[Senate Hearing 119-483]
[From the U.S. Government Publishing Office]
S. Hrg. 119-483
POISONED PILLS: THE HUMAN COST
OF DANGEROUS FOREIGN DRUGS
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HEARING
BEFORE THE
SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE
ONE HUNDRED NINETEENTH CONGRESS
SECOND SESSION
__________
WASHINGTON, DC
__________
JUNE 3, 2026
__________
Serial No. 119-31
Printed for the use of the Special Committee on Aging
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
64-196 PDF WASHINGTON: 2026
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SPECIAL COMMITTEE ON AGING
RICK SCOTT, Florida, Chairman
DAVE McCORMICK, Pennsylvania KIRSTEN E. GILLIBRAND, New York
JIM JUSTICE, West Virginia ELIZABETH WARREN, Massachusetts
TOMMY TUBERVILLE, Alabama MARK KELLY, Arizona
RON JOHNSON, Wisconsin RAPHAEL WARNOCK, Georgia
ASHLEY MOODY, Florida ANDY KIM, New Jersey
JON HUSTED, Ohio ANGELA ALSOBROOKS, Maryland
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McKinley Lewis, Majority Staff Director
Claire Descamps, Minority Staff Director
C O N T E N T S
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Page
Opening Statement of Senator Rick Scott, Chairman................ 1
Opening Statement of Senator Kirsten E. Gillibrand, Ranking
Member......................................................... 3
PANEL OF WITNESSES
Lisa Salberg, Founder and CEO, Hypertrophic Cardiomyopathy
Association, Denville, New Jersey.............................. 4
Adam Clark-Joseph, Ph.D, Chief Analytics Officer and Co-Founder,
Valisure, New Haven, Connecticut............................... 7
Suzanne de La Monte, MD, MPH, Professor and Vice Chair of
Pathology and Laboratory Medicine, Alpert Medical School of
Brown University, Providence, Rhode Island..................... 9
Dinesh Thakur, Public Health Activist, St. Petersburg, Florida... 10
APPENDIX
Prepared Witness Statements
Lisa Salberg, Founder and CEO, Hypertrophic Cardiomyopathy
Association, Denville, New Jersey.............................. 28
Adam Clark-Joseph, Ph.D, Chief Analytics Officer and Co-Founder,
Valisure, New Haven, Connecticut............................... 40
Suzanne de La Monte, MD, MPH, Professor and Vice Chair of
Pathology and Laboratory Medicine, Alpert Medical School of
Brown University, Providence, Rhode Island..................... 77
Dinesh Thakur, Public Health Activist, St. Petersburg, Florida... 82
Questions for the Record
Adam Clark-Joseph, Ph.D, Chief Analytics Officer and Co-Founder,
Valisure, New Haven, Connecticut............................... 95
Dinesh Thakur, Public Health Activist, St. Petersburg, Florida... 97
Statements for the Record
Association for Accessible Medicines Statement................... 100
Peter C. Butler, M.D., Statement................................. 107
Taxpayers Protection Alliance Statement.......................... 109
POISONED PILLS: THE HUMAN COST
OF DANGEROUS FOREIGN DRUGS
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Wednesday, June 3, 2026
U.S. Senate
Special Committee on Aging
Washington, DC.
The Committee met, pursuant to notice, at 3:29 p.m., Room
216, Hart Senate Office Building, Hon. Rick Scott, Chairman of
the Committee, presiding.
Present: Senator Scott, McCormick, Tuberville, Gillibrand,
and Alsobrooks.
OPENING STATEMENT OF SENATOR
RICK SCOTT, CHAIRMAN
The Chairman. Thank you. The U.S. Senate Special Committee
on Aging will now come to order. This country has a big drug
problem, and it is 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.
Congress needs to do everything it can to change that.
Ninety-one percent of prescriptions in the United States are
for generic drugs, and many older Americans will rely on one or
more medications to lead healthy and happy lives. This
Congress, I have 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 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 sent a letter to the FDA asking
about foreign inspections and the quality of drugs coming into
our country. We also wrote letters to group purchasing
organizations, 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's 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 ranking member Gillibrand, 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 takes comes from. That doesn't make any sense. I encourage
all members of this Committee to co-sponsor 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. Today, we want to 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 54 percent more
serious adverse events than equivalent drugs made the U.S.,
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 has been going on for decades. In 2008,
contaminated heparin from Communist China killed nearly 100
Americans. This was a lifesaving blood thinner medication that
these people needed, and it killed them.
Leroy Hubley lost his wife of 48 years, Bonnie, and his
son, Randy, because of contaminated heparin from Communist
China. They relied on this medication for their dialysis
treatment they were 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--there are sadly
too many such stories.
In 2023 contaminated eye drops from India killed four
people and blinded 14 others. This cannot keep happening. As
long as we are not regularly testing drugs coming from
Communist of China and India, and lag behind in foreign
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 has been almost two decades since the heparin incident,
and we are even more reliant on Communist China and India for
our medications than we were then. The bottom line is foreign
manufacturers are not being held to the same standards as
domestic manufacturers. This lets bad actors cut corners. When
it comes to patient safety, patients' lives are on the line.
Here in the U.S., the FDA doesn't announce when it goes to
inspect a manufacturing facility, but overseas, in Communist
China and India, the majority of inspections are pre-announced
so they can cleanup any problems they have 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 2013 when Ranbaxy settled with the Department of
Justice for $500 million 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 to 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 our hearing in March, ChinaRx author, Rosemary Gibson
testified about the Department of War's testing of generic
drugs. What they have found so far is shocking. Of 13 medicines
tested, 15 percent were found to have serious manufacturing
defects, including containing toxins and carcinogens, and not
dissolving properly. These stories of bad quality drugs coming
from Communist China and India aren't isolated incidents. 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--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 as vulnerable as we are on this matter.
When American manufacturing is not an option, we must turn
to our affiliate or 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 in today's hearing
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. Now, I would
like to turn it over to Ranking Member Gillibrand for her
opening statement.
OPENING STATEMENT OF SENATOR
KIRSTEN E. GILLIBRAND, RANKING MEMBER
Senator Gillibrand. Thank you, Chairman Scott. Thank you
for calling today's hearing. Welcome to all our witnesses. I am
very grateful to meet you and excited to hear your testimony. I
am looking forward to continuing this conversation on how we
can improve the quality and reliability of our generic drug
supply chain. As we have 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 Americans take 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
costs 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. 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 U.S. market
are high quality. This includes legislation, like our
bipartisan CLEAR LABELS Act, or proposals to expand supply
chain mapping.
I am 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.
