $7 instead of $6. You are still1256offering a lower price, but you are guaranteeing the quality.1257    Dr. Clark-Joseph. Absolutely.1258    Senator Gillibrand. There is a huge difference in price. If1259you are price sensitive, you are buying the generics generally.1260There is still room between the brand and versus the generic to1261add a little more value.1262    Dr. Clark-Joseph. Absolutely, 100 percent.1263    Senator Gillibrand. Mr. Chairman, I have asked all my1264questions, and I have to go pick up my son. Thank you all. I1265have a child arriving at an airport. Thank you all for your1266testimony today. I am very grateful.1267    The Chairman. Thank you, Ranking Member Gillibrand. Dr.1268Clark-Joseph, have any insurance companies or anybody listened1269to you that you could save them money by--at all? Has anybody?1270    Dr. Clark-Joseph. We have pitched it a number of times.1271That was earlier on in our trajectory. At the time, we didn't1272have well-established data. It was just, hey, it seems entirely1273rational that this would save you money in the long term.1274    We hope that with the accretion of more and more data that1275is, in some ways, becoming overwhelming, pointing to the actual1276economic health costs these things, that insurance companies1277and health systems will be much more interested.1278    The Chairman. Can you show me that Medicare would save1279money?1280    Dr. Clark-Joseph. I would have to followup with you for1281detailed analysis, but I think it is overwhelmingly likely that1282Medicare would ultimately save a lot of money.1283    The Chairman. Well, whenever you are ready, I can organize1284a meeting for you with CMS to do that.1285    Dr. Clark-Joseph. I would be delighted. Thank you.1286    The Chairman. Right now, you guys know the risks. How do1287you pick your drugs? Because you have got some pill bottles1288there, right? Does it say where you got it?1289    Ms. Salberg. I brought these three because this is the one1290that was under dosing me. This is the ones that was overdosing1291me and this one came in the middle, but it is a generic and1292then I went to name brand, and I am not risking it anymore1293    The Chairman. You know where those all came from?1294    Ms. Salberg. Where did they come from? No, I didn't know.1295This one is an interesting one. You will like this. It is1296Sandoz. I am from Jersey. They used to be down the street. I1297figured it was a local. It is made in India.1298    The Chairman. How did you find that out?1299    Ms. Salberg. Because I have smart friends who help me1300research, and I am a patient advocate who has more resources.1301    The Chairman. It is not on the bottle, is it?1302    Ms. Salberg. No, no, no. It is on the bottle----1303    The Chairman. Show that--your clothing all has country of1304origin----1305    Ms. Salberg. My clothing does, my shoes do--everything,1306yes.1307    The Chairman. Yes, and that makes you feel good.1308    Ms. Salberg. Yes. You don't know where it is coming from.1309You don't know who made it. There is another component here1310that I do want to bring up, and that is temperature. When these1311drugs are imported, we don't that they are temperature1312controlled, and we don't what the temp really is----1313    The Chairman. We know they are not.1314    Ms. Salberg. What is that?1315    The Chairman. No, no, you know they are not temperature----1316    Ms. Salberg. We know they are not temperature regulated,1317yes. They can get very hot. That is not safe.1318    The Chairman. Yes. How about the rest of you? If you know--1319I guess you know. Are you pretty good about everything you1320might, you or your family might take, or your friends?1321    Dr. Clark-Joseph. I try----1322    The Chairman. It is an important friend to have.1323    Dr. Clark-Joseph. I like to think so. I try very hard, but1324even I--sometimes it is just something I worry about and have1325very little control over. In spite of my connections with1326Valisure and so on, I am still ultimately forced to use1327basically the same pharmacies that everyone else is.1328    If the ones in town have made what strike me as poor1329purchasing decisions that month there's little I can do. I take1330duloxetine. It has been a lifesaver for me. There is a whole1331thing with drug specific nitrosamines in duloxetine. That has1332had me very worried.1333    The Chairman. Somebody else? Dr. de La Monte, do you know1334where your drugs come from?1335    Dr. de La Monte. I wonder----1336    The Chairman. You should know this stuff, right? It is1337impossible, isn't it?1338    Dr. de La Monte. It is really tough. The thing is, somebody1339has to have skin in the game to get this to work.1340    You know, I have asked people I know who are in the higher1341levels of making drugs whether they could actually make their1342own generics, or whether they would supervise the generics,1343because they are the source of the compound. They all claim it1344is impossible. I think it is they just want to push it aside1345and not do it.1346    The Chairman. They don't have to, so then why do it, right?1347    Dr. de La Monte. Right. This is extra work. I think the1348push can come from consumers. If this concept were somehow1349popularized and made aware, you get a lot of pushback from1350people who are angry that this is what is happening.1351    You know, there are some people out there who are on TV and1352the like who might be interested in sharing the information and1353making people aware, and, you know, they are so good at drama.1354    You know, showing the outrageous component of what we are1355getting and realizing that, you know, things could be fixed.1356Sometimes you need a lot of pressure from people who are1357actually the victims, especially the senior citizens who have a1358lot of political clout.1359    The Chairman. It is how our Government is supposed to work,1360right?1361    Dr. de La Monte. Well, it is supposed to, but if people1362don't know, if it is a secret. You know, if you are getting1363food that comes from wherever, you could at least read the1364label. Now you can read the labels, but medicines, we don't----1365    The