[Senate Hearing 119-166]
[From the U.S. Government Publishing Office]
S. Hrg. 119-166
PRESCRIPTION FOR TROUBLE:
DRUG SAFETY, SUPPLY CHAINS, AND
THE RISK TO AGING AMERICANS
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HEARING
BEFORE THE
SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE
ONE HUNDRED NINETEENTH CONGRESS
FIRST SESSION
__________
WASHINGTON, DC
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SEPTEMBER 17, 2025
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Serial No. 119-14
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
61-634 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
Peter Baker, Former FDA Inspector, President, Live Oak Quality
Assurance, Austin, Texas....................................... 4
George Ball, Ph.d, Associate Professor and Weimer Faculty Fellow,
Kelley School of Business, Indiana University, Bloomington,
Indiana........................................................ 6
Brandon Daniels, CEO, Exiger, Washington, D.C.................... 8
Ronald Piervincenzi, Ph.D, CEO, U.S. Pharmacopeia, Washington,
D.C............................................................ 10
APPENDIX
Prepared Witness Statements
Peter Baker, Former FDA Inspector, President, Live Oak Quality
Assurance, Austin, Texas....................................... 42
George Ball, Ph.d, Associate Professor and Weimer Faculty Fellow,
Kelley School of Business, Indiana University, Bloomington,
Indiana........................................................ 47
Brandon Daniels, CEO, Exiger, Washington, D.C.................... 55
Ronald Piervincenzi, Ph.D, CEO, U.S. Pharmacopeia, Washington,
D.C............................................................ 61
Questions for the Record
Peter Baker, Former FDA Inspector, President, Live Oak Quality
Assurance, Austin, Texas....................................... 76
George Ball, Ph.d, Associate Professor and Weimer Faculty Fellow,
Kelley School of Business, Indiana University, Bloomington,
Indiana........................................................ 80
Brandon Daniels, CEO, Exiger, Washington, D.C.................... 83
Ronald Piervincenzi, Ph.D, CEO, U.S. Pharmacopeia, Washington,
D.C............................................................ 85
Statements for the Record
AARP Statement................................................... 99
American Society of Health-System Pharmacists (ASHP) Statement... 101
Amneal Pharmaceuticals LLC Statement............................. 106
Association for Accessible Medicines Statement................... 109
Indian Pharmaceutical Allicance (IPA) Statement.................. 122
National Consumers League Statement.............................. 130
Partnership for Safe Medicines Statement......................... 132
PRESCRIPTION FOR TROUBLE:
DRUG SAFETY, SUPPLY CHAINS, AND
THE RISK TO AGING AMERICANS
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Wednesday, September 17, 2025
U.S. Senate
Special Committee on Aging
Washington, DC.
The Committee met, pursuant to notice, at 3:24 p.m., Room
216, Dirksen Senate Office Building, Hon. Rick Scott, Chairman
of the Committee, presiding.
Present: Senator Scott, McCormick, Johnson, Moody,
Gillibrand, Kim, and Alsobrooks.
OPENING STATEMENT OF SENATOR
RICK SCOTT, CHAIRMAN
The Chairman. Nearly everyone will be prescribed a
medication at some point. Whether it be an antibiotic for an
infection or a treatment for a chronic condition, people depend
on access to safe and high-quality medications. This is
especially true for seniors.
In 2021, a federal study found that 88.6 percent of older
Americans surveyed reported having been prescribed at least one
medication in the past 12 months. Ninety-one percent of
prescriptions filled are for generic drugs. The problem is the
United States relies disproportionately on foreign made generic
drugs from communist China and India.
The U.S. currently depends on overseas manufacturers for
about 75 percent of its essential, essential drug supply.
Communist China is not our friend. They are the world's largest
producers of the active pharmaceutical ingredients, and India
relies on Communist China for approximately 80 percent of the
active pharmaceutical ingredients they use.
A study from Washington University in St. Louis found that
83 percent of the top 100 generic drugs consumed by U.S.
citizens have no U.S. based active source--U.S. based source of
active ingredients. Not only is the U.S. over-dependent on
foreign drugs, but these foreign drugs are often lower quality
and more dangerous than drugs manufactured in the United
States.
Earlier this year, a study showed that serious adverse
events like hospitalization and death were 54 percent more
likely for foreign generic drugs compared to American made
drugs. Bad drug quality doesn't just mean that a drug is less
effective--it can kill. In 2007, 2008, the medication Heparin
had contaminated ingredients from Communist China, killing
nearly 100 people.
Deaths from unsafe medications like these, contaminated
Heparin, devastated families. LeRoy Hubley lost his wife of 48
years, Bonnie, and his son, Randy, just weeks apart. Bonnie and
Randy died due to contaminated Heparin that they needed for
their dialysis treatment. They were undergoing due to a genetic
kidney disease. People who relied on their medication, and
trusted that it was safe, died. This was an absolute tragedy
and must never happen again.
Almost 20 years later, we are still seeing many of the same
problems and quality issues that existed back then. There is
still no routine testing done by the FDA and no incentive for
quality. In 2023, contaminated eye drops from India killed four
people and caused adverse events in at least 55 patients.
Foreign drug manufacturing plants simply aren't subject to
the same level of oversight as manufacturing plants here in the
United States, and Americans are--that doesn't make sense to
any American. Inspections of drug manufacturing facilities in
the Unites States--they are unannounced.
In Communist China and India, many inspections are pre-
announced up to weeks in advance, giving manufacturers time to
present false conditions or conceal non-sterile and unsafe
manufacturing practices. While many quality issues present an
immediate threat to the lives of seniors and their loved ones,
supply chain vulnerabilities presents an existential threat to
the country.
I know my remarks paint a very dark picture of the reality
we face, but it gets much worse. Think about this, if Communist
China or India want to shut down the supply of prescription
drugs to the United States, they can do so at any moment, and
currently the United State does not have a backup plan.
Let me say that again. If the Communist China or India
decide to stop supplying the United States with prescription
drugs, we will run out of prescription drugs very quickly and
people will die. Let that sink in. Millions of Americans will
not have life-saving drugs available to them. Americans will
get sick. Americans will die. We have seen China place expert
restrictions on rare earth elements over trade negotiations,
and there is no reason they can't do that for drugs.
Additionally, during the COVID-19 pandemic, we saw India
block the export of critical ingredients. Many of the
disruptions were prompted by supply chain disruptions from
Communist China, the birthplace of the COVID-19 pandemic. We
simply cannot rely on other countries, especially those who
want to destroy us like Communist China for something as vital
as essential medicines.
Yet, despite these dangers, we still depend almost entirely
on Communist China and India for generic medications, and their
grip on the market continues to grow. As of 2021, Communist
China and India accounted for 85 percent of active drug master
file submissions--85 percent--applications submitted to the FDA
by companies that want to supply drug ingredients to another
company.
In 2000, that accounted for just 24 percent. The
Administration for Strategic Preparedness and Response, the
federal agency that oversees the Strategic National Stockpile,
ensures the Nation has medical countermeasures ready for public
health emergency, lacks the data to understand the supply chain
of the key starting materials or critical building blocks for
pharmaceuticals.
Communist China has a stranglehold on antibiotics, with 90
percent of global antibiotics being of Chinese origin. While
Communist China and India have dominated the market, American
manufacturing has just withered away. A 2024 report from the
API Innovation Center stated that in the past decade, the
number of facilities located in the U.S. that produce active
pharmaceutical ingredients has decreased by 61 percent.
In 2024, the U.S. manufactured 37 percent of its consumed
pharmaceuticals. Just over 20 years ago, in 2002, that figure
was 83 percent. Over 40 percent of generic drugs sold in the
U.S. have just one FDA approved manufacturer. I am a business
guy. You would never rely on one supplier.
This means in the event of a shortage, the FDA must
scramble to find an alternative. In 2023, the chemotherapy drug
Cisplatin went into shortage due to the FDA placing import
restrictions on the manufacturer that accounted for 50 percent
of the market. There was no FDA approved alternative, which
forced the FDA to turn--unapproved Chinese drug company to fill
in the gap. The supply chain is unacceptably vulnerable, and we
can't just hope that shortages won't occur.
If we can't solve this problem, our public health and
national security are in grave danger and people will die. We
will soon hold another hearing to discuss the solutions to
these problems, but the American people deserve to know the
dangers of bad quality medications and a vulnerable supply
chain.
Now, let me turn it over to the Ranking Member Gillibrand
for her opening statement.
OPENING STATEMENT OF SENATOR
KIRSTEN E. GILLIBRAND, RANKING MEMBER
Senator Gillibrand. Thank you, Chairman Scott, for calling
today's hearing. I really appreciate it. Thank you to our
witnesses for being here today. Combating drug shortages and
supporting high quality generic drug production is one of the
most important issues facing Congress today.
In 2023, I heard from countless New York constituents who
struggled with access to chemotherapy treatment due to
shortages of essential generic cancer drugs, including
Cisplatin and Carboplatin. When you are fighting a disease as
devastating as cancer, the last thing you want to worry about
is whether the life-saving drug you need is available.
Another issue that is extremely concerning is the quality
of generic drugs, especially those that we import from
overseas. I have heard time and time again the difficulties the
FDA foreign inspectors face when they are inspecting these
foreign facilities. This can include basic logistical support
or a third-party translator.
When an inspector is abroad for months in a place where
they may not speak the language, it can be very disheartening.
Inspectors can also be put in a position where they must
recommend the closure of a facility, but this can have a
cascading effect of domestic generic shortages.
The FDA needs adequate funding and support from Congress to
ensure that they cannot only conduct these inspections but also
enforce violations to protect the health and safety of the
American public. We also need to work on solutions that promote
transparency and quality benchmarks in the generic drug supply
chain. The pharmaceutical supply chain can be very long and
opaque, where several countries and companies are manufacturing
various ingredients at various levels of quality.
Purchasers need to be incentivized to purchase high-quality
drugs that have proven reliability and a proven reliable supply
chain. Hospitals and practitioners are spending millions of
dollars a year due to drug shortages.
Ultimately, it is the health and safety of our patients and
our constituents that are being put at risk. I am looking
forward to working on bipartisan solutions to promote safe and
reliable supply chains for generic drugs. Thank you, Mr.
Chairman.
The Chairman. Thank you, Ranking Member. I would like to
welcome our witnesses, experts who are here to talk about why
dangerous, low-quality drugs have been allowed to enter the
U.S. market and just how reliant we are on foreign countries
for the medications we need. First, I would like to recognize
Peter Baker.
Mr. Baker is a former FDA Inspector who spent time in both
India and Communist China. As an Inspector, he witnessed
firsthand the unsafe manufacturing conditions and tactics used
by manufacturers to deceive and even obstruct the FDA from
conducting proper investigations of manufacturing facilities.
Mr. Baker, thank you for being here today and I look
forward to hearing your testimony.
STATEMENT OF PETER BAKER, FORMER FDA INSPECTOR,
PRESIDENT, LIVE OAK QUALITY ASSURANCE, AUSTIN, TEXAS
Mr. Baker. Chairman Scott, Ranking Member Gillibrand,
members of the Committee, thank you for the opportunity to
testify today. I want to thank you for this bipartisan focus on
enhancing the security of our generic pharmaceutical supply
chain.
When a patient, especially those most vulnerable, such as
the young and old, fill a prescription which has a 91 percent
chance of being generic here in the U.S., there could be no
doubt about the safety and efficacy of the medicine, or if the
generic will perform as well as the brand name.
There are too many uncontrollable variables to allow this
one to play any role. The FDA has a long history of protecting
and promoting public health and performs extremely challenging
work around the world on a daily basis to achieve that goal
through site inspections, often in remote corners of the world
that do not have internationally recognized regulatory bodies,
which I will refer to as unregulated markets.
FDA investigators often have to deal with demanding travel
conditions and can fall ill due to other unsafe conditions,
such as drinking untreated water, a contaminated meal,
communicable and non-communicable diseases, or fall prey to
other risks often present in still developing nations.
The majority of our overseas pharmaceutical inspections are
pre-announced, often up to two months in advance of our
arrival. In my experience, upon arrival for the inspection, a
strong smell of paint is in the air, fresh paint. The
landscaping is immaculate. All garbage cans are empty.
Potential problematic operations are all shut down, some
employees are sent home, and critical operations are
choreographed as if performing on a stage. Those of us who
performed foreign inspections refer to this as the dog and pony
show, which is frustrating because this is serious business.
How do I know this to be true? Having spent seven years in
three different FDA foreign offices starting in 2012, based out
of our embassies strategically located around the world, we
were tasked with developing inspection techniques capable of
identifying if products exported to the U.S. from unregulated
markets were really meeting our standards because things seemed
too good to be truth. No rejected batches. No issues at all,
really.
