[House Hearing, 119 Congress]
[From the U.S. Government Publishing Office]
RESTORING TRUST IN FDA:
ROOTING OUT ILLICIT PRODUCTS
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON OVERSIGHT
AND GOVERNMENT REFORM
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED NINETEENTH CONGRESS
FIRST SESSION
__________
APRIL 9, 2025
__________
Serial No. 119-19
__________
Printed for the use of the Committee on Oversight and Government Reform
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available on: govinfo.gov,
oversight.house.gov or
docs.house.gov
_______
U.S. GOVERNMENT PUBLISHING OFFICE
60-029 PDF WASHINGTON : 2025
COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM
JAMES COMER, Kentucky, Chairman
Jim Jordan, Ohio Gerald E. Connolly, Virginia,
Mike Turner, Ohio Ranking Minority Member
Paul Gosar, Arizona Eleanor Holmes Norton, District of
Virginia Foxx, North Carolina Columbia
Glenn Grothman, Wisconsin Stephen F. Lynch, Massachusetts
Michael Cloud, Texas Raja Krishnamoorthi, Illinois
Gary Palmer, Alabama Ro Khanna, California
Clay Higgins, Louisiana Kweisi Mfume, Maryland
Pete Sessions, Texas Shontel Brown, Ohio
Andy Biggs, Arizona Melanie Stansbury, New Mexico
Nancy Mace, South Carolina Robert Garcia, California
Pat Fallon, Texas Maxwell Frost, Florida
Byron Donalds, Florida Summer Lee, Pennsylvania
Scott Perry, Pennsylvania Greg Casar, Texas
William Timmons, South Carolina Jasmine Crockett, Texas
Tim Burchett, Tennessee Emily Randall, Washington
Marjorie Taylor Greene, Georgia Suhas Subramanyam, Virginia
Lauren Boebert, Colorado Yassamin Ansari, Arizona
Anna Paulina Luna, Florida Wesley Bell, Missouri
Nick Langworthy, New York Lateefah Simon, California
Eric Burlison, Missouri Dave Min, California
Eli Crane, Arizona Ayanna Pressley, Massachusetts
Brian Jack, Georgia Rashida Tlaib, Michigan
John McGuire, Virginia
Brandon Gill, Texas
------
Mark Marin, Staff Director
James Rust, Chief Counsel for Oversight
Mitch Benzine, General Counsel
Dan Ashworth, Chief Counsel for Oversight
Madeline Brewer, Counsel
Reagan Dye, Senior Professional Staff Member
Billy Grant, Professional Staff Member
Peter Spectre, Professional Staff Member
Mallory Cogar, Deputy Director of Operations and Chief Clerk
Contact Number: 202-225-5074
Jamie Smith, Minority Staff Director
Contact Number: 202-225-5051
C O N T E N T S
----------
Page
Hearing held on April 9, 2025.................................... 1
WITNESSES
----------
Mr. Guy Bentley, Director of Consumer Freedom, Reason Foundation
Oral Statement............................................... 5
Mr. Jonathan Miller, General Counsel, Hemp Roundtable
Oral Statement............................................... 6
Dr. Richard A. Williams, Senior Affiliated Scholar, Mercatus
Center
Oral Statement............................................... 8
Mr. Shabbir Imber Safdar, Executive Director, The Partnership for
Safe Medicines
Oral Statement............................................... 9
Dr. David Kessler (Minority Witness), Former Commissioner, U.S.
Food and Drug Administration
Oral Statement............................................... 11
Written opening statements and bios are available on the U.S.
House of Representatives Document Repository at:
docs.house.gov.
INDEX OF DOCUMENTS
----------
* Article, Healthcare Finance News, ``Nonprofit linked to
campaign against drug imports has deep ties to pharmaceutical
research''; submitted by Rep. Biggs.
* Article, NPR, ``Nonprofit Linked To Pharma Lobby Works To
Block Drug Imports''; submitted by Rep. Biggs.
* Article, KFF Health News, ``Nonprofit Linked To PhRMA Rolls
Out Campaign To Block Drug Imports''; submitted by Rep. Biggs.
* Report, PSM, ``New report reveals illegal ingredients for
knockoff weight loss drugs flooding into U.S.''; submitted by
Rep. Biggs.
* Statement for the Record, Council for Responsible Nutrition;
submitted by Chairman Comer.
* Statement for the Record, NACS; submitted by Chairman Comer.
INDEX OF DOCUMENTS
* Statement for the Record; Peter Pitts, Center for Medicine in
Public Interest; submitted by Chairman Comer.
* Statement for the Record, Aliance for Pharmacy Compounding;
submitted by Chairman Comer, and Rep. Biggs.
* Article, Richard Williams, ``Measles Outbreak, RFK Jr.'s
Health Agenda & Surprising Health Wins''; submitted by Rep.
Krishnamoorthi.
* Article, CBS News, ``FDA planning for fewer food and drug
inspections due to layoffs, officials say''; submitted by Rep.
Lee.
* Article, Lancaster Farming, ``Raid on Farm Sparks Debate Over
Raw Milk Oversight and Government Overreach''; submitted by
Rep. Luna.
* Clinical Research, ``Transthyretin V142I Genetic Variant and
Cardiac Remodeling, Injury, and Heart Failure Risk in Black
Adults''; submitted by Rep. Mfume.
* Public Law 116-291; submitted by Rep. Mfume.
* Report, GAO, ``Cancer Clinical Trials''; submitted by Rep.
Mfume.
* Article, Axios, ``Drug industry worries about FDA delays'';
submitted by Rep. Subramanyam.
* Article, Axios, ``FDA cuts threaten medical product review
programs''; submitted by Rep. Subramanyam.
* Article, The New York Times, ``FDA Layoffs Could Raise Drug
Costs and Erode Food Safety''; submitted by Rep. Subramanyam.
* Article, The Washington Post, ``Veterinarians working on bird
flu, pet food safety are fired in HHS purge''; submitted by
Rep. Subramanyam.
* Article, The Washington Post, ``Worries grow over risks to
Americans as Trump cuts health, safety agencies''; submitted by
Rep. Subramanyam.
* Article, L.A. Times, ``Trump's Assault on Science Will Make
Americans Dumber and Sicker''; submitted by Rep. Subramanyam.
The documents listed are available at: docs.house.gov.
ADDITIONAL DOCUMENTS
----------
* Questions for the Record: to Mr. Bentley; submitted by Rep.
Foxx.
* Questions for the Record: to Dr. Williams; submitted by Rep.
Krishnamoorthi.
* Questions for the Record: to Mr. Miller; submitted by Rep.
Foxx.
* Questions for the Record: to Mr. Miller; submitted by Rep.
Garcia.
* Questions for the Record: to Mr. Sadfar; submitted by Rep.
Jack.
These documents were submitted after the hearing, and may be
available upon request.
RESTORING TRUST IN FDA:
ROOTING OUT ILLICIT PRODUCTS
----------
Wednesday, April 9, 2025
U.S. House of Representatives
Committee on Oversight and Government Reform
Washington, D.C.
The Committee met, pursuant to notice, at 10:04 a.m., in
HVC-210, U.S. Capitol Visitor Center, Hon. James Comer
[Chairman of the Committee] presiding.
Present: Representatives Comer, Gosar, Grothman, Cloud,
Palmer, Higgins, Sessions, Biggs, Mace, Fallon, Donalds, Perry,
Timmons, Burchett, Greene, Luna, Burlison, McGuire, Gill,
Norton, Krishnamoorthi, Khanna, Mfume, Brown, Stansbury,
Garcia, Frost, Lee, Crockett, Subramanyam, Bell, Min, Pressley,
and Tlaib.
Also present: Representative Moskowitz.
Chairman Comer. This hearing of the Committee on Oversight
and Government Reform will come to order. I want to welcome
everyone here today.
Without objection, the Chair may declare a recess at any
time.
I apologize for my laryngitis. We are going to try to fight
our way through this. So, I will recognize myself for the
purpose of making an opening statement.
Again, welcome to the Committee on Oversight and Government
Reform. Today, we will examine solutions to ensure the Food and
Drug Administration keeps our Nation's food and drug supply
safe for all Americans. There might not be another Federal
Agency that more profoundly impacts every American's daily life
than the FDA. The FDA oversees the safety of the food, drugs,
and medical devices we rely on. These responsibilities make it
a key pillar of public health in the United States, but
Americans are not getting healthier. Americans' life expectancy
is 4 years less than other developed countries despite spending
more than any other country on healthcare. Six in 10 Americans
suffer from chronic disease. One in 5 Americans live with a
mental illness. Nearly 20 percent of America's children are
considered obese. Twenty percent of American children.
So, you would think the FDA under the Biden Administration
would have prioritized making Americans healthier, right?
Wrong. President Biden's FDA pushed burdensome gender identity
requirements on clinical trials that made compliance more
expensive. They turned a blind eye to the Chinese Communist
Party targeting our children by flooding our streets with
illicit tobacco and nicotine products. They neglected infant
formula facility inspections that led to mothers and fathers
across the country being unable to buy the formula their
children needed, and they failed to work hand in hand with U.S.
Customs and Border Protection to root out illicit
pharmaceuticals, food, tobacco, and CBD.
We are facing a national epidemic of chronic disease,
mental health, and obesity, and the FDA under the previous
Administration sat on its hands. Thankfully, President Trump
and Secretary Kennedy are taking action to make America healthy
again. Soon after his return to office, President Trump signed
an executive order removing unscientific pseudoscience
compliance burdens for clinical trials. The FDA recently
restarted approvals of safer alternatives to traditional
tobacco products, and I am hopeful more will come soon to bring
greater clarity to the market. Secretary Kennedy announced
Operation Stork Speed, which will provide families with access
to safe infant formula for their babies and prevent shortages
going forward. And President Trump's efforts to re-secure the
Southern border have returned law enforcement's ability to stop
the influx of illicit pharmaceuticals, food, tobacco, and CBD
coming into our country.
This Committee has spent years investigating failures at
FDA, and our findings are clear. The Biden Administration
stifled innovation with red tape and put bureaucrats before
health of the Nation. Reform is essential. The FDA must
prioritize innovation, safety, and the health of all Americans.
The FDA needs better systems to identify and address drug
shortages. Quick approval of innovative medicines and
techniques identified with AI in support of President Trump's
promise to cure cancer is a necessity. The FDA must work with
food producers to make our food healthier while not upending
supply chains. Incentivizing domestic manufacturing of
pharmaceuticals is essential to improving the safety of
prescription drugs and will enable more research. Clearly and
effectively regulating hemp products will reduce confusion and
prevent intoxicants and poisonous contaminants from
infiltrating the market.
These examples are just scratching the surface of the
dysfunction and failures within the FDA. Today, I am hopeful we
can take a deep dive to better understand how we can improve
the FDA to make Americans healthier. I now yield to the Ranking
Member for his opening statement.
Mr. Subramanyam. Thank you, Mr. Chair. Today's hearing
comes at a critical moment for public health and safety. All
Americans should be able to trust that our government is
working to ensure their food and medicine will be safe and
affordable, but over the past 2 months, the Trump
Administration has purged thousands of FDA workers, putting
this essential mission and American lives at risk. Last week,
the Administration purged 10,000 people at HHS, including 3,500
FDA employees. This was on top of a purge of approximately
1,000 FDA workers in February, and Secretary Kennedy
subsequently admitted that 20 percent of last week's purges
should not have happened. He tried to brush it off saying, ``We
will make mistakes,'' but how long will it take them to realize
the full extent of the mistakes that they have made? How long
will it take for them to try and very possibly fail to undo
them, and how many Americans will get sick or die in that time?
The FDA is supposed to make sure that our children have the
vaccines they need to survive outbreaks of preventable
diseases, like measles, which has killed at least two children
in the U.S. since February and sickened more Americans in 2
months than the entirety of 2024. The FDA is supposed to
protect us from counterfeit drugs and contaminated infant
formula, which are serious bipartisan concerns, but how is the
Agency supposed to stop dangerous, illicit products from
entering American homes and threatening American lives when
under-funded Food and Drug inspection teams are being cut even
more? A hundred and seventy employees from the FDA's Office of
Inspections and Investigations were reportedly let go last
week.
And let me tell you some of the expertise we are losing
because of the Administration's actions besides that. They
fired people responsible for regulating e-cigarettes and
ensuring that predatory companies cannot market vapes to
children. They fired people responsible for monitoring drugs
for side effects and updating warning labels. They have fired
the scientists monitoring bird flu and taking steps to prevent
it from killing people. They fired the scientists with
expertise in fighting heavy metals, toxins, and additives in
our food supply. And they fired the people who monitor
prescription drug shortages and ensure that Americans have
access to affordable prescription medication. How is this
making Americans healthier? We all know the answer to that
question. It is not. People are going to die.
As a dad, I am especially concerned by the Administration
undoing the progress we have made to protect babies from
contaminated infant formula and formula shortages, and we
should all be concerned by the risk posed by contaminated meat
and produce. This chaos will keep us in the dark about looming
shortages for essential drugs like antibiotics and chemotherapy
drugs, and it will leave people no choice but to pay for pricey
brand-name drugs because there are no FDA employees to approve
generic versions. In the name of efficiency, this
Administration even fired employees who were critical in
approving new medications, meaning Americans will have to wait
longer for new treatments, if they get them at all. And on top
of that, we just heard last night from the President that
pharmaceutical tariffs will be next, making the drugs we all
rely on even more expensive.
One of the Americans impacted by these cuts is one of my
constituents, a former teacher who spent 35 years working at
the Department of Education. She has idiopathic pulmonary
fibrosis, a terminal lung condition that took her aunt's life
and is slowly taking hers. It is a rare disease that does not
get much funding, but she had hope. A drug to slow down the
disease received the FDA's breakthrough therapy designation in
2022, and the trials show that it might actually stop the
progression of her disease. Her doctor anticipated FDA approval
this year, but the FDA's funding cuts and the firing of
researchers and staff who sit on the approval committees have
made this impossible.
This Administration is stripping both hope and lifesaving
medications out of the hands of Americans who need it most. The
FDA can and must do more for Americans. Addressing our
country's chronic disease epidemic, ensuring our children are
set up to live long and healthy lives, getting more lifesaving
medications to those who need them, and ensuring that food on
our shelves is safe and wholesome should be at the top of that
list of things to do. But rather than making it better and more
efficient, this FDA is left ransacked and reeling from the
chaos and destruction of the Trump Administration. It is
unclear whether the Agency can even perform some of its most
basic functions anymore.
I do not know how much clearer I can be: these health cuts
will kill people. They will make us less safe and less healthy.
I was not elected to watch people suffer from diseases awaiting
new treatments while this Administration dismantles the offices
that offer that hope. It is the responsibility of this
Committee to conduct meaningful oversight. If we are not
talking about this and doing something about these cuts, we are
not doing our jobs. I yield back.
Chairman Comer. The gentleman yields back. Without
objection, Representative Moskowitz is waived onto the
Committee for the purpose of asking questions at today's
hearing.
I am now pleased to introduce today's witnesses. Mr. Guy
Bentley is the Director of Consumer Freedom at the Reason
Foundation, focusing on taxation and regulation of nicotine,
tobacco, alcohol, and food. Mr. Jonathan Miller is the General
Counsel of the Hemp Roundtable and partner at Frost Brown Tood
Attorneys. Jonathan is known for being a leading advocate for
hemp and CBD legislation and has continually worked to promote
policies that benefit the hemp industry. And just so my
colleagues on the other side of the aisle know, my friend
Jonathan Miller is a former Chairman of the Kentucky Democrat
Party, so we try to be bipartisan in this Committee, despite
what you read in the papers, Mr. Miller.
Mr. Richard Williams is a senior affiliated scholar at the
Mercatus Center at George Mason University. He is an expert in
cost-benefit analysis and risk analysis associated with food
safety and nutrition. Mr. Shabbir Safdar is the Executive
Director of The Partnership for Safe Medicines. He leads a
coalition representing much of the pharmaceutical supply chain.
And Mr. David Kessler is a former Commissioner of U.S. Food and
Drug Administration under Presidents Bush and Clinton.
Pursuant to Committee Rule 9(g), the witnesses will please
stand and raise their right hand.
Do you solemnly swear or affirm that the testimony you are
about to give is the truth, the whole truth, and nothing but
the truth, so help you God?
[A chorus of ayes.]
Chairman Comer. Let the record show that the witness has
answered in the affirmative. Thank you all. You may take a
seat. We appreciate you being here today and look forward to
your testimony.
Let me remind the witnesses that we have read your written
statement. They will appear in full in the hearing record.
Please limit your oral statement to 5 minutes. As a reminder,
please press the button on the microphone in front of you so
that it is on, and the Members can hear you. When you begin to
speak, the light in front of you will turn green. After 4
minutes, the light will turn yellow. When the red light comes
on, your 5 minutes have expired, and we would ask that you
please wrap it up.
I now recognize Mr. Bentley for his opening statement.
STATEMENT OF GUY BENTLEY
DIRECTOR OF CONSUMER FREEDOM
REASON FOUNDATION
Mr. Bentley. Chairman Comer, Ranking Member Subramanyam,
and Members of the Committee, thank you so much for the
opportunity to testify today. My name is Guy Bentley, and I am
the Director of Consumer Freedom at the Reason Foundation, a
non-profit public policy think tank. The Consumer Freedom
Project analyzes and promotes policy solutions that improve
public health while avoiding unintended consequences and
protecting consumer choice.
I would like to focus on three points: first, the current
state of the tobacco market; second, how we got here; and
third, what can be done to reduce the illicit e-cigarette
market while ensuring adult smokers have legal access to a
range of safer alternatives.
The focus of this hearing is rightly on rooting out illicit
products, including illegal e-cigarettes, but there is some
good news amid the disorder. Youth vaping has declined more
than 70 percent since 2019 and is at its lowest level in 10
years. Youth smoking fell by 68 percent and is at its lowest
level on record. These declines followed the decision to raise
the age of purchase for tobacco products to 21, for which there
was bipartisan support. Cigarettes remain the most widely used
tobacco product, with 28 million adult smokers and more than
400,000 deaths per year attributable to smoking. There are also
18 million adult vapers who are using e-cigarettes to quit
smoking, but thanks to the FDA's regulatory bottlenecks, since
2019, illicit products have flooded the market, with almost 90
percent of e-cigarettes being sold illegally, mainly consisting
of disposable products from China.
Despite the huge demand for safer nicotine alternatives
among adult smokers, the FDA has authorized just eight vaping
devices for sale and 34 vaping products in total, and only in
tobacco and menthol flavors, which have little appeal to most
e-cigarette users. E-cigarette authorizations account for just
.2 percent of all tobacco product authorizations, compared to
22 percent for combustible cigarettes.
So, how did we arrive at a situation where it is easier to
release a new cigarette onto the market than the safer products
invented to displace cigarettes and the illicit products
thrive? The answer is the FDA's approach to the pre-market
tobacco product application pathway, which is how e-cigarettes
are evaluated and authorized for sale or not.