The Chairman. I want to thank Ranking Member Gillibrand for
her bipartisan support 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 would like to thank them for being here today to discuss
their experiences and how we can stop substandard foreign drugs
from entering the U.S. market. Lisa Salberg 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 decline in health before it was too late.
Now she is an advocate, a strong advocate for drug quality
and transparency. I want to thank you for being here today, and
please tell your story.
STATEMENT OF LISA SALBERG, FOUNDER AND CEO,
HYPERTROPHIC CARDIOMYOPATHY ASSOCIATION,
DENVILLE, NEW JERSEY
Ms. Salberg. 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 is a first. I am asking for your help to protect
lives of patients like me who depend on generic medication
every day. We think we are 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 1980 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, and a lifetime of cardiac
medication. I had a stroke in 1990. I am partially blind in one
eye. I have had progressive heart failure, and then in 2017, I
got a transplant. It was on Groundhog's Day that I received a
donor heart from a woman named Brandy, and we are a beautiful
match.
We are perfect together. She has helped me regain nearly
perfect health--health I am fighting now to protect. In 1995,
after I lost my sister, I founded the Hypotrophic
Cardiomyopathy Association, a non-profit that has served over
20,000 families worldwide, and HCMA has developed 62 centers of
excellence across the Nation's most prestigious academic and
health communities in the country.
We have aided in drug discovery, advanced diagnostics, and
we have connected over half a million patients with the right
doctors. I have published over 20 peer-reviewed journal
articles, I have written three books. I am not a physician. I
am a patient advocate. I am here because the system is failing
people like me.
My first experience with generic drugs, we will talk about
in just a second. 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 is a pattern.
First time was 1996. I was taking beta blockers to manage
my heart rate. A generic beta blocker replaced my name brand,
and after two doses, my heartrate wasn't coming down. I went
back to the brand name and thought this was a me thing. Years
later, my dear friend, Dr. Harry Lever from the Cleveland
Clinic had heard a news report and said, Lisa, we need to talk.
I think I know why we are having these problems with our
patients having erratic responses to their blood pressures.
Guess what? It wasn't a me thing. It is a "we" thing. In 2017,
I get my transplant. I am going to be prescribed tacrolimus,
brand name PROGRAF. It is 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 got too low, you risk
rejection. My target is 6.5 to 7.5.
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 through 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, 9.9. You shake when it
goes too high. When it came in at 3.9 and it is too low and I
am open to rejection, there are no symptoms. You are just open
to rejection. Now I pay $120 a month per dose of my name brand
PROGRAF 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. We do the work, and we find
that they have changed their manufacturer of a drug and let's
go back to the other one and see how you are feeling. There is
no accountability, no transparency, and no recourse for
patients in these situations.
We should mention that 85 percent of our generic drugs come
into this country through three different providers or
purchasers. What do we do to fix it? Well, I am going to urge
all of you to pursue concrete codified reforms, not voluntary
guidelines, to modernize our generic drug system, and to hold
purchasers and manufacturers and decisionmakers accountable.
The base of all this is Hatch-Waxman. We got to go back and
fix it. We need to make sure that ANDAs not only require
meeting bio equivalents, but dissolution rates. That has been
the problem in all of my drugs, the dissolution rate is wrong.
We need to inspect every batch of medication brought into the
United States before it hits anybody's system.
We cannot send red labeled 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. I would hope that the FDA would publicly manage
a website where all those test results could be made public.
Anything red goes back to the manufacturer or destroyed at
their expense, and we do not allow anybody to take red
medication. We need to get 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 DeLauro. I will let my friends explain that one. 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.
Good actors should--if they get green scores, good actors
shouldn't be burdened with 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.
Last, I will state that I agree with Drs. Kellermann and
Schulman in their recent New England Journal article when they
said, "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 am happy to take any questions.
The Chairman. Now, I will recognize Ranking Member
Gillibrand for the next witness.
Senator Gillibrand. Thank you, Mr. Chairman. I want to
introduce our next witness, Dr. Adam Clark-Joseph. Dr. Clark-
Joseph is a Chief Analytics Officer and Co-Founder of Valisure,
a technology company working to address a critical gap in the
pharmaceutical supply chain through independent quality
assurance.
Dr. Clark-Joseph was driven to founding Valisure by his
personal experience with significant complications arising from
batch variability in his anticonvulsant medication. Dr. Clark-
Joseph utilizes his expertise as a digital chemist to employ
big data and machine learning for enhancing transparency in the
pharmaceutical supply chain. You may begin.
STATEMENT OF ADAM CLARK-JOSEPH, PHD, CHIEF
ANALYTICS OFFICER AND CO-FOUNDER, VALISURE,
NEW HAVEN, CONNECTICUT
Dr. Clark-Joseph. Ranking Member Gillibrand, Chairman
Scott, members of the Committee, thank you for the honor of
speaking before you today.
I have taken medicine for depression for most of my adult
life. I first encountered a bad batch of medicine when I was
25. After a refill, I suddenly fell ill, and after my doctor
identified the problem, he told me that 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 massively
underdosed, so that was the last straw for me.
I reached out to my longtime friend and scientist, David
Light, and together we founded Valisure, America's first
laboratory dedicated to independently testing and certifying
on-market drug products.
We started Valisure 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 25 million pharmacy products worth over nine
billion. We began testing the blockbuster drug Zantac because
my infant daughter had just been 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.
Why is this shocking problem of low-quality drugs in America so
under-recognized? Bluntly, it is because for 40 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.
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 are forced to buy
drugs in America. Recently, the New England Journal of Medicine
published an article, which Ms. Salberg referenced, titled,
"Substandard Generic Drugs, Threats to Patient Safety and
National Security."
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 were 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 levels than another's, then all else
being equal, shouldn't we prefer the objectively cleaner
product, even if neither are so bad that they break the law? In
pursuit of exactly this end, the military, via the Uniformed
Services University, began a project with Valisure a few years
ago to independently test 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
can easily favor objectively higher quality manufacturers and
avoid lower quality ones. Incidentally, tacrolimus, which you
just heard about from Ms. Salberg, 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 11
years, it completed a clinical study and concluded a lack of
bioequivalence to the brand. Our independent chemical testing
effectively reached the same conclusion in weeks rather than
years and identified the root cause mechanism.
More broadly, testing across 25 drugs and 359 suppliers has
already shown that 72 percent of suppliers scored green, while
15 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 U.S. Simply buying green and
avoiding red could be transformational for incentivizing
quality and American made medicine.
It 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 U.S. 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.
Representatives Rich McCormick and Rosa DeLauro will be
introducing the Bipartisan Transparency and Quality in
Pharmaceuticals Act to incorporate the USU's chemical quality
metrics and also independently derived manufacturing location
metrics into military drug procurement. They are also working
to include this bill in the NDAA and provide funding in the
Fiscal Year 2027 Defense Appropriations Bill.