We knew the quality of products being manufactured in Ohio
but really had no idea what was happening outside of our
borders, especially in unregulated markets. We spent countless
hours reviewing computer records, dug through piles of garbage,
and showed up at times unannounced.
Booking our travel through Expedia versus the embassy
travel portal to alleviate any concerns, someone would tip off
the sites to our plans. What we found was terrifying. This
testimony only addresses the tip of a massive iceberg. Fake
laboratories pumping out hundreds of results a day that
certified products as 100 percent pure when in fact the product
was never tested.
For those products that did get tested, any failing result
was simply ignored and replaced by a fabricated passing value.
We identified filthy registered shadow facilities that would
funnel their drugs through modern and clean registered sites
which we refer to as the show facility.
We found fabricated manufacturing and quality records,
painting a picture of a site in total compliance, when in fact
substandard or fake medicines were being shipped to the U.S. by
the tens of thousands a day. Following these experiences, I
have no doubt that adverse events, including death happen on a
daily basis here in the U.S. as a result of substandard generic
products from unregulated markets.
The true culprit of these preventable adverse reactions
lies in shortcuts and fraud. Shocking inspection reports
continue to roll in on a monthly basis. The bad players list is
no secret, and they continue to avoid any significant
consequences. Meanwhile, those most vulnerable in our society
taking these drugs have no idea of the games being played and
certainly no idea that the game as designed today can never be
won.
Personally, if I had a choice, I would never consume a drug
product produced in an unregulated market, and any experienced
FDA investigator will give you the same answer. When my 91-
year-old grandma was alive, we would go pharmacy hopping around
our rural Oregon hometown in hopes of finding a batch that was
made by a reliable producer. Sometimes we succeeded and
sometimes not.
I remember one time having to settle for a product
manufactured by Rambaxi, who had just settled with the DOJ for
$500 million for faking countless data points used to
demonstrate their products were safe. I tried to stay positive
because causing her panic wasn't going to help, but inside I
felt sick, and I was not the one receiving cancer treatment.
I urge this Committee to consider these four points. One,
harsher penalties for companies who engage in illegal practices
via the existing authority within FDA and DOJ. Two, changes to
labeling so that patients can see where their medications were
made and put pressure on supply chain decisionmakers to prevent
them from taking a pill made from an unregulated market.
Three, independent third-party testing of every batch of
every product arriving from an unrelated market. The European
Union already does this, and it is a proven model. Four,
resources to support the foreign pharmaceutical inspection
program.
The FDA has made great progress to increase the number of
unannounced inspections they are conducting, but they need
additional resources to be directed to expand the number and
quality of unannounced inspections as already outlined by
Commissioner Makary's public statements. Thank you for your
time and attention to this important matter. I welcome your
questions.
The Chairman. Thank you, Mr. Baker. Next, I would like to
introduce Dr. George Ball from Indiana University, where his
teaching and research focus on operations, supply chains, and
regulatory compliance in the drug industry.
Dr. Ball has been at the forefront of generic drug quality
research, analyzing the intersection of global manufacturing,
FDA oversight, and patient safety.
His work provides critical insights into how supply chain
vulnerabilities translate into risk for American consumers. In
a study published this past February, he and his colleagues
found that generic drugs manufactured in India have higher
rates of adverse events compared to those made here in the
United States.
This research highlights in measurable terms what other
witnesses have seen firsthand. Weaknesses in oversight of
foreign manufacturing can directly affect the safety and
quality of medicines reaching American patients. Dr. Ball,
thank you for being here. I look forward to your testimonie.
STATEMENT OF GEORGE BALL, PH.D, ASSOCIATE PROFESSOR
AND WEIMER FACULTY FELLOW, KELLEY SCHOOL OF
BUSINESS, INDIANA UNIVERSITY, BLOOMINGTON, INDIANA
Dr. Ball. Thank you, Chairman Scott, Ranking Member
Gillibrand, and members of the Committee for the invitation to
speak with you. As Chairman Scott mentioned, I am an Operations
Management Professor at the Kelly School of Business at Indiana
University.
For the last 15 years, I have researched causes of product
quality problems in FDA regulated industries. Prior to that, I
spent a decade as a medical device manufacturing manager. Most
recently, my research has examined generic drug quality and FDA
policy. These topics are the focus of my detailed submitted
written testimony, which I will briefly overview now.
In my view, the root cause of the generic drug quality
problem is the original design of the generic drug marketplace.
While the Hatch-Waxman Act lowered health care costs via
affordable generic drugs, it relies on an unrealistic
assumption. That is, if an original drug is safe and of high
quality, then its generic counterparts will be as well,
requiring little quality verification and no transparency.
Why is this unrealistic? The answer lies in operations
research regarding cost and quality, as well as sources of
defects. First, quality is not free. Higher quality products
normally require higher production costs. Further, quality
defects originate from two primary sources, design and
manufacturing. While the design of a generic drug must be
equivalent to that of the original, two equivalently designed
drugs can be made in vastly different ways.
One can use well-trained employees, sophisticated
equipment, and mature suppliers that make premium raw
materials. Another can be made using poorly trained employees,
cheap equipment, and corner cutting suppliers. In a market
where quality is assumed to be high, while it is unverified and
opaque, the rational economic choice is to focus solely on
cost. This will nearly guarantee poorly manufactured drugs.
This assertion, however, has remained predominantly
theoretical because identifying where a drug is made, which
allows one to study plant, firm, or country level factors that
may influence drug quality is quite onerous. As mentioned, a
team of colleagues and I have recently published a study
referenced in my submitted testimony that begins to address
this gap.
We exactly match generic drugs made in the U.S. against
equivalently designed generic drugs made India. We find that
generic drugs made in India, particularly older ones that have
lower profit margins with greater incentives to cut costs, have
significantly more serious adverse events than equivalent
generics made in U.S. Two working papers that our team has
under review, also referenced in my testimony, provide two
policy changes that may help mitigate this problem.
Transparency is first and foremost. In an experimental
study with thousands of subjects, we find that consumers and
pharmacists are unconvinced by FDA messaging that generic drug
quality is to be trusted regardless of where it is made. We see
a strong preference for U.S. and Canada made drugs over China
and India made ones when we only reveal manufacturing location.
However, when location and quality are both made
transparent, quality tempers these location effects. High
quality China or India made drugs are preferred over lower but
moderate quality U.S. or Canada made drugs. When comparing
equally high-quality drugs however, subjects continue to prefer
U.S. and Canada over China and India.
Drug quality and location transparency can enable market
forces to reward firms for high quality regardless of where
they are made while simultaneously incentivizing high quality
onshoring and near shoring of generic manufacturing. Second to
this is aligning FDA's inspection strategy across the globe.
As has already been mentioned, the FDA inspects China and
India plants after giving weeks or months of advance notice
versus conducting them unannounced in the U.S. In another
working paper that we have under review, we have examined newly
available data from an FDA unannounced inspection pilot
conducted in India. We conclude that pre-announcing inspections
hinders the FDA's ability to assess the true state of quality
at foreign manufacturing plants.
We show that such inspection obscurity aggravates the cost
only focused on harming generic drug quality. I advocate for
drug quality and location transparency, as well as global FDA
inspection parity. Our research indicates these two changes
should help to meaningfully improve generic drug quality. Thank
you.
The Chairman. Thank you, Dr. Ball. I would like to
introduce Brandon Daniels. Mr. Daniels is the Chief Executive
Officer of Exiger, a global leader in supply chain risk
management, transparency, and compliance.
With decades of experience in regulatory compliance and
technology, Mr. Daniels has led efforts to help Governments and
private industry strengthen the security and integrity of
critical supply chains, including those in pharmaceuticals,
defense, and healthcare.
At Exiger, he has overseen the development of innovative
tools that identify vulnerabilities, improve visibility, and
help ensure that products and medicines reaching American
consumers are safe, reliable, and free from hidden risk. Mr.
Daniels, thank you for being here, and I look forward to your
testimonie.
STATEMENT OF BRANDON DANIELS,
CEO, EXIGER, WASHINGTON, D.C.
Mr. Daniels. Chairman Scott, Ranking Member Gillibrand, and
distinguished members of the Committee, thank you for the
opportunity to testify today.
For 20 years, I have worked with pharmaceutical and medical
device companies supporting them through some of the most
significant crisis management and litigation matters affecting
their product development, research, and supply chains.
During the COVID-19 pandemic, I served on the White House's
Joint Acquisition Task Force where I worked alongside federal
partners to secure PPE, medical devices, and life-saving
pharmaceuticals.
That experience underscored for me the fragility of our
pharmaceutical supply chains and the urgent need for reform. In
my role at Exiger, I am leading the development of artificial
intelligence to map supply chains down to their raw material
origins.
This work reveals, in precise detail, the vulnerabilities
hidden in our healthcare system. The scope of this problem is
enormous. America's medicine cabinet is no longer made in
America.
Nearly three-quarters of the essential medicines used in
the United States are sourced overseas. India now supplies
about half of the generic drugs we consume, but 80 percent of
the active pharmaceutical ingredients that make those drugs
possible come from China.
In Fiscal Year 2024, Chinese firms supplied 77 percent of
India's penicillin G and 94 percent of its 6-APA, which is the
indispensable intermediate for penicillin-derived antibiotics.
This concentration creates a dangerous single point of failure
for drugs that every hospital, clinic, and pharmacy in this
country depend on.
That means a Medicaid prescription filled in Ohio, or a
Medicare prescription processed in Florida can often be traced
back to a Chinese supplier. The choke points for our most basic
medicines are controlled by Beijing, and we are not just
dependent, we are actively financing that dependency.
In 2024, Medicaid reimbursed more than $150 million to a
single generic drug company that sourced ingredients from at
least six Chinese firms tied to forced labor and national
security concerns. Dual eligible patients who represent just
about 14 percent of Medicaid enrollment, but consume more than
a third of its spending, are the most exposed to this fragile
system.
Every taxpayer dollar spent on these medicines strengthens
the leverage Beijing has over our health care system. The
consequences for seniors and all American citizens cannot be
ignored. As Chairman Scott mentioned, contaminated eye drops
from India have left American seniors permanently blind.
Blood pressure and diabetes medications imported from Asia
have been recalled after testing positive for carcinogenic
impurities. These are not outliers. Over 30 percent of recent
FDA import alerts involve Chinese producers, and another 16
percent involve Indian suppliers. These are the very countries
we rely on most.
Even more troubling, our data shows that forced labor is
woven into these pharmaceutical supply chains. Chinese state-
owned enterprises with documented links to Uyghur forced labor
in Xinjiang supply raw materials and active ingredients that
ultimately find their way into drugs consumed by Americans.
This creates both an economic competitiveness barrier
through labor arbitrage and a quality hazard for U.S.
pharmaceutical supply chains. The weakness in our medicine
cabinet is also a weakness in international security. More than
54 percent of the Department of War's pharmaceutical supply
chain is classified as high or very high risk because of
reliance on foreign suppliers.
Chinese State media has openly suggested that drug exports
could be withheld as a weapon in conflict. In that scenario,
the most basic medicines in our hospitals, our pharmacies, our
military stockpiles could become tools of coercion. No
adversary needs to fire a shot if they can choke off our access
to antibiotics or insulin. The path forward will not be simple,
but it is clear.
We must expand domestic production of critical medicines,
particularly antibiotics and essential generics. We must
diversify supply chains to trusted allies and ensure no federal
program relies on a single country. We must enforce forced
labor laws so that no American patient consumes medicine
produced through coercion.
We must demand transparency at every level, using modern
mapping and monitoring to stress test these supply chains
before they fail.
The stakes could not be higher. Every time a senior fills a
prescription, every time the service member receives treatment,
every time our children and grandchildren need to fight an ear
infection, there is a real chance the supply chain leads back
to a potentially compromised source.
Thank you for your time this afternoon. I look forward to
answering any questions you may have.
The Chairman. Thank you, Mr. Daniels. Now we are going to
hear from the Ranking Member to introduce the next witness.
Senator Gillibrand. Thank you, Chairman Scott. I want to
move to introduce our next witness, Dr. Ronald Piervincenzi. As
Chief Executive Officer of U.S. Pharmacopeia, Dr. Piervincenzi
is responsible for providing strategic leadership to his global
staff of over 1,300 employees.
Dr. Piervincenzi has helped USP modernize and expand its
operations, including in the areas of digital medicine,
advanced biologics, quality manufacturing, consulting, and
education. You may begin.
STATEMENT OF RONALD PIERVINCENZI, PH.D, CEO,
U.S. PHARMACOPEIA, WASHINGTON, D.C.