The PMTA pathway, established as part of the Tobacco
Control Act, was supposed to facilitate innovation for safer
alternatives to cigarettes. In reality, it presents an almost
insurmountable barrier. In 2022, an independent review of the
FDA's performance as a tobacco regulator was published by the
Reagan-Udall Foundation, which criticized the FDA's lack of
transparency and timeliness in authorizing e-cigarettes into
the legal market. It is unfortunate that in response to a
report that emphasized the need for timeliness and
transparency, the FDA issued a 5-year plan of generalities with
no substantive changes to the PMTA pathway.
With a large illicit market now in place, the FDA has taken
steps to ameliorate the problem with the creation of a multi-
agency task force last year, increases in seizures,
injunctions, and civil money penalties. But the only way to
sustainably resolve the problem of the illicit e-cigarette
market is to streamline the PMTA process to have regulated
companies sell their e-cigarettes in the United States and
reduce death and disease from smoking. Reforming the PMTA
process would lessen current burdens on FDA staff reviewing e-
cigarette applications, hasten the creation of a regulated
marketplace, and restore public trust.
The FDA insists its current approach to authorizing or
denying e-cigarette products is guided by science and is
appropriate for the protection of public health, but despite
the best of intentions, a regulatory regime that results in a
de facto ban of almost all e-cigarettes, incentivizing the
illicit market, is not appropriate for the protection of public
health. When it is easier to bring a cigarette onto the market
than a vape or a nicotine pouch, both of which the FDA
acknowledges are dramatically safer, that is not appropriate
for the protection of public health. And an Agency that fails
to correct the misperceptions around e-cigarettes, with the
majority of Americans now believing that e-cigarettes are just
as or more dangerous than combustible cigarettes, that is not
appropriate for the protection of public health. It is within
FDA's current powers to change this dynamic and pursue a
different path.
Thank you, and I look forward to your questions.
Chairman Comer. Thank you. The Chair recognizes Mr. Miller.
STATEMENT OF JONATHAN MILLER
GENERAL COUNSEL
HEMP ROUNDTABLE
Mr. Miller. Mr. Chairman, Ranking Member, I am grateful for
the opportunity to testify before your Committee today. Mr.
Chairman, I am especially grateful for your decades-long
leadership on behalf of Kentucky hemp farmers. You and I
started on this journey in 2012 and worked across the aisle to
secure hemp's legalization in the Bluegrass state. Indeed,
hemp's policy success has always been a bipartisan hallmark,
and it is no wonder. Hemp products are made in the USA,
harvested from crops grown by American farmers, manufactured by
innovative U.S. entrepreneurs, and sold by small businesses
dotting the Nation.
Unfortunately, the U.S. hemp industry continues to
encounter avoidable bureaucratic headwinds in the marketplace,
and this turmoil is due in large part to statements, actions,
and indecisions of the FDA. When Congress passed the 2018 Farm
Bill, it explicitly legalized the sale of hemp and its
derivatives such as CBD, but just a few hours after the Farm
Bill was signed into law, the FDA reasserted its opinion that
it was illegal to market CBD as a dietary supplement. We have
watched in bewilderment as FDA has jerked back and forth with
contradictory opinions.
First, the Agency affirmed its ability to regulate CBD
under current law, but then FDA stalled, even ignoring
congressional appropriations report directives to take
expedited action. Finally, in 2023, the Agency stated that it
cannot regulate CBD under existing regulatory pathways,
essentially punting responsibility to Congress. This regulatory
uncertainty resulted in a collapse of the CBD market, as
demonstrated on this chart behind me, denying economic
opportunity that was promised to farmers.
[Chart].
Mr. Miller. The FDA's inaction does not just threaten CBD.
A new industry focused on the adult market has emerged to meet
consumer demand for hemp-derived cannabinoids like delta-8 and
delta-9 THC. These products provide plant-based options for
adults seeking functional health and wellness benefits.
Furthermore, a promising new hemp beverage industry has soared
into popularity, meeting adult consumer demand for non-
alcoholic options through domestic inputs from our farmers. The
only upward line on this chart represents the price of hemp
flour, which recovered when it started being widely used for
adult products, offering a lifeline to U.S. farmers.
Unfortunately, lack of uniform quality control standards
for hemp products at the Federal level has forced responsible
farmers and small business owners to compete against
unscrupulous actors who generate headlines by distributing
poorly manufactured products that are sometimes inappropriately
marketed to children. A political backlash has ensued. Language
was added into the 2024 House Farm Bill that purported to crack
down on the bad actors. Unfortunately, the language went much
farther. It would have federally banned 90 to 95 percent of the
hemp product marketplace, including most non-intoxicating CBD
products and animal feed, which offers great promise to
farmers, while undermining a decade of progress for hemp fiber
production.
I want to be very clear. The hemp industry is united behind
an appropriate response to these challenges, robust regulation
of hemp products, not misguided prohibition. We support an
approach that includes the following four pillars: restrict
youth access, increase quality control standards, standardized
labeling, and standardized packaging. FDA could act today on
applying this four-pillar approach to hemp products. We are
hopeful that new leadership at the FDA will reverse the past
course of inaction and take deliberate steps to robustly
regulate hemp. This approach is precisely in line with the new
Administration's focus on providing adult consumers the freedom
to make their own healthcare choices with holistic solutions
that are grown on American farms.
If laws must be changed, we urge Congress to act now. There
are two viable pathways. First, we hope you will consider
Senator Ron Wyden's effort in the last Congress, S. 5243, that
would ensure that the FDA regulates applying the 4-pillar
approach. A parallel effort could be to invest more authority
in the states to properly regulate their own markets. In the
absence of Federal regulation, many states, like our Kentucky
home, Mr. Chairman, have filled the policy void by developing
new laws and regulations that balance market access with
consumer safety. We urge you to implement a Federal framework
that authorizes the sale of hemp products and develops uniform
standards for labeling, packaging, and testing, while allowing
states flexibility on more complex issues.
In the meantime, we have taken the additional step of
establishing the U.S. Hemp Authority, the industry's self-
regulating organization, which sets rigorous standards for
safety, quality, and transparency across the supply chain. The
hemp industry may be unique in that we are coming to Congress
to ask, please regulate us. Thank you for your consideration.
Chairman Comer. The Chair now recognizes Mr. Williams for
his opening statement. Dr. Williams?
STATEMENT OF RICHARD WILLIAMS
SENIOR AFFILIATED SCHOLAR
MERCATUS CENTER
Dr. Williams. Thank you. Mr. Chairman, Ranking Member, and
Members of the committee, thank you for inviting me to testify
about the FDA today.
As I was nearing the end of my career at FDA, we were
working on a rule governing how dietary supplements are made.
After a year of looking, my staff could find virtually no
benefits. When I suggested to the program office that maybe we
should not regulate, the response was, ``but, Richard, we have
to get these guys somewhere.'' So, we ended up with a
regulation, not because it would make supplements any safer,
but because we could start exercising control over that
industry. With approaches like that, is it any wonder the FDA
has lost the trust of the American people?
During the course of my career, one of my employees asked
me, ``who do we work for?'' I thought about it. Well, they are
FDA managers, the Health and Human Services Secretary, and the
President, but then I made up a person. She is a 30-year-old
widow with two kids working in a diner in the Midwest. That is
who we are working for. We should only be concerned about
getting results, safer food, and helping people eat more
nutritious diets. Again, when I look over my 27-year career, I
was saddened by the fact that we had not made food any safer,
and American diets have gone horribly wrong. But we justified
our regulations to say we would prevent hundreds of thousands
of cases of food-borne disease, and people would use the food
labels to change their diets--preventing cancer, heart disease,
and diabetes. None of that happened.
FDA justifies budget increases with the same information
every year, coupled with new challenges, but increased funding
for FDA means more regulations, more control over the economy,
and higher prices. I do not think people care about giving FDA
more money or seeing them exercise greater control. They just
want safe and healthy food. FDA never talks about those actual
outcomes as they do not want to be held accountable for
failures. In fact, they fight fiercely against any notion of
accountability.
FDA has to get the science right. For example, FDA ignores
the biological science of evolution that shows us that tiny
amounts of exposures to substances, natural and synthetic, are
not harming us. In fact, when we are exposed to tiny amounts,
well over half of all chemicals and all radiation, they not
only do not harm us, they are actually beneficial. In addition,
given the massive testing of food and colored additives, it is
unlikely that that is where the significant risks are. FDA
needs to cut out ineffective programs and regulations, and
going forward, needs to produce far fewer regulations.
Ineffective programs include things like food standards. These
are recipe standards from the 1930s that ensure manufacturers
are producing foods just like mother used to make.
If we cut out useless programs and we have far fewer
regulations, resources will be freed up to meet new challenges.
For example, a better use of FDA resources would be to produce
information that helps food producers, particularly the small
ones. A good example would be letting producers know the root
causes of food-borne outbreaks. The challenges are real. We
need to know whether chemicals like PFAS and microplastics
present health risks, and, if so, which ones of the many
varieties are actually risky? We also need to address food
coming into this country with intentionally added poisons from
some of the most powerful enemies we have ever faced.
FDA must embrace new science and technology. To start with,
FDA must be fully committed to precision health, including
nutrition, as we are now beginning to understand that
individuals respond differently to foods. That means that some
national advice and even some regulations, while it may help
some, will harm others. New technologies that will make food
safer and healthier include smart packaging that will alert
consumers to spoilage; blockchain-enabled tracebacks, which FDA
has recently begun, I am glad to say; robotics that can produce
food more safely. There are new types of treatments for
pathogens for manufacturers. Better foods can be produced
through genetic modification and precision fermentation. And
finally, for nutrition, there are new monitoring technologies
that will give us real-time advice on what to eat based on our
personal characteristics. FDA needs to make sure that the new
technologies are safe, but also that we do not inhibit
innovations that will save lives.
To restore trust, FDA should be working for consumers like
that mythical waitress who cares about results for her family.
Thank you.
Chairman Comer. Thank you. I now recognize Mr. Safdar for
his opening statement, and I apologize for mispronouncing that.
Maybe you can correct my----
Mr. Safdar. It is fine.
STATEMENT OF SHABBIR IMBER SAFDAR
EXECUTIVE DIRECTOR
THE PARTNERSHIP FOR SAFE MEDICINES
Chairman Comer, Ranking Member Subramanyam, distinguished
Members of the House Oversight and Government Reform Committee,
thank you for your leadership on this issue and for inviting me
today. My name is Shabbir Imber Safdar. I am the Executive
Director of the Partnership for Safe Medicines, a coalition of
all members of the supply chain dedicated to protecting
Americans from counterfeit medicines. You have read my written
testimony, and it is long and I apologize for that, but it is
very thorough. We have been doing this for over 20 years. But I
want to just focus my comments on just three areas today, which
I think are of great concern, and they focus on the current
crop of crime and patient endangerment around GLP-1s, or weight
loss injectables.
First, unlicensed vendors are selling unregulated GLP-1s to
patients without prescriptions. We see these sold on e-commerce
websites like Etsy; through med spas, which are unlicensed to
often distribute prescription drugs; and also through fake
online pharmacies, selling them as peptides. They are often
labeled as research chemicals, like this one, and not for human
consumption, and yet people are being sold them with
instructions to inject them anyway, and they often do. We are
not the only group worried about this. In February, 38 states'
Attorneys General wrote to the FDA asking them to take action
on these, and the FBI issued a similar alert, also raising
concerns about compounders using illegal ingredients in their
products and illegal compounding.
Second, the FDA has cited patient safety issues even with
legally compounded weight loss injectables. Now, compounded
medicine fills a critical need in our drug supply and makes our
drug supply more resilient. For example, consider a medicine
that commercially comes in only an oral dosage form, like a
pill, and the patient has swallowing issues, perhaps because
they are a child or because their swallowing abilities are
compromised. In that case, a compounding pharmacy can make a
liquid form and allow that patient to take the treatment. That
compounded treatment, while an unapproved drug by the FDA, is
still better than skipping the treatment altogether. However,
the FDA has been clear that these are not FDA approved and pose
a safety risk because they are not clinically tested for safety
or efficacy.
If a patient must choose between taking a needed medicine
or skipping treatment, obviously you do take the medicine, but
what we are seeing in compounding of GLP-1s is a different
situation altogether. Opportunistic telehealth companies are
enticing people who do not plan on using weight loss
injectables to start therapy on these compounded, unapproved
products. And GLT-1s are sterile injectables, and compounding
sterile products is very challenging, something we have
actually seen from reading inspection reports by state boards
of pharmacy and the FDA. On top of that, legitimate and safe
ingredients for compounded medications, for these medications,
are actually difficult to come by, and in every case I have
seen in my experience, when things are difficult to come by,
criminals step in to fill the gap.
PSM recently studied freight shipments of both semaglutide
and tirzepatide, the active ingredients in major weight loss
injectables, coming in as freight, using the FDA imports data
base. And most of these were coming in from China and India, in
some cases Canada, and we found multiple entering shipments
that should have been denied entry at our ports. By studying
that data base, we found one shipment of semaglutide that
claimed to be manufactured at a JW Marriott in Canada. Now, not
surprisingly, we did check the FDA's registered facilities data
base for facilities in Canada, and that JW Marriott is not, in
fact, an approved manufacturing site that has ever been
inspected. It was refused by inspectors, which I am grateful
for, but the second one was a shipment that was stated to be
manufactured at a health club in Toronto, Canada. That shipment
did actually make it through, and so it came in, and we do not
know where it went. I am sure the FDA's Office of Criminal
Investigation probably does, but it went somewhere in the U.S.
and is destined for U.S. patients, either by a legitimate or
illegitimate dispenser.
A third bucket of GLP-1s that I would like to point out are
these lookalike counterfeits. It looks exactly like an injector
pen that would come from the branded manufacturer, but it does
not, in fact, contain the active ingredient or the right
ingredient. Sometimes it even contains needles that have been
compromised with bacteria. This is an example of a unit of fake
Ozempic that is not, in fact, Ozempic. The criminals actually
peeled off the label of the real product and then printed up an
Ozempic label and put it on. A very alert pharmacist in
Arkansas spotted this unit and quarantined it so that it would
not be given to a patient and called the investigator at the
Board of Pharmacy. The Board of Pharmacy's investigator came
over and used a new tool developed by the National Association
of Boards of Pharmacy called Pulse. It is a scanner app, it is
on your phone, and they used that tool to make an, literally,
under-a-second determination that that product was counterfeit.
That quick thinking by that pharmacist and that investigator
almost certainly protected patients in Arkansas and around the
country because the Arkansas State Board of Pharmacy then
immediately moved to suspend the license to the Florida
distributor, who was shipping it into Arkansas, so they could
no longer do business in Arkansas.
I am very proud of the safety of the U.S. prescription drug
supply. It is the best in the world, and yet it contends with
an enormous, perhaps globally record-breaking amount of
criminality. And despite that, none of us have to worry about
walking into a bricks and mortar pharmacy and getting a safe
medicine. That is something that both keeps me up at night and
actually also makes me very comfortable about living in the
United States. I thank you for your time and I look forward to
your questions.
Chairman Comer. The Chair now recognizes Dr. Kessler. Make
sure you got the microphone pulled right up to you so we can
hear and C-SPAN can hear.
STATEMENT OF DAVID KESSLER
FORMER COMMISSIONER
U.S. FOOD AND DRUG ADMINISTRATION
Dr. Kessler. Mr. Chairman, Ranking Member, Members of the
Committee, my name is Dr. David Kessler. I have worked for both
Republican and Democratic Presidents. I was appointed by
President George H.W. Bush and reappointed by President Bill
Clinton as Commissioner of the FDA. We were responsible for
accelerated approval, user fees, the food label, and the
regulation of tobacco products. The FDA is a national resource.
In January 2021, I had the privilege of returning to Federal
service and co-leading Operation Warp Speed.
[Graph.]
Dr. Kessler. Mr. Chairman, I am in full agreement with you
and share significant concerns about the safety and efficacy of
illicit and sometimes licit drug products originating from
overseas, particularly China. As you can see from the first
graph, only 4 percent of active pharmaceutical ingredients,
that is the key component of a drug, are produced in the United
States. Eighty percent are produced in China and India. In my
opinion, for example, we have been conducting a reckless
national experiment with compounded new weight loss drugs, the
GLP-1s.
Based on the information I have received from the FDA, it
does not appear that there is routine FDA surveillance of the
GLP-1s that are being imported into the United States from
China for compounding to assure what is in the product. We
cannot have confidence in the safety of compounded GLP-1 drugs,
but that is only the tip of the iceberg. The conventional
wisdom is that illicit cheap copies are coming from China. That
has changed. The more significant threat, Mr. Chairman, is that
China is attempting to surpass the United States in the
sciences.
As shown in the next figure, the highly respected Nature
Global Index reveals that eight of the top universities in
terms of impactful research in the natural sciences are located
in China. Specifically in chemistry, all 10 of the highest-
ranked universities are in China, and only in the health
sciences does the U.S. hold the lead. Do you want China to eat
our lunch when it comes to science and innovation? We need to
recognize that China is poised to surpass us in the sciences.
We need to quickly act to make the necessary investments to
shore up our competitiveness and avoid putting our Nation at
risk.
I know there are limitations in methodology. However, the
U.S. scientists that I have spoken with increasingly see much
higher-quality work coming out of China. Look at the last
figure. China is increasing investment in research and
development currently at approximately $500 billion as of last
year. In contrast, our investment in the NIH increased only
slightly from 2004 to 2016 and is now facing cuts. Whatever
needs to be fixed, let us fix it, but we need to make a marked
increase in our investment.
I was a kid and went into the sciences after Russia
launched Sputnik in 1957 as a result of our country's decision
to be preeminent in the sciences. We are facing Sputnik 2.0
today, but with China. The current cuts to scientific research
at the NIH and universities needs to be reversed. Otherwise, we
are ceding the scientific primacy that Congress over the last
75 years has worked on a bipartisan basis so hard to ensure.
One of the reasons we have been able to lead the world in
health sciences is due to a strong FDA and its rigorous
standards. One of my goals as Commissioner was to ensure that
if you needed access to a lifesaving drug and you lived in the
United States, you would have access to it before anyone else
in the world.
We saw that with COVID-19, for example, with the monoclonal
antibodies. Those drugs appear to have saved President Trump's
life back in October 2020. Dr. Peter Stein's office made that
drug available to the President and thousands of others. Dr.
Peter Stein was removed from office in the recent rounds of
cuts, as were thousands of others. It is no way to restore
trust in FDA when you cut the person who may have saved the
President's life. These cuts appear to me as devastating,
haphazard, thoughtless, and chaotic.
Mr. Chairman, I agree with your priorities of increased
enforcement against illicit imports and counterfeits. I agree
with your priority of improving the safety of our food. The
current cuts will make achieving those priorities impossible.
We need to be clear-eyed about the threat that China poses to
American exceptionalism, especially in the sciences. We cannot
afford to be haphazard in our support of the American
scientific enterprise, not when China's commitment to the
sciences is more real than it has been in the past. America's
real competition in the sciences is China. The Administration
and Congress need to understand the nature of that competitive
challenge and respond strategically, thoughtfully, and with
appropriate strength. Thank you, Mr. Chairman.