We respectfully ask that this Committee support this
legislation. It is our one 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.
The Chairman. Thank you. Now I would like to introduce Dr.
Suzanne de la Monte, 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 when Americans unknowingly consume
drugs with manufacturing defects, toxins, and carcinogens.
Thank you for being here. Please begin your testimony.
STATEMENT OF SUZANNE DE LA MONTE, MD, MPH,
PROFESSOR AND VICE CHAIR OF PATHOLOGY
AND LABORATORY MEDICINE, ALPERT MEDICAL
SCHOOL OF BROWN UNIVERSITY,
PROVIDENCE, RHODE ISLAND
Dr. de La Monte. Chairman Scott, Ranking Member Gillibrand,
and committee members, thank you for this opportunity to
participate in these hearings on drugs safety, supply chains,
and risk to aging Americans. I am 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 genetics per se.
What could possibly be the culprit? Convergent factors
including several of the testimoneys 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 will refer to
as Sam.
Sam was previously healthy, gainfully employed, and
productive. His only medical problem was hypertension. However,
after taking two years of a prescribed generic antihypertensive
medication, Sam developed type 2 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 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's now debilitating chronic disease state mirrors what
we have observed in experimental models and in humans exposed
to nitrosamines 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 2025,
contaminated lots of the index medicine continue 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, end 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
manufacturing disproportionately impact seniors in part because
they are victims of polypharmacy.
More than 40 percent of Americans who are over 65 take five
prescribed medications a day, and between 10 percent and 20
percent take 10 or more per day. Healthcare 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 the
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
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, 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.
The Chairman. Thank you for your testimony. Next, we have
Dinesh Thakur, he is a public health advocate who put
everything on the line as a whistleblower against Indian
manufacturer Ranbaxy, exposing systemic violations of FDA
manufacturing standards that resulted in a $500 million
settlement with the DOJ.
Now he advocates for drug quality, stronger FDA oversight,
and holding foreign manufacturers accountable who cut corners
at the expense of American patients. He is a proud Floridian.
Thank you for being here. Please begin your testimony.
STATEMENT OF DINESH THAKUR, PUBLIC HEALTH
ACTIVIST, ST. PETERSBURG, FLORIDA
Mr. Thakur. Thank you. Chairman Scott, Ranking Member
Gillibrand, and distinguished members of this Committee, I
thank you for convening this hearing on this topic that impacts
all of us.
My background and training is documented in my statement. I
was a whistleblower in the prosecution of a generic drug
company by the U.S. DOJ in May 2013, where that Indian company
pled guilty to seven counts of criminal felony and agreed to
pay half a billion dollars in fines to the U.S. 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 referenced in
my statement. We intentionally picked these examples that are
not technical. I have a whole stack of these investigation
reports here which I am more than happy to hand it over to the
Committee today.
Let me give an example of a company called IPCA
Laboratories, an Indian generic 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 16 years.
In 2014, based on an inspection report on Form 483, USFDA
Inspectors Peter Baker and Joanne King, this is what they said,
the company was manipulating test results so that they could
pass the inspections by playing with instruments in their
controls. Backdating 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 2014, USFDA Inspectors Peter Baker and Dipesh Shah
had similar observations in their inspection reports.
They spoke about attempts to hide results from review,
overwriting raw data files, original reports--results not being
reported, and partially shredding documents. The USFDA went
back to do followup inspections five years later, in August
2019. Inspectors Arsen Karapetyan and Patrick Upadhyay 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 2023, led by
Investigators Rajiv Srivastava and Kellia Hicks and they said
in their report, which I have a copy here, the company
invalidated outer specification results without a scientific
valid cause. The investigation kept open for 10 months without
justification.
The USFDA conducted another inspection last year, led by
Investigator Salim Akhter. It said in his report here, for the
U.S. market, the facilities are not cleaned properly to
minimize contamination and fail to provide scientific data. In
fact, in January 2016, the USFDA Director of Manufacturing
Quality, Thomas Cosgrove had this to say about this company.
Your firm routinely retested samples without justification. We
observed systematic manipulation of data, backdating test data,
manipulating parameters to obtain passing results, and here is
the punchline.
In 2017, in August, the USFDA Office of Criminal
investigation closed the investigation of this firm. In late
2022, the USFDA inspectors for--you know, so this is one
example. Another example is a drug called cisplatin. This is a
drugs that is used to treat cancer. We had a shortage of this
drug in this country back in 2022, and this company, the
company that made this drug, was a single source for us based
in India.
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 have investigated and
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. He wrote, 20 batch records allowed changes to be made in
manual entries.
The point I am trying to make here, Chairman Scott and
Ranking Member Gillibrand, imagine if this behavior was
observed and documented in a financial services firm. The
records demonstrating illegal behavior were destroyed by
pouring acidic acid into waste bins. Would we accept that? The
fact that, you know--would we let and draw and go by paying a
fine and not holding Mr. Lay and Mr. Skilling accountable?
This is what we are doing right now. Then we hear from my
panelists here that we continue to have bad quality drugs in
the country. This is the time for you to call up the USFDA
Office of Criminal Investigation and ask them very pointedly
why these investigations have been closed. I thank you for your
time.
The Chairman. I want to than each of you. We will start
with questions. We will start with Senator Tuberville.
Senator Tuberville. Thank you, Mr. Chairman, for holding
this hearing. Today we are not discussing a new issue. As we
all know, America has lost power in the generic drug and
pharmaceutical ingredient market. We are 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. We just heard an excellent testimony from Ms.
Salberg here about her past and her problems, and we thank her
for being here today. I want to start with Dr. de La Monte. Can
you tell me how often unannounced inspections happen in foreign
pharmaceutical facilities?
Dr. de La Monte. I can't tell you how often, but I know
they are infrequent, and they are often tipped. There is no way
to actually hold them truly accountable for what is going on.
Senator Tuberville. Thank you. Mr. Thakur, can you paint a
really good picture for us of a lab in India, and especially
you, you know, worked in them, about what you see when you go
in there, what they are trying to hide and not trying to hide?
Can you paint good picture of everybody here for that?
Mr. Thakur. Sure. I can speak to you from my own experience
working in India. I had a misfortune of working in a company in
India for 18 months. Typically what happened in those days was
that the USFDA gave essentially a 2-month intimation saying
that we are coming to inspect your facilities.
Now, that changed after Ranbaxy. The USFDA established an
office in India and China, but they closed them down, and I
don't know why. 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 want to make sure
that we see that you follow what you have told us 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 processes and it is very easy to game that if people are
given ahead notice.
In my case, the greatest example that I knew about was that
in 2005, when an inspector came in and asked for certain
documents which were not available, the inspector was told,
well, we will 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?