Dr. Piervincenzi. Thank you, Ranking Member Gillibrand, and
Chairman Scott, and members of the Committee for the
opportunity to provide the testimony here today about the
United States medicine supply chain that our Nation's seniors
rely on.
As CEO of the United State Pharmacopeia, sometimes I have
to describe who we are, and USP is an independent scientific
nonprofit organization founded on the 1st of January in 1820
when 11 physicians gathered together in the old Senate chamber
concerned about the safety and quality of imported medicines to
the then new United States. On that day, they formed the
world's first national Pharmacopeia.
Today, the 1,200 employees work with hundreds of scientific
experts to set thousands of quality standards for medicines.
USP also offers ingredient verification, product quality
testing, and programs to advance the adoption of pharmaceutical
advanced manufacturing technologies.
USP works to strengthen medicine supply chains to ensure
that patients, and especially older Americans managing their
chronic conditions, can access the generic medicines they need,
when they need them, and very importantly, to trust in their
consistent quality.
Low-cost generic drugs, which account for over 90 percent
of the U.S. medicine supply, have grown quantitatively and
increasingly vulnerable due to geopolitical tensions, natural
disasters, pandemics, and importantly, market pressures. The
globalization has expanded capacity and lowered costs, but it
has also made the supply chains longer, more fragmented, and
less transparent, jeopardizing both patient care and national
security.
Since launching the medicine supply map in 2019 to gain
insight into an opaque supply chain, USP now analyzes 94
percent of U.S. prescription drugs, providing an unprecedented
visibility into key public health and national security
vulnerabilities. USP's work quantitatively points to four
interconnected drivers of our vulnerability. The first is a
continual downward pricing pressure on generic drugs that
creates an unsustainable market for these essential medicines.
The vulnerability number two, is manufacturing complexity,
which is limiting capacity and causing an even greater risk.
Third vulnerability is geographic concentration, exposing
supply to single points of failure wherever those might be, and
finally, the fourth vulnerability are quality disruptions,
which destabilize the supply.
These four factors combine to create an environment that
undervalues resilience, constrains abilities to build
redundancy, and discourages reinvestment in quality systems.
This leaves patients, especially vulnerable seniors, at risk of
delayed access or reliant on less effective secondary
treatments. It is simply unacceptable when we know practical
solutions exist.
No one stakeholder is to blame for the current supply--for
the current state of our supply chain, but our hurdle is rather
our willingness to take this first step together. Solution must
uphold quality, incentivize greater stewardship of our supplied
chain, and preserve the savings that generic medicines have
delivered to patients and seniors.
I commend the chair and the ranking member for their
holistic approach and respectfully urge the Committee to
consider the following solution in three parts. Part one is to
improve the supply chain visibility, identifying key
vulnerabilities and updating this assessment continuously.
Tools like the medicine supply map provide the intelligence
needed for proactive risk management. Understanding risk starts
with increasing visibility into our current blind spots such as
the vulnerable essential medicines, widely used excipients, and
single-sourced key starting materials. We recommend authorizing
an annual assessment that provides insights into our most
significant vulnerabilities and makes recommendations for
mitigation.
These insights could help guide commercial investment to
shore up risky supply lines, certainly involve and inform
policymaking, and direct agency attention and funding where it
matters most.
Part two of the solution is to create pathways for America
to innovate and scale new methods for manufacturing essential
medicines. Advanced manufacturing, alternative synthesis
routes, and new biology-based methods are no longer
theoretical.
USP is partnering with ARPA-H today to explore wheat germ
extract as a U.S. based method for producing a critical API,
thymidine, an example of how the U.S. Government might leverage
advanced manufacturing to reduce reliance on foreign sources
for key ingredients, and part three, establish a benchmark for
a stronger, more resilient medicine supply.
The most important factor underlying the fragility of the
U.S. medicine supply chain is the unsustainable U.S. generics
market. Pricing pressure on low-cost essential medicines drives
generic drug purchases below sustainable production costs,
discouraging investment in quality systems and pushing
manufacturing offshore. Shifting the paradigm to reward a more
resilient supply of medicines is central to promoting an
environment that values reliability, reinvestment in quality
systems, and a competitive domestic industrial base.
Specifically, we propose a resiliency benchmark for
manufacturers of important medicines prepared with incentives
for purchasers to prioritize those who need it, encouraging
sustainable procurement and investment in quality systems,
surge capacity, diversified supply, and greater domestic
production.
To help ensure that America's seniors have consistent
access to quality, the Government should leverage Medicare's
significant purchasing power, along with the DOD-NVA to
incentivize the resilience. Strengthening the supply is a
national security imperative and critical to millions of
seniors.
Together we can and must forge a more secure future for
America's medicine supply. The well-being of millions depends
on it, and I thank you for this opportunity.
The Chairman. Thank you, Dr. Piervincenzi. Now, we will go
to questions. I will turn it over to Senator Ron Johnson.
Senator Johnson. Thank you, Mr. Chairman. Thank you for
holding this hearing. This may be the most important hearing of
this Congress, and maybe many Congresses. Now, it is not
getting much attention, but it needs to.
I first became aware of our vulnerability in February 2020,
my first hearing as Chairman of Homeland Security about the
pandemic, and I had Scott Gottlieb, Judy Gerberding there. I
had no idea that we were so dependent on advanced--or API and
the precursor chemicals on China and India's.
Have we done anything about it? No. We passed a one and a
quarter-trillion-dollar infrastructure bill and didn't even
address it. I think the issue is how do you bring the
manufacturing back to the U.S. where it can be inspected
properly, right. It is not an easy task, but part of the
problem is the precursors chemicals, that is refining and that
needs permitting.
That is expensive to do in America, which is why we have
offshored it to China, so you know, how do we do it? What I
like, and this was Mr. Ball's suggestion here, and I would love
to co-sponsor this bill with you, just simply requiring
labeling in terms of where the drug comes from. They are
putting tremendous pressure on the companies to reshore these
things.
It is not going to happen overnight, but, you know,
Government edicts--you know, spending money to bring, you
know--what you could do potentially is just not tax somebody
who brings a refinery over here, but you got to be able to
permit it. I mean, there is so many impediments to this.
This is a very complex issue, but we have got to start
doing the basics first. But the first one is, again,
understanding the problem, acknowledging we have it.
Understanding how vulnerable we truly are. You know, things
like Heparin. We have known about this for years and we have
literally done nothing about it.
Again, I am looking for really the most practical first
steps we can take. I mean, we can talk about all kinds of, you
know, complex solutions but would you agree that just the
labeling itself--I mean, that would be a pretty easy bill to
pass. It will be interesting to see if we could.
I guess I want from all four of you, what is your number
one single first step that we could take here to address this?
By the way, first it starts with the information, and we need a
lot more information. Again, there is all this--you have all
mentioned the pricing pressure, right. You are all beating up
on drug companies over pricing.
Well, the fact is, on generics, it is probably underpriced
is what you are telling us. Let's just go down the list and
just give me kind of the one thing that you--you know, the
first step we ought to take.
Mr. Baker. From my perspective, I think enforcing the
existing laws, as they are already written through the
authority of the FDA and DOJ, would let the good players know
that it is going to be a level playing field for them.
Senator Johnson. We have laws that are not being enforced.
Why? I mean, how would you enforce them?
Mr. Baker. It is difficult to enforce them at the moment
because of the issue of drug shortages. When issues are
uncovered at some of these factories, they are allowed to--they
carved out the ability to keep supplying these drugs, because
if they were prevented from entering the U.S., then we would
have a supply chain issue, a shortage issue, so it is going to
have to be weaning off of that situation, but it is going to
have to start with letting everybody know that the laws are
going to be enforced, and it is going to----
Senator Johnson. You know, one thing Congress relies on is
whistleblowers. I have been trying to pull information out of
Government agencies for many years now. They don't give up
their secrets very well. Will there be whistleblowers that
would tell us of those instances where there is a quality
problem here and FDA just looked the other way? I mean, we are
going to need examples of that.
Mr. Baker. Absolutely. FDA works with whistleblowers all
over the world pretty much on a daily or a weekly basis.
Senator Johnson. I guess I would encourage whistleblowers
to come forward to this Committee or Permanent Subcommittee on
Investigations. Tell us your story so we can highlight that, so
we can expose it, so we actually start enforcing our laws. Mr.
Ball, I already used yours, but if you got a better one.
Dr. Ball. Well, I agree with you, obviously, because it was
something I talked about. It is the only marketplace where
firms do not reveal their quality and consumers that purchase a
product cannot assess it.
The marketplace is not allowed to work properly for generic
drugs. If quality and location are transparent, the market
would fix, in my view and from research we have done, quite a
bit of the problem. Because market forces would then start to
reward high quality manufacturers and punish low quality ones.
It is a relatively inexpensive solution because it is--
somewhat the invisible hand of the market would fix this issue
if the market was no longer opaque. When it is opaque, the
market is broken, and we have thought long and hard about other
comparable markets like this, and there are very few.
I think transparency of both quality and location is the
answer.
Senator Johnson. I used that when I said it is about
information. The consumers need information which we don't have
right now. Mr. Daniels.
Mr. Daniels. I think the biggest thing from my perspective
is right now we have economic coercion on the other side that
is keeping these key starting materials in particular at
artificially low prices. That is not actually how much they
cost to manufacture. They are significantly subsidized. They
are in free economic zones.
In many cases, they are using labor that is insufficient in
order to conduct these operations. There has got to be an
economic disincentive, some sort of ADCVD against the KSMs that
China is dumping into the market in order to create a U.S.
domestic market that is available and viable, and there are
today, whether it is in fermentation for critical key starting
materials for antibiotics or it is for drugs like Heparin,
there are continuous flow manufacturing capabilities that we
could bring to the United States.
Everyone thinks it is going to take some huge delta between
the current price and the future price to bring investment into
a market. It is not. I mean, you remember in 2008 we had gas
prices spike.
IKEA brought Swedwood, furniture manufacturing, back to
Danville, North Carolina because of the small additional cost
that sat on the top of every piece of furniture. They brought
their entire manufacturing capability back.
Senator Johnson. As long as you can permit it.
Mr. Daniels. Yes, the permitting is a big piece.
Senator Johnson. I suggest to all of you, help us identify
those drugs or drug that we need to start with. You start with
one, you know, succeed in that and then move forward. Mr.
Piervincenzi, actually--I think I got that right. Close?
Dr. Piervincenzi. Perfectly. Thank you. I appreciate that.
I would suggest a market based resiliency benchmark, which is a
positive incentive. It would need to be market-based. It would
absolutely require the Government to kick-start it, and this
would reward the resiliency of having a secure facility with
past inspections on a consistent basis.
All the things we know, and in fact, we created a draft of
these types of benchmarks and just about every factor that was
shared, very much including location of production, your own
supply chain, and from that, even if we were to start, let's
say in hospital systems for hospital use drugs as a starting
point, although I am not saying it is the whole solution, and
then put a hook on that where hospitals have to reward this
through a better contract, a slightly better price.
These are the cheapest medicines, which means a better
price is still not going to break the bank.
Senator Johnson. I think hospitals are still going to be
opaque. I think it has got to be consumers, and if you have too
many elements in that benchmark, again, it is going to
difficult to pass. That is why I am kind of looking at how much
just country of origin as a starting point.
Mr. Chairman, honestly, this is an incredibly important
hearing. I want to work very closely with you and your
witnesses and other experts on this, and we need
whistleblowers.
The only way this gets passed in Congress is the American
public has to understand how vulnerable we are and what risk
they are at, but thank you for this hearing.
The Chairman. Thank you. Ranking Member Gillibrand.
Senator Gillibrand. I would like to turn it over to Senator
Kim.
Senator Kim. Thank you, Chairman and Ranking Member. I
agree, this is an incredibly important issue, and I hope that
this is something that can spur us to work in a bipartisan way.
You know, certainly from my State of New Jersey, a lot of
what we need to be thinking about in terms of what comes next
when it comes to medicine, pharmaceuticals, but recognizing
that we need to do a lot more when it come to the manufacturing
and the supply chain side to make us more resilient.
I think resilient is the right word, because we see not
just with the national security side, but you know, a lot when
it comes to just the economic competitiveness of the United
States and understanding where we need to be going to on a
number of different fronts. I would like to just pick up where
my colleague left off.
You know, Dr. Piervincenzi, I just wanted to get a little
bit more of a sense of this market-based resilience benchmark I
think you framed. Is there a comparable example or is there
something that is being used in other industries or sectors
that can help us kind of understand how this might come about
and how it might be structured?
Dr. Piervincenzi. Thank you for that question, and yes, in
fact, you don't have to leave the pharmaceutical industry.