Chairman Comer. Thank you, and now we begin our questions.
The Chair recognizes Mrs. Luna from Florida.
Mrs. Luna. Thank you, Chairman. Good morning, everyone. I
want to thank you all for being here today, but what we are
dealing with is not just about counterfeit vape pens or illicit
Chinese imports. This is how the FDA, the Agency that is
supposed to protect the American people, has utterly failed to
keep toxic chemicals out of baby formula, sunscreen, and food
products being sold in stores here in America. Let me be
crystal clear: American parents have every reason to distrust
the FDA when Red 40, a known dye, is in their child's cereals;
benzene is in sunscreen, also a known carcinogen; and Chinese-
owned companies are allowed to dump trash on our shelves with
``Made in the USA'' slapped on it. The FDA has become a rubber
stamp for big pharmaceuticals, big agriculture, and the CCP,
instead of looking out for the best interest of the American
people.
Mr. Safdar, is benzene, a known carcinogen, safe in any
quantity in consumer products like sunscreen or face wash?
Mr. Safdar. Congresswoman, thank you for the question. PSM
focuses mostly on prescription medications and entirely in
prescription medications, and so I do not have the expertise to
answer your question about sunscreen.
Mrs. Luna. OK. I appreciate your honesty there. For the
American people watching, so you know, benzene is a known
carcinogen, and the FDA is allowing products with detectable
levels of benzene to remain on the market. If they are
generally fighting for the best interest of the American
people, my question would be, why are they not saying anything
about this? Mr. Safdar, would you also agree that the FDA can
send armed agents into Amish dairy farms, but they are not
keeping toxic Chinese-made face washes out of our stores?
Mr. Safdar. Congresswoman, thank you for the question. I
neither work on anything related to food products or face
washes, so I cannot answer the question.
Mrs. Luna. Got it. Does anyone on the panel have an answer
to that?
[No response.]
Mrs. Luna. No? OK. Just for context, here is an article
that I would like to enter into the record, Mr. Chairman.
Chairman Comer. OK. Without objection, so ordered.
Mrs. Luna. The FDA was raiding Amish farms over raw milk,
which, to be honest with you, is pretty absurd given that the
FDA has dropped the ball on many other things that are actually
causing cancer. Mr. Bentley, you talk about consumer freedom,
but isn't it true that freedom is based on informed choices?
And how can parents make informed choices when the FDA has
allowed known neurotoxins, like Red 40, in kids' food without
warning labels?
Mr. Bentley. Congresswoman, thank you so much for the
question. Food dyes is, I think----
Chairman Comer. Make sure you got the microphone in front
of your face, everybody. Yes. There you go.
Mr. Bentley. I beg your pardon. Thank you so much,
Congresswoman. I appreciate the question. I think the issue of
red dyes is a particularly important one, and I think there
does need to be further research into its relative safety and
to whether the FDA has taken a relaxed attitude or and whether
these products, even if there is not a known health risk at the
moment, whether a precautionary approach should be taken into
removing them from the market. So, I think that is very up for
discussion, and I hope new leadership of the FDA can look at
these, perhaps under-examined, questions in more detail.
Mrs. Luna. Yes, we will be making those suggestions. As I
am sure you know, products based and manufactured in the U.K.,
even in other parts of the world, are way different than
American products. And just to put it in perspective, I mean,
aside from corporate lobbying and regulatory capture, do you
think that there is a reason why Red 40 would still remain in
American products when it is actively banned in the rest of the
world? Just, if you could, yes or no?
Mr. Bentley. No.
Mrs. Luna. OK. I would say that because of the utter
incompetence being displayed by the FDA, I understand that you
are all not the head of the FDA, but I am going to be choosing
to reintroduce, and I am glad that you backed me up on this
one, the Do or Dye Act, which is what I introduced in the 119th
Congress, to remove some of those toxic chemicals and dyes from
our food products. Dr. Williams, you are a former FDA
economist. Can you please help me understand something? Why is
the FDA moving faster to approve experimental drugs for
billion-dollar pharmaceutical companies than it does to ban
known toxins like benzene?
Dr. Williams. First of all, I worked in the food section of
FDA, not in the drug section, so I really cannot comment on
that. I will say that----
Mrs. Luna. Just real quick, does anyone have a comment for
that, because we are at 41 seconds. Pharmaceutical?
[No response.]
Mrs. Luna. Nothing. OK. So, continue.
Dr. Williams. OK. I will say that in terms of color
additives, there is some misinformation out there. They are not
banned in Europe. Actually, Europeans do not care that much
about having color in their foods. The other thing is that you
really have to focus on the amount of exposure. Simply saying
something is a toxin or a carcinogen does not mean a lot. What
matters is what the exposure is.
Mrs. Luna. Sir, if I can just interrupt you for a second,
and I appreciate your position, but what I will tell you is if
you have something that is known to cause autism with children,
you have a young child's brain that is developing, I do not
think that that is misinformation. I think that the American
people are trusting the FDA to ensure that they do not even
have to worry about levels of additive that has something that
has known detrimental effect on a child. Either which way, why
are we adding fake stuff into a product that can just be
naturally made? I think that that would be the biggest
argument, and I would say that Big Food wants it to be a
cheaper manufactured product because it is more of a net profit
for them on the back end.
Look, I am already over time. I appreciate you guys being
here today, but if you have anything that you can provide my
office with, I would appreciate it because I think that the FDA
needs an entire overhaul, and I think that the FDA currently is
for sale. Thanks, guys.
Chairman Comer. The Chair recognizes Mr. Subramanyam.
Mr. Subramanyam. Thank you, Mr. Chair. Dr. Kessler, I was
very interested in your testimony about how these cuts are
affecting our food safety and, really, just our ability to have
a functioning FDA. And so, could you just tell me a little
more, these firing at HHS and FDA, in particular, we are trying
to find effective strategies to bring new drugs to market in a
safe manner, but in an expedient manner, but how do these cuts
affect our ability to do that?
Dr. Kessler. Imagine, Ranking Member, that, you know, there
was a major airline. That major airline decided today that it
was going to fire everyone except the co-pilots, and it was
going to run that airline and it only had the co-pilots, OK? No
pilots, the senior people are gone. People who fix the planes
were gone. People who got people on the plane were gone. I
think that is what we are facing with these cuts. Imagine if
you try to run this Congress and there were only Congressmen
and Congresswomen in the building, all right? That is what is
going on at FDA today. I have major concerns. We are at risk. I
think we are less safe today.
Mr. Subramanyam. I have talked to farmers who have talked
about the outbreak of avian flu, and we actually had the first
mammal case of bird flu in the state of Virginia, the
Commonwealth of Virginia, and my district on Monday. How would
these cuts impact the FDA's ability to deal with the bird flu
epidemic?
Dr. Kessler. The leading experts on avian flu are certainly
at FDA and at NIH. This is not just about FDA. Dr. Jeanne
Marrazzo, who is running NIAID, taught me everything about
avian flu. She is no longer there. We are at risk from
infectious diseases. Look, I cannot tell you whether we are one
mutation away or two mutations away, all right? It has had
devastating effects, I mean, on our animal livestock, and it
gives me great concern, but that day is going to come, OK, and
those people we need are not there.
Mr. Subramanyam. And I would like to enter into the record
a Washington Post article titled, ``Worries Grow Over Risks to
Americans as Trump Cuts Health Safety Agencies.''
Chairman Comer. Without objection, so ordered.
Mr. Subramanyam. April 6.
And so, how would these firings at the FDA impact its
ability to make sure that infant formula is safe and that we do
not have another infant formula crisis?
Dr. Kessler. Absolutely. You are exactly right. What we
heard, I think, from my panelists, whether it is hemp, whether
it is e-cigarettes, these are complicated regulatory decisions.
You have industries asking at this table, please, we need
thoughtful regulations, right, that are well-balanced. Those
people who are in charge of that policy at FDA to be able to
work through, to get the right answers with the Congress, even
to answer your request for information, they are not there.
Mr. Subramanyam. And you said recently, it is not too late
to undo at least some of the damage that has been done. How
much time do we have left before we cannot fix what has been
broken, and what would you do to fix it?
Dr. Kessler. I always believe that things were fixable,
right? You know, I think we have seen that, right? You can
always go in and fix. The problem is, especially in the
sciences, I have been the dean of two major medical schools.
This is about expertise. This is about pipeline, right? If we
lose a generation of young people--I mean, young people got hit
with COVID--I think we cannot underestimate the effect. They
could not go into their laboratories. They had to sacrifice
their training. If we now have these cuts, right, at NIH, you
know, a second time, they cannot get jobs as postdocs, we are
going to lose a generation of scientists. They are going to set
back this country, and that is true at FDA. We have lost a
thousand person years of expertise in a few weeks. I mean, if
we let this go on for much longer, I mean, I think it is a
matter of weeks. I mean, you know, this may not be fixable.
This may affect us for decades.
Mr. Subramanyam. Thank you, Dr. Kessler. I yield back.
Chairman Comer. The Chair now recognizes the Chairman of
the Government Operations Subcommittee, Mr. Sessions from
Texas.
Mr. Sessions. Mr. Chairman, thank you very much. Dr.
Kessler, thank you for being here. We have had the former head
of the FDA in before this Committee several times. It was a
purely political dance that he provided this committee, not
only on answering the people that were not going to work, the
empty parking lots at FDA, people who chose to work from home,
not collaborating, working with each other for 4 years. This
happened all across government, and I find it interesting that
now the argument is everybody wants to come back to work when
you and I know that we disagree on that issue.
[Slide]
Mr. Sessions. To the panel, I would like to say to you, I
had an opportunity this morning to look at WebMD, and you may
have your own ideas about the effectiveness or how WebMD works,
but the bottom line is, is that I am looking at what might be
delta-8, which is this unregulated form of hemp THC. It is
called delta-8 THC. THC is an addictive product. WebMD says
that marijuana, which is what THC is, use over several years
causes brain effects, like lower IQ, slower processing speed,
memory, and attention issues. I would direct you to this slide
here where delta-8 is involved and it is marketed in such a way
that it appeals to not only adults, but also to children.
WebMD further says, ``hemp's legality stems from the so-
called Federal Farm Bill--and I am quoting this--``the so-
called Farm Bill, which removed hemp and its byproducts from
the list of controlled substances.'' The reason hemp's low THC
levels, less than .3, which was in the bill, but the bill does
not mention delta-8 anywhere. And what has happened is chemists
have come in and changed that viewpoint, not only of hemp,
which I was, as the Chairman of the Rules Committee, very open
to when the gentleman, the young Congressman, former Chairman,
former head of the Agriculture Committee in Kentucky, came and
asked me if I would allow this to be put into the Farm Bill.
And I went through a detailed explanation with him about what
hemp stood for and how it might be used.
I was told it was this: ropes, things that are used by
Americans every day, but to build the market, and he did not
say anything that was wrong to me. He said what was right at
the time. But now these so-called loopholes, chemistry, these
are dangerous products that create in, not only my
congressional district, the Sheriff in McLennan County came to
me and said, ``Congressman Sessions, please go to our hospitals
and look and see what is happening as a result of delta-8,''
what is happening as a result of this hemp product that has
become loaded with THC.
I think what I would say to you is this: it is widely seen
by many people as a dangerous product. It is dangerous not only
to adults, it is very dangerous to children, children who do
not recognize the difference between what might be a small
product, a gummy, perhaps, or something else, and then turns
into an emergency episode at an emergency room. I think one of
the telling things comes from a guy whose name is Elton John, a
well-known musician, who has stated that of all the things that
he has seen in his life, one of the worst things that he has
seen is America and anybody else that legalizes marijuana.
Marijuana is THC, and so, gentlemen, I will be watching
you, and I am interested in the hemp industry, the same reason
why, as Chairman of the Rules Committee, I allowed it to be in
the Farm Bill. But gentlemen, we have got to understand, it is
a dangerous product that causes IQ problems, it causes problems
with slowness of adults, and it causes problems that are
harmful to children. Mr. Chairman, I yield back my time.
Chairman Comer. Thank you. The Chair recognizes Mr.
Krishnamoorthi from Illinois.
Mr. Krishnamoorthi. Thank you, Mr. Chair. I want to show a
visual here.
[Chart]
Mr. Krishnamoorthi. And, Dr. Williams, according to the
CDC, measles cases have skyrocketed during Donald Trump's time
in office, with 607 confirmed cases and two tragic deaths. You
do not dispute that, right? You got to turn on your mic.
Dr. Williams. Yes, sorry. No, I do not dispute that.
Mr. Krishnamoorthi. And, Dr. Williams, you wrote that
``This tragic measles outbreak is a direct consequence of
spreading misleading information about vaccines, and,
unfortunately, Health Secretary, Robert F. Kennedy Jr., has
played a role in perpetuating these false claims.'' You wrote
that, correct?
Dr. Williams. No, I did not write that. It must be another
Williams.
Mr. Krishnamoorthi. ``Measles Outbreak, RFK, Jr.'s Health
Agenda & Surprising Health Wins.''
Dr. Williams. No, sir, I did not write that.
Mr. Krishnamoorthi. OK. Let me mention this. On Sunday, Mr.
Kennedy finally said the most effective way to prevent the
spread of measles is the MMR vaccine, but he did not disavow
false claims that many people have said were directly linked to
the measles outbreak. And this, obviously, is something that
must be addressed immediately, correct?
Dr. Williams. Yes, sir.
Mr. Krishnamoorthi. Let me turn to my next topic. President
Trump has put tariffs on just about everything, sending prices
skyrocketing, and, unfortunately, the stock market is
plummeting right now. Mr. Bentley, you wrote that ``Tariffs of
any kind are a direct tax on consumers,'' correct?
Mr. Bentley. That is correct.
Mr. Krishnamoorthi. And Mr. Safdar, in a February 18 Q&A at
the White House, the following was asked and answered of the
President. The question was asked to the President, ``And what
about pharmaceutical tariffs?'' Answer, ``It will be 25 percent
and higher.'' You do not dispute he said that, correct, Mr.
Safdar?
Mr. Safdar. I was not at the White House, Congressman, but
I will take your word for it.
Mr. Krishnamoorthi. OK. Thank you. Well, look, today,
according to The New York Times and many other periodicals,
even common medicines like Tylenol and the active
pharmaceutical ingredients in Advil are primarily made outside
the U.S. and are now subject to tariffs. Moreover, according to
Forbes and ING, researchers have found that tariffs will
increase the price of all generics by about $42 per drug per
year. So, I come back to you, Mr. Bentley. You said in this
article, ``Tariffs are not just a threat to the economy, they
are a threat to public health,'' correct?
Mr. Bentley. Correct, Congressman. I was talking about
tariffs on e-cigarettes, which would be a threat to public
health because e-cigarettes are a substitute for combustible
cigarettes.
Mr. Krishnamoorthi. And of course, tariffs on generic drugs
would also be a threat to public health as well. Now, let me
turn to you again, Mr. Bentley, regarding e-cigarettes. Mr.
Bentley, by 2018 and 2019, 20 percent of our kids were vaping,
and the rate was doubling year-over-year, prompting Trump's
then FDA Commissioner, Scott Gottlieb, to call it an epidemic.
However, at this time in 2018, you call the situation ``an
alleged epidemic,'' right?
Mr. Bentley. Correct.
Mr. Krishnamoorthi. And today, there are over 1.6 million
youth vapers, yet despite millions of underage users, you said
recently that ``claims of widespread youth vaping are
disputable.'' You said that in this article, correct?
Mr. Bentley. Correct, because youth vaping has fallen
dramatically since 2019.
Mr. Krishnamoorthi. I assure you that the parents of the
1.6 million youth vapers do not believe that somehow claims of
widespread youth vaping are somehow disputable. Now, let me
turn to another article that you wrote here. You said, ``A
Question of Taste: The Public Health Case for E-Cigarette
Flavors.'' You believe, as the title suggests, that there is a
public health case for flavored vapes, right?
Mr. Bentley. That is correct, Congressman.
Mr. Krishnamoorthi. Let me just show you some of the
American-sourced vapes that are on the market currently.
Strawberry Super Strudel. There is a public health case for
that, right?
Mr. Bentley. There are 18 million adult vapers in the
United States----
Mr. Krishnamoorthi. There is a public health case for
Strawberry Strudel?
Mr. Bentley. Yes, there is because most----
Mr. Krishnamoorthi. And how about this one, Rainbow Road?
There is a public health case for Rainbow Road, right?
Mr. Bentley. They all need to go through FDA review to be
evaluated on their public health merits, which I completely
support, but flavors are the overwhelming choice of adults, 18
million of whom are using e-cigarettes to quit smoking.
Mr. Krishnamoorthi. On page 3 of your statement, 13 percent
of youth who vape cite the availability of flavors as their
reason for vaping, so hundreds of thousands of children who
have never smoked are taking up vaping because of these
flavors. This is Sour Skittles. This is a Sour Skittle vape.
Sir, your defense of flavored vapes is completely unacceptable
and endangering our youth today. Thank you, and I yield back.
Chairman Comer. The gentleman yields back. I will recognize
myself for questions. Mr. Bentley, tobacco is still a huge crop
in my congressional district. Tobacco is still legal in the
United States. In 2014, the FDA collected $1.8 billion in user
fees by the Center for Tobacco Products. Today, that number is
$3.5 billion in user fees. Despite this increase, the FDA
continues to put out unclear or incomplete guidance, causing
the people in the business that want to play by the rules to
have uncertainty. Why can't FDA properly regulate tobacco
despite charging the tobacco companies billions of dollars?
Mr. Bentley. Thank you for the question, Congressman, and
you are exactly right. The Center for Tobacco Products run by
FDA has collected billions of dollars in user fees, and yet we
have a nicotine market that is in chaos with 90 percent of e-
cigarettes being bought on the illicit market. What can change
at FDA to resolve the problem of the illicit market is not more
funding and staff----
Chairman Comer. Right.
Mr. Bentley [continuing]. But the process of approvals.
Chairman Comer. And just to touch on what my friend, Mr.
Krishnamoorthi said, it is my understanding that the FDA
approves very few tobacco and nicotine products, even though
many of the products the PMTA processes are safer than
traditional cigarettes. Is that true?
Mr. Bentley. That is exactly true.
Chairman Comer. So, why is the FDA refusing to authorize
safer products?
Mr. Bentley. Because the FDA interprets what is called the
appropriate for protection of public health standard in a
particularly opaque and, we imagine, strict way, and that means
fewer products by companies, as you say, Congressman, who want
to play by the rules----
Chairman Comer. All right.
Mr. Bentley [continuing]. Are getting to the market.
Chairman Comer. And I would argue, to go along with what
Mr. Krishnamoorthi said, the FDA's refusal to approve new
tobacco products created a thriving market for illegal and
unsafe products, the ones that Mr. Krishnamoorthi was talking
about, from China. These products are targeted at children.
What should FDA be doing to prevent these illicit Chinese
products targeting our children?