Senator Tuberville. No. Ms. Salberg, how can we have high-
quality generic drugs? How do you think we can do that?
Ms. Salberg. 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.
Senator Tuberville. Dr. Joseph, I am intrigued with your
ability to test your own drugs. Can you explain that?
Dr. Clark-Joseph. Yes. Although my degree wasn't in
chemistry, I studied quite a bit of chemistry in college, and I
worked in my professor's laboratory one summer. Everybody has
got to have a hobby. I am a little bit on the nerdy side.
Senator Tuberville. You think?
Dr. Clark-Joseph. Yes.
Senator Gillibrand. He is a football coach. Do not listen
to him. He doesn't know what he doesn't know.
Dr. Clark-Joseph. Yes, so I had a number of reagents,
glassware, microbalances and so on, and I had been playing
around with similar sorts of--you know, I took lots of
supplements. I tried breaking those down into their component
pieces and so on, so I had done similar tasks before and, yes,
the stars aligned in this case.
Senator Tuberville. Yes. You brought up one point there
when we are 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 is no telling what is in these
things, and you know, they look pretty in the bottles and most
of us in here take a supplement or whatever. You got any
thoughts on that Mr. Thakur?
Mr. Thakur. Regulation for medicine actually is fairly
extensive. Regulation of supplements is significantly below
standards for us in terms of regulation of what really happens.
The example that Senator Scott spoke about, the deaths from
eye drops, these were over the counter eye drops and should
trusted, that when we go to CVS and Walgreens and actually buy
these, that, you know, they are supposed to work the way that
they are intended. We see issues of contamination of bacteria
that, you know, people lost sight.
We had deaths, you know, in those cases. That is an
egregious example, but the regulation of supplements is
significantly smaller, lower, compared to the regulation for
medicine.
Senator Tuberville. Thank you. Thank you, Mr. Chairman.
The Chairman. Ranking Member Gillibrand.
Senator Gillibrand. Thank you, Mr. Chairman. Dr. Clark-
Joseph and Mr. Thakur, independent testing for international
manufacturing, the global nature of generic drug supply chain
means that 40 percent of finished dose products sold in the
U.S. are produced abroad.
When inspecting international facilities, the FDA routinely
gives foreign manufacturers up to 12 weeks advance notice,
which is a lot. This allows bad actors 3 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
when a foreign facility fails an audit, the FDA 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 care about drug
quality or reliability. Dr. Clark-Joseph, could independent
third party testing of generic drugs change the financial
incentives to prioritize quality among companies operating in
the U.S.? Is it possible to scale enough testing to make an
impact?
Dr. Clark-Joseph. Yes, absolutely, to both questions. The
first point as to, could it change financial incentives, I
believe that procurement reform of precisely the type included
in Representative McCormick and DeLauro's Transparency and
Quality in Pharmaceuticals Act would. Introducing quality
metrics and independently derived drug manufacturing metrics
into the military drug procurement would, in addition to the
direct effects, have ripple effects throughout the private
sector.
Senator Gillibrand. Are you saying start with just the
military's acquisition, seven percent, and then you think doing
that, testing that, making that the highest quality would then
create more incentives for the rest of the thirty-three
percent?
Dr. Clark-Joseph. Absolutely, because once there is a kind
of gold standard for examining quality, one set by the
Government, ideally codified into law, that will both create a
precedent that these other large group purchasers can follow
without fear of being a pioneer.
Though kudos to Kaiser for their pioneering work in that
manner. Perhaps more importantly, this will create at least the
specter of potential liability either in a legal sense or
liability to their patients who might become aware of things
and force decisionmakers at the purchasing level to take
quality into account.
Senator Gillibrand. Create a certification standard so it
can be certified, inspected type thing.
Dr. Clark-Joseph. That would be wonderful.
Senator Gillibrand. Dr. Thakur--or Dinesh Thakur.
Mr. Thakur. I think that clearly there is 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 a
consequence of poor quality medicine in terms of
hospitalization, in terms of adverse events. We just don't
track that kind of information.
In order to justify what is needed to create a testing
program, you always look back and say, well, we have gotten
over this far by doing this. Mostly when patients go to their
pharmacist and say, my medicine isn't working, they are usually
told that it is a psychosomatic thing. It is all in your head
because the drug looks different. Here is the challenge.
The challenge is that there is no liability for purchases
today. They can determine what goes in the formulary. Like, for
example, most formularies essentially have manufacturers, two
or three manufacturers, and usually they are located overseas.
As a patient, if I go to my CVS and say, look, if my
formulation 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 I was
talking about, that I think at least will change the equation a
little bit and incentivize buyers to be able to look at quality
as well. Right now, every negotiation is about price. It is not
about quality at all.
Senator Gillibrand. Thank you, Mr. Chairman.
The Chairman. Thank you, Ranking Member. Ms. Salberg, how
did you figure out your drug wasn't working?
Ms. Salberg. My drug didn't work in a number of different
ways, at different points. The beta blocker, my heart rate
didn't come down. The tacrolimus, I found in the morning when I
had my coffee, and my hand was shaking. That is a telltale sign
of being high dosed on tacrolimus.
This one over here is the one that sent it below normal,
3.9 and opened me for rejection. This has no symptoms. You just
are open to rejection. You have to do a lot of blood testing
and I have been through a lot of IVs and a lot of blood draws
in my life. I don't have good veins. At certain points, they
are going to have to literally start pumping my fingers for
blood to test my levels.
They have had to do that in the past when you couldn't get
access to a vein. I have challenged veins that I have to pay
somebody to poke to go test the drugs again. Sometimes it is
twice a month to make sure my levels are proper. Now that I am
on name brand, I am down to my monthly to every other month
blood tests.
The Chairman. You have insurance, I guess.
Ms. Salberg. I do have insurance.
The Chairman. If your generic doesn't work, do you have to
pay the higher co-pay because of the brand, even though it
doesn't work?
Ms. Salberg. Yep.
The Chairman. Even though you proved it doesn't work?
Ms. Salberg. Yep.
The Chairman. That surprised you, didn't it?
Ms. Salberg. It's--I am sorry?
The Chairman. Doesn't that surprise you?
Ms. Salberg. Oh, it shocks me, but I am a patient advocate,
and I have watched how the health insurance companies put us in
a really bad position, especially those with chronic illness.
The Chairman. Yeah, that doesn't make sense. Dr. Clark-
Joseph, so the argument that some buyers have is they say, oh,
it is going to cost more money. Have you ever done an analysis
that, because when you end up back in the hospital or your
condition is not treated, it actually costs more money? Have
you ever done an analysis that says that is not actually--even
if it costs a little bit more for the, you know, American drug,
it's still worth it?