Chairman. Senator Gillibrand and I have a bill, the1366CLEAR LABELS Act, so it will have country of origin for the1367ingredients of manufacturing, so that is a start. We are also1368working on mapping where all the ingredients come from.1369    I think--and you know, the Federal Government has got1370unbelievable buying power. I used to run the largest hospital1371company. I can tell you what--you know, I was only two percent1372of the healthcare dollar, but I could buy on volume so I could1373direct the market, right.1374    The Federal Government can do the same thing if they want1375to do it, but, you know, they will say, oh, gosh, it is going1376to cost us more money, or blah, blah, blah. It doesn't really1377matter. If you are dead, it doesn't help you much. We are going1378to get this done. Thank each of you for being here. I think1379this was a great hearing.1380    Problems with drug quality are affecting the American1381people, especially older Americans whose health relies on these1382medications. No American should have to wonder if the drug they1383are taking is safe or contains the medicine they need to stay1384healthy. I am going to continue to work with all my colleagues1385to support policies that bring safe and high quality drugs to1386patients.1387    I look forward to continuing to work with my members on1388this Committee. If any Senators have additional questions for1389the witnesses or statements to be added, the hearing record1390will be open until next Wednesday at 5:00 p.m. I want to thank1391each of you for being here.1392    [Whereupon, at 4:39 p.m., the hearing was adjourned.]1393=======================================================================13941395                                APPENDIX13961397=======================================================================13981399                      Prepared Witness Statements14001401=======================================================================1402[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]14031404=======================================================================14051406                        Questions for the Record14071408=======================================================================14091410                 U.S. Senate Special Committee on Aging14111412      "Poisoned Pills: The Human Cost of Dangerous Foreign Drugs"14131414                              June 3, 202614151416                        Questions for the Record14171418                         Dr. Adam Clark-Joseph14191420                        Senator Raphael Warnock14211422    Question:14231424    Rural health providers in Georgia rely on generic drugs to1425treat patients, including older Americans. Due to financial1426vulnerability, rural providers have limited capacity to build a1427stockpile of drugs in preparation for supply shortages.1428    How can Congress ensure rural hospitals and clinics provide1429affordable and safe generic drugs to seniors in times of a drug1430shortage crisis?14311432    Response:14331434    Two of the leading causes of drug shortages are quality1435problems and supply-chain fragility. At a high level,1436incentivizing generic-drug quality and domestic manufacturing1437are vital steps to address the drug-shortage problem.1438    Representatives Rich McCormick and Rosa DeLauro are1439introducing the bipartisan Transparency and Quality in1440Pharmaceuticals Act ("TRaQ Pharma Act") to incorporate the1441Uniformed Services University's chemical quality metrics along1442with independently derived manufacturing location metrics into1443military drug procurement. (They are also working to include1444this bill in the NDAA and provide funding in the Fiscal Year14452027 Defense Appropriations Bill.) The reforms supported by1446this legislation would shift military pharmaceutical1447procurement away from a model in which suppliers compete only1448on cost, in favor of a model in which quality and manufacturing1449location also factor into purchasing decisions.1450    This reform to military drug procurement would have a1451meaningful direct effect to incentivize improved quality and1452American drug manufacturing, which would spill over and improve1453conditions for the non-military segment of the generic-drug1454market. In addition, these reforms, by establishing a "gold1455standard" of sorts for quality and demonstrating well-1456functioning procurement that considers quality, would introduce1457a specter of potential liability for private-sector purchasers1458vis-a-vis quality, and thereby exert an important indirect1459influence to further incentivize high-quality drug selection by1460the private sector. In our view, the reform of military drug-1461procurement is the best option available in the near term to1462address shortages throughout the nation, including in rural1463Georgia.14641465    Question:14661467    It is critical to ensure transparency into where and how1468medicines are manufactured for both patient safety and supply1469chain security.1470    How would requiring country of origin or manufacturing1471facility information on labels improve the security of our drug1472supply chain, particularly for seniors in states like Georgia?14731474    Response:14751476    Requiring country-of-origin labels, as in the Clear Labels1477Act, is an excellent first step towards the greater1478transparency so desperately needed in the American generic drug1479market. While transparency to patients is admirable and1480desirable, patients have little choice or say in the1481manufacturer from which their pharmacy or health system decides1482to purchase drugs.1483    The most important step is to make independent quality and1484place-of-manufacture information available to those large1485purchasers, and to incentivize them to use that information in1486making their purchasing decisions.1487    Military drug procurement reform, of the sort proposed in1488McCormick and DeLauro's TRaQ Pharma Act and NDAA amendment is1489the most readily available measure to start this process.1490Adopting analogous reforms to CMS generic drug procurement,1491though moderately more involved (as it would require updating1492aspects