Mr. Bentley. FDA has set up a multi-agency task force,
particularly with partnership with DOJ and CBP, to try and
track and halt the importation of products from China. But at
the end of the day, this will be nothing really more than a
bandage unless its own internal processes can be reformed,
which also, fortunately, do not require more staff or more
funding.
Chairman Comer. All right. Mr. Miller, we are going to
shift gears to talk about hemp and hemp derivatives. So, the
Congress legalized the sale of hemp, like Mr. Sessions was
talking about, and hemp derivatives, by removing them from
being Schedule I substances. To what extent has FDA regulated
hemp derived products like CBD?
Mr. Miller. They have not, and we as an industry are
begging for that regulation.
Chairman Comer. Why hasn't the FDA refused to regulate hemp
and its derivatives despite having the authority to do so and
despite the leading organization representing the credible
manufacturers and producers begging them to do that?
Mr. Miller. They have gone back and forth. They initially
said that they were going to regulate products, and then they
have now claimed they need to have congressional authorization
to allow them to regulate that. We dispute that. And I do want
to mention, because Congressman Sessions raised that issue
about youth use of these products, we as an industry strongly
oppose the sale of these products or the marketing of these
products to children and really are looking for the FDA's help
to make sure that that does not happen.
Chairman Comer. How long would it take the FDA to do
something like this? I mean, what are we talking here?
Mr. Miller. Well, we----
Chairman Comer. Do we need a gazillion bureaucrats that
work from home? What is involved in FDA to regulate this,
especially when you have the industry wanting to be regulated?
Mr. Miller. So, there currently are a number of safeguards
under current law that the FDA could use and has chosen not to
use within the Federal Food, Drug, and Cosmetic Act. For
example, the law precludes manufacturers and distributors from
selling mislabeled or adulterated products, and it requires the
manufacture and sale of products consistent with good
manufacturing practices. The law also requires reporting of
serious adverse events, and it mandates strict labeling,
including, if FDA desires, warning against the use of products
by children. Finally, the FDA, with the Consumer Product Safety
Commission, could require child-proof packaging.
Chairman Comer. All right.
Mr. Miller. So, there are existing----
Chairman Comer. Got it.
Mr. Miller [continuing]. Laws out there that they can take
advantage of.
Chairman Comer. Very good. My last question, Dr. Williams,
we investigated the infant formula crisis extensively in this
Committee last Congress. Can you talk through, quickly, how the
FDA failed to prevent the crisis and what needs to be done to
improve competition and resilience to ensure an infant formula
crisis never happens again?
Dr. Williams. Yes. One of the main problems, particularly
with supply, was that we would have manufacturers write to FDA
and say we are thinking about getting into the infant formula
business. The FDA would respond with please do not. They wanted
to keep the number of suppliers down to six, and they did that.
So, consequently, when we had one plant that had a problem that
actually had been investigated, when it had stopped production,
that is when we hit a huge supply problem. But there was one
other problem, and this stems from the Infant Formula Act
dating back, I believe, to the 1980s, where FDA produced a
regulation that was addressing manufacturing of infant formula,
good manufacturing practices. None of it, in my estimation, in
my analysis, would help infant formula at all. Nevertheless,
the FDA was determined to go forward. The problem with that was
when FDA passes regulations on infant formula, that raises the
price of infant formula for people who cannot get it for free.
What happens is less well-off consumers extend the infant
formula with water, and there is nothing more dangerous than
the primary source of nutrition being extended with water for
infants. So, that is another problem that I think FDA needs to
be aware of.
Chairman Comer. Very good. The Chair recognizes Ro Khanna
from California.
Mr. Khanna. Thank you, Mr. Chairman. Dr. Kessler, there is
a dangerous anti-intellectualism that has become fashionable in
our country today: attack the scientist, attack the thinker,
attack the academic. Vice President Vance says the universities
are the enemy. He is calling an enemy the university where the
President who appointed you went, Yale; calling Harvard, where
you were educated, the enemy; calling the very university he or
I studied at the enemy. And I am tired of politicians having
this kind of false populism where they are attacking people who
read, attacking people who think, attacking people who actually
engage in intellectual excellence. What has been the
alternative? Appointing people who did not do the homework, who
never read a book about economics or health sciences. We see
what that is turning out to be.
And I want to ask you, Dr. Kessler, because I was so
concerned about the firing of Dr. Peter Marks, who has more
qualifications than the entire Cabinet put together, who
actually did the one thing with Operation Warp Speed that was
Donald Trump's contribution. Can you talk about how offensive
it is that people far less qualified, far less knowledgeable
fired this man?
Dr. Kessler. I do not think I could say it better,
Congressman, than you just said it.
Mr. Khanna. I mean, go ahead.
Dr. Kessler. I mean, this feels a little surreal just
sitting here, because everybody wants a stronger FDA, everybody
wants more regulation, fix this, make sure that infant formula
is safe, make sure that drug is safe, make sure that dietary
supplement is safe, do a better job, go here, go there, make
sure this import, right, does not contain any harmful products.
But over the last several weeks, this Agency has been
devastated.
Mr. Khanna. And, Dr. Kessler, I am talking about something
even deeper, because I agree with you. These cuts are going to
hurt people, the lifesaving treatments are not going to get
approved. But I understand people are angry in this country.
They are angry that jobs have gone offshore. They are angry
that wages have stagnated. But what you have is politicians
exploiting it in a false populism to blame anyone who thinks,
to blame anyone who reads, to blame anyone who has ideas. They
are attacking the smartest people in our country and blaming
them for problems that were caused by political failures, and
we need politicians in this country who are going to say we are
going to stand to defend intellectuals. We are not going to be
afraid of that. We are going to stand to defend institutions
that have led thought.
You know, Lincoln called it mob rule. It is a story that
goes all the way back to the Athenian mobs taking on Socrates,
and I want people in our country, politicians, to stop with the
false populism, to stop attacking the people who do their
homework and who are leading inventions and who are leading
science and leading thinking. President George Herbert Walker
Bush, who actually sacrificed and fought in World War II, what
would he have thought about this Vice President attacking Yale,
about this Health Secretary firing people of competence and
exceptional talent?
Dr. Kessler. I was there sitting at graduation as a dean
when President Bush came to give the commencement address.
These universities have contributed mightily to, not only the
intellectual life, right, not only to our freedoms, but to our
competitiveness, and scientific advances have been generated by
these universities. That was what this Congress, back in the
1950s and 1960s, set up this system. Bush, right, had a system
that gave rise to the medicines that we have available today.
We have to be able to support that biomedical infrastructure.
That is under attack. It needs to stop.
Mr. Khanna. And I appreciate your service.
Chairman Comer. The Chair now recognizes Mr. Grothman from
Wisconsin.
Mr. Grothman. Thank you. I got to respond to a little bit
of that. First of all, wages are stagnating. They are
stagnating under the law of supply and demand. We just had a
President who let 10 million people in this country. Of course,
wages are stagnating, and I think a lot of times the business
community is just fine with that. I have had businessmen
complain to me, you know, I have to give my workers another
raise here. Isn't that horrible? You know, can we have more
immigrants around here? So, we know why wages are stagnating.
They are stagnating because of excessive immigration.
As far as our universities, there is no diversity of
thought there. My one other comment, you talk about people who
think and read. In my experience, people who are skeptical of
our medical community, our pharmaceutical community, are the
most well-read people in my district. That is why they are
skeptical. They go beyond just the blather you get in the
mainstream media, but OK.
Now we got to ask some questions here. I will ask one of
you folks. It seems to me, am I correct here, we have more
pharmaceuticals per person prescribed, consumed, or whatever in
this country than the world, or at least more than any other
Western countries?
[No response.]
Mr. Grothman. You do not know. OK. We will try to give you
another question. Do we have more antidepressants consumed in
this country than other countries?
[No response.]
Mr. Grothman. You do not know. Stumped again. OK. OK. I
will go for Mr. Williams. Americans have been grappling with--I
will digress for a second. As far as bringing new
pharmaceuticals on the market, do you believe the
pharmaceutical industry itself has a disproportionate influence
in determining which drugs come on the market and which off-
brand drugs are not going to be researched?
Dr. Williams. My expertise is in food safety and nutrition,
not in pharmaceuticals, unfortunately.
Mr. Grothman. OK. Well, we will give you a food question
then. Americans have been grappling with high inflation,
especially food inflation. During the Biden Administration,
grocery prices rose 22 percent. Would you simplify the FDA's
food regulatory structure to lower prices? Could you give me
some examples of what could be done?
Dr. Williams. Yes. I believe that is exactly what I would
do. I think a lot of the problem with FDA's food regulations
from my expertise--and it really is now going on over 40 years,
and I continue to look at it--is that too many of FDA's
regulations were not being made because it was going to keep
food safer or because it was going to help nutrition. A lot of
it is because of some firms controlling FDA saying we want
regulations to put our competitors at a disadvantage. All those
regulations have to be complied with and all of that compliance
by those firms raises prices. They do not pay for the
regulations. This is a big misunderstanding, particularly in
FDA. It is consumers.
Mr. Grothman. Yes. Can you give me a ballpark number on,
what you think, food prices? Could it drop if we did not have
what I will refer to as unnecessary regulation?
Dr. Williams. I wish I had that information, and I do not.
But I think it would certainly help, and it would certainly
help FDA to target their inspections and focus their resources
on real risk.
Mr. Grothman. OK. We will give Mr. Bentley a question or
Mr. Miller. America does spend a great deal on medicine and a
lot of that is on drugs. Nevertheless, our life expectancy
seems to be less than other developed countries. Can you
comment on that?
Mr. Bentley. Congressman, my expertise is basically in
tobacco policy, but I will say an easy way that we could
increase life expectancy and reduce cancer is have more
authorized safer alternatives to cigarettes onto the market,
which FDA has been stymieing for the last 5 years.
Mr. Grothman. OK. Mr. Miller, you got any comments?
Mr. Miller. I would just add that when it comes to holistic
products, products made from American agriculture like hemp,
these give alternatives to pharmaceuticals that a lot of
Americans find tremendous relief in, and we should be promoting
them, but we should also, as I have been saying, regulate them
strictly.
Mr. Grothman. OK. I will give Mr. Bentley and Williams and
the fourth one down the line one more question or one more
crack at it. It seems to me, compared to other countries, that
we are over medicated, and I am not sure that it is resulting
in better health. Could you comment on that?
Mr. Safdar. Congressman, my expertise is not in that area,
but I will say that our drug supply, which is my expertise, is
probably the safest in the world. In fact, the next time you go
up and pick up a prescription, you probably should buy a $2
lottery ticket. You are more likely to hit that than to ever
get a counterfeit medicine in a pharmacy. It is really the
pride of the world.
Mr. Grothman. Thank you.
Dr. Williams. I will just add to that. In fact, I think
medicine has been responsible for our longevity up until now,
but I think it is time to focus on prevention, and I am very
glad to see that there are a number of people entering
government now that are focused on prevention more than
medicalizing people who are already ill.
Mr. Grothman. OK.
Chairman Comer. Before I recognize Mr. Mfume, Mr.
Krishnamoorthi has asked for recognition of unanimous consent.
Mr. Krishnamoorthi. Yes. Mr. Chairman, thank you so much
for allowing me to enter into the record, or I request
unanimous consent for this article by our witness, Mr. Richard
Williams, entitled, ``Measles Outbreak: RFK, Jr.'s Health
Agenda & Surprising Health Wins'' from his website, and I give
the witness a chance to remember that he wrote this, but it is
from your website. This is your picture, this is your article,
and this is your quote that I had from earlier.
Chairman Comer. Without objection, so ordered.
Mr. Krishnamoorthi. Would you give him a chance to respond
or----
Chairman Comer. If he wants to respond. It is up to the
witness.
Dr. Williams. I will go back and take a look, but, yes, I
do not recall that one.
Mr. Krishnamoorthi. We will give you a copy of this, OK? It
is serious to deny that you wrote this article.
Chairman Comer. All right. The Chair recognizes Mr. Mfume
from Maryland.
Mr. Mfume. Thank you very much, Mr. Chairman. My thanks to
the witnesses who are here today. I want to just say a couple
of things that are quite obvious and then turn the attention a
bit to clinical trials. Dr. Kessler, I am going to start by
saying I am going to end with you because I found your comments
to be chilling and to be a real warning to where we are and
where we are headed if we do not heed----
Dr. Kessler. Thank you.
Mr. Mfume [continuing]. The fact that we are making big
mistakes right now every day as we dismantle the Food and Drug
Administration. But before I do that, let me just state the
obvious, and that is that everyone I think wants to protect the
health of all Americans, at least everybody should, and
everybody wants to root out illicit products that always find
their way into our markets, and that is why ensuring the health
of the FDA is so vital to this country. It has got to have the
resources to protect all of us regardless of race, ethnicity,
sex, or any other designation. It is critical to public health.
Since the FDA Commissioner Makary was sworn into service on
April 1, Secretary Kennedy and he have pushed out and fired, as
has been stated, over 4,000 Federal employees at FDA, and just
last week, more than 800 staff at FDA Center for Drug
Evaluation and Research were also fired. That center in
particular is responsible for approving and monitoring new
medications that come onto the market for side effects and for
updating drug warning labels accordingly. Those fired workers,
as has been stated earlier, are some of the Nation's best and
brightest scientists in charge of ensuring our supply of infant
formula to make sure that it is safe, our medications for our
family members and grandparents, food for all of us, and many,
many ways the highest quality of food safety that we can expect
in this country.
So, to have trust in the FDA, its decisions, and its
ability to ensure effectiveness of the drugs that are approved,
that requires research, it requires clinical trials, and those
trials must include all American groups that may have need for
the treatment. So, effectiveness and safety cannot be ensured
to all without the inclusion of all Americans in those clinical
trials, which is why I am particularly disturbed that these
mass firings at our Nation's health agencies, in addition to
these anti-DEI efforts, and similar rhetoric across this
Administration will make improving the overall health of
Americans much, much more difficult. So, it was unfortunate to
see that the FDA removed previously issued draft guidance on
diversity in clinical trials from its website, as if to suggest
that disease is racially monolithic. Clinical trials refute
that. Clinical trials, when they are done correctly and with
diverse participants, give us the ability over and over again
to produce the best medications and to chart out the best
courses.
In this Congress, we passed, several years ago, something
known as the Henrietta Lacks Enhancing Cancer Research Act in
January 2021. Many of you will remember this was initially led
by the former Chairman of this Committee, the late Elijah
Cummings, and this very Committee listened to testimony about
why it was important, and it was many of you on this Committee
that joined me and others on the Floor to argue for its
passage, and it was indeed passed. Mrs. Henrietta Lacks and her
extraordinary story of her HeLa cells, which were alive many,
many years after her physical death, have been very instructive
in terms of finding a way to create cures for diseases. Jonas
Salk will tell you that, before he was able to finalize the
polio vaccine, he had it tested against her cells long after
her death to make sure that it was, in fact, effective. It has
been effective in HPC vaccines and it has been effective in
helping the mapping of human genomes. So, we do not want to go
back to the days prior to Mrs. Lacks when no one wanted to talk
about diversity in clinical trials, and we do not want to stay
where we are, where we are erasing any allusion to diversity in
those trials from the website of the FDA. I just do not
understand it at all.
I want to, if I might, just get your opinion, those of you
who are here right now, as to whether or not you think that
removing diversity from clinical trials helps the American
public or advances medical science. Dr. Kessler?
Dr. Kessler. It is absolutely essential that our clinical
trials be done in a diverse population. There is great
variability of biological response. I am humbled when I look at
medicines and how variable they respond in different people. It
is just the nature of biology. We work very hard--the
pharmaceutical industry, FDA, the universities--to make sure
that clinical trials are increasingly representative and
diverse. If we want to understand how medicines work, if we
want safe and effective medicines, clinical trials require a
representative and diverse population.
Mr. Mfume. Mr. Chairman, if I might have an additional 15
seconds. I would like to ask unanimous consent that we enter
into the record the GAO report to congressional committees 2
years ago entitled, ``Cancer Clinical Trials.''
Chairman Comer. Without objection, so ordered.
Mr. Mfume. I would like to ask unanimous consent that we
enter into the record Public Law 116-291, which many of the
Members of this Committee voted in favor of, that created this
whole notion of more diverse clinical trials, particularly in
cancer research.
Chairman Comer. Without objection, so ordered.
Mr. Mfume. And I would like to ask unanimous consent to
enter into the record clinical research entitled, ``Genetic
Variant and Cardiac Remodeling, Injury, and Heart Failure Risk
in Black Adults.''
Chairman Comer. Without objection, so ordered.
Mr. Mfume. Thank you. I yield back.
Chairman Comer. The Chair recognizes Mr. Perry from
Pennsylvania.
Mr. Perry. Thank you, Mr. Chairman. Gentlemen, thank you
for being here. The average life expectancy for Americans is 78
years despite spending more than every other Western developed
country, which has a life expectancy of 82 years, so we are not
doing so well. Six in 10 Americans have at least one chronic
disease, with more than 40 percent of children suffering from
at least one health condition. I think that is astounding.
Mr. Safdar, as of March 31 of this year, the American
Society of Health-System Pharmacists lists 238 drugs in
shortage. These shortages include pharmaceuticals used to treat
infections, heart failure, psychiatric conditions, and cancer,
and include drugs such as amoxicillin, penicillin, cisplatin,
and active ingredients in most chemotherapeutic regimes. As you
probably know, the medications taken by Americans are
manufactured largely overseas, and their active ingredients are
overwhelmingly made in India and China. Can you explain to us
how our dependence on foreign pharmaceutical markets has
created manufacturing delays for critical medications across
the USA?
Mr. Safdar. Thank you, Congressman, for the question. While
I am not an expert in the inspection of foreign facilities, it
is clear that our supply chain is global at this moment, and
medicines come from and the ingredients come from all over the
place. We are usually very pleased to see efforts to secure the
supply chain and to secure manufacturing facilities with
inspectors from the FDA, and it is part of what makes our
supply chain most resilient.
Mr. Perry. Do you think it is a good plan for the United
States to rely so heavily on other countries, including ones
that consider us their enemy, which would be the Communist
Party of China?
Mr. Safdar. Well, the national security implications of
that are definitely outside my expertise, but I think that the
doctor here has probably got a better perspective.
Mr. Perry. OK. Dr. Kessler, what do you got?
Dr. Kessler. I agree with you a hundred percent. I mean, I
was in charge of, you know, with my colleagues, Operation Warp
Speed of sourcing for the monoclonal antibodies, for example.
We are at risk as a country. We are not producing in this
country essential medicines for lifesaving conditions. We need
to do a better job.
Mr. Perry. So, either one of you, or anybody, is it because
the precursors or the drugs themselves are rare and
unattainable in the United States of America?
Dr. Kessler. If you look at the top universities for
chemistry today--Nature Index has them--10 out of 10 are in
China.
Mr. Perry. But is that because they are unavailable in the
United States of America?
Dr. Kessler. Chemists make the drugs, right? Where are they
training the chemists? Where is that scientific expertise,
right? We are not investing in this country in the natural
sciences----
Mr. Perry. So, you are saying we have the material. We do
not have the know-how. Is that what you are saying?