Let's take a sophisticated multinational company, generic or
innovator, they do this themselves on the goods that they
purchase.
Let's say you are a large innovator pharma company, and you
are looking to ensure that your multi-billion-dollar product is
never short because you have a huge economic incentive to do
so. What you do in your own supply chain is you would never buy
all your key ingredients from one place.
You will have two sources for every ingredient. In
addition, you will send your team to inspect their facilities
and make sure they meet your own quality standards. You will
create a contract which is a long enough term that the supplier
is committed to you just as you are committed to them.
This is normal. Everybody does this. This is nothing
innovative. That process I just described, it works. It is why
innovator drugs are not on the shortage list except for unusual
demand spikes, which we know are something entirely different.
Senator Kim. Then, how do we then take that type of model
though at a societal level? When we are not talking about just
a company looking out for its own bottom line, and in
particular, you know, what is the role of Government? What can
Government do that others can't do so that we can understand
how to fit this all together?
Dr. Piervincenzi. The key here is that the buyer, in the
case I just described, is one single company with a rational
reason to create a resilient supply.
The challenge we have in the U.S. is there are thousands
and thousands of buyers who all wish this to be true, don't
feel empowered to do so, and actually don't have the mechanism
to even pay more money because they don't know what they are
paying for.
Then the answer would have to be both, the creation of the
benchmark, so they no longer have the excuse that they don't
know how to pay for quality, and once you have that, then you
have to create an incentive, or perhaps force, there to be
contracts that reward people from scoring high on those
benchmarks.
There are different parts of our drug supply which will be
harder in some than others, but we believe that where you see
the most drug shortages today, which are in hospital
administered drugs, is actually probably one of the easier
places for leverage, especially because the Federal Government
has its own leverage for how it purchases medicines, and you
see this in quality of care, the tools that can be used. I am
not saying it is extremely easy, but it is not unprecedented,
even in health care.
Senator Kim. Thank you for that. Dr. Ball, I wanted to just
pick up on something you said, which is about that quality
assessment and being able to have that alongside the
geographic. Can you give me a better sense of how that quality
assessment could be done at the scale of what we are talking
about here?
Dr. Ball. Absolutely. The paper I referred to assumes that
the FDA's site selection model scores, which are risk adjusted
scores that the FDA uses both at the drug and plant level to
determine when to inspect a plant, that some form of those
would be amalgamated into a five-star rating on a drug, and
that a five star would be the lowest risk facility, three star
would moderate risk, and that is what we used in this study.
The FDA has this data. They would be very resistant, I believe
from my experience in discussing this with them, to give it out
and use it, but it is at least a starting point, and it is a
combination of adverse events, recalls, inspection scores.
Anything that has happened at the plant or the drug that is a
negative experience creates a higher risk drug and that would
be used to put a score on the label.
Senator Kim. I see. Mr. Baker, I just want to end with you
here. You know, in your testimony, you highlighted how FDA
investigators often have to deal with demanding travel
schedules and conditions, can fall ill. How, you know, in many
parts--and many of these inspections are taking place in
locations where English may not be a primary language spoken,
yet there is no requirement for independent translators. I
wanted to just get a little bit more of a sense from you. What
steps do you think Congress should prioritize to ensure that we
are giving our FDA workforce the support that they need? Also
just thinking through, are there other steps like better
strengthening our collaboration with foreign regulators and
other steps that we can do to try to address these needs?
Mr. Baker. Yes, thanks for that question. I think one of
the things that can be done is to increase the level of
investment in the FDA investigators. A lot of disruption
happened in the FDA during the COVID times where a lot of, for
example, for onsite training and hands-on training was sort of
moved to remote, and that isn't as effective. You know, prior
to that, it would take two or three years to get qualified, so
to speak, to do a foreign inspection. Whereas now, due to
resource constraints, you may be tasked with doing those
inspections, those challenging inspections that you just
mentioned, in like two months after getting hired. You may not
have the skills and the training necessary to do those
effectively. It is very challenging. You will fly into an
airport and then you get in it--especially if you are trying to
do it unannounced. You are going to get in a car, taxi, with
someone you don't know, and drive four to six hours to get to
your hotel that may or may not air conditioning. It is very
difficult and challenging. They need additional support to
really enhance this existing program that they know works.
Those unannounced inspections have about a four time greater
chance of identifying a problem that is going to cause harm to
a human versus an announced. That is what the data shows. They
are very effective, so investment in that area is worth the
effort.
Senator Kim. Thank you, and with that, I will yield back.
The Chairman. Thank you, Senator Kim. Mr. Baker, as a
former FDA Inspector, are you confident in the quality and
safety of generic drugs coming from foreign countries like
China and India?
Mr. Baker. Thanks for that question. The answer is going to
be no. I am not confident about the quality. I am confident in
the sites that I have been to, and I have seen world-class
sites everywhere in the world, manufacturing drugs, and I am
confident in taking those products. But for the majority, I
would say no.
The Chairman. Dr. Ball, what types of adverse events,
deaths, did you find foreign medications caused in your
research?
Dr. Ball. We found examples of cardiac arrests,
gastrointestinal hemorrhage, delirium, cellulitis, acidosis.
Those were just a random sample I took this morning of the
adverse events in our study. There are millions of adverse
events that get reported to the FDA's adverse event reporting
system. These are just a few.
They are serious, and in this paper, we only counted those
adverse events that were caused by the drug, reported by the
manufacturer, mandatorily reported, and caused serious health
outcomes, and there is still millions of those.
The Chairman. Do you think they might be under-reported?
Dr. Ball. I think underreporting is a problem for recalls
and adverse events, and it leverages a lot of what Peter
mentioned. The more FDA is present in a facility in an
unannounced manner, the less likely an un-reporting will go,
because you can discover unreported events in these
inspections, but not if they are announced weeks or months in
advance.
Those are exactly the type of things that a firm is likely
to hide if they have advanced notice. If they don't, it is very
hard to hide those things. The FDA inspection strategy goes
hand in hand with reducing these adverse events.
The Chairman. Mr. Daniels, how much supply of drugs do we
have if Communist China shuts supply off to the United States?
Mr. Daniels. Thank you for the question, Chairman. The
supply chains are interwoven, and I think that is the biggest
issue because you will have specialty pharmaceuticals that are
untouched for six or nine months.
Then when you start to get to the end of that supply chain
and that manufacturing process, you might have severe runs on
the key starting materials or the precursors that are necessary
to support that drug manufacturing.
In the context of generics, and specifically critical
generics like antibiotics, heart medications, insulin, you
could see all supply outside of what is used in emergency rooms
shut down within months if China decided to stop supply to the
United States, especially if they decided to stop supply chains
on a supply chain like sanction, like we have done on forced
labor prevention in China.
If they stopped the sort of intermediaries from selling us
the goods that are manufactured utilizing their materials, it
could be a severe constraint that would look cataclysmic.
The Chairman. Dr. Piramvincenzi, USP is a global
organization with labs and operations abroad. From your
perspective, are foreign made drugs consistently meeting USP
standards, or do you see widespread quality failures?
Dr. Piervincenzi. Thank you, Senator. I may also just maybe
build a bit on Mr. Daniel's comment. The quantifying the if
China were to cutoff supply, what would the impact be is
challenging, but in the next two months or so, USP will issue a
report that covers about 90 percent of our generic supply, so
not all of it, but a vast majority, that will map down to the
key starting material and location of origin.
It will actually be the first time ever I will be able to
answer it. A rough number though, just because we have to start
with something. Half our medicines come from India. Seventy or
eighty percent of their starting materials come from China.
You start to do the math, it is not going to be a majority,
but it is going to be a very large percentage of U.S. medicines
that would become highly vulnerable. Some completely, but many
highly, highly disrupted in short.
The Chairman. Do you have any feel for how much is in the
supply chain that is already in the United States? I mean, I
can't imagine that people that--I used to run a hospital
company. I don't think we sat there and said, let's have one
year supply of drugs just in case something happens. Do you
have any feel for what a typical doctor's office, a group
purchasing organization, or hospital would have in inventory?
Dr. Piervincenzi. At the very end of the supply chain is
extremely little but if you were to say what is onshore in the
United States at a distributor and such, of course it varies,
but it is months, not years, and not weeks--it is months.
If you continue down to your starting materials in your
API, it gets a little longer, and that matters because it makes
it hard for us to get signals. Something might happen, the
manufacturer stops producing, and everything seems fine for a
while. Nine months goes by and suddenly we have a shortage. It
is not really sudden, but it appears sudden at the end because
it takes a while for the chain, and since we don't have good
transparency, we are not watching this happen as it comes
along.
Months is the answer. However, as soon as somebody knows it
has been cutoff, hoarding behavior begins, and the shortage
would take a matter of days in real life. In real life, you
would know if a hurricane hit a plant and everyone knows there
is a problem, everything would be bought up within hours.
The Chairman. Those stores are empty in hours, actually.
Yes.
Dr. Piervincenzi. If nobody knows it happened, of course,
then it would be months. But odds are it is going to leak,
right.
The Chairman. All right. Let me turn it over to Ranking
Member Gillibrand.
Senator Gillibrand. Thank you. For Mr. Piervincenzi, what
are the risks of relying solely on the United States for
production of drugs, and what precautions can we take against
such risks?
Dr. Piervincenzi. Thank you, Senator. One of the four
drivers of resilience was the geographic concentration. That is
agnostic to location. There are different issues about quality
that we are also talking about. Some of the most acute drug
shortages the U.S. has had in the last few years have been
actually on the U.S. shores with an unfortunate hurricane and
other things.
Natural disasters--just things can happen, and they do. It
is possible to create diversification even within the United
States, as long as you don't have all your plants in one place,
and so, there is a nuance to this, what geographic diversity
looks like. If you have two plants in North Carolina across the
street from each other, I would argue that is not very
resilient. If one was on the West Coast and one on the East
Coast, you might be in pretty good shape.
Senator Gillibrand. In your testimony, you indicate the
importance of aligning supply and demand forces so that
American patients have more predictable, sustainable, and
quality supply chain. How can the Federal Government promote a
coordinated effort amongst different stakeholders to move
toward a resilient supply chain?
Dr. Piervincenzi. The simple answer is somebody has to pay
for it. I think you have heard four different versions of that
same thing here, is that somebody has to be not just willing
to, but able to, so a willingness says, I am willing to pay
$0.13 rather than $0.10 for a pill.
Just about everyone is willing to do that. The problem
today is no one has any evidence of how do I do that? If I can
pay $0.13 for the same pill, I don't--it doesn't buy me more
resilience, so this is where a large organization, including--
very much including the U.S. Government, has that power.
To say, for now on, especially for a certain set of drugs
as we know are vulnerable, we will only pay with resilience.
Meaning, this is what we expect, and you will get this price.
The market solution like that means if somebody doesn't meet
those benchmarks, they will be less preferred, so the market
can fill in. It won't force it because it is not a binary
decision.
Because margins are so small, just extending--having a
small, tiny bit paying just a bit more or having a slightly
longer contract could make an enormous difference. I think that
is the benefit of this problem, is that it can be solved with
much less money than if these were expensive medicines.
Senator Gillibrand. Mr. Daniels, in your written testimony,
you recommend the Federal Government conduct regular stress
tests of the pharmaceutical supply chain to stimulate worst
case scenarios and identify weak points before failure. Can you
speak a bit more about how the Federal Government could address
identified weak points from these stress tests?
Mr. Daniels. Absolutely, and thank you, Ranking member
Gillibrand, so two things. One, just to speak about what Dr.
Piervincenzi just mentioned. There are multiple ways to reduce
the cost of these drugs as we reshore them. One of them is also
relying on the innovation of our allies, right.
I mean, there is a global market for pharmaceuticals, and
as we start to look at that market, we do need to diversify
both location, but also, we need to diversity end platforms,
and so, in many cases, there are multiple areas in the supply
chain where we are advising our customers, which are the
Fortune 500, we are advising our customers to find two or three
suppliers downstream to purchase metals, to purchase chemicals,
to purchase goods from.
They can do two things at that point. They can, one,
utilize their purchasing power to actually reduce the cost of
the underlying chemicals, precursors, whatever it might be, key
starting materials. Two, they can give back some of that. Our
customers, when they do what is called a directed or embedded
spend program, they typically save between seven to twenty-two
percent on landed cost on the end goods.
They can actually share back some of that to get to a
resilient supply chain and to get a supplier that is willing to
agree to ethical quality standards, so these programs exist
today. They exist in other industries. They are not as common
in pharmaceutical supply chains, but there are pharma companies
in Europe that we are working with today that are engaged in
these activities, and they are doing it specifically to address
CSDDD.