Dr. Clark-Joseph. Yes, absolutely. I am actually, both I
and my co-founder, David Light, are co-authors on a recent
working paper on precisely this issue. We estimated the cost
from adverse events associated with low quality drugs.
I am very happy to followup with detailed calculations and
so on. We found a number that we feel is very conservative of
about $18 billion per year and the actual cost of testing every
batch would be a tiny fraction of that.
Generic drugs in the United States, although we do pay
significantly more than the rest of the world for our branded
drugs, we pay something like 33 percent less on average for our
generic drugs. We found in our experience with Kaiser and
others that testing and certifying every batch would add about
one to three percent to the cost.
We could still pay more than 30 percent less than the rest
of the world and have a fully certified generic drug supply
that would be of high quality.
The Chairman. Dr. de La Monte, you talked about a drug that
was recalled?
Dr. de La Monte. Yes, the drug was recalled by the FDA, and
yet it remained on the market, and, you know, one of the
pharmacies----
The Chairman. If I have a--if my car is recalled, right, I
get a letter sent, right, and they tell me I have to go in and
get something done, so that is not the way the FDA works?
Dr. de La Monte. Not that I am aware. First of all, the
physicians who prescribe the drug are usually unaware that
something has been recalled. The company, you know, one of
the--I don't want to name pharmacies, but specific pharmacies,
they should know that a drug has been recalled and not sell it
to the clients. It seems irresponsible to just get away with it
and not--and to enable disease to go forward.
Again, it is clearly a pricing issue, or they had it
shelved and they want to sell it. It is a big problem because I
think lack of awareness on the client, the physician, and the
people who are purchasing it just don't seem to be aware.
Hospitals may also be involved in this. They just buy stuff up
in large amounts, again, price driven.
The Chairman. What kind of contaminants are found in
medicines, and what kind of risk do they pose to patients?
Dr. de La Monte. Well certainly nitrosamines are one of the
big ones, and the reason I really pay a lot of attention to
that is because they are linked to chronic diseases which are
currently pandemic in the world. You know, we have--just taking
low dose nitrosamine causes diabetes, obesity, fatty liver
disease, and dementia.
You can just name the gang of four that is causing trouble
in the United States and all the money we spend on trying to
treat these people. Unfortunately, once you have these kinds of
diseases that are drug induced, they are harder to treat. Now,
I will give you a good example.
The 1960's and 70's, the rates of diabetes in people who
were between 60 and 70 were far lower than they are today. The
cost of treating them today is much higher. If you look at 60
to 70 year olds back then to those now, the rate is so much
higher, and yet our medicine is supposedly better. What
happened?
The Chairman. Mr. Thakur, so when you were a whistleblower,
did the FDA say thank you? Thank God that you are here. You
know, why won't you come in and show us how we are going to
improve this, and then can you brag about all the changes they
have made?
Mr. Thakur. I wish it was true. I am sorry it wasn't.
The Chairman. Oh, it is not true?
[Laughter.]
Mr. Thakur. I did offer to meet with the FDA.
Unfortunately, that never came to pass.
The Chairman. They didn't--they don't care.
Mr. Thakur. I am sure they must have a good reason for
that. I can't comment why, I mean, they wouldn't want to meet
with somebody like me. I had something to offer.
The Chairman. Ms. Salberg, what do you hear from--do you
have any stories of other patients that have gotten bad quality
drugs or ineffective drugs?
Ms. Salberg. Many. Dr. Lever and I meet up on a podcast
every couple of weeks, and we were talking about generic drug
quality. About five days later, a young man from--who was at
that time living up in--by Buffalo, New York, and he called and
said, I am taking myself to the hospital right now.
I am like, what is going on, hon? He is like a 28-year-old
guy. He said, my beta blocker is not working. My heart rate, I
feel like I am going to die. I got to go to the hospitals. I
am, like, go, go get it checked out. Then he got stabilized,
looked at the meds, changed the generic.
He went back to his old drug, and he was fine again. That
was just like a regular old Tuesday afternoon in the office
with somebody calling saying they have got a problem. I have a
board member who is on thyroid medication, and she had a battle
trying to keep her thyroid levels even on generics and gave
that up decades ago for name brand only because thyroid
medications are very specific. I have had many people
hospitalized, and Dr. Lever at the Cleveland Clinic was
constantly dealing with this.
Not only with beta blockers, but the problems back in about
2017, or 1916, 1917, 1918, with tacrolimus. We were losing
transplant patients, and nobody could figure out why. Why are
they dying? They have been stable for 10 years and then all of
a sudden they are in rejection. It is because they got inert
drugs.
You know how much it costs to put a heart in a person? It
is about a million bucks, and this is like five bucks. Why are
we not supporting the amazing work that we are doing with this
high expense, high output procedure with a five dollar drug?
The Chairman. Dr. Clark-Joseph, why aren't we testing? I
mean, the FDA--I think the Department of War is starting to
test now, right?
Dr. Clark-Joseph. That is correct.
The Chairman. Why isn't the FDA doing that? I mean, it
seems pretty simple.
Dr. Clark-Joseph. Well, the FDA is mostly set up from a
process perspective in their inspection and examination
capacities and that is certainly an important part of the
equation. Making sure that the production facilities and
production lines are as they are supposed to be is important.
However, as we have seen, it doesn't catch everything. We,
Valisure, are very much mission aligned with the FDA, but have
a complementary set of expertise and capabilities. I don't have
a full explanation beyond that of why the FDA has not gone this
route. We look forward to any productive collaboration we can
have with them going forward.
The Chairman. Are there examples that you know of in the
private sector where, in contrast to Federal Government, where
with drugs they purchase based on quality first, then price?
Dr. Clark-Joseph. I know we have been running a program
with Kaiser for a number of years now, wherein in order for
manufacturers to enter their bidding process for their next
year's procurement, the manufacturers need to first get their
medications tested and then if they are selected, agree to
ongoing certification. Kaiser is therefore a private-sector
example--they are still asking manufacturers to compete on
price but filtering down to the ones who are highest quality
and then letting them compete on the price.
The Chairman. Dr. de La Monte, the FDA relies heavily on
self-attested manufacturing data to meet manufacturing
standards. Do you feel comfortable that if somebody has an
economic incentive to cut costs and the FDA just relies on
their stuff, does that make any sense to you?
Dr. de La Monte. The economic incentives are unacceptable.
We have to go for quality and patient care and outcomes. We are
in a healthcare profession to make people well, not worry--I
mean, the small amount of money that is cited for additional
testing and third-party qualification, seems like we should be
willing to pay that amount. You can't get everything for
nothing, so, right.
The Chairman. Senator Gillibrand.
Senator Gillibrand. Thank you. Dr. de La Monte and Ms.