Dr. Kessler. We do not have the know-how, we do not have
the plants, we do not have the commitment.
Mr. Perry. Do these drug shortages then enhance the
proliferation of the illegal knockoff drugs? Is that a cause-
and-effect relationship? We cannot get them here, so there are
knockoffs produced overseas, even in our country, that are
often dangerous to people in our society that think they are
taking a legitimate drug. They get it on the internet or get it
through the mail and then take it and then overdose. Is that a
part and parcel to this?
Dr. Kessler. It is a much better strategy, right, to have
the talent, the expertise, and the commitment, and have those
chemicals come from a secure supply chain, right, than through
a lot of different unregulated sources. I mean, you want to
lose sleep? That is what you should lose sleep about, where our
medicines are coming from.
Mr. Perry. Mr. Safdar, does the presence of a strong
domestic compounding industry contribute to supply chain
resilience and patient access at any time, but certainly during
national emergencies or supply chain disruptions?
Mr. Safdar. Congressman, thank you for the question. Yes.
As I said in my opening remarks, I think that there is a
critical niche role that compounding plays in our drug supply,
but as the FDA has said, compounded medications are not
approved and they are not tested for safety or efficacy, so
they should be used as a last resort. But as you pointed out,
if there is a medicine you need for treatment that would be
dangerous to your health to delay, you should definitely take a
compounded version if the normal product, the FDA-approved
product, is not available.
Mr. Perry. But what you say seems to imply that there is
somehow dangerous. Aren't they manufactured domestically in a
licensed facility with oversight of state boards?
Mr. Safdar. The FDA has actually been very clear that their
safety is not the same as FDA-approved drugs, which should be
generics or the branded products, that they take a second tier
to safety. They are not to be used as a first line of
treatment, and that is one of the problems we are seeing, is
that we are seeing upstart and unknown and somewhat shady
telehealth companies.
Mr. Perry. You are not conflating compounded drugs made in
a licensed facility under state monitoring or oversight with
illicit counterfeit drugs? You are not conflating the two, are
you?
Mr. Safdar. No, that is a whole other problem.
Mr. Perry. OK.
Mr. Safdar. There are three types of danger that we have
seen in the GLP-1 space, but even a medicine made in a state
board of pharmacy or FDA inspected 503B, for example,
outsourcing facility, is not an FDA-approved drug. The FDA has
given it a status of being not approved and not tested for
safety or efficacy. Now, would I take it if it was that or skip
my cancer treatment? I would absolutely take it, but it is not
supposed to be the first-line product. You do not start
treatment on it.
Mr. Perry. I understand. Thank you, Mr. Chairman. I yield.
Chairman Comer. Before I recognize Ms. Brown, I have four
UC requests: a letter from the Alliance for Pharmacy
Compounding, a letter from the Council for Responsible
Nutrition, a letter from the National Association of
Convenience Stores, and a statement from Peter Pitts, the
president of the Center for Medicine in the Public Interest.
Without objection, so ordered into the record.
The Chair now recognizes Ms. Brown from Ohio.
Ms. Brown. Thank you, Mr. Chairman. The Food and Drug
Administration exists to protect the public. It makes sure the
foods we eat, the medicines we take, and the cosmetics we buy
are safe and effective. Before any of these products reach
store shelves, the FDA carefully reviews their development,
testing, manufacturing, and labeling, and the Agency keeps
checking even after products are approved and available to make
sure they remain safe and reliable. This work is vital. People
need to trust that the FDA is making decisions based on science
and facts.
Unfortunately, from day one, the Trump Administration has
worked to undermine that trust. RFK pushes misinformation and
lies, and just last week, President Trump recklessly fired
thousands of workers across the FDA. These hardworking
individuals, many of whom have been at the Agency for decades
and dedicated their lives to public service, were locked out of
the building with no explanation. This is not so-called
government efficiency. It is playing petty politics with the
health and well-being of the American people. These mass
layoffs will delay reviews for new treatments and make it
harder to ensure the safety of consumer products.
Dr. Kessler, how will these staff cuts affect the Agency's
ability to oversee everyday consumer items like personal care
products and cosmetics? And additionally, what is the typical
review timeline for those products and how might that change
with less staff?
Dr. Kessler. I think it endangers the safety of all
Americans. I mean, I am told, for example, that no inspectors
are cut, but what I hear is now the inspectors have to do all
their administrative work themselves. Their travel cards are
restricted, laboratories cannot purchase the supplies that they
need, so they are not being used efficiently. They cannot do
their jobs, and this just makes no sense to me. I do not
understand what the strategy is. Why would you take the entire
infrastructure of the FDA and blow it up?
Ms. Brown. Thank you. The FDA plays a role in our everyday
lives, right, even if we do not see it. In 2023, after hearing
troubling reports from around the country, Congresswoman
Pressley and I asked the FDA to investigate the link between
chemical hair straighteners, often used by women of color, and
uterine cancer. Shortly after, the FDA proposed a ban on
formaldehyde in those products, but when the Agency missed the
deadline to ask, we followed up late last August because our
communities deserve answers and action.
Black women have long faced discrimination and scrutiny for
how we wear our hair, pressuring many of us to turn to certain
hair products just to meet societal expectations, but here is
the truth. Many of these products are poorly regulated and pose
serious health risks. Studies have shown alarming results. Most
recently, Consumer Reports revealed that several synthetic hair
braiding products used predominantly by Black women contain
known carcinogens. This is not just about beauty. It is about
public health. So, let me be absolutely clear. These hair
products we rely on every day are putting our health at risk.
Today, we sent another letter to the FDA, urging them to move
forward with the banning of formaldehyde in relaxers.
With that being said, Dr. Kessler, given the historical
under-regulation of personal care products marketed toward
Black women, what should the FDA be doing right now to ensure
these products are thoroughly tested and safe, and during your
time as FDA Commissioner, did you encounter any barriers when
it came to addressing equity and product safety?
Dr. Kessler. Congresswoman, I just want to applaud you and
your colleague's efforts. I think the issue you have raised is
an enormously important one, and I applaud you for that.
Ms. Brown. Thank you. So, I am assuming there were some
challenges there, and by your response, I am grateful for your
accolades, but I want to say this. We cannot let the new
Administration drop the ball on something this important, so I
plan to stay engaged and hold this Administration accountable.
Passing laws like the CROWN Act to prohibit hair-based
discrimination is critical, but we also need to crack down on
products that impact women's health and well-being. By
requiring safety testing and making sure that public health
research reflects the diversity of the market, we can help
build a safer, healthier, and more trusted America. So, with
that, I want to say thank you, and I yield back the balance of
my time.
Chairman Comer. The Chair now recognizes Mr. Biggs from
Arizona.
Mr. Biggs. Thank you, Mr. Chairman, and thank you witnesses
for being here today. As Congress looks to restore trust in the
FDA and crack down on dangerous illicit products in our drug
supply, it is critical that we distinguish between true public
health threats and legitimate medical practices, such as
pharmaceutical compounding. Compounded medications, when
prepared by licensed U.S. pharmacies and FDA-registered
outsourcing facilities, are a vital part of our healthcare
system. These drugs are not counterfeit, they are not knockoff,
they are not illicit. They are produced legally under rigorous
oversight from state pharmacy boards and, in many cases, the
FDA itself. These are personalized medications crafted to meet
unique patient needs or to fill gaps in the drug supply, such
as when the FDA added semaglutide injection products Ozempic
and Wegovy to its drug shortage list back in March and August
2022, prompting compounding pharmacies to step in and fill the
gap.
Mr. Safdar told Mr. Perry that compounded drugs are
manufactured domestically in licensed facilities under the
oversight of state boards of pharmacy and the FDA, but some
narratives conflate compounded medications with counterfeit or
unsafe knockoff drugs. It is true that manufacturing standards
are the same for compounded outsourcing facilities in the U.S.
as those for branded pharmaceutical companies, and both adhere
to the good manufacturing practice system. Compounded drugs
serve a critical role in maintaining access to care,
particularly during times of FDA-approved drug shortages. There
was a company in my district that was able to step up during
the FDA shortage of semaglutide injection products. The
presence of a strong domestic compounding industry contributes
to supply chain resilience and patient access during national
emergencies or supply chain disruptions.
Mr. Safdar, your organization, the Partnership for Safe
Medicines, from 2007 to 2017, was staffed or led by a guy named
Scott LaGanga. Is that right?
Mr. Safdar. I believe so, yes.
Mr. Biggs. Did you follow him?
Mr. Safdar. I am the Executive Director that came after
him.
Mr. Biggs. Yes. So, when you say, ``I believe so,'' what
you really meant to say, yes, of course, I know that was Scott
LaGanga, right? You meant to say you knew that he was the guy
that was leading your organization before you were, right?
Mr. Safdar. I do not know the exact dates, but I know the
end date was 2017 because that is when I started.
Mr. Biggs. So, that is a real cutesy response, and the
reality is you know he was your immediate predecessor.
Mr. Safdar. I do. He was.
Mr. Biggs. Right, right, and so I have a series of reports
sitting right here. Before I go through with them, I just want
to know, is your funding sources still the same as they were
under him?
Mr. Safdar. We are funded by our members and dues from our
members, which are listed on our website under----
Mr. Biggs. Right. I have gone to your website. I have read
them. Do you get money from large pharmaceutical companies?
Mr. Safdar. No, sir. We get money only from our members,
and our members are only trade associations or not-for-profits.
So, if you are an actual company, a for-profit company, you
cannot give us money. You cannot provide us funding.
Mr. Biggs. All right. Very good. I have here now, Mr.
Chairman, these following items here: an article called
``Nonprofit Linked to Pharma Lobby Works to Block Drug
Imports;'' ``Nonprofit Linked to Pharma Rolls Out Campaign to
Block Drug Imports''----
Chairman Comer. Go ahead.
Mr. Biggs [continuing]. ``Nonprofit Linked to Campaign
Against Drug Imports Has Deep Ties to Pharmaceutical Research
and Manufacturers of America.'' And then, Mr. Chairman, I have
now another one. It is a blow-by-blow takedown of a report by
this organization. This is produced by Alliance for Pharmacy
Compounding, and it deals with a report issued by Mr. Safdar's
company called, ``New Report Reveals Illegal Ingredients for
Knockoff Weight Loss Drugs Flooding into U.S. from Foreign
Sources, Endangering Patient Safety.''
Chairman Comer. Without objection, so ordered.
Mr. Biggs. Thank you. And then, also, I have a letter from
the Alliance for Pharmacy Compounding, dated April 8, 2025,
that was sent, I believe, to you, Mr. Chairman.
Chairman Comer. Without objection, so ordered.
Mr. Biggs. Thank you, Mr. Chairman. I do think that attacks
on compounding pharmacies by this particular organization when
we are talking about whether something is a knockoff, illicit,
or illegal, or a counterfeit drug is in inapt and unfortunate.
And Mr. Chairman, with that, I yield back the balance of my
time.
Chairman Comer. The Chair now recognizes Ms. Stansbury from
New Mexico.
Ms. Stansbury. Thank you, Mr. Chairman. I just want to ask
a quick question. This is the Oversight Committee, correct?
Chairman Comer. Uh-huh.
Ms. Stansbury. That is right. We are in the Oversight
Committee. So, I have to say I found this to be a very bizarre
committee hearing because here we are in Oversight, and our job
is to conduct oversight over the Administration because of the
separation of powers between Congress and the executive branch.
And right now, the Administration is dismantling the Food and
Drug Administration, and we are sitting here, and Members on
both sides of the aisle are asking questions of industry-funded
groups, about how the FDA is going to protect public health
from medicines and food, while the Secretary is firing
thousands of FDA employees. In fact, just this last week, they
announced they were firing 3,500 members of FDA, and RFK, Jr.
announced that he was going to fire 10,000 HHS employees across
the entire Agency.
So, my question is, if this is the Oversight Committee, why
are we not conducting oversight over the Administration and
their mass firings and the actual deconstruction of the exact
Agency that is supposed to protect the public health? That is
what we should be doing right now in this hearing room. So, I
find it very bizarre that many of my friends across the aisle
are asking, you know, how these folks are going to protect the
public health, because they are not, because they are
dismantling and taking out the top experts who do this work.
Now, some of my colleagues have already pointed out that
one of the top vaccinologist, not just in the United States,
but in the world, Dr. Peter Marks, was forced to resign, and in
a few moments, I am going to enter his resignation letter into
the record, because it is instructive. In his resignation, he
says that for the last 13 years, he has tried to ensure the
efficiency and effectiveness of the science and the public
health, and he says at the end of his letter, ``However, it has
become clear that truth and transparency are not desired by the
Secretary, but rather, he wishes subservient confirmation of
his misinformation and lies.''
I have been trying to figure out for the last couple of
weeks what exactly the end goal is inside of HHS, what exactly
the end goal is inside of FDA, what exactly the GOP's theory of
MAHA, Make America Healthy Again, is because today, you want to
take a vote on dismantling Medicaid. Your President is mass
firing thousands of public health officials, including the
people who make our drugs, our medications, our food, our
cosmetic safety. Your President has announced yesterday that he
wants to put tariffs on pharmaceuticals, and you are going
after Social Security and Medicaid by dismantling the offices
and the services and programs through DOGE that actually serve
the people of this country. So, I do not understand it. I do
not understand how this serves the public interest.
Dr. Kessler, I am very grateful that you are here today.
You are a legend. You are so well known across the public
health space. And I know you are not currently serving in this
Administration, but help us understand the scope and the scale
and why the American people need to be paying attention to what
is happening inside the Agency right now.
Dr. Kessler. Twenty cents of every consumer dollar is spent
on a product that FDA oversees, all our foods, essentially,
right--except meat and poultry, USDA does that--all our drugs,
all cosmetics, our blood supply, our medical devices, many of
our radiological devices. The Agency is absolutely essential
for the safety of the American family. It is also absolutely
key for our competitiveness. I mean, I am concerned that China
is going to beat us scientifically, you know, if we are not
careful with all these cuts that are going on, but the reason I
am concerned about that, it is not about China. It is about the
health of us.
Ms. Stansbury. And Dr. Kessler, I want to end with this
note. As Vera Rosenthal was leaving the Department after being
fired by the Secretary, she said, ``People are going to die,''
from these cuts. I am not being an alarmist. The day after they
announced these mass firings and cuts, pharmaceutical prices
tanked on the market, and that was before tariffs, and that is
because the ability to get lifesaving drugs to market, the
ability to save American lives, the ability to get----
Ms. Greene. [Presiding.] The gentlelady's time has expired.
Ms. Stansbury [continuing]. Cheap medications to our
people----
Ms. Greene. The gentlelady's time has expired.
Ms. Stansbury [continuing]. Depends on having a functioning
Agency.
Ms. Greene. The gentlelady's time has expired. I now
recognize Mr. Higgins from Louisiana.
Ms. Stansbury. And people are going to die if they do not
have the public health to protect them.
Ms. Greene. The gentlelady's time has expired.
Ms. Stansbury. I am sorry, Madam Chairwoman----
Ms. Greene. The gentlelady's time has expired.
Ms. Stansbury [continuing]. But the American people need
to----
Ms. Greene. The gentlelady's time has expired.
Ms. Stansbury [continuing]. Understand what is happening--
--
Ms. Greene. Ms. Stansbury?
Ms. Stansbury [continuing]. Inside this Agency----
Ms. Greene. Ms. Stansbury? The gentlelady's time has
expired.
Ms. Stansbury [continuing]. And the risk to the public
health.
Ms. Greene. No, you are lying to the American people.
Ms. Stansbury. I am sorry, ma'am----
Ms. Greene. You are lying to the American people.
Ms. Stansbury. The American people need to understand their
health is at risk, and this is a five-alarm emergency.
Ms. Greene. Mr. Higgins is now recognized. Mr. Higgins from
Louisiana is now recognized.
Mr. Higgins. It is always fascinating to witness the
wailing and gnashing of teeth, is it not, gentlemen? Mr.
Williams, I am going to be talking to you mostly, sir, some
questions and observations regarding FDA and food safety. Let
us just talk about seafood for a second, please. About a year
ago, we had a hearing where Members interacted, mostly were not
over spoken by other Members. Members interacted with our
witnesses, and it was confirmed broadly that only about one
tenth of 1 percent of seafood imported into our country was
inspected for chemical and biological poisons, and we are
talking about billions and billions of pounds of seafood coming
into our country that is consumed by Americans, or else why is
it coming here. And the only reason you do not get immediately
sick in many cases is because we cook it and it kills some of
the potential biological hazards and things, but the chemicals
and the long-term impact is cancer or neurological disorders
and serious problems can arise.
You know, one might say, a reasonable observer may say,
that if you are consuming billions of pounds of poisonous
seafood imported into our country, somebody might get sick,
speaking to health. So, we believe there has been progress made
in this arena of protecting Americans from the harmful
biological and chemical elements that have been found broadly
in imported seafood. Can you speak to how we are doing with
that, Dr. Williams, since this year, 2025?
Dr. Williams. Yes. I guess I can start briefly by just
saying originally, we had a rule on seafood called Hazard
Analysis Critical Control Points, where we hoped that was going
to make a big difference. Unfortunately, the problems with
seafood, most of it is, seafood consumed raw, and I am thinking
raw oysters from the Gulf of wherever, and that is a problem
because there is not much in the way you can do about that.
They are taken right from the Gulf. They are already
contaminated by the warm waters of the Gulf, and when they go
straight to people and eat them, they are eating in many cases
dangerous pathogens. I think one of the problems that we have
with imported seafood, again, it is the problem that we have
with everything, is the resources that we devote to so many
things at FDA that are not useful could be better used if we
got rid of ineffective programs, if we got rid of regulations
that do not work so we could really focus, have more resources,
to target our inspections on those products.
Mr. Higgins. Would you agree that there is a high level of
responsibility for the nations of origin to do proper
inspections? And their procedures for farming and harvesting
and packaging and shipping, in no way do they meet American
standards that American producers are required to comply with.
In fact, they are in violation of agreements that they will
perform at standards equivalent to American standards. Don't
you believe we should enforce that?
Dr. Williams. Yes. I think one of the problems is, where
are they actually coming from? I mean, I can give an example
in----
Mr. Higgins. We have identified many nations, and they
bounce their products around.
Dr. Williams. Exactly, sir.
Mr. Higgins. So, the question is, because I am running out
of time here, are we making progress regarding controlling
poisoned seafood coming into our country?
Dr. Williams. I really cannot speak to whether or not we
are actually making progress, but I want to agree with you. For
example, if seafood says it is coming from Vietnam, for
example, where I was, it may actually be coming from China.
That is one of the things they do. They send their products
through Vietnam to us. So, I think it does make it difficult
for our inspectors.
Mr. Higgins. Well, we are going to aggressively pursue
that, and this Administration, the Trump Administration, has
been quite aggressive, and I am thankful to that, to protect
Americans from harmful seafood coming into our country. The
FDA's control over other poisons that find their way into our
food supply, the colored foods, et cetera, can you just speak
to that? And I will allow you to answer if the Chairwoman will
allow the balance of my time.
Dr. Williams. I do not quite understand your question. Can
you repeat it?