To get to your second question, which is on these stress
tests. We have been working across a number of different
federal agencies, DLA, FDA, to map the 227 critical medicines
within our supply chains and to understand what are the
consequences of whether it is disruption, like the hurricane
which knocked out our IV fluids capacity in the United States,
or it is major shortages in war gaming due to conflicts with
near peer adversaries, or if it is due to significant changes
in availability of underlying materials. When we are doing this
analysis, it is simple supply chain planning.
Companies do this all the time. Now, what we have to do is
we have to work probably across a consortium with companies
like Exiger and Pharmacopeia to create a complete view of the
supply chain, and that complete view the supply chain doesn't
stop at sort of the specialty pharma or the innovative pharma
company or the generic pharma companies and their suppliers.
It has to go all the way down, and what we have to see is
that reverberating impact. Because Dr. Piervincenzi said, it is
true that many companies have 15 suppliers of the same product
at that next year, and then they have four suppliers at the
next year, and then it goes back to one.
Just no one knows it. That is what happened with
ventilators during the COVID-19 pandemic. All of our solenoid
valves went back to one company in Italy, and so, even though
Ford and GM and everybody stood up to make more ventilators, we
couldn't truly make more because there was only one company
that had that solenoids valve for the commodity ventilators.
We actually have to make sure that mapping is complete, and
then we have to makes sure that we are assessing all of the
risks that can actually impact to that environment, whether it
is geopolitical, it is natural disasters, or it is material
shortages.
The Chairman. Thank you. Senator McCormick.
Senator McCormick. Thank you all for being here. Mr. Baker,
can you describe what level of transparency already exists for
American health care consumers with regard to what country a
medicine or its APIs are from, and what improvements could be
made to ensure Americans have better insight and understanding
on the origins of their medicines?
Mr. Baker. Yes. At the moment the transparency in the
supply chain, as far as patients know about where their
medications are made, is virtually nonexistent. There could be
some improvements in the labeling. It is a complicated issue,
because there is many players in the supply chain as outlined
already, from the key starting materials all the way to the
finished drug.
We would have to take a risk-based approach, where the most
critical step--like for example if it is an aseptically filled
product that is intended for injection, the step in a supply
chain at which that product was aseptically filled in a sterile
environment would be on the label.
It is not a perfect solution, but it is the best we can do
to help increase transparency and let the market fix the issues
as already outlined by my colleagues.
Senator McCormick. Thank you. Mr. Daniels, how can
technology and AI be deployed for hospitals and others to map
their supply chains? I know you touched on this at some level,
and what can be done to advance any reshoring or near-shoring
of drugs and APIs?
Mr. Daniels. Thank you, Senator McCormick, for the
question, so first, hospitals are mapping their supply chains.
We work with multiple hospitals across the United States to map
their supply chains.
They also, in large part, go back to large distributors,
right, that are intermediaries between those hospitals and the
actual drug manufacturers or medical device manufacturers or
PPE manufacturers. The key first step is to use artificial
intelligence to actually break down that bill of material of
each of those pharmaceuticals and then tie those back to the
literal suppliers that those pharmaceutical are coming from.s
The thing is, you can't just map the products you are
buying. You should be mapping the products you are not buying,
and what I mean by that is, you should be--you should
understand the spectrum or the panoply of alternative suppliers
that you have available to you prior to a major disaster--the
customers of ours--we are endorsed by the American Hospital
Association as the key risk management technology company for
all U.S. hospitals.
The customers of ours that had our software deployed knew
almost a month in advance that IV fluids would be subject to
disruption due to Hurricane Helene, and so, that kind of
visibility, of course, it can lead to the stockpiling point
that we just made, but it also can save American lives,
especially in operating rooms.
The second question you had was on the reshoring. I mean,
first, Senator Johnson brought up this point. One of the
biggest issues we have is permitting. We have a huge backlog
and delays in permitting of new facilities and capabilities.
The other thing is a lot of this stuff is pretty dirty to make.
Acetaminophen, just taking as an example, creates a waste
broth that the EPA would not allow us to dispose of in the way
that India or China does today. One of the things that we have
to look at is that there are novel ways to actually manufacture
these. These aren't novel ways that are not taken to scale yet
through BARDA and multiple other programs that are looking for
advanced research and development capabilities in emerging
biotechnology.
In BARDA, we have actually taken some of the continuous
flow manufacturing capabilities to scale, so first, if we can
permit, we can actually make it cost effective, and then the
second thing is, with AI and automation in the actual
manufacturing line, we take away the single and only
differentiation between us and emerging markets in
manufacturing pharmaceuticals at scale, which is labor
arbitrage.
Implementing AI and automation inside of the pharmaceutical
manufacturing process--I mean, there are places in North Texas
that are cheaper than places in Shenzhen, right. We can start
building these factories and actually start, you know,
competing on a global basis.
Senator McCormick. Thank you. Mr. Chairman, Ranking Member,
thank you for having this hearing. Great, great topic. Thank
you.
The Chairman. Senator Alsobrooks.
Senator Alsobrooks. Thank you. Thank you so much, Chair
Scott. Thank you so much, Ranking Member Gillibrand, for
hosting today's hearing, and thank you so much as well to our
witnesses for being here.
What we know is far too many seniors still face the cruel
reality of needing medication that they can't reliably access
or afford. High drug prices, unexpected shortages, and now
Secretary Kennedy's policies are preventing Americans from
accessing the medicine and vaccines that will keep them safe
and healthy. This couldn't be a more relevant topic.
In the past few weeks, I have heard from my constituents,
so many seniors across our state who are eligible for the
latest COVID vaccine, and they are now being turned away
because of the confusion caused by Secretary Kennedy's new
guidelines, and others are being told that their local pharmacy
is struggling to stock the vaccine because of a lag between FDA
approval and the forthcoming recommendations from the Advisory
Committee on Immunization Practices.
When it comes to vaccines, we know that so much doubt is
being cast on life-saving vaccines, as well as dismantling our
public health infrastructure, and that is why this conversation
is so critical. Seniors deserve not just reliable medications,
but a health system that they can trust to put science and
safety above politics. My first question is for Dr.
Piervincenzi.
I would like to ask you, when we see how fragile our drug
supply chains can be when it comes to medicines that seniors
rely on, and vaccines we know are no different, this is a time,
as I have mentioned, when Secretary Kennedy, I believe, is
really destabilizing public trust in vaccines.
Older Americans can't afford disruptions to flu, RSV, or
COVID. I would like to know, how has the confusion regarding
vaccine approvals and recommendations this year made seniors
across the country less safe?
Dr. Piervincenzi. Thank you, Senator. An interesting fact
on the vaccines, as compared to many of the low-cost generics,
there are quite a few manufactured in the United States.
If you consider United States, Europe, Canada, there is a
disproportionately high quantity, so there is the ability for
FDA to do more robust inspections, including surprise for
majority of vaccine sites, and so, the public should have more
confidence, if anything, that they are able to rely on the
quality of the vaccines. As a complex biologic, there are
linkages to the complex generics that are the ones showing up
on the shortage lists the most.
Because they are the kind of medicines used in hospitals,
just for that reason alone, they are impacting two groups the
most--the most senior, especially in oncology, and the
youngest, the pediatric population. Also tending to be oncology
but not only, and these two populations have been most
affected. There is an extra layer to this problem is that these
are the medicines that are least substitutable--it is an art
form to try to treat these cancers.
We haven't cured cancer, so the best we can do is slow it
down in many cases. But a small change from one chemotherapy to
another and the progression advances, it is the person's life
that is at stake, so the vulnerability isn't just about the
medicine, but about the patient and essentially what the next
best alternative is.
From a quality standpoint, items like vaccines are very
different because they are given, of course, to a healthy
patient, so you are measuring it in two very different ways.
However, a poor quality vaccine, you are only going to test
that perhaps 30 or 40 years later when you are exposed to a
disease.
You think about when you need to rely on quality, I can't
think of a medicine more important than vaccines. Thank you.
Senator Alsobrooks. Thank you. Now, I have one other
question regarding--or two actually. The next question is
regarding transparency, and what we know is for seniors in
particular, and this is for any witness, it is not just about
how the drug or where the drug is manufactured, but it is
whether or not they can trust that what is in their pill bottle
is safe, effective, and available when they need it.
Too often our system reacts after a crisis, instead of
putting preventive measures in place, leaving seniors and their
caregivers to find out too late that their medication is
suddenly unavailable.
How should we be thinking about transparency, not just as a
tool for regulators and industry, but as a preventive measure
that empowers patients, especially seniors, to make informed
choices about their medications and avoid being blindsided by
shortages? That is for any witness.
Dr. Piervincenzi. I will be brief to allow others time as
well. I would emphasize pharmacy, if I might, so there is a big
gap to the patient in knowledge and understanding, but we have
an army of hundreds of thousands of health care practitioners
called pharmacists out across our country who are unusually
close to patients, have access on essentially a prescription by
prescription basis.
That is a huge positive. There is an opportunity to have
them play a more active role when it comes to supply chain and
quality. It is not typically a topic that they touch. I think
if we want to be able to help empower patients, we are going to
have to solve this through partnership with pharmacy and
pharmacy organizations that I know are very open and willing to
have this conversation. Thank you.
Senator Alsobrooks. Thank you.
Dr. Ball. Thank you for the question on transparency, so
this is something I have spent a lot of time working on, and
when our paper that I talked about in my introduction got
published, our author team started getting random emails from
the public, scared emails about how can I find out where my
drug is made?
We know know how to figure this out, so this is something
that we were able to do in this study we published, but it is
very difficult, and this is why we advocate for forcing firms
to put the country, the location on the label so that it is
transparent for everyone. We have developed a website that we
are hoping to launch where you can type in a national drug code
number and a flag will pop up to tell the consumer this is
where it is made.
Even developing that website by this author team that we
worked on this paper has been very hard for us because it is a
difficult step to go from a national code, which is on every
drug label, to a country manufacturer, which is very hard to
find out.
Senator Alsobrooks. Thank you.
The Chairman. Thank you, Senator Alsobrooks. Mr. Baker, in
your testimony, you mentioned that Indian generic drug
manufacturers using fake labs to pump out fake results to show
a product was never tested. Can you talk us through what is
supposed to be happening, and what you found and how you found
it?
Mr. Baker. Thanks for the question. Yes, what is supposed
to be happening is that the FDA publishes manufacturing
standards and the Code of Federal Regulations that they are
supposed to follow says when you test something, for example,
you are supposed report all the results that you generate.
You can't just pick one or two that you like and then use
that as the data to release the product. That is what is
supposed to happen. What we found when we started the
unannounced inspection pilot back in 2012 and 2013 is that
those standards aren't being always followed. Some players are
following those standards, but some aren't.
It is difficult because the ones that want to follow the
rules oftentimes won't be able to win a contract to ship those
products to the U.S. because they can't compete with the folks
that aren't actually testing it. Because as already mentioned,
it does cost a few more cents to do it right, but not a lot.
That makes a difference when the margins are so small.
The Chairman. Mr. Baker, in the book, A Bottle of Lies, it
talks about how foreign companies plan guided tours, but you
rejected that, instead wanting to go directly to the quality
control labs. Can you talk about your experiences with foreign
companies? Why did they start with the tour?
Why did you decide to change things up and go directly to
quality control instead? How has that changed the inspection
process? Were you the only one doing that? Do other inspectors
do similar things?
Mr. Baker. I remember the moment that we decided to focus
on the unannounced inspection pilot, and, you know, I had been
trained to do inspections here in the U.S., and we did those
before I got deployed into New Delhi.
Fraud happens here, too, but it is much more limited, like
one person or a small group. I remember that moment being over
there, and I was with a co-inspector, and I just remember like
we looked at each other and we thought, actually, this is--
everybody is involved in this. It is not just a single person
or a small group. It comes from the top down, and it was kind
of like an aha moment.
It is like, have we got to do something about this. We went
back and worked with folks at the embassy to develop ways where
we could gain further insight into what is actually happening,
and that involved showing up unannounced, which hadn't been
done prior to that.
We would arrive unannounced, and we would skip the
conference room presentation and go straight to the lab, and
what we found, like for example, I can think of one that really
just sticks out, one of the larger aseptically filling sites in
the entire world. I mean, some of these are the size of a small
town, and instead of going to the conference room, we went
straight to the microbiology laboratory where they do the
sterility testing. I mean this is a life or death test.
We walked in and there was only one microbiologist on
staff. That was unusual, right. We walked into the chambers
where they are supposed to be testing all these products, and
they were all there, but they were all unlabeled, and so, we
are like, well, where is the sample number on all these samples
that you are supposed to be testing?