Salzberg--or Salberg--in both of your testimoneys, you discuss
the long term impacts that low quality medication has on the
health of patients. However, many consumers do not have the
background or expertise to discern whether a medication is safe
or not. This could potentially lead to mistrust with all
generic drugs.
Ms. Salberg, as a patient advocate, how should policymakers
promote the need for oversight and increasing transparency,
while avoiding panic that could lead patients to stop treatment
or delay care if they are financially unable to pay for brand
name drugs?
Ms. Salberg. Thank you for that question. I think, number
one, we have to be honest. We have to tell the American people
the honest truth, and we can start today by having the FDA
update their website, because it tells you generics are the
same. That is a lie. We can't lie to the American people.
We have to tell them the truth. The good news is 70-plus
percent of generic drugs are great quality, and they work very
well. We should lean into enforcing good actors to be
prominent. We should also tell people if they are taking a
medication that they have taken for a chronic illness for a
long period of time, and they notice they are feeling
different, to immediately communicate with their physician.
Senator Gillibrand. Make that a red flag. Do you have a--
have you worked with the AARP to get them to notice that on
their website, so like as a trusted source of information?
Ms. Salberg. The HCMA is much smaller than the AARP, and
they have not listened to my advice thus far, so maybe this
might change that, and I hope that they would do that. I would
just really love if you guys could get the FDA to actually tell
the truth on their website. That would be helpful.
Senator Gillibrand. We will work on that. Dr. de La Monte,
can you expand on the potential public health consequences if
patients lose confidence in FDA approved medicines and begin
avoiding or discontinuing medically necessary therapies based
on incomplete or misunderstood information? How should we
increase doctor and patient education on this issue?
Dr. de La Monte. First, I think there is a relatively low
awareness in general among physicians about side effects that
are specifically due to the drugs. That is a big problem in
medical education where we just assume that the drug will work.
We think because it was FDA approved, it is FDA approved to buy
the generics, and I think that is a misunderstanding.
Second, I like the idea of third party testing and then
having a validation of color codes, so they know this has been
third-party tested. I actually contacted a supplement company
that I use, and I said, by the way, how do I know this is not
poison? They actually showed me all their third party testing
and validation.
I said oh, so it is out there, and you could actually tell
people. I like the idea of having a website, but there is so
much on the web, so you need to have a way for--I mean, right
now, people are using AI for medicine. I mean you may just dial
it in, whatever it is. You would think that some of those
complications of a specific generic from company X is
problematic and shouldn't be prescribed.
I mean eventually we have to drill down to physicians and
health care workers telling people that we are going to keep to
the safe ones. I think that is the way to go. There are safe
ones, people are not dying every second, but they have these
complications.
I think because they are not dying every second, we just
keep dismissing the ones that are bad. We need to come up with
the good group and tell people that there in fact are bad
groups.
Senator Gillibrand. Yes, agreed. It would be great to have
a clearinghouse of information on an FDA-approved website to
actually track production and manufacturers that have bad track
record.
Dr. de La Monte. I agree.
Senator Gillibrand. I would think. Dr. Clark-Joseph,
Valisure is a leader in independent chemical testing for
carcinogens and toxic impurities in generic drug manufacturing,
filling a critical transparency gap in the global
pharmaceutical supply chain. You have partnered with the
Department of Defense on pharmaceutical quality assurance
assessment studies to chemically test and score generic
medications.
How has this collaboration informed your ability to scale,
standardize for a model for large purchasers, and how can we
use it to reward safe manufacturers? Along with that, when
various pharmacy chains offer their own generics, do they have
better quality assurance because they themselves become brand
names like CVS or Walgreens?
Dr. Clark-Joseph. Let me go in reverse order. With respect
to large pharmacies such as, as you mentioned, CVS or Walgreens
having their own brand, my impression is that they are still
sourcing them and procuring them in exactly the same way, and
that they do not yet have any additional internal or
independent quality verification or certification built in.
As to our project with the Uniformed Services University
for the military, it has led to fleshing out an operational
version of this red, yellow, green scoring system, which has
been guided by an expert review panel, and we have further put
in the details to do this. We have gotten an excellent snapshot
of the quality risk profile of the extant manufacturers, of the
top essential medicines, which also overlap with high use
medicines in general.
That said, we also know through our work with Kaiser
Permanente, that this absolutely can be done at scale. The kind
of snapshots that we have been generating for the Uniformed
Services University, ideally would both be updated on a regular
basis because manufacturers can change their procedures if
things turn over, and also perhaps pave the way for batch
testing in kind of the Kaiser model nationwide.
Not to sound like a broken record but this is again why we
are really, really excited and urge your support for the
Transparency and Quality in Pharmaceuticals Act.
Senator Gillibrand. Yes. It makes sense because you could
incentivize not only drug--pharmaceutical chains to do it. You
could incentivize hospital networks to do like with Kaiser
Permanente.
The DOD to do it. You can find the large purchasers or even
group purchasing organizations to do it, to mandate that they
have to have the high quality and testing done. Then they say
we have been tested.
My assumption is if you create these large groups doing it,
it will create a standard and then people will all be asking
for that standard. It will also raise awareness that you can
pay for a higher level quality of drug and that everyone should
have that choice to pay for higher quality level of drug.
Dr. Clark-Joseph. Absolutely. Yes, we really believe that
beginning with military appropriation reform will start that
ripple effect exactly as you described.
Senator Gillibrand. Then the elite hospital networks will
be next. Then from there, I think the most successful
pharmaceutical chains will be next. I mean, CVS is going to
want to certify that their drugs and their medicines that they
are putting on their label are tested.
Dr. Clark-Joseph. Absolutely. One point--although, yes,
there is some minimal additional cost to testing, it is
important to note that we didn't find a correlation between
price and quality in these drugs.
It is not like the greens are the most expensive ones.
There is actually a paper by Kevin Schulman and someone else
not too long ago that looked at the impact of the recalls of
the angiotensin II receptor blockers (ARBs) that were recalled
because they were contaminated with nitrosamines.
He compared the price and volumes for those to the
angiotensin-converting enzyme inhibitors, the ACE drugs that
serve a similar purpose but weren't recalled.
He found that despite the recalls of these objectively bad
batches, the price of the ARBs did not increase relative to the
control, and the volume, if anything, slightly increased.
Senator Gillibrand. Even if they did slightly, people would
be happy to pay it. If you just look at a generic of Zyrtec and
then you look at Zyrtec, the generic is--let's say it is a $10
dosage model. The generic might be $6. There is $4 in there you
can play with. If it has to be $7 instead of $6. You are still
offering a lower price, but you are guaranteeing the quality.
Dr. Clark-Joseph. Absolutely.