Mr. Higgins. The way the FDA will address poisons in our
food, to add, like, say, brightness of color to children's
cereal, et cetera.
Dr. Williams. Yes, the color additives, these are tested
particularly for carcinogens, every single one of them, before
they come on the market. There still may be things that they
did not test for that might cause a problem, but they are some
of the most tested substances on earth.
Mr. Higgins. Thank you. I appreciate your answers.
Dr. Williams. So, I think there are other issues which we
should be concerned about.
Mr. Higgins. Mr. Chairman, I yield.
Chairman Comer. [Presiding.] The Chair now recognizes Mr.
Garcia from California.
Mr. Garcia. Thank you, Mr. Chairman. I want to first begin
by thanking all of our witnesses for being here and for your
testimony, obviously for all the comments that we have heard
here from both sides of the aisle on the Committee. I do think
that it is ironic that we are holding a hearing on restoring
the trust in the FDA while we are ignoring the single biggest
threat to public health today, which, of course, is Donald
Trump's Health Secretary, Robert F. Kennedy, Jr.
Now, together with Elon Musk, RFK, Jr. is actively
undermining the institutions that protect public health and the
safety of all Americans. Now, we know that RFK, Jr. already has
a history of outrageous medical opinions and a dangerous anti-
vax record. Now, let us just look at the measles alone. Before
the measles vaccine, we know that measles would kill 400 to 500
American children annually. Now, after, of course, that vaccine
was released, that number fell to almost nothing. But now with
RFK's anti-vax movement growing and his dysfunction at HHS, we
have seen over 600 confirmed measles cases across 22
jurisdictions, and that, of course, is not a coincidence. We
also know that this is also just the beginning. This Committee
is not serious about actually taking on the public health
threat of measles, which, by the way, our measles cases today
is 50 times higher than we have trans athletes in college
sports, yet they obsess about that every single day. The
Committee is obsessed with things that do not matter but not
the public health of actual Americans and children. But, by the
way, children are now actually dying, and we know, of course,
that is just the beginning.
RFK, Jr. said that 5G and Wi-Fi can cause brain damage,
ADHD, radiation sickness. He said that pesticides are actually
turning people transgender. He has even questioned whether HIV
causes AIDS. He has made comments, of course, that alkyl
nitrite, better known as poppers, the sum is the actual cause
of AIDS. He said during a campaign event that a hundred percent
of the people who died, the first thousand who had AIDS, were
people who were addicted to poppers. In his 2021 book and 2023
interview with The New York Times and New York Magazine, he
repeated claims that questioned the causes of AIDS, despite
overwhelming evidence to the contrary. In my opinion, RFK, Jr.
has been, and will always be, a tinfoil hat conspiracy
theorist. He should be nowhere near HHS, medical opinion, and
our research in this country.
Now, Dr. Kessler, I hate to have to even ask you this, but
is there any serious medical evidence that HIV does not cause
AIDS?
Dr. Kessler. No.
Mr. Garcia. Thank you, and that is exactly why these cuts
by DOGE and RFK, Jr. to HIV research, treatment prevention are
so dangerous. Public health experts were warned these actions
will set us back decades. Now, despite Donald Trump's 2019
State of the Union promise to end the HIV epidemic, we have
seen over 800 million in HIV research actually cut. The HHS
Office of Infectious Disease and HIV policy has been shuttered.
CDC surveillance efforts have been gutted. PEPFAR, The Global
Fund, all, of course, lifesaving initiatives, are being
dismantled.
Now, Dr. Kessler, you led the effort to fast-track approval
for lifesaving AIDS programs. Can you just briefly in a
sentence or two explain how DOGE is going after the work?
Dr. Kessler. I also chaired the board of the Elizabeth
Glaser Pediatric AIDS Foundation with President Bush, the son.
I mean, the goal was to stop mother-to-child transmission
throughout the world of HIV. It was the moral conscience of
this Nation. Global health relies on America, and that has been
drastically cut.
Mr. Garcia. That is absolutely right, sir. And we also know
that RFK, Jr., while this is happening globally and here back
home, he has fired 10,000 people from his Agency, and then
claimed that 2,000 of those was actually a mistake. So, firing
people, claiming they are a mistake, gutting the Agency, taking
away support from lifesaving programs, spreading anti-vaccine
conspiracy theories. That is what RFK, Jr., right now, is all
about, and these are not just mistakes. These are life-or-death
decisions. Critical staff have been lost. Experts overseeing
medicines, food safety and medical devices, as we know, have
been shuttered or let go, and we are incredibly concerned.
I want to read this quote by former FDA Commissioner,
Robert Califf: ``The FDA as we have known is finished, with
most of the leaders, institutional knowledge, a deep
understanding of product development, and safety no longer
being employed.'' It is totally unacceptable that Congress is
doing nothing to prevent, of course, its absolute destruction
of our public health infrastructure. We need to stop this now.
And with that, I yield back.
Chairman Comer. The gentleman yields back. I just have to
comment, Mr. Garcia, in all good faith. The predecessor for the
Ranking Member, Mr. Raskin, said that those of us who wondered
if COVID came from the lab at Wuhan, we were conspiracy
theorists, and that when we suggesting that maybe former
President Biden was in mental decline, that we were conspiracy
theorists. And now, you know, there are just books coming out
by all these Democratic journalists every day saying what we
had wondered, too. I am not defending or trashing what you said
about Robert F. Kennedy. It is just that, you know, conspiracy
theories are in the eyes of the beholder.
Mr. Garcia. Sir, do you think that children should be
getting the measles vaccine?
Chairman Comer. That children----
Mr. Garcia. That children should be receiving the measles
vaccine?
Chairman Comer. All my children are vaccinated.
Mr. Garcia. Thank you, and do you think that we should be
getting vaccinated for COVID?
Chairman Comer. Well, I think there are a lot of questions
about COVID that we need answered, but measles, yes.
Mr. Garcia. And I----
Chairman Comer. I am going to recognize----
Mr. Garcia. And again, our current HHS Secretary is an
antivax conspiracy theorist, and that is a fact. He caused a
measles outbreak in another country that caused the death,
absolutely.
Ms. Greene. No, he did.
Mr. Garcia. He absolutely did.
Ms. Greene. That is a lie.
Mr. Garcia. That is a proven----
Ms. Greene. RFK did not cause a measles outbreak.
Mr. Garcia. Ms. Greene.
Ms. Greene. You sound ignorant.
Mr. Garcia. Ms. Greene, you are antivax----
Ms. Greene. That is ignorant, and that is a lie.
Mr. Garcia. You are an antivax conspiracy theorist
yourself.
Ms. Greene. No, I am for choice. I am for parents and
people choosing.
Mr. Garcia. You are the No. 1 antivax conspiracy theorist--
--
Ms. Greene. Choosing.
Chairman Comer. All right. That was my fault.
Ms. Greene. Vaccines kill people.
Mr. Timmons. Mr. Chairman, am I recognized? Am I
recognized, Mr. Chairman?
Chairman Comer. Our witnesses were snoozing, so I had to
spice it up a little bit.
Mr. Timmons. Wake up.
Chairman Comer. The Chair recognizes Mr. Timmons from South
Carolina.
Mr. Timmons. Thank you, Mr. Chairman. So, I realize that we
are here to have a hearing about ``Restoring Trust in the FDA:
Rooting Out Illicit Products,'' but I am actually going to turn
it upside down, and I am going to talk about how the FDA is not
approving products that will help Americans. So, I guess,
normally, it is good to be leaders in the world, but not when
it comes to obesity, not when it comes to chronic disease
management, not when it comes to diabetes, and these are all
things that I believe technology has the ability to help
ameliorate, and really facilitate better outcomes. And so, what
I want to talk, Dr. Williams, is about continuous glucose
monitors.
I have used them. I was in a test trial, and it was one of
the most enlightening experiences. It attached to my cellphone.
I am not a diabetic, but the information I got from that piece
of technology changed my life. It did. It changed my life, and
the FDA has not approved use of a continuous glucose monitor
without a prescription. Well, they just did, but you have to
have type 2 diabetes who are not insulin. Dr. Williams, do you
believe that any American that wants to use a CGM to understand
what the food that they are putting into their body does to
their blood glucose levels? Do you think that is something that
should be available to the general public?
Dr. Williams. I do. I do not see any harm if they want
that.
Mr. Timmons. These have been around for a very long time,
and the technology is used by millions of Americans,
unfortunately, because they need it. They have diabetes of some
kind, and I do not understand why it has taken them this long,
and it is interesting, because a lot of companies are using
CGMs. They are marketing them, they are selling them to
Americans, and it is technically illegal because they were not
approved. They were approved, I guess, in March of last year,
but why is the FDA not approving the use of technology that
will help improve Americans' lives?
Dr. Williams. I think part of the issue lies in medical
device laws, and they are really antiquated, and I had
researched this years ago. The problem is, when you go to
invent something, you first have to get it approved. It costs a
lot of money and a lot of time to get approved. So, a lot of
inventions that actually would come from physicians, they do
not do it because they look at the time and the expense and
having to raise money, and they do not want to do it. The
second problem is, once you get it approved, if you think about
how inventions work, think of computers. You make a computer,
you find bugs in it, and then you change it, and you change it
repeatedly.
Medical device laws do not allow for that. Every single
change you make, you have to go back to the FDA. And so, that
is one of the reasons I think we are not seeing the innovation
that we should, particularly on these kind of monitoring
devices. The ones you are talking about are just the beginning.
We need to monitor what we eat, how much we eat. We need to
know everything about our biomarkers, our genes, our
epigenetics, and everything. Put all of that together and give
people real-time advice on what to eat. It is doable.
Mr. Timmons. Well, and hold them accountable when they do
not eat well, when they treat their body poorly. So, I mean,
diet and exercise is the answer to 95-99 percent of health
problems, and we have a pill for everything. We have shot for
this, shot for that, pill for this, pill for that, and I think
that we can use technology to create an incentive structure and
possibly a disincentive structure to facilitate decisions. And,
I mean, you know, if you take the technology in an Oura Ring,
in a Fitbit, in a CGM, and you put it all together, and you
have one device that is monitoring all of that, I mean, I think
it could then communicate with your health insurance company,
and you will get a benefit in your premium if you are not
spiking your blood glucose level and if you are exercising
every week. This technology exists. It just needs to be put
into one and the incentive structures and disincentive
structures need to be placed on the free market. I mean, does
that make sense?
Dr. Williams. It does make sense, and one of the things
that we see, particularly in the obesity sphere, is everybody
wants to blame food companies for selling foods that Americans
want to buy. It is a positive sum game. They do not make foods
unless you want to buy them. The truth of matter is, we started
gaining weight in 1980. Since 1980, we have increased our
calorie consumption. This is individuals eating more by 400
calories a day. That can lead to a lot of weight, so part of it
is we have to look at ourselves. We are eating too much, and
maybe some of that is because people are eating out more and
the portion sizes are bigger, but again, these devices can help
with that, they can tell us maybe what to eat and how much to
eat.
Mr. Timmons. Again, I have had a scale for 6 years, and it
records my weight every morning, and that is another variable
that we could put into the algorithm that determines the
premium of your health insurance. If you are gaining weight,
you need to pay more. If you are eating poorly and you are not
sleeping, these are all things that factor into your health and
can be used in underwriting. I am out of time, Mr. Chairman.
With that, I yield back. Thank you.
Chairman Comer. The gentlemen yields back. The Chair
recognizes Mr. Frost from Florida.
Mr. Frost. Thank you, Mr. Chair. This past month, the FDA
reported 15 food and drug recalls. That is about a recall every
48 hours. It was even higher in January and February, and many
of these recalls are very serious. They were for things like
food allergen, cross-contamination, cancer-causing arsenic and
lead, which can cause severe learning disabilities in children
and miscarriages in adults. The past month also saw pet foods
contaminated with bird flu. While these recalls save lives,
when folks are alerted in time, they also can cost working
families time and money to replace recalled food. You know,
this year, tuna was recalled. That is about $3 per can down the
drain. Prepared salads were recalled, another $5 bucks each.
Frozen dinners were recalled, $4, $5, $6, bucks a serving.
These numbers might seem small, but folks managing a family
budget know how grocery costs add up and what a waste it is to
throw out food.
Dr. Kessler, how does the work of the FDA's labs and
inspectors help catch problems before bad food hits the grocery
stores?
Dr. Kessler. The laboratories are absolutely essential at
that detection. Four FDA laboratories, two labs, two medical
product labs have been shut. Those recalls that are absolutely
essential, the people who communicate about those recalls, the
communication shops have been gutted.
Mr. Frost. Trump and Musk claimed that the mass layoffs at
the VA and the Social Security Administration would not impact
the services, but we are seeing that is not true. Services for
veterans and seniors across the entire country are getting
worse. Wait times are at all-time highs. Now, Trump and RFK,
Jr. are claiming that the mass layoffs at the FDA will not
negatively impact food inspections. Dr. Kessler, how could mass
layoffs at the FDA impact food inspections?
Dr. Kessler. It will have a real and demonstrable effect.
Yes, the inspectors have not been touched as of today, from
what I can tell, but all their support, all their
infrastructure is gone, so all those inspectors cannot get the
supplies they need to inspect. They have to do their own
travel. The travel cards are not working. I am not sure what
the strategy is.
Mr. Frost. And what does this mean for Americans'
vulnerability to serious foodborne illnesses.
Dr. Kessler. I fear that we are less safe today. You know,
I wish that were not the case, but you cannot take thousands of
people out of the FDA and not understand you are putting the
American people at risk.
Mr. Frost. You know, I am one of the 33 million Americans
living with potentially life-threatening food allergies. I have
almost died, actually, because of an anaphylactic attack. Dr.
Kessler, how could cuts to the FDA impact day-to-day safety of
folks like me who live with serious food allergies?
Dr. Kessler. The people who communicate, who share that
information, who share that risk information, the people who
write the policies that give the industry the guidance of what
to put on the labels, they are not there anymore.
Mr. Frost. Say we are lucky and these mass layoffs have no
impact at the FDA with under covering potential foodborne
disease outbreaks before they spread. How will cuts to FDA
staff impact the people who are still there, their ability to
alert the public to the threat of allergen cross-contamination
or an E. coli outbreak?
Dr. Kessler. I think the effect of these cuts, not only on
the people who left--I am hearing repeat stories, I mean, about
how these were done, when they were done, right, I mean, the
real thoughtless, careless, almost mean aspects of how this
information was communicated. But people who have enormous
expertise, decades of expertise on those kind of questions, on
those allergies, they are not staying at the Agency. And
recruitment, getting the best and the brightest, something that
we all believed in, that we dedicated our careers to be able to
go into these agencies and provide that kind of public service,
what signal is that sending? We are losing generations of
future public servants, and that concerns me greatly.
Mr. Frost. Thank you. I yield back.
Chairman Comer. The Chair recognizes Byron Donalds from
Florida.
Mr. Donalds. Thank you, Chairman. In 2019, President Trump
warned of the horrible consequences of the Chinese Communist
Party filling the void if Americans could not find federally
approved tobacco products. To date, the Food and Drug
Administration has only approved 34 vaper products, despite
millions of applications submitted to the Center for Tobacco
Products. The disastrous Biden Administration instead allowed
illegal Chinese vape products to control more than half the
market. This is one of the such products. This is Lost Mary.
The flavor is ginger beer. Mr. Bentley, does the American
consumer know what the contents of this Chinese vape are?
Mr. Bentley. Congressman, thank you for the question.
Obviously, for that particular vape, I cannot speak to its
ingredients, but typically, most vape products do have to
register and register their ingredients if they are going to
submit a pre-market tobacco application form in order to get
FDA authorization. But you highlight the important point, which
is that millions of these products from American companies who
manufacture, for instance, the e-liquids that smokers, looking
to switch away from deadly cigarettes, want to use. Those
American companies have been denied authorization for their
products, and instead, illicit companies who often change their
registration, can change their name, change the ingredients are
unaccountable to the FDA, have managed to fill the void. So now
18 million adult vapers, exactly as you point out, do not know
what they are getting, and the FDA has lost control of the
market completely unnecessarily.
Mr. Donalds. Does the FDA even have a multi-agency task
force to combat the sale of illicit vapes?
Mr. Bentley. The FDA last year, did, in collaboration with
DOJ and CBP and other agencies, set up a multi-agency task
force to try and get a grip on the illicit market. But
unfortunately, that is FDA passing the buck to other agencies
already overstretched, like DOJ and CBP, when the solution for
them, which would not need any more staff, would not require
any more funding is to change how they evaluate how to
authorize these products in the first place. They can do it
quicker and better as other countries, such as the United
Kingdom, Canada, New Zealand, Germany, France, all of these
countries have tens of thousands of authorized e-cigarette
products with no problem with mass levels of, for instance,
youth vaping that we all want to reduce. So, it is possible for
FDA to change its practices and get the products that will save
millions of Americans from smoking by switching it to a safer
alternative.
Mr. Donalds. Let me ask you a follow-up question to that.
Was the Biden Administration aware of the numerous instances of
illicit products that were showcased in the presence of FDA
personnel at trade shows around the country?
Mr. Bentley. I cannot speak to what the Biden
Administration may or may not have been aware of, but it was
widely known that this was a developing problem. Indeed, it was
predictable and predicted that the minute you take off millions
of products from the market, for which there is high demand,
and that we must remember are dramatically safer than
combustible cigarettes, then somebody is going to supply those
18 million adult consumers with those products.
Mr. Donalds. Well, listen, to be clear, I am not against
Americans who want to use vaping products or tobacco products.
I think it is important for the American people to understand
that the previous Administration did not do the job of making
sure that there were products on the shelf where they could
clearly understand what they were consuming or ingesting. And
then you have products like this that have hit the shelves in
the United States, primarily because the previous
Administration was derelict in their duty in making sure that
they were approving applications of companies in America who
could supply the demand from the American consumer. With that,
Mr. Chairman, I yield back. Madam Chairman, I yield back.
Ms. Greene. [Presiding.] The gentleman yields. I now
recognize Ms. Lee from Pennsylvania for 5 minutes.
Ms. Lee. Thank you, Madam Chair. I think it is insulting
that Republicans have set this hearing on restoring trust to
the FDA while they are wholeheartedly backing Trump and RFK,
Jr.'s efforts to dismantle the Agency. We used to do bipartisan
work with the FDA, so why are Republicans politicizing it now?
None of the actions taken have done anything to improve the
health or safety of Americans.
If RFK, Jr. and Trump cared about things like protecting
the public from unsafe medications, they would not have
illegally fired people responsible for making sure that the
drugs we take are actually safe and effective. They would not
have fired an estimated 170 people from FDA's Office of
Inspections and Investigations, which inspects factories to
make sure the pharmaceutical companies are not cutting corners.
They would not have fired the people and closed the labs that
make sure our medicines are safe from contamination. They would
not have fired the people in the offices that check to make
sure that drug companies are not making false claims in their
ads. They would not have forced out Dr. Peter Marks, FDA's top
vaccine regulator, while measles is killing kids, you know, the
same disease we have a 97-percent effective vaccine for and
damn near eradicated.