All the paperwork was completed, you know, no growth, no
growth, it is sterile, it is sterile, but in reality, none of
the products were getting tested, and once we sort of caught on
that this was happening, that program expanded and continues to
today, and again, like I mentioned, when those inspections are
performed, they result in an ability to find those problems
that are causing these adverse events.
About 40 percent of the time we find issues. Whereas on an
announced inspection, where we show up and the dog and pony
show continues, that is about a five to ten percent chance of
finding those problems, because it is so much more difficult.
We don't do announced inspections in the U.S. Why would you
do that? You show up unannounced and you want to see what is
the real quality of the product. You know, this is shown that
maybe the playing field isn't so level.
The Chairman. You mentioned that the bad players list is no
secret, and these bad companies continue to avoid any
significant consequences. That is telling me that the FDA knows
which are the problem companies, but they aren't being
inspected frequently enough or are still being allowed to
import drugs. Does the FDA have a list of bad companies? What
consequences should these companies be facing?
Mr. Baker. Yes, that list exists. Yes, I mean, I could just
look into the data base and see if which--if I was going to
fill a prescription, which provider I would like to choose, and
I will do that pharmacy hopping to find it, and--sorry, what
was the second part of your question?
The Chairman. Well, what consequences should they--?
Mr. Baker. Oh, yes. The consequences should be, if you are
caught breaking the law, you know, as outlined in the
regulations, you should be prevented from shipping products to
the United States.
The Chairman. They have got a list----
Mr. Baker. Yes.
The Chairman. There is no consequences.
Mr. Baker. Very little consequences. When the FDA takes
action, what they will do is they will just shift those
products to another facility in their network, and so, it is
this cat and mouse game, right.
Then this facility gets shut down, so now they are shipping
out of this one. Then FDA goes over here, but by this time--by
that time, this one is already back in the market, you know,
because they will go back two years later.
It will sometimes be an announced inspection and the game
resets. It is just I go here, I go here, and so, you know, just
enforcing the law and saying, if you break the laws, you are
not going to be allowed to participate, could go a long way.
The Chairman. Then we put that in our bodies.
Mr. Baker. That is correct, yes.
The Chairman. Ranking Member.
Senator Gillibrand. Very depressing. Dr. Ball, you have
studied the impact of five-star quality ratings and country of
origin labeling on consumer choice. As you know, not everybody
has the skill set that Mr. Baker described of being able to
know which vendor is actually safe.
Patients don't have much choice in choosing which medicines
their pharmacies or hospitals or nursing homes choose to stock,
and they arguably don't have the level of sophistication they
would need to be able to choose anyway. In hospitals and some
nursing homes, patients may not have access to containers where
the five-star quality rating or country of origin labels would
be placed.
How can a five-star quality rating system and country of
origin label promote the use of high-quality drugs when
patients often don't have much choice? How can this proposal
incentivize hospitals and other purchasers to purchase high-
quality drugs when institutions often face pressures to keep
costs low?
Third, how would you recommend that the FDA conduct
inspections and update their five-star quality ratings?
Dr. Ball. Thank you Senator for the great questions. Our
solution that we have tested in our paper is a first step. The
first step is--and I have had my parents and elderly family
members ask me, how do I know where this drug is made and if it
is safe. If you arm the person at the pharmacy desk or the
patient to look at a bottle and say, now, why is this a three-
star drug?
That question in and of itself could make a big difference
because groups like the AARP could all of a sudden have a voice
to say, why are we selling three-star or two-star drugs to our
constituents? You are correct that it wouldn't fix everything
overnight. That hospitals, when they buy it in group packaging,
may not have the stars on them until the solution get properly
fixed there. That group purchasing organizations may be less
sensitive.
The notion is that if it becomes transparent for every
level of the supply chain, the manufacturers are no longer able
to hide, and they have to somehow figure out a way to compete
on quality.
It wouldn't fix the problem overnight, but it would also
allow group purchasing organizations who change suppliers based
on pennies, which is often the case that we hear in our
research, to look at this and say, yes, we may save a penny,
but this is going from a three star drug to a two star drug.
That has consequences for the people that are in the
insurance program that they serve, or the elderly person that
picks it up at CVS and asks their pharmacist, why are you
giving me a two-star drug? That conversation is the starting
point to put pressure on firms. It is not perfect, but it is
the beginning, and it is much better than what we have now.
Senator Gillibrand. Thank you. Mr. Baker, off of Dr. Ball's
answers, how should country of origin labeling be implemented
to take into account the origins of a generic drug's components
versus the manufacturing site of the generic in its final form?
Mr. Baker. Yes, I have been thinking a lot about that
because over the years, having seen the sites and thinking
about transparency, that this would eventually come based on
what we were uncovering.
There is no real perfect solution, but there are some--for
each different type of drug, if you are talking about a solid
oral product or an injectable product, there are--at least one
step that is very critical to quality, for the purity and in
some cases, sterility.
Putting that on the label would force companies to take
that step seriously, and also possibly diversify supply chain
for those critical steps to have those in areas that are
reliable, and so, for example, an aseptically filled product,
where is that bottle being filled? Because that is, again--
there are other players, but that one is the most critical.
Senator Gillibrand. Dr. Piervincenzi, your written
testimony indicated the United States relies heavily on Indian
and China, and I think the chairman's questions about those two
countries have been very insightful.
The majority of these KSMs are produced in China. You also
highlighted how one KSM, thymidine, is produced only in China.
Can you speak to why the United State is currently unable to
produce certain key starting materials, beyond the
environmental impacts of the manufacturing process?
Dr. Piervincenzi. Yes, so thank you, Senator. The key
starting material is a fancy term, I think Senator Scott you
sort of said this earlier, that is only relevant to its use in
a pharmaceutical arena.
What the rest of the world will call them is chemicals.
They are chemicals. The chemical industry left the U.S., for
the most part, a long time ago, before pharma. In fact, that is
how pharma started in the U.S. It followed the chemical
industry in New Jersey--it became pharma.
There is no mystery as to why it left the U.S.--for
environmental reasons and just cost and all the reasons we
know. There is something unique about medicines is that they
are very light users of very expensive chemicals. What I mean
is--and many of the chemicals used in drugs are used for lots
of other industrial and other purposes, but in much, much
larger quantities.
That the chemical company--so they are very rarely to have
a key starting material company, because most of them are
chemical companies who sell some key starting materials. They
therefore are a small portion of their business.
This further complicates the supply chain, because later
on--we are talking about medicines all the way along, API,
finished dose, regulated by FDA, but these chemical companies,
they are not even in the medical business, so the incentive or
to think about how do we secure our key starting materials, it
is not only in the area of greatest risk.
It is what we least have in the U.S., or even among U.S.'s
allies. It is also the hardest of the three pieces to solve,
and we think we have to look at the KSM model, your chemicals,
and think, well, how do we start to source it? Where else in
the world--I think we need to be more flexible about the world
and think about it.
We may consider more onshoring on API, but we have to be
pretty flexible on the key starting materials, but the current
model is unsustainable, but we will have some real numbers in a
couple of months. I think it is about even less than two months
where we can start to look at them as tangible.
Senator Scott, to your point earlier, we have to be able to
have some data. Otherwise, it is very hard to get action going,
and hopefully, this will be the first time we have data on
specifically what key starting materials, where, and then we
have the very important next conversation, is how else can we
make them.
Maybe just to wrap up there, but there are some cases we
can make them a different way that doesn't follow the chemical
industry but uses biotech processes, and that we could do in
the U.S.
Senator Gillibrand. That is good. Thank you, Mr. Chairman.
Great hearing.
The Chairman. Mr. Baker, you highlighted the story of your
grandmother. What was your experience pharmacy shopping? How
many pharmacies did you visit? Did you find that they had the
same drug from the same company? Was there diversity in
manufacturers?
Mr. Baker. Yes, I come from a pretty small town in Oregon
called Lebanon, and there is about three pharmacies in the
area, and so, we went to all three, and each one actually had
the same product by the same manufacturer, so we reluctantly
made that choice, and I felt bad because already then--at the
first pharmacy, I had already sort of hinted that this was not
going to go well, and so, you know, it is an experience that is
going to stay with me for the rest of my life because it
shouldn't be like that. I think we can do better.
The Chairman. How would you feel buying a drug from a
company that just settled with the DOJ for faking lab data?
Mr. Baker. Yes, it was a tough decision, and again, as I
mentioned, trying to stay positive is the one thing because you
don't want to cause unnecessary panic in someone, and, you
know, a lot of people ask me before they will take it. They
will give me a call or send me an email, like, hey, what do you
think about this one?
I will give them advice, and to be honest, over the years,
sometimes I have to fake that advice because I know there is no
alternative, and I will have to just send a positive email when
in fact inside I know that that is not the truth.
The Chairman. How do you do it when you buy drugs for
yourself?
Mr. Baker. For myself, I would do the same thing. I live
now in Austin, so I have more choices there and try to do my
best to shop around or even consider like an online pharmacy if
I can call them and find out where--you know, what manufacturer
they are going to use to fill that prescription.
The Chairman. Do you believe Americans are dying because of
poor oversight done at foreign generic drug manufacturing
facilities?
Mr. Baker. Not poor oversight, but poor enforcement, but
again, it is complicated to enforce because of the drug
shortage issue. Again, it is not one person or one
organization's fault. It is just--it is the system.
The Chairman. Why did the FDA set up this foreign
surveillance system the way they did?
Mr. Baker. It was a collaboration with embassy, and FDA,
and folks at HHS to sort of evaluate--to tell the story. You
know, what we were finding in our initial times when those
foreign--you mentioned Heparin earlier.
That was the reason, one of the reasons, but I think the
main one why the foreign offices were established in strategic
locations around the world was to be that sort of rapid
response and gain further insight into what was happening with
our supply chain. I think, you know, 15 years later, the
picture is pretty clear.
The Chairman. Dr. Ball, so what causes--if they are all FDA
approved, what are some of the things that causes one to be
different than the other one?
Dr. Ball. I think the notion that if it has the same active
pharmaceutical ingredient dosage form and route of
administration, which is kind of what a generic equates to an
original, if you match those, the drug will work. That
discounts all of the manufacturing influence on quality.
These are subtle changes, and my intuition is that they are
often not on purpose. If I was in a market where I was only
competing on cost, I would find the very cheapest place to make
my product, the cheapest labor, the cheapest equipment, the
cheapest suppliers. It is the rational thing to do.
When Peter says it is the system, it truly is, because I
believe these manufacturers are acting very rationally. If you
cannot judge quality and it is opaque, cost is the only thing
that matters, that will inevitably reduce quality. It actually
must. It is like a scientific fact.
If you cut the corner in every part of making a product, if
quality doesn't suffer, something is wrong. You haven't cut
corners enough, so quality will suffer eventually. It is in
every aspect of the supply chain.
The Chairman. Mr. Baker, when you did a foreign site
inspection, did the FDA or the foreign facility pay for your
translator? Is that a problem either way?
Mr. Baker. Yes, so in my experience, most of the
translation is provided by the sales department within that
company, who oftentimes has the best English because of their
job. They don't know much about manufacturing, but they know
they are supposed to tell the story well. That is oftentimes
what I experienced.
Luckily for me, I had studied Mandarin for about 15 years
prior to going to China, so I could sort of overcome those
challenges, but yes, that is the norm. Not always. Sometimes
they will provide an independent translator, but it is
voluntary.
The Chairman. Mr. Baker, when you went to China, did they
let you just go anywhere you want?
Mr. Baker. Yes.
The Chairman. You could go, but the Government would let
you go anywhere, and you could walk in any facility--and you
can walk around any facility you wanted?
Mr. Baker. Oh, yes. Yes, we had a very good working
relationship with what they would call CFDA at that time, and
they would shadow us on a lot of our inspections to learn our
techniques.
The Chairman. Why would they shadow you?
Mr. Baker. To learn how we uncovered the issues that we
were finding using forensic computer inspection techniques,
things like that.
The Chairman. What would be--what would--give me an example
of a facility that you were most disappointed.
Mr. Baker. Most disappointed, I think, are the ones where--
there is multiple, but you would show up at the show--I
mentioned this in the five-minute testimony where you would up
at show facility. This is the clean one. We knew, like showing
up, you knew that there is no way they are making the amount of
products that I can see on the customs import list, right.
There is just no way, and so, what you will do is you will
try to find--you will show up midnight and just watch
operations, you know, from the outside and try to out what is
going on, and then you will eventually uncover like a shadow
facility. It could be like next door, or it can be somewhere
else you will watch trucks come in, right.