Senator Gillibrand. There is a huge difference in price. If
you are price sensitive, you are buying the generics generally.
There is still room between the brand and versus the generic to
add a little more value.
Dr. Clark-Joseph. Absolutely, 100 percent.
Senator Gillibrand. Mr. Chairman, I have asked all my
questions, and I have to go pick up my son. Thank you all. I
have a child arriving at an airport. Thank you all for your
testimony today. I am very grateful.
The Chairman. Thank you, Ranking Member Gillibrand. Dr.
Clark-Joseph, have any insurance companies or anybody listened
to you that you could save them money by--at all? Has anybody?
Dr. Clark-Joseph. We have pitched it a number of times.
That was earlier on in our trajectory. At the time, we didn't
have well-established data. It was just, hey, it seems entirely
rational that this would save you money in the long term.
We hope that with the accretion of more and more data that
is, in some ways, becoming overwhelming, pointing to the actual
economic health costs these things, that insurance companies
and health systems will be much more interested.
The Chairman. Can you show me that Medicare would save
money?
Dr. Clark-Joseph. I would have to followup with you for
detailed analysis, but I think it is overwhelmingly likely that
Medicare would ultimately save a lot of money.
The Chairman. Well, whenever you are ready, I can organize
a meeting for you with CMS to do that.
Dr. Clark-Joseph. I would be delighted. Thank you.
The Chairman. Right now, you guys know the risks. How do
you pick your drugs? Because you have got some pill bottles
there, right? Does it say where you got it?
Ms. Salberg. I brought these three because this is the one
that was under dosing me. This is the ones that was overdosing
me and this one came in the middle, but it is a generic and
then I went to name brand, and I am not risking it anymore
The Chairman. You know where those all came from?
Ms. Salberg. Where did they come from? No, I didn't know.
This one is an interesting one. You will like this. It is
Sandoz. I am from Jersey. They used to be down the street. I
figured it was a local. It is made in India.
The Chairman. How did you find that out?
Ms. Salberg. Because I have smart friends who help me
research, and I am a patient advocate who has more resources.
The Chairman. It is not on the bottle, is it?
Ms. Salberg. No, no, no. It is on the bottle----
The Chairman. Show that--your clothing all has country of
origin----
Ms. Salberg. My clothing does, my shoes do--everything,
yes.
The Chairman. Yes, and that makes you feel good.
Ms. Salberg. Yes. You don't know where it is coming from.
You don't know who made it. There is another component here
that I do want to bring up, and that is temperature. When these
drugs are imported, we don't that they are temperature
controlled, and we don't what the temp really is----
The Chairman. We know they are not.
Ms. Salberg. What is that?
The Chairman. No, no, you know they are not temperature----
Ms. Salberg. We know they are not temperature regulated,
yes. They can get very hot. That is not safe.
The Chairman. Yes. How about the rest of you? If you know--
I guess you know. Are you pretty good about everything you
might, you or your family might take, or your friends?
Dr. Clark-Joseph. I try----
The Chairman. It is an important friend to have.
Dr. Clark-Joseph. I like to think so. I try very hard, but
even I--sometimes it is just something I worry about and have
very little control over. In spite of my connections with
Valisure and so on, I am still ultimately forced to use
basically the same pharmacies that everyone else is.
If the ones in town have made what strike me as poor
purchasing decisions that month there's little I can do. I take
duloxetine. It has been a lifesaver for me. There is a whole
thing with drug specific nitrosamines in duloxetine. That has
had me very worried.
The Chairman. Somebody else? Dr. de La Monte, do you know
where your drugs come from?
Dr. de La Monte. I wonder----
The Chairman. You should know this stuff, right? It is
impossible, isn't it?
Dr. de La Monte. It is really tough. The thing is, somebody
has to have skin in the game to get this to work.
You know, I have asked people I know who are in the higher
levels of making drugs whether they could actually make their
own generics, or whether they would supervise the generics,
because they are the source of the compound. They all claim it
is impossible. I think it is they just want to push it aside
and not do it.
The Chairman. They don't have to, so then why do it, right?
Dr. de La Monte. Right. This is extra work. I think the
push can come from consumers. If this concept were somehow
popularized and made aware, you get a lot of pushback from
people who are angry that this is what is happening.
You know, there are some people out there who are on TV and
the like who might be interested in sharing the information and
making people aware, and, you know, they are so good at drama.
You know, showing the outrageous component of what we are
getting and realizing that, you know, things could be fixed.
Sometimes you need a lot of pressure from people who are
actually the victims, especially the senior citizens who have a
lot of political clout.
The Chairman. It is how our Government is supposed to work,
right?
Dr. de La Monte. Well, it is supposed to, but if people
don't know, if it is a secret. You know, if you are getting
food that comes from wherever, you could at least read the
label. Now you can read the labels, but medicines, we don't----
The Chairman. Senator Gillibrand and I have a bill, the
CLEAR LABELS Act, so it will have country of origin for the
ingredients of manufacturing, so that is a start. We are also
working on mapping where all the ingredients come from.
I think--and you know, the Federal Government has got
unbelievable buying power. I used to run the largest hospital
company. I can tell you what--you know, I was only two percent
of the healthcare dollar, but I could buy on volume so I could
direct the market, right.
The Federal Government can do the same thing if they want
to do it, but, you know, they will say, oh, gosh, it is going
to cost us more money, or blah, blah, blah. It doesn't really
matter. If you are dead, it doesn't help you much. We are going
to get this done. Thank each of you for being here. I think
this was a great hearing.
Problems with drug quality are affecting the American
people, especially older Americans whose health relies on these
medications. No American should have to wonder if the drug they
are taking is safe or contains the medicine they need to stay
healthy. I am going to continue to work with all my colleagues
to support policies that bring safe and high quality drugs to
patients.
I look forward to continuing to work with my members on
this Committee. If any Senators have additional questions for
the witnesses or statements to be added, the hearing record
will be open until next Wednesday at 5:00 p.m. I want to thank
each of you for being here.
[Whereupon, at 4:39 p.m., the hearing was adjourned.]
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APPENDIX
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Prepared Witness Statements
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Questions for the Record
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U.S. Senate Special Committee on Aging
"Poisoned Pills: The Human Cost of Dangerous Foreign Drugs"
June 3, 2026
Questions for the Record
Dr. Adam Clark-Joseph
Senator Raphael Warnock
Question:
Rural health providers in Georgia rely on generic drugs to
treat patients, including older Americans. Due to financial
vulnerability, rural providers have limited capacity to build a
stockpile of drugs in preparation for supply shortages.
How can Congress ensure rural hospitals and clinics provide
affordable and safe generic drugs to seniors in times of a drug
shortage crisis?