Dr. Kessler, looking back at some of the very events that
Members of both sides of this Committee did work on, like the
infant formula contamination and shortage, how much worse could
it have been if the FDA was short thousands of workers at that
time?
Dr. Kessler. These are very challenging problems. It took a
lot of dedicated people working with both sides of the aisle on
any of these. I have been there in these kind of crisis
moments, and I fear that that infrastructure, the ability to
handle those challenging problems, we have now gutted the
Agency.
Ms. Lee. Madam Chair, I would like to enter into the record
an article titled, ``FDA Planning for Fewer Food and Drug
Inspections Due to Layoffs, Officials Say.'' Madam Chair?
Ms. Greene. Without objection, so ordered.
Ms. Lee. Thank you. Dr. Kessler, what is the worst-case
scenario that could result from FDA's planned cuts to drug
inspections? Is there anything that keeps you up at night
around that? I think that is a yes then.
Dr. Kessler. I mean, people will die.
Ms. Lee. Excuse me.
Dr. Kessler. You want to know the worst thing?
Ms. Lee. Yes, please.
Dr. Kessler. All right. Go back to 1938, we forget the
founding of the Agency, sulfanilamide, the 1938 Act, Congress
acted. There were deaths in children because adulterants ended
up in those medicines because we did not have the inspection
system. We did not have the pre-approval system. We have
developed the most sophisticated system, right? So, when you
take a medicine today, I mean, what it says on the label is
actually what is in the product. That has taken an enormous
effort by the Congress over the last hundred years working with
dedicated scientists and public servants. Why are we putting
that at risk?
Ms. Lee. Yes. I thank you for your candor, even as you
hesitated to start. I think it is important that we speak
frankly and plainly while we are watching what can or will be a
catastrophe if we do not change course. Before the mess we are
currently in, the FDA have been working with other agencies to
prevent the spread of counterfeit and contaminated drugs coming
in illegally or being made locally by people who would rather
make a profit than make sure people have safe medications. Dr.
Kessler, are you at all confident that the FDA can continue to
do important work like that with the thousands of firings that
Trump and RFK have initiated?
Dr. Kessler. I am not confident that that can continue,
Congresswoman.
Ms. Lee. Just last week, Trump and RFK, Jr. also fired more
than 800 staff from FDA Center for Drug Evaluation and
Research, which monitors medications for side effects and
shortages, among other things. Dr. Kessler, do these cuts raise
the risk that people might suddenly find themselves without
access to the medicines they need?
Dr. Kessler. I think that is a real risk.
Ms. Lee. Thank you. My Republican colleagues want to sit
here and pretend that everything is fine and that somehow the
FDA is actually better under the Trump Administration. But just
look at the fact that none of the witnesses the Republicans
invited here today represent patients, healthcare providers,
scientists, parents, or any of the rest of us who stand to lose
from these firings at the FDA. Nobody in this country should
have to show up at a pharmacy wondering if their blood pressure
medication or their insulin is going to be in stock today. It
is truly ridiculous and a tragedy that we have arrived at this
point.
To quote Dr. Marks in his resignation letter to the FDA,
``It has become clear that truth and transparency are not
desired by the Secretary, but rather he wishes subservient
confirmation of his misinformation and lies.'' Thank you, and I
yield back.
Ms. Greene. The gentlelady yields. I now recognize Mr.
Burlison from Missouri for 5 minutes.
Mr. Burlison. Thank you, Madam Chair, and thank you to all
of our witnesses for joining us today to confront the pressing
crisis at the FDA. For too long, this Agency has faltered,
leaving hundreds of products approvals stalled for years at
times, while illicit vapes and counterfeit drugs from China
flood our communities unchecked. The FDA's inaction has handed
the Chinese Communist Party an open door to peddle dangerous
knockoffs, threatening our kids and our sick, all while safer
options languish under red tape. It is not complicated: fix the
FDA, fix their sluggish process, and ramp up enforcement and
stop letting the Chinese Communist Party profit off of
poisoning our children.
Mr. Safdar, can you discuss the recent incidents of
counterfeit drugs, particularly the GLP-1s, that are flooding
the market, the counterfeit ones?
Mr. Safdar. Yes, and thank you for the question,
Congressman, fellow Missourian. We are seeing dangers to
patients in three different areas in the GLP-1 space that are
very concerning. There is look-alike counterfeits. It is a pen
that maybe is an insulin pen where a criminal has pulled off
the label and re-wrapped it with an Ozempic label, for example,
and then sold it to an unsuspecting pharmacy--just discovered
one of those in Arkansas at the end of last year. A clever and
attentive pharmacist caught it and quarantined it so that it
would not reach a patient. The second category is, we are
seeing enormous one----
Mr. Burlison. Pause. How did that get in the hands of the
pharmacist? So, surely their supply chain is more reliable than
that.
Mr. Safdar. The pharmacist was defrauded. What happened
was, there is a distributor in Florida who had obtained units
of these counterfeit products and had obtained a license to
distribute some products in Arkansas. It is not clear exactly
what kind of distribution license they had, and they shipped it
into Arkansas. So, the pharmacist thought they were dealing
with a licensed distributor who was licensed by their State
Board of Pharmacy, and not until it showed up and the
pharmacist had reason to suspect it, was the pharmacist able to
say, OK, I know they have a license, but let me set that aside
and call the inspector.
And the inspector from the Arkansas State Board of Pharmacy
came over and used a new tool we have, because of the Drug
Supply Chain Security Act called Pulse, made by the National
Association of Boards of Pharmacy, and scanned it, and that
barcode, in under a second, detected that Ozempic as
counterfeit. And the Board of Pharmacy then moved immediately
to suspend the license of the Florida distributor. It is a real
great story of patient safety.
The second category is we are seeing criminals selling
illegal research-grade pharmaceutical ingredients to Americans,
and they are doing it through illegal, foreign, fake online
pharmacies and even sometimes on ecommerce sites like Etsy. We
have captured images of research-only on Etsy.
Mr. Burlison. On Etsy, people are buying?
Mr. Safdar. Yes, unfortunately. I can even show you an
example ad of what this looks like, and they are often labeled
``not for human consumption,'' but when you get them, there are
instructions to inject yourself with them, and people are, in
fact, doing that.
Mr. Burlison. That is crazy.
Mr. Safdar. It is crazy. The third thing is, one, we just
did a study about which is freight shipments of semaglutide and
tripeptide ingredients coming into the U.S. that were not made
in any FDA-inspected facility. And because they are freight,
they have to actually come with a bill of lading that states
the manufacturing location, and we found 179 shipments that
were declared in facilities that are not FDA inspected, for
example, a high school in Toronto, a gym in Toronto, and JW
Marriott in Vancouver. None of these--I checked--none of these
are actually FDA-inspected facilities, and yet, in some cases,
they were let in. And so, one of the improvements we would like
to see from this next Commissioner would be to actually refuse
those based upon the bill of lading because if you know that
that is not an FDA-inspected registered facility, there is no
reason to even let it be shipped to the U.S. There is no reason
to have to turn it around here when you know it is not going to
be any better when it arrives.
Mr. Burlison. Yes. I have limited time, but I want to talk
about the FDA's process of approvals. It is reportedly holding
approvals for numerous generic drugs, even drugs that have
shortages, about 238 drugs as of March of this year. What is
the impact of this?
Mr. Safdar. So, the drug approval process is actually not
my specialty. I am going to defer to my fellow witness, Dr.
Kessler.
Mr. Burlison. Mr. Kessler?
Dr. Kessler. Generic drugs are an absolutely essential part
of what American families rely on. We need and FDA has a
responsibility to make sure we all have access to safe and
effective generic drugs, but I am concerned that that
requires----
Ms. Greene. The gentleman is out of time.
Mr. Burlison. Thank you. I yield back.
Ms. Greene. I now recognize Ms. Crockett from Texas for 5
minutes.
Ms. Crockett. Thank you so much, Madam Chair. Are we tired
of winning yet? We are hugely winning. We have the best of the
best, right? Wrong. That was sarcasm, if you did not catch it.
The fact is, we should never have partisan politics playing a
role when we are talking about something such as science, but
unfortunately, in today's times, Democrats believe in
scientists and experts and data, and Republicans instead
believe in conspiracy theorists. And right now, that is who we
have leading one of the most important agencies in this
country, is a conspiracy theorist, not someone who has an
actual resume to get the job done. So, why would anyone trust
the Republicans on anything, let alone matters of public health
and safety?
It has taken Texas' largest measles outbreak in 30 years,
with more than 500 confirmed cases and the death of two
children, for the Secretary of the Department of Health and
Human Services to say what we already knew: the most effective
way to prevent the spread of measles is the MMR vaccine. This
is the same guy who chaired the anti-vax's nonprofit Children's
Health Defense. Just last month, during an interview with Fox
News, he suggested that somehow, being infected with measles
could provide protection against cancer and heart disease.
The Republicans are implementing the most dangerous public
health agenda and modern American history and people are
literally dying as a result. This Administration does not
believe in science. They are firing thousands of scientists and
public health officials who keep our food and medicine safe,
slashing funding for scientific agencies that help cities and
states respond to public health emergencies, limiting public
access to research and data that contradicts their
misinformation. They are using financial threats to manipulate
which studies the government will sponsor and blocking
researchers from diversifying clinical trials. This reckless
and chaotic approach will make it more difficult for the FDA to
achieve its mission of protecting the public health of
Americans.
But there are two issues that I want to address before my
time expires. Staffing at FDA has long been a challenge. The
Government Accountability Office has identified several
challenges at FDA as high-risk issues. One of the bigger issues
the GAO has identified is FDA's extensive workload. Last
Congress, the Senate held a hearing on the sale of unauthorized
and illegal vaping products and e-cigarettes. During the
hearing, Dr. Brian King, Director of FDA's Center for Tobacco
Products, testified that the volume of pre-market tobacco
product applications is overwhelming, so FDA is instead
prioritizing its enforcement responsibilities when it comes to
e-cigarettes products. But just last week, Trump not only fired
the Director of FDA's Tobacco Center, he closed two entire
offices responsible for drafting new tobacco regulations and
setting policies.
Dr. Kessler, in its 2025 High Risk Report, GAO stated that,
``Stable senior FDA and center leadership remains of vital
importance to the Agency.'' How will this vacuum of leadership
impact the public health and safety of Americans?
Dr. Kessler. It will put Americans at risk. Congresswoman,
you raised a very, very important point. I am the only
pediatrician on this panel today, and your constituents,
please, the most important thing is what you said, if you want
to prevent measles, please have your children vaccinated
against that very dangerous disease.
Ms. Crockett. Thank you so much for that, Doc. And I only
got 56 seconds, and I do not know if I am going to go through
my last question because you just--I am looking at Greg to see
if he is going to make me do it. Listen, I am going to go off
instead. Sorry. I appreciate the fact that you are an expert in
this, and here is the reality. The Republicans, and definitely
MAGA, loves to troll me in so many ways, and the reality is
that I trust and believe experts. I do not believe that I know
everything. I believe that I was elected by my constituents to
make sure that I could keep them safe and always making sure
that they are not going to be victimized if they have, say,
family members that are serving abroad because of Signalgate,
because of that incompetence, making sure that they have access
to vaccines if they need it, making sure that they can actually
provide for their family because we have real economists that
are deciding----
Ms. Greene. The gentlelady's time has expired.
Ms. Crockett [continuing]. Whether we are in engaging in
tariff war.
Ms. Greene. The gentlelady's time has expired. I now
recognize Mr. Fallon from Texas for 5 minutes.
Mr. Fallon. Madam Chair, thank you very much.
[Poster]
Mr. Fallon. You know, a year ago, we held a hearing on the
FDA, and at that hearing, I had the graphic behind me, and I am
perplexed as to why things have not changed. So, I am so glad
that you all are here. And I really appreciate it, because
according to the law, pre-marketed tobacco product applications
must be processed within 180 days, but unfortunately, the
rolling average has been 3 years, and we bring this to light a
year ago, and it does not seem like anything has changed. This
is a picture from a shop a couple of miles from where we are
right now, and it is littered with illegal, smuggled Chinese
vaping products. And so, I do not want anybody to vape, I do
not want anybody to smoke, but it is their choice, and yet, if
they are going to vape, I want them to vape with a product that
is American made, preferably, that also went through a
regulatory process. Now we do not know. This is the Wild West.
It does not make much sense.
Mr. Bentley, what happens, let us say, if the FDA actually
discovered it, because I want to focus more on enforcement
because nothing has seemed to change. What happens if the FDA
becomes aware of this shop and they are selling illegal
products?
Mr. Bentley. Thank you, Congressman, for the question. The
FDA can issue warning letters to distributors. It can also
institute civil money penalties.
Mr. Fallon. What do they typically do when they find this?
What is the first defense?
Mr. Bentley. Typically, often, there will be warning
letters about----
Mr. Fallon. A sharply worded rebuke.
Mr. Bentley. I agree, Congressman. It is absolutely nothing
of a deterrent selling illicit products, and that is how FDA
has left the door open here by making its own regulatory
processes so complicated that, as you suggest, that American
companies--who want to do their best to tell what is in the
ingredients, to sell products that are safer than cigarettes--
those smaller companies have not been able to get through FDA
review, so other actors will jump into the void.
Mr. Fallon. Right, because there is a demand, right?
Mr. Bentley. That is exactly correct.
Mr. Fallon. Prohibition did not work in this country in the
1920s, did it?
Mr. Bentley. Absolutely not.
Mr. Fallon. No. OK. So, they send a sharply worded letter,
which everyone will ignore and not care about, and they are
going to continue to sell. At what level do they typically at
least confiscate?
Mr. Bentley. Now, I would not have the precise level of how
much of the illicit market has been confiscated. I would assume
it to be somewhere in the de minimis region, as you demonstrate
there. This is just a few miles from this building and a few
miles from FDA's White Oaks campus, and the illicit market is
still rampant.
Mr. Fallon. So, it is not typical that once they discover
it, they do not even just take it. They do not seize.
Mr. Bentley. No.
Mr. Fallon. That is amazing to me, and I like that word,
``de minimis.'' I am going to have to put that in my
vocabulary, particularly with a British accent. Sounds
delicious.
Mr. Bentley. It is very kind of you.
Mr. Fallon. Dr. Williams, so I do not know if you know this
answer, but I am curious. When did we switch from mainly sugar
to high-fructose corn syrup?
Dr. Williams. Well, interestingly, we have not actually
switched. For example, the colas, back when I was at FDA, what
we found out was they would look at the relative prices of
high-fructose corn syrup and sugar, and depending on the
relative prices, they might put more sugar and less HFCS.
Mr. Fallon. Well, when did the corn syrup enter the food
supply in large quantities?
Dr. Williams. I am not sure of that.
Mr. Fallon. I think it was in the 1970s. Do you happen to
know, Dr. Kessler?
Dr. Kessler. It was actually in the 1940s and 1950s, but
you are right, Congressman, and then it increased.
Mr. Fallon. Do you think, Dr. Kessler, that that was one of
the contributing factors to America's general problem with
obesity?
Dr. Kessler. Yes.
Mr. Fallon. Yes. And it is just one of those things that I
think we need to discuss more is preventative and we spend more
on healthcare than any country per capita in the world, I
believe. But if we are preventative, you do not get sick in the
first place, it is a heck of a lot better for the individual
and for the country because you do not have that expense.
Dr. Kessler. There is an enormous opportunity to make
inroads in chronic disease, Congressman, as you are saying
that, and I would love to be able to spend time discussing that
with you.
Mr. Fallon. Thank you. Thank you to the witnesses. Thank
you, Madam Chair. I yield back.
Ms. Greene. The gentleman yields. I now recognize Mr. Bell
from Missouri for 5 minutes.
Mr. Bell. Thank you, Madam Chair and Ranking Member, and
thank you to the witnesses for being here. When I came to
Congress, I made a commitment that public health and public
safety would be at the core of my work. That mission becomes
harder when agencies like the FDA face disruption, especially
from actions like those recently taken by DOGE. Last month,
DOGE abruptly announced it was canceling leases for 30 FDA
field offices, including a critical 52,000 square foot drug
testing facility in my district of St. Louis, described by
former officials as the most important FDA drug testing lab in
the country. This lab exposed cancer risks in the drug Zantac,
and just last month, triggered a recall of acne treatments with
dangerous levels of benzene. Though DOGE and HHS reversed the
decision days later, the damage was done. And so, we must ask,
are we putting the public at risk by undermining the FDA's
ability to do its job? Are we creating conditions that allow
unsafe or ineffective drugs into the U.S. market?
The FDA plays a vital role in protecting public health,
from food and medicines to medical devices. A key part of that
is safeguarding the integrity of our drug supply, but right
now, that work is under threat. Due to staffing cuts, the FDA
has frozen a pilot program for foreign drug inspections and is
planning to reduce both food and drug inspections. Just last
week, 800 employees were cut from FDA's Center for Drug
Evaluation and Research, or CDER. Cutting CDER staff will
almost certainly slow the approval of new drugs and generic
alternatives which working families depend on to afford their
prescriptions.
Dr. Kessler, even if no food or drug inspectors were
directly fired, how does a reduction in the Office of
Inspections and Investigations impact FDA's ability to conduct
inspections?
Dr. Kessler. It has a great impact, and Congressman, that
laboratory in St. Louis is one of the great laboratories in the
world. It has enormous specialty expertise and can detect
things that no one else can detect, but there are other
laboratories that work on a more routine basis that check on
the surveillance of imports. Four of those laboratories were
closed. That means more problematic products come into the
United States. We need to have a robust laboratory system that
can detect illicit and harmful products.
Mr. Bell. And Dr. Kessler, how will losing 800 staff affect
CDER's ability to approve new medications, especially timely,
affordable generics?
Dr. Kessler. Those officials were the officials who
communicated with the public, who came up with creative
solutions to the problems we have been discussing. And those
people, that is the infrastructure that supports the people who
are looking at the applications. So, what you are going to see
is you are going to see increasing delays. Things that we
worked hard over the last 20 years to eliminate, those delays
are going to manifest.
Mr. Bell. And Dr. Kessler, will fewer drug inspections make
FDA better or worse at catching counterfeit or contaminated
drugs?
Dr. Kessler. It is going to make people less safe.
Mr. Bell. And quickly, what is the cost difference between
brand name and generic prescriptions, and how would delays in
generics affect working families?
Dr. Kessler. We all rely on generic drugs. I worked very
hard to make available lifesaving medicines, but if people
cannot get access to them, if they cannot afford them, right,
what good is all that effort? Generic drugs are a very
important part of the pharmaceutical armamentarium in this
country.
Mr. Bell. The Trump Administration claims these cuts are to
make America healthy again, but they will do the opposite.
President Trump and Secretary Kennedy are slashing critical FDA
functions while Republicans and Congress aim to redirect
taxpayer dollars into tax cuts for the wealthy. The result?
Americans will wait longer for cheaper medications, and it will
be harder to trust that our food and drugs are safe. That is
the last thing working families need right now. Thank you, and
I yield back.
Ms. Greene. The gentleman yields. I now recognize Mr.