When you find that shadow facility, that is I think one of
the most concerning things because those are totally off the
radar. I mentioned the problems with announced inspections, but
just exponentially worse when you don't do any inspections
there, and so, that is the--and I think when we were there we
probably figured that 10 percent of the API getting exported to
the U.S. was from shadow facilities.
I have no data to support that. That was just a rough
number that we sort of came up with, and compounding pharmacies
are really suffering as a result of this because they are
importing products, and they really don't have any ability to
determine where they are coming from.
The Chairman. How long could the facility that was doing
the wrong thing stay in business before they are shut down?
Mr. Baker. A long time, especially if they had any drug
that was on the shortage list, and so, you could prevent some
of their products from reaching the U.S., but they would
continue to ship a couple that we called them carve-outs,
right, because we just couldn't prevent the supply, and then
they will ask for a re-inspection in about one to two years.
It will--FDA will go back, and oftentimes that will be
announced because it is resource intensive to do unannounced
all the time, and then that would be a choreographed inspection
and the clock resets. They can hang on for years because we are
addicted to these sites.
The Chairman. Dr. Ball, you reviewed adverse event data
that the FDA had cross-referenced to drugs made in India,
right?
Dr. Ball. Correct.
The Chairman. Okay. Where does the adverse event data come
from? What did you consider to be an adverse event? What
conditions were eliminated as an adverse event?
Dr. Ball. An adverse event--we used FDA's FAERS data base,
and they make the determination. The manufacturer must report
an event that occurs, that they hear about, where a consumer
was injured, hospitalized, or died because of a drug, and then
through the FDA's analysis of these adverse events, there are
flags that are put on to the adverse event. Things like a drug
characterization field.
That field means that the drug is the likely cause of the
event, and a de-challenged field. The de-challenged field means
that if the patient was taken off the drug, the problem that is
discovered went away.
We tested just the de-challenged drugs, which was very
convincing for us as an author team, we are really onto
something here because our effects still hold on the de-
challenged drugs on those that cause death, hospitalization, or
injury. To answer your very first question, the firm must
report it when they hear about it. It is mandatory.
The Chairman. The firm, who is that?
Dr. Ball. The manufacturer. The manufacturer hears about
adverse events from patients, from physicians, from lawyers.
The Chairman. There is no obligation that a patient says
it?
Dr. Ball. Correct.
The Chairman. There is no obligation to the hospital, and
there is no obligations that a doctor?
Dr. Ball. Correct. In the order you just gave though, the
nurses and physicians are much more attuned to how the system
works than patients, and so, from our experience, like
physicians and hospitals know that this FAERS data base is
there and that they need to report what they have found, but
there is no obligation.
There is a selection bias there. It must be under-reported.
It has to be because it is not forced, but this does come back
to the FDA's enforcement authority because these reports come
into firms, and these firms maintain complaint data bases.
When you can access those complaint data bases on an
unannounced inspection, you are going to get a real honest look
into how the quality of the firm is operating, versus if you
give them even a week's notice, the look may not be the same.
The Chairman. How many--what is the total list of adverse
reactions? Do you have a list of how many?
Dr. Ball. I can get that to you. It is incredibly long.
The Chairman. A half a million?
Dr. Ball. I know it is in the thousands. It is a very long
list.
The Chairman. Why do you think it is different in the
United States if it is manufactured in the United States versus
India or China?
Dr. Ball. This is speculation somewhat because in the study
we were not able to get at that core mechanism.
Theoretically it makes a lot of logical sense that when you
source a product in the lowest cost place where you are
furthest from the regulator, the temptation to cut corners that
will affect quality just goes up and up, and then to accentuate
that temptation, if quality is assumed to be high, as soon as
you get FDA approval, you have that stamp of approval, you no
longer have to worry about quality.
The difference I think lies in the fact that in the United
States, you are much closer to the FDA, their authority is much
more felt, and the costs of the suppliers and the raw
materials, they are more, and as soon you get that far away,
the FDA's authority is more distant and the cost of everything
is lower, and that lower cost will come through in lower
quality.
The Chairman. You don't have oversight.
Dr. Ball. The oversight is much more distant. It is much
more distant. I don't envy the FDA. It is much harder to
enforce their standards there.
The Chairman. If I understand correctly, according to your
study, generic drugs manufactured in India have a 54 percent
higher chance of an adverse event, which hospitalization,
disability, and death compared, to similar drug made in the
U.S., right?
Dr. Ball. It is more precise to say that the predicted
number of serious adverse events for older generic drugs made
in India (those generics that have been on the market for eight
years or more) is more than 54 percent higher than the number
of serious adverse events for equivalent, older generic drugs
made in the U.S.
The Chairman. Let's say you are going to buy two of
anything. Let's say, you are going to buy two cars. If you knew
if you bought one of them, you bought like one car, you had a
54 percent chance of something bad happening to you, so, what
would you do?
Dr. Ball. Well, because cars have quality ratings, like
J.D. Powers, I would buy the higher quality rated car, but that
can't be done in drugs, but if I knew the difference, then I
would spend the money to buy the higher quality product.
The Chairman. You think the National Highway Traffic Safety
Administration would let a car that was 54 percent more
dangerous on the road?
Dr. Ball. See, and the regulator--NHTSA doesn't have to
worry too much about that because car quality is accessible to
the consumer before they buy it, and that is the difference
between that and the pharmaceutical industry.
It is inaccessible before you buy it and oftentimes even
after you buy. This adverse event increase is hidden in
millions of adverse events. That is what makes studies like
this so difficult. There is so many data points that it is easy
for these types of increases to hide.
The Chairman. What was the FDA's reaction to your study?
Dr. Ball. While I have worked with the FDA before, since we
published that paper, I have not had a lot of interaction with
the FDA, and in the last several months, some of my contacts
have left, and so, I don't honestly know what the FDA's
reaction is.
The Chairman. Did your studies show a difference in quality
between generic drugs made in developed nations like Canada or
the EU compared to India?
Dr. Ball. There is an overall difference between emerging
economies and advanced economies, but when we took that
difference and we broke it out by country, the only country
that showed a difference was India to U.S.
No, there wasn't a difference between U.S and Canada.
However, the volume of drugs in our study was overwhelmingly
advanced economy drugs were U.S., and overwhelmingly emerging
economy drugs are India.
The volume helped make the difference findable, but it was
something that we didn't see when we compared like us to Canada
for instance.
The Chairman. What was the landscape of generic drugs that
you looked at? Did you limit it to sterile injectables, or did
you try to look at everything?
Dr. Ball. We looked at everything that we could get label
data on.
The Chairman. Statins, antibodies--antibiotics, and blood
pressure medicine?
Dr. Ball. All of those. Everything that had a label on the
data base we used, we measured it.
The Chairman. Why do you think the FDA doesn't put in,
require, you know, country of origin of ingredients and country
of origins of manufacturing? Why don't they do it?
Dr. Ball. This is speculation, of course, but I believe
that there is a few reasons. I have heard that through some of
our discussions with them that if they were to put quality or
country labeling, it could cause some unexpected market
reactions. It could cause shortages, for instance, because if
you look at a drug and there is----
The Chairman. People might buy American first?
Dr. Ball. If the supply isn't there, then all of a sudden
we have overnight shortages because we have made the market
transparent. That is one of the concerns I have heard. The
other is that I believe, and this is speculation, that the FDA
doesn't think they have the authority to force the manufacturer
to put the country on there.
They believe that is company confidential information, and
then the quality rating is something that we have taken from
data that they possess, and we have come up with a measure that
we believe they could translate it to, but it is not something
that is immediately available right now.
The Chairman. Mr. Daniels, I think you said that challenge
supplies about 90 percent of antibiotic APIs consumed in the
U.S. Can you talk about how you figured this out?
Mr. Daniels. Yes. What we found was that 90 percent of the
antibiotic APIs used by India, and India being the vast
majority of the generic antibiotics that we were getting, were
manufactured in China, and the way that we mapped this, we took
every single, critical medicine that we had in our study. We
built a bill of materials for each of them.
Every single component of that pharmaceutical, of that
drug, and what we did was we, once we had that bill of
material, we identified each supplier, each supplier that was
connected to every single one of those components. Once we
identified the supplier, we knew how much of the active
ingredient was in every dose, and we could see the doses that
were being consumed in the United States.
We mapped that up to supplier capacity, supplier volumes
coming into those companies, which we have proprietary data and
customs, trade, shipping, invoicing data that informs us as to
what is happening between those two companies, and we can see
where the next company was sourcing their key starting
materials, excipients, whatever it might have been, at that
next level.
We just kept tracing down the line to the facility, so we
knew which facility was actually producing which chemical
compounds. Once we got down to that facility, we cross-
referenced the data that we had pulled through with their
certification levels, their employee information, their square
footage to ensure that that capacity was visible and to
identify things like shadow facilities, which there certainly
is a significant volume of that kind of product coming through.
Then we rolled that all the way back up to the supply chain
and identified that essentially these manufacturers in India
were using this significant cost differential between the
locally made goods and what was being made in China and were
utilizing that to accelerate and to expand margins and the
goods being sent to the United States.
The Chairman. Are there other drugs that you are aware of
that we have such acute dependency on, on Communist China or
another adversarial country?
Mr. Daniels. Yes, about 50 percent of our critical
medicines are in that category.
The Chairman. Do you think this is a national security
risk?
Mr. Daniels. It 100 percent is.
The Chairman. I am a grandfather. Kids usually get ear
infections and strep throat, so if China were to drop liability
and limit antibiotic-related APIs from being exported, would it
impact us?
Mr. Daniels. Yes. You would see at least 50 percent of the
antibiotics that your kids have access to evaporate. In fact,
the next time one of your grandchildren gets a strep throat or
an ear infection, I encourage you to look at it. I bet you
dollars to doughnuts, it is made by Aurobindo, which is an
Indian manufacturer using Chinese KSMs and APIs.
The Chairman. Do you think this could create a public
health emergency?
Mr. Daniels. It almost did during COVID. I experienced it.
I was working with Ellen Lord, Honorable Ellen Lord and Jen
Santos and Stacey Cummings, and when they said they were going
to drown us in a sea of COVID--I mean, those calls really did
happen.
The Chairman. How long do you think--if they shut it off
tomorrow, how long you think our supply is for?
Mr. Daniels. I mean, it is months. As Dr. Piervincenzi
said, it is months. It is month with severe constraints. I mean
you would probably be treating--you know, you would be treating
people in sepsis. Kids would have to weather through, and that
could be very dangerous.
The Chairman. Are there any sole source drugs, which, you
know, there was only one supplier?
Mr. Daniels. There are.
The Chairman. They are relying on Communist China or India?
Mr. Daniels. There are--I don't have the names off the top
of my head, but I remember looking in the study, there were
significant volumes.
The Chairman. Let me make sure I got this right, 95 percent
of ibuprofen is imported from China?
Mr. Daniels. Ninety-five percent of ibuprofen, so there is
a key starting material that is--that 95 percent of it I
believe is pulled from China, is sourced from China, and that
ingredient then goes into ibuprofen.
There are other ways in which to source that same material.
The same goes for acetaminophen. There are other ways to source
that material, but they are not cost advantageous and so
therefore are not used.
The Chairman. Ninety-one percent of hydrocortisone is
imported from China. Does that sound right?
Mr. Daniels. That sounds right.
The Chairman. Ingredients. Half of U.S. Penicillin and
Heparin are imported from China?
Mr. Daniels. Yes.
The Chairman. The Federal Government knows this and has
done absolutely nothing about it.
Mr. Daniels. At the moment, after COVID, there was a huge
fervor. It died. We started studying the problem and stopped
executing against the reshoring and strategic activities, and,
you know, I am hopeful that HHS, particularly the FDA picks
this up, but as of right now, we are not actively policing
these supply chains.
The Chairman. Are you familiar with the Uyghur Forced Labor
Prevention Act?
Mr. Daniels. I am, Chairman, yes.
The Chairman. Do you think that is being complied with?
Mr. Daniels. I do not believe we are conducting significant
or thorough investigations in this pharmaceutical space, and at
the beginning of the year, there was a significant drop in
detentions that would indicate a lower volume of enforcement.
Those have since rebounded, Chairman Scott. I think we could
significantly stiffen and significantly strengthen our policing
of that law.
The Chairman. Have you tracked the Department of Defense's
reliance on China for drugs?
Mr. Daniels. I have, yes.
The Chairman. Do we have our own source, so our military is
never dependent on China?
Mr. Daniels. We do not.
The Chairman. Why wouldn't we?
Mr. Daniels. We, in many areas, are reliant on--it is kind
of like we have in critical minerals and in magnets, Chairman
Scott, where the commercial markets have so deeply been usurped
by China that we don't have the investment capital coming in to
offset it.