of their reimbursement system), would be the most1493impactful longer-term measure for improving drug quality and1494security nationwide, especially for seniors.1495    Question:14961497    How can Congress enforce existing reporting requirements1498and ensure greater transparency overall?14991500    Response:15011502    A critical problem with existing reporting requirements in1503the U.S. is that most rely on manufacturers to self-report.1504This is, in essence, like relying on an honor system. We1505strongly believe that a shift towards independent assessment,1506both in the form of independent chemical quality testing of1507finished drug products, and in the form of independently1508derived location metrics, is vital to the development of a1509transparent, safe, and secure generic drug supply in the U.S.15101511                 U.S. Senate Special Committee on Aging15121513      "Poisoned Pills: The Human Cost of Dangerous Foreign Drugs"15141515                              June 3, 202615161517                        Questions for the Record15181519                             Dinesh Thakur15201521                        Senator Raphael Warnock15221523    Question:15241525    According to a Government Accountability Office report,1526there have been inspection workforce shortages at the Food and1527Drug Administration (FDA) since 2018. From November 2021 to1528June 2024, the vacancy rate of investigators who oversee drug1529manufacturers increased from 9 percent to 16 percent, leading1530to fewer safety inspections of generic drugs. The Trump1531administration also dismissed more than 3,500 FDA employees in1532April 2025, further exacerbating the FDA's inspection workforce1533capacity.1534    How can Congress help stabilize the FDA inspection1535workforce and improve oversight over foreign manufacturing of1536generic drugs?15371538    Response:15391540    In the report you reference in your question, the GAO1541identifies the root cause of this increase in the vacancy rate1542to be "frequency and conditions of travel, pay, insufficient1543training, heavy workload and issues of work-life balance".1544    Among these issues, pay and training are something that the1545Congress can have a direct oversight of. The cadre of1546inspectors, their training, their pay is within the remit of1547the Senate Committee on Health, Education, Labor and Pensions.1548This committee can directly influence these factors.1549    The issue in my opinion is different. I am reproducing the1550following from the GAO report:1551    According to FDA officials, pilot implementation in China1552was slowed by COVID-19-related travel restrictions, a new visa1553application process, and new Chinese laws related to espionage1554and national security. In addition, FDA officials said that1555increased resource needs for pilot inspections have affected1556the pace of implementation. Specifically, FDA determined that1557unannounced inspections in the pilot are to be conducted by two1558investigators for safety reasons (historically, the majority of1559inspections were conducted by solo investigators).[36]1560    As of May 2024, FDA had initiated 114 pilot inspections in1561India (94 of which were unannounced) and 28 in China (16 of1562which were unannounced), according to an FDA presentation on1563the pilot's status. FDA plans to continue pilot implementation1564through each phase until it has completed about 250 unannounced1565and about 250 preannounced inspections in total across both1566countries.1567    This assumes that we continue to send inspectors located in1568Rockville, MD to conduct inspections of manufacturing1569facilities located in India and China, where a large volume of1570our drug supply originates from.1571    An inspectorate model that depends on international travel1572is bound to fail in my opinion. I have conveyed this to the1573House Energy and Commerce Committee in my testimony two years1574ago. Expecting inspectors located in the US to travel1575reasonably frequently, and therefore be subjected to workload1576and work-life balance issues which are a direct consequence of1577being away from home for weeks or months is not sustainable.1578Further, it also hinders in hiring inspectorate staff whose1579responsibilities are to be away from home and family for1580months, despite being offered better pay.1581    The US FDA conducted a pilot in the aftermath of the1582Ranbaxy case where they had local inspectorate staff in Delhi1583and Mumbai, located within our Embassies. This pilot ended1584after a year, but we don't know why the US FDA did not pursue1585this model. In my opinion, hiring and locating inspectorate1586staff, like our diplomatic cadre in our embassies in these two1587countries which have hundreds of manufacturing facilities1588registered with the US FDA and supply our drugs is a more1589viable model. The agency has not stated publicly why they don't1590consider this model viable after they concluded their pilot,1591therefore I am at a loss to offer an explanation.1592    As far as the HHS Transformation by reducing the number of1593staff at the US FDA, the agency fact sheet said that the DOGE1594reductions "will not affect drug, medical device, or food1595reviewers, nor will it impact inspectors." I do not have access1596to the most recent data on how many of the inspectorate staff1597were affected by these reductions; it is reasonable to assume1598that any reductions would have further exacerbated an already1599untenable situation among the foreign inspectorate staff and1600thereby directly impacting our ability to ensure the quality of1601our medicines supply.1602    At the next opportunity, I hope you would ask the1603Commissioner why the model of locating an inspectorate staff at1604our Embassies in India and China is not a workable one, given1605all the challenges identified in the GAO report.1606=======================================================================16071608                       Statements for the Record16091610=======================================================================1611[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]16121613                                  [all]