Response:
Two of the leading causes of drug shortages are quality
problems and supply-chain fragility. At a high level,
incentivizing generic-drug quality and domestic manufacturing
are vital steps to address the drug-shortage problem.
Representatives Rich McCormick and Rosa DeLauro are
introducing the bipartisan Transparency and Quality in
Pharmaceuticals Act ("TRaQ Pharma Act") to incorporate the
Uniformed Services University's chemical quality metrics along
with independently derived manufacturing location metrics into
military drug procurement. (They are also working to include
this bill in the NDAA and provide funding in the Fiscal Year
2027 Defense Appropriations Bill.) The reforms supported by
this legislation would shift military pharmaceutical
procurement away from a model in which suppliers compete only
on cost, in favor of a model in which quality and manufacturing
location also factor into purchasing decisions.
This reform to military drug procurement would have a
meaningful direct effect to incentivize improved quality and
American drug manufacturing, which would spill over and improve
conditions for the non-military segment of the generic-drug
market. In addition, these reforms, by establishing a "gold
standard" of sorts for quality and demonstrating well-
functioning procurement that considers quality, would introduce
a specter of potential liability for private-sector purchasers
vis-a-vis quality, and thereby exert an important indirect
influence to further incentivize high-quality drug selection by
the private sector. In our view, the reform of military drug-
procurement is the best option available in the near term to
address shortages throughout the nation, including in rural
Georgia.
Question:
It is critical to ensure transparency into where and how
medicines are manufactured for both patient safety and supply
chain security.
How would requiring country of origin or manufacturing
facility information on labels improve the security of our drug
supply chain, particularly for seniors in states like Georgia?
Response:
Requiring country-of-origin labels, as in the Clear Labels
Act, is an excellent first step towards the greater
transparency so desperately needed in the American generic drug
market. While transparency to patients is admirable and
desirable, patients have little choice or say in the
manufacturer from which their pharmacy or health system decides
to purchase drugs.
The most important step is to make independent quality and
place-of-manufacture information available to those large
purchasers, and to incentivize them to use that information in
making their purchasing decisions.
Military drug procurement reform, of the sort proposed in
McCormick and DeLauro's TRaQ Pharma Act and NDAA amendment is
the most readily available measure to start this process.
Adopting analogous reforms to CMS generic drug procurement,
though moderately more involved (as it would require updating
aspects of their reimbursement system), would be the most
impactful longer-term measure for improving drug quality and
security nationwide, especially for seniors.
Question:
How can Congress enforce existing reporting requirements
and ensure greater transparency overall?
Response:
A critical problem with existing reporting requirements in
the U.S. is that most rely on manufacturers to self-report.
This is, in essence, like relying on an honor system. We
strongly believe that a shift towards independent assessment,
both in the form of independent chemical quality testing of
finished drug products, and in the form of independently
derived location metrics, is vital to the development of a
transparent, safe, and secure generic drug supply in the U.S.
U.S. Senate Special Committee on Aging
"Poisoned Pills: The Human Cost of Dangerous Foreign Drugs"
June 3, 2026
Questions for the Record
Dinesh Thakur
Senator Raphael Warnock
Question:
According to a Government Accountability Office report,
there have been inspection workforce shortages at the Food and
Drug Administration (FDA) since 2018. From November 2021 to
June 2024, the vacancy rate of investigators who oversee drug
manufacturers increased from 9 percent to 16 percent, leading
to fewer safety inspections of generic drugs. The Trump
administration also dismissed more than 3,500 FDA employees in
April 2025, further exacerbating the FDA's inspection workforce
capacity.
How can Congress help stabilize the FDA inspection
workforce and improve oversight over foreign manufacturing of
generic drugs?
Response:
In the report you reference in your question, the GAO
identifies the root cause of this increase in the vacancy rate
to be "frequency and conditions of travel, pay, insufficient
training, heavy workload and issues of work-life balance".
Among these issues, pay and training are something that the
Congress can have a direct oversight of. The cadre of
inspectors, their training, their pay is within the remit of
the Senate Committee on Health, Education, Labor and Pensions.
This committee can directly influence these factors.
The issue in my opinion is different. I am reproducing the
following from the GAO report:
According to FDA officials, pilot implementation in China
was slowed by COVID-19-related travel restrictions, a new visa
application process, and new Chinese laws related to espionage
and national security. In addition, FDA officials said that
increased resource needs for pilot inspections have affected
the pace of implementation. Specifically, FDA determined that
unannounced inspections in the pilot are to be conducted by two
investigators for safety reasons (historically, the majority of
inspections were conducted by solo investigators).[36]
As of May 2024, FDA had initiated 114 pilot inspections in
India (94 of which were unannounced) and 28 in China (16 of
which were unannounced), according to an FDA presentation on
the pilot's status. FDA plans to continue pilot implementation
through each phase until it has completed about 250 unannounced
and about 250 preannounced inspections in total across both
countries.
This assumes that we continue to send inspectors located in
Rockville, MD to conduct inspections of manufacturing
facilities located in India and China, where a large volume of
our drug supply originates from.
An inspectorate model that depends on international travel
is bound to fail in my opinion. I have conveyed this to the
House Energy and Commerce Committee in my testimony two years
ago. Expecting inspectors located in the US to travel
reasonably frequently, and therefore be subjected to workload
and work-life balance issues which are a direct consequence of
being away from home for weeks or months is not sustainable.
Further, it also hinders in hiring inspectorate staff whose
responsibilities are to be away from home and family for
months, despite being offered better pay.
The US FDA conducted a pilot in the aftermath of the
Ranbaxy case where they had local inspectorate staff in Delhi
and Mumbai, located within our Embassies. This pilot ended
after a year, but we don't know why the US FDA did not pursue
this model. In my opinion, hiring and locating inspectorate
staff, like our diplomatic cadre in our embassies in these two
countries which have hundreds of manufacturing facilities
registered with the US FDA and supply our drugs is a more
viable model. The agency has not stated publicly why they don't
consider this model viable after they concluded their pilot,
therefore I am at a loss to offer an explanation.
As far as the HHS Transformation by reducing the number of
staff at the US FDA, the agency fact sheet said that the DOGE
reductions "will not affect drug, medical device, or food
reviewers, nor will it impact inspectors." I do not have access
to the most recent data on how many of the inspectorate staff
were affected by these reductions; it is reasonable to assume
that any reductions would have further exacerbated an already
untenable situation among the foreign inspectorate staff and
thereby directly impacting our ability to ensure the quality of
our medicines supply.
At the next opportunity, I hope you would ask the
Commissioner why the model of locating an inspectorate staff at
our Embassies in India and China is not a workable one, given
all the challenges identified in the GAO report.
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Statements for the Record
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