Just like we are doing in MP materials and neodymium, iron,
boron magnets and things like that for our weapons systems, we
have to make those same kind of investments in our
pharmaceutical supply chains.
The Chairman. If China invades Taiwan or continues to
attack the sovereignty of the Philippines and we go to their
defense, do you think they will keep shipping us drugs?
Mr. Daniels. I think Chairman Scott, it would be a key
tactic to stop doing this.
The Chairman. Do you think it would be safe for our
military to continue taking Chinese drugs?
Mr. Daniels. No, sir.
The Chairman. Can you explain the role that Chinese
Communist Party and the People's Liberation Army links play
into the generic drug supply chain, and how federal programs
like Medicare and Medicaid are paying for it?
Mr. Daniels. Yes, Chairman Scott. The PLA is infused into
the Chinese economy. It is called the military-civil fusion,
and in many cases, and as we have pointed out in the Bitter
Pill Report, several of the organizations that are producing
these active pharmaceutical ingredients or KSMs are actually
sponsored and funded by PLA-funded entities are directly by the
PLA.
Those situations create a significant amount of command and
control, what we call foreign ownership control and influence
risk, in those companies, and make them essentially beholden to
not only the CCP, but the PLA.
The Chairman. Would you say that the U.S. health care
system is entirely beholden to the Communist Party of China?
Mr. Daniels. At the moment, yes, sir.
The Chairman. Dr. Piervincenzi, how many sole-sourced APIs
come from Communist China?
Dr. Piervincenzi. Thank you, Senator. We are aware of 11
that are directly coming from China, but that is not the real
answer. The real answer is the APIs are coming from China to
India, and we know that is where 95 percent of our challenges.
I think antibiotics are a unique case, and it is real, and it
was strategic.
It was a choice in China many years ago, in fact, 15 years
ago to have that as a strategic asset, and it was successful,
while the world wasn't really paying attention, but that is a
bit of an outlier. I think the vast majority of reliance on
China is coming back to the starting materials, the chemicals,
in some cases the excipients as well--less often, but in some
case.
The Chairman. How many generic drugs use key starting
materials from China?
Dr. Piervincenzi. We are going to have a real answer for
that, but it is going to be somewhere in the range of 20 to 40
percent would be my guess, but give me about two more months
and we will have a better answer for you.
The Chairman. How about brand name drugs? Do they use APIs
from India or China?
Dr. Piervincenzi. Rarely, and it just goes to the different
incentives. It is not that they couldn't. It is just that it is
not necessary. The incentive is high value product. We need to
have a very reliable supply chain.
Their finished dose is rarely in those countries. They
don't want to have a big, complicated supply chain halfway
around the world, so they try to simplify, and so, therefore,
you see the APIs manufactured mostly in U.S., Europe, Canada.
If you think of those, that is going to be your majority. A bit
more in Europe than the U.S. in this case.
The Chairman. What sort of random testing of generics drugs
happen in our marketplace?
Dr. Piervincenzi. The U.S. market is a bit unique in the
world today. There is a risk-based approach at FDA, which is
taking into account known issues and that drives testing, and
FDA has its own labs and of course can outsource testing as
well.
There is very little random testing, and currently today
there really is no private sector solution to do so. This is
relatively common practice in most markets including in Europe,
but in middle-income countries as well. It is generally called
post-market surveillance, which is a fancy way to say you buy
something from the pharmacy and you test it.
The Chairman. Does USP track how many drugs Americans are
taking that rely on Chinese APIs?
Dr. Piervincenzi. Yes.
The Chairman. Does that present a risk to our supply chain?
Dr. Piervincenzi. If you believe that China supplying our
drugs is a risk, then the answer would be yes.
The Chairman. How many of you would buy a generic drug made
in India or China if you knew there was American-made drug
available?
Dr. Piervincenzi. Senator, if I have an offer, I would if I
had the assurance on the front end of the system. The system as
we described is tilted today and that is the issue, and that it
is an important nuance to me because that is where the solution
lies, is that un-tilting and I think that is a consistency that
you hear from us.
The Chairman. I think, if you listen today, based on the
testimony, Americans, we have hospitalizations, we have illness
and death because of adverse effects from some foreign-made
generic drugs.
Does anybody disagree with that? Bad drug quality doesn't
just mean drugs are less effective, which it could be, right?
Also make you sick or could kill you, so every American
senior--see if you agree with this, every American Senior needs
to look into their medicine cabinet and ask this question, am I
confident that the generic drugs I am taking are truly safe?
Do you believe today they could say that? Do they have any
ability to say that? Do any of you think they have any ability
to that today that if they look in their medicine cabinet, or
they go to their pharmacy, they can say it is safe? I talked
about LeRoy Hubley, lost his wife at 48 years, Bonnie and his
son, Randy, just weeks apart due to contaminated Heparin that
they needed for their dialysis treatment. It is horrible.
This should never happen in this country. If Americans
don't know where the generic drugs are taken or made, if there
is no measurement system, there is nowhere they can feel
confident, they can feel safe. It is clear that we have a big
problem.
I am from Florida. I was the Governor. We have hurricanes.
At least in hurricanes, in contrast to some other things, at
least you can get out of the way, or you should. I always tell
people that you can rebuild a house, but you can't rebuild your
life, and you tell people to get prepared.
It seems like we are number one, even if we didn't have the
concern about the way that Communist China acts, we say to
ourselves, it is crazy that we are not focused on quality and
focused on supply.
On top of that, we know that we have Communist China that
is threatening Taiwan and threatening the Philippines, and why
in God's great Earth would we ever allow our country to be
dependent, whether you are talking about anybody that takes a
generic drug, including our seniors, or why would we ever, ever
put our military in that position? It just doesn't make any
sense.
I think the bottom line is we have no choice, but we have
to make significant changes. I hope the new head of the FDA
will take this seriously and hope we will see change. I think
we are going to see change is if the American public demands
it.
My experience as Governor of Florida, my experience in this
job is that if people demand it, then it is going to happen.
People continue to be complacent, it is not going to happen. I
would like to thank everyone for being here today and
participating. I look forward to continuing to work with
members across the aisle.
If any Senators have additional questions for the witnesses
or statements to be added, the hearing will be open until next
Wednesday at 5:00 p.m. Anything else anybody wants to add? [No
response.]
The Chairman. Thanks, everybody. Thanks for being here.
[Whereupon, at 05:23 p.m., the hearing was adjourned.]
=======================================================================
APPENDIX
=======================================================================
Prepared Witness Statements
=======================================================================
U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Prepared Witness Statements
Peter Baker
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U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Prepared Witness Statements
Dr. George Ball
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Prepared Witness Statements
Brandon Daniels
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Prepared Witness Statements
Dr. Ronald Piervincenzi
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Questions for the Record
=======================================================================
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U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains, and the Risk to
Aging Americans"
September 17, 2025
Questions for the Record
Brandon Daniels
Senator Elizabeth Warren
Questions:
How would requiring drug manufacturers to disclose the source
of active pharmaceutical ingredients (APIs) and key starting
materials (KSMs) used to make drugs consumed in the U.S.
increase the supply of safe and effective drugs for U.S.
consumers?
During the hearing, you explained that supply chain mapping can
help to anticipate supply chain disruptions and critical drug
shortages. Would requiring pharmaceutical manufacturers to
report API and KSM sources to the federal government improve
supply chain mapping?
Would a federal database with this information help avoid
supply chain disruptions and critical drug shortages?
Based on your experience at Exiger, which components of the
pharmaceutical supply chain need the greatest scrutiny or
investment to increase the supply of safe and effective
pharmaceuticals?
a.What are the most significant barriers preventing the
United States from onshoring more pharmaceutical manufacturing
that Congress should prioritize addressing?
b.How would you suggest Congress address these barriers?
In your testimony, you highlighted that there are national
security risks to the Department of Defense (DoD) being
overreliant on foreign pharmaceutical manufacturing. How do
these risks undermine military readiness?
How do U.S. national security risks increase with higher rates
of unsafe, foreign pharmaceutical manufacturing?
Which essential medicines should DoD prioritize securing safe,
reliable access to for service members?
As you noted in your testimony, DoD revealed that "54% of the
DoD pharmaceutical supply chain is considered either high or
very high risk, with dependency on non-[TAA] compliant
suppliers, sourcing from China, or unknown." What would be the
impact on the military readiness if DoD lost access to 54% of
the supply chain?
Can you provide examples of how DoD has been adversely impacted
by pharmaceutical supply chain disruptions?
Can you provide examples of how DoD has been adversely impacted
by drug shortages?
Can you provide examples of how DoD has been adversely impacted
by unsafe pharmaceuticals?
How do DoD pharmaceutical supply chain challenges, drug
shortages, or access to unsafe pharmaceuticals result in direct
additional health care expenditure?
What types of indirect costs result from higher rates of
illness if DoD experiences pharmaceutical supply chain
challenges, drug shortages, or access to unsafe
pharmaceuticals?
What other costs to DoD occur as a result of supply chain
challenges, drug shortages, or access to unsafe
pharmaceuticals?
How would DoD benefit from domestic manufacturing of
pharmaceuticals?
What are the dangers of DoD being overreliant upon a single
supplier for pharmaceutical products?
How would DoD benefit from government-owned, contractor-
operated pharmaceutical manufacturing facilities? Please
provide relevant examples.
How would DoD benefit from government-owned, government-
operated pharmaceutical manufacturing facilities? Please
provide relevant examples.
How would the civilian population benefit from government-
owned, contractor-operated pharmaceutical manufacturing
facilities? Please provide relevant examples.
How would the civilian population benefit from government-
owned, government-operated pharmaceutical manufacturing
facilities? Please provide relevant examples.
What are the dangers of DoD being forced to purchase drugs or
medical countermeasures considered less secure under the
Defense Logistic Agency hierarchy of drug security due to
shortages or supply chain challenges? Please provide examples
of when this has occurred.
What are the dangers of DoD being forced to adjust dosages or
dispensing of drugs and medical countermeasures due to
shortages or supply chain challenges? Please provide examples
of when this has occurred.
What are the dangers of DoD being forced to pay a higher cost
for pharmaceuticals and medical countermeasures due to
shortages or supply chain challenges? Please provide examples
of when this has occurred.
What are the dangers of DoD being forced to use different,
less-optimal medication due to shortages or supply chain
challenges? Please provide examples of when this has occurred.
What challenges could DoD face in finding enough adequate and
cost-efficient suppliers for pharmaceuticals and medical
countermeasures in instances where DoD represents all or nearly
all of the U.S. commercial marketplace for that drug or medical
countermeasure?
Response:
Responses were not available at the time of printing. Please
contact the Committee if there are questions.
Senator Raphael Warnock
Questions:
In your testimony, you emphasized the role of advanced data
analytics in identifying vulnerabilities before crises occur as
well as the importance of "stress testing" the pharmaceutical
supply chain.
Looking back at Hurricane Helene, could predictive modeling
have flagged Baxter's IV fluid facility as a single point of
failure for the U.S. health system, and how can Congress better
leverage supply chain mapping to prevent similar crises?
What would a meaningful stress test look like in practice,
particularly for scenarios such as a natural disaster or
international trade disruption, including a Chinese export ban?
In Georgia, we have both a rapidly aging population and one of
the nation's largest Veteran populations. Veterans represent a
uniquely vulnerable population in the U.S. drug supply chain-
not only because they are aging, but also because they often
need a greater number of medicines to manage service-connected
injuries, Post-Traumatic Stress Disorder (PTSD), and other
chronic conditions. When shortages occur, as we saw after
Hurricane Helene with IV fluids, Department of Veterans Affairs
facilities could be forced to ration care.
How should Congress ensure that resilience planning and
procurement contracts specifically account for the higher
medication needs of Veterans, especially aging Veterans, so
that this population is never left behind in a crisis?
Transparency into where and how medicines are made is critical
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?
What steps should Congress take to enforce existing reporting
requirements and ensure greater transparency overall?
Response:
Responses were not available at the time of printing. Please
contact the Committee if there are questions.
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=======================================================================
Statements for the Record
=======================================================================
U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Statements for the Record
AARP Statement
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Statements for the Record
American Society of Health-System Pharmacists (ASHP) Statement
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Statements for the Record
Amneal Pharmaceuticals LLC Statement
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Statements for the Record
Association for Accessible Medicines Statement
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Statements for the Record
Indian Pharmaceutical Allicance (IPA) Statement
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Statements for the Record
National Consumers League Statement
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
U.S. Senate Special Committee on Aging
"Prescription for Trouble: Drug Safety, Supply Chains,
and the Risk to Aging Americans"
September 17, 2025
Statements for the Record
Partnership for Safe Medicines Statement
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
[all]