Burchett from Tennessee for 5 minutes.
Mr. Burchett. Thank you, Chairlady. These are some
questions--what I am trying to do is separate hemp from
marijuana, all right, and there seems to be a lot of confusion
in that realm, especially when I walk into one of our hemp
stores in East Tennessee, when they see me walk in there. Mr.
Miller, now, do you support hemp products that contain
intoxicating cannabinoids?
Mr. Miller. We support any product that has less than .3
percent delta-9 THC, which is the measurement. Some of those
products do indeed cause impairment, but at the same time, we
feel very strongly that they need to be strictly regulated and,
most importantly, kept out of the hands of children.
Mr. Burchett. OK. Because doctors at East Tennessee
Children's Hospital, where I spent a lot of quality time in my
formative years during my Evel Knievel phase, as I called it,
and this is a hospital in my district, East Tennessee
Children's Hospital, they have reported that 56 newborns and
over 30 kids have been exposed or, as they say, poisoned by THC
products. Does that sound right to you?
Mr. Miller. I do not know the numbers, but there certainly
is a real problem, given the lack of regulation, and, you know,
really the point of my testimony is that we need to get the FDA
engaged, particularly to get these products out of the hands of
children.
Mr. Burchett. I guess I am just worried because kids are
ending up at the hospital, and the public needs to be educated
on this issue, and I am not seeing a lot of that. It just seems
that the rules and regulations are kind of all over the place.
Mr. Miller. I know Tennessee has been making a strong
effort to try to regulate these products. My home state of
Kentucky has as well. Again, we feel very strongly that adult
products, when taken responsibly by adults, are a good health
and wellness alternative, but we have got to keep these out of
the hands of kids, and we need help. We do our self-regulation
as an industry. Our U.S. Hemp Authority helps crack down
internally, but only if we get the Federal Government working
with the states will we ensure that this problem goes away.
Mr. Burchett. I have talked to several people, some in this
room actually, that support the legalization of marijuana but
do not support it in the hands of children, and I am wondering
how are we expected to trust you all if you condone the sale of
these things like delta-8.
Mr. Miller. Well, we do not condone the sale of products
like that to kids. That is a hundred percent. Delta-8 is a
product that many adults use and swear by for their own health
and wellness, and as long as the products are regulated and
made sure there are no contaminants, make sure they are labeled
properly, and again, make sure they are kept out of the hands
of children, they can be a healthy alternative for adults. But
you are absolutely right, it is a real problem. These products
are dangerous for kids, and we are trying to do as much as we
can as an industry, but we really need government regulation to
crack down on it.
Mr. Burchett. Is it true that compounded drugs are
manufactured domestically under the oversight of the FDA or
state boards? Does anybody care to answer that? Jump in there.
Mr. Safdar. Well, thank you for the question, Congressman.
They are, but the FDA applies a different safety label to them
than they do the branded or generic drugs. They are marked as
FDA-unapproved drugs, and they are not guaranteed for safety or
efficacy. So, while they provide an important niche part of our
drug supply to make it resilient, they are only used as a last
resort.
Mr. Burchett. Yes, Doctor?
Dr. Kessler. One of the key questions is, those compounding
pharmacies may be mixing the final ingredients, but where are
they getting their ingredients from? And some of those
ingredients, that API that is----
Mr. Burchett. I know what API stands for. None of the rest
of the Committee does.
Dr. Kessler. I am sorry.
Mr. Burchett. So, you will explain it to them, but I
already know.
Dr. Kessler. It is the active pharmaceutical ingredient.
That first chart that I showed, 80 percent of our API is coming
from either China or India approximately, so that is my concern
about the compounding. Where is the raw material coming from?
Mr. Burchett. OK. Well, I guess, the follow-up to that was,
we have got some compounding pharmacies in our areas, we do
every other area, and I worry that the vast majority of them
are doing the right thing, but I am afraid some of them could
be doing some folks some ill will. So, thank you all. I have
run out of time. Thank you, Chairlady, for your indulgence.
Thank you, ma'am.
Ms. Greene. The gentleman's time has expired. I now
recognize Ms. Pressley from Massachusetts.
Ms. Pressley. Thank you. For decades, a known carcinogen,
formaldehyde, has been allowed to seep into chemical hair
straighteners, especially those marketed to Black women and
girls. These products are advertised as tools for beauty and
self-expression, but to be clear, they are contributing to a
public health crisis.
This is not dissimilar from the link that has been drawn
between talc and talcum powder, baby powder, Johnson & Johnson,
and a number of Black women who similarly suffered from ovarian
cancer because of that link. Three in 5 Black women use these
products, and according to the National Institutes of Health,
they face a 31 percent higher risk of breast cancer. These
women are also twice at risk of developing uterine cancer
compared to those who do not use these chemical straighteners.
And it is not just impacting consumers. Salon workers are
regularly subjected to the constant inhalation of these
chemicals. They disproportionately face asthma, burns, and
long-term illnesses. Despite this clear and present danger, the
manufacturers of these products continue to sell them. This is
not a coincidence. This is exploitation. This is profits over
people.
In March 2023, I led a letter with Congresswoman Shontel
Brown urging the FDA to ban formaldehyde from chemical hair
straighteners. The FDA proposed a ban that was scheduled for
implementation under the Biden Administration. Most recently,
Trump froze all new regulations, leaving this rule in limbo.
Dr. Kessler, the FDA's mission is to safeguard public health.
Do you believe indefinitely delaying rules that have undergone
rigorous research pose significant health risks to the public?
Yes or no.
Dr. Kessler. I believe that poses significant risks,
Congresswoman.
Ms. Pressley. OK. I agree, and the science has not changed,
and the harms are still real and ever present. Dr. Kessler, for
public health rules that have made their way through the
regulatory process in the previous Administration, what should
the current FDA Commissioner be doing?
Dr. Kessler. One of the most dedicated public servants, the
Chief Science Officer, took on the responsibility recently for
cosmetics, because cosmetics was always the least resourced,
the least regulated. And, Congressman [sic], I applaud, again,
your bringing this up. This has been a real issue--Namandje
Bumpus left the Agency because she did not think it was a place
she could work anymore, and that concerns me.
Ms. Pressley. It concerns me as well. Thank you. In fact,
just this morning, Congresswoman Shontel Brown and Nydia
Velazquez and I sent a letter urging Commissioner Makary to
act. There have already been some states, like Maryland,
California, and Washington, that have banned formaldehyde from
these products, but while these states have acted, they cannot
solve the nationwide problem. It is clear that we need Federal
action to protect every woman, every worker, and every person
who uses these products, regardless of where they live.
In the courts, thousands of women have filed Federal
lawsuits against the manufacturers of these hair straighteners,
alleging that their products have caused uterine cancer, breast
cancer, and other devastating health outcomes. These lawsuits
are not just legal cases. They represent the lived experiences
of women who have been harmed by this industry. They are
mothers, daughters, sisters, and they deserve justice. It is
well past time we take formaldehyde off the market. We cannot
wait another month, another year, or listen to another excuse.
It is time to ban formaldehyde. Thank you, and I yield.
Ms. Greene. The gentlelady yields. I now recognize Mr.
McGuire from Virginia for 5 minutes.
Mr. McGuire. Thank you, Madam Chair, and thank you for our
witnesses for being here today. You know, I was listening to
the discussions going back and forth today, and many of you
said that there were dangerous ingredients in not just
cosmetics, but our foods and other places. And I believe I
heard testimony that many of these dangerous chemicals are
coming from China. Is that correct?
Mr. Bentley. Yes.
Mr. Miller. Yes, Congressman.
Mr. Safdar. Yes.
Dr. Williams. Correct.
Dr. Kessler. Agreed.
Mr. McGuire. So, if these dangerous chemicals are harming
the American people and they are coming from China, how do they
get into our country? Would it be the cartels?
Mr. Bentley. Congressman, in the case of illicit tobacco
products and e-cigarettes, whilst the market is underregulated,
because FDA has choked off the supply of authorized legal e-
cigarettes, we do not know, for some products, what is
contained in them. However, I would also make a caveat that
might differ from some other industries. Almost every e-
cigarette currently being sold or on the market, even if it is
illicit, is probably still dramatically safer than a
combustible cigarette and actually can provide a public health
benefit.
Mr. McGuire. And how is it getting here? Is it getting here
through the cartels?
Mr. Bentley. In terms of e-cigarettes, they are mostly from
China, not from the South of the border.
Mr. McGuire. Well, I understand they are made in China, but
they have got to come across the border somehow. How do they
get across the border?
Mr. Bentley. They get across the border because these
products can be sold by e-cigarette distributors that can ship
them in. They have tracking numbers that FDA can track, so-
called STNs, so that is how they get into the border, through
ports of entry. Some, however, are obviously not monitored and
even outside of that regulatory system.
Mr. McGuire. OK. Mr. Miller, what do you know on this?
Mr. Miller. I know very little. We have heard reports that
Chinese-made purely synthetic cannabinoids, so these are
products that were made completely out of a lab and not come
from nature at all. We hear that they may be coming through the
country, but again, because there is not a Federal regulatory
structure, we just do not have details and are unaware of the
scope of their impact.
Mr. McGuire. All right. Dr. Williams?
Dr. Williams. Yes. I am not aware of exactly how these
things are coming in. One thing I am aware of, though, is
fentanyl was just the start. They are creating things that are
much, much more dangerous than fentanyl.
Mr. McGuire. That is right, and, well, I have got to tell
you, fentanyl is the one we know about, but you are right. I
have heard there are different color versions of these drugs
that are even more dangerous.
Mr. Safdar. Congressman, we have studied the routes by
which illegal ingredients for knockoff weight loss medications
have come into the country, and they come in both in freight,
as I testified before. And my written testimony has some
explanation of the report that we did where we studied these
ingredients that came in through freight, and there are reforms
that we could do to prevent that. But you are right, they
primarily came from China and then India is the second, and
then these products also come in through de minimis.
Mr. McGuire. With all due respect, because of time, Dr.
Kessler, do you have any knowledge of how they get here?
Dr. Kessler. In December 2019, there was a decision,
unfortunately, by the Administration, if you talk about e-
cigarettes, not to regulate any disposables, and that opened
the door.
Mr. McGuire. So, what I would say is many of these drugs do
come in from the cartels. Now, thank God we have got President
Trump wanting to return manufacturing of drugs back to the
U.S., and the border has been shut down for the most part. I
mean, we have still got a lot of work to do. There is still
certainly a threat. That means less fentanyl, for example, is
coming in. You think a hundred thousand people a year being
killed from fentanyl overdose, epidemic, we should be jumping
up and down and making a lot of noise. So not only are we
stopping the fentanyl, we are stopping the flow of a lot of
these other chemicals that are poisoning the American people.
Now, earlier you guys talked about high-fructose corn syrup
being a danger to the obesity issue in our country. Mr.
Williams, what about trans-fats? How big a deal is that?
Dr. Williams. Well, it is interesting. Originally, trans-
fatty acids came on because there was a concern about animal
fats. Nobody said what is the replacement, if we do not use
animal fats, what are we going to use? Nobody thought about the
replacement. As so often happens in these decisions, they never
think about the substitute. So, we got trans-fatty acids, which
were much more dangerous for heart disease than animal fats.
Now it seems like we are going back. The concern is seed oil,
so let us get rid of----
Mr. McGuire. How do we have Crisco on the label that says
zero trans-fats per serving when it has trans-fats in it? How
does that make sense?
Dr. Williams. I do not know about Crisco.
Mr. McGuire. Well, it is certainly an issue.
Dr. Williams. But the issue is that before you make these
decisions to take something off the market, you have to know
what is going to replace it.
Mr. McGuire. Definitely. Well, I am glad we are bringing
supply chains and drug manufacturing in America to save our
people. Thank you. I yield back.
Ms. Greene. The gentleman yields. I just want to clarify
something that has been said. There is an enormous difference
between state-licensed compounding pharmacies, compounding
drugs on FDA shortage lists, and illegal drug manufacturers
making counterfeit drugs that they sell on TikTok. We must root
out illegal drug manufacturers while ensure pharmacies have the
ability to respond to drug shortages. I just wanted to clear
that up.
I now recognize myself for 5 minutes for questioning, and I
am going to speak on behalf of a community of people here in
America that largely get ignored on an extremely important
issue, and that is the issue of vaccines. And while we are
talking about the FDA losing the trust of Americans, there is a
very important reason why for that, and I have to recognize
autism rates.
Now, anytime you mess with people's children, this is
getting to the heart of a family, and, you know, in the 1980s,
1 to 4 out of every 10,000 individuals had autism. Twenty years
ago, it was 1 in 150. And just recently, the rate has been said
to be 1 in 36, but today, there was a study that just came out
of 12 million children ages 5 to 8, and it has been released by
the Children's Health Defense, that the autism rate is now 1 in
33.
I mean, we are talking about something that cannot be
ignored anymore. This is a crisis, and people are losing their
children. They are watching their children go from being happy,
active, babbling, growing, reaching milestones to completely
disappearing. Completely disappearing, and parents, over and
over and over again, point to vaccines. And they are called
conspiracy theorists, they are dismissed, and they are
completely ignored, and this cannot be ignored anymore. This is
a crisis, and we are losing our children, and this cannot be
allowed.
Let us talk about another reason why the FDA has lost all
trust from Americans, and we can talk about the COVID vaccines.
Emergency use authorization was given for these vaccines, and
the FDA took approximately 21 days to give it for the Pfizer-
BioNTech mRNA vaccine. Moderna, the emergency use authorization
was given in 18 days--18 days--and then for Johnson & Johnson,
it was given in 23 days. Now, this comes after typically
vaccine development approval takes 10 to 15 years, but for
these vaccines for COVID, the emergency use was given in a
matter of days, and then full approval was given in months.
Now, what has been the result of that? Another thing, and
people that have been ignored. These are the VAERS reports. Now
there are 1,662,426 VAERS reports, and it is listed here that
there are 38,541 deaths, 220,494 hospitalizations, 156,527,000
urgent care, 17,913 Bell's palsy, 5,175 miscarriages, 22,247
heart attacks, 28,908 myocarditis, 77,311 permanently disabled,
and these are people reporting themselves, and no one seems to
give a damn. And this is why the people do not trust the FDA,
along with the myriad of reasons that has been given today, and
it is unbelievable. And at the same time, medicines that have
been trusted for years, like ivermectin, one of the safest
drugs, was called horse paste, and has been one of the best
effective treatments against COVID.
Now, Mr. Kessler, did you object when Dr. Marks forced out
the two top vaccine scientists at the FDA, Dr. Gruber and Dr.
Krause, due to their opposition of mandating booster shots? Did
you object to that?
Dr. Kessler. I had enormous respect----
Ms. Greene. Did you object, yes or no? Yes or no? I have a
little time left. Yes or no.
Dr. Kessler. No, but, Madam Chair----
Ms. Greene. No, you did not object.
Dr. Kessler [continuing]. May I respond?
Ms. Greene. I reclaim my time. No, you may not.
Dr. Kessler. May I please respond?
Ms. Greene. I reclaim my time. You did not object. You did
not object.
Dr. Kessler. I had enormous respect for Dr. Marks, his
judgment.
Ms. Greene. Well, I am glad that you do, but you did not
object to him when he said the booster shots should not be
mandated, and people that have been vaccinated with COVID-19
are the people that keep getting COVID-19, and the people with
the booster shots keep spreading and getting COVID-19--no, this
is my time--where people like me, with natural immunity, do not
get it and do not spread it around.
Dr. Kessler. Madam Chair, may I please respond?
Ms. Greene. No, and this is my time, Dr. Kessler, and my
time has expired. So, I now recognize--Mr. Min has made it. I
now recognize Mr. Min from California for 5 minutes.
Mr. Min. I would like to hear Dr. Kessler's response to
that last question.
Dr. Kessler. Thank you so much, Congressman. I am a
pediatrician here, and it just is very important to state,
there is no scientific link between vaccines and autism.
Respectfully, on the issue on VAERS, VAERS is an open reporting
system, and you have to look and ask the question. You have to
apply scientific principles.
Mr. Min. Selection bias, things like that.
Dr. Kessler. Bradford Hill, you are there, Congressman.
Mr. Min. Facts are facts, data is data, and a random
website is not necessarily the best way to get any kind of real
data. And we all understand, Dr. Kessler, the importance of
peer review, don't we?
Dr. Kessler. Exactly. The issue, just because you see a
reaction in a data base, you have to ask whether there is
causation. There are certain Bradford Hill principles that have
to be applied, and they were not being applied.
Mr. Min. And it is unfortunate right now that science is
being rejected by people going on Google, going on websites of
dubious origin to try to find their own information.
Dr. Kessler. We should all be concerned about that.
Mr. Min. First, I want to thank the Chair and the Ranking
Member for holding this hearing on the FDA. It is, as we know,
the gold standard in the world for drug and medical product
regulation. Its critical work has included the regulation and
approval of a wide range of products, ranging from the drugs we
consume to the infant formulas that we feed our children, and,
of course, plays a crucial role in cracking down on counterfeit
medical products and drugs. That is why I believe the FDA
should be fully funded and independent. It is absolutely
essential, particularly today, to ensure a safe supply chain
and that our products that we consume for our health have been
properly reviewed for market.
Now, under the leadership of current HHS Secretary Kennedy
and Donald Trump, the great public health apparatus is in the
process of firing thousands of workers at HHS, NIH, and the
FDA. The FDA has seen proposals to slash 20 percent of its
workforce, including 170 of those from the Office of
Inspections and Investigations. And I just want to note that
when we talk about efficiency--that is a word that gets thrown
around a lot--we have to actually talk about what we mean when
we talk about efficiency. What is the timeframe we are looking
at? What are the goals and parameters we want? If I want to
lose weight, the fastest way to do that is maybe just cutoff my
leg. That is not an efficient way if you are thinking beyond
the immediate term, and one can argue that the cuts to FDA are
having a similar effect.
In particular, I want to talk about the effects on the drug
approval pipeline. And so, my understanding--Dr. Kessler, I
think you are in a position to answer this--that I have been
told by a lot of the life sciences companies that I represent
in Orange County, California, that many of those drug approval
people are actually paid for by user fees. Is that your
understanding?
Dr. Kessler. The CDER has resources that are paid for by
user fees, but that does not guarantee that the application
will be approved.
Mr. Min. Of course, no, and that is not the point.
Dr. Kessler. It is just to make sure that there are people
there who can review them.
Mr. Min. And so, I think the point I would like to make
here is that by cutting these people, by terminating staff, you
are creating potentially a much longer pipeline for drug
approval, product approval. That is something that a lot of the
companies I represent, including companies like Edwards
Lifesciences and Masimo, some of the pharmaceutical companies I
represent are very concerned that they are going to see much
longer approval processes. And again, these are positions that
are paid for out of the user fees. They actually do not cost
the taxpayer anything. So, when we look at efficiency beyond
anything, but the immediate term, these cuts look very
counterproductive. They look like they are going to have
massive negative economic impacts on our communities, on the
drug pipeline.
And so, I guess, Dr. Kessler, I just want to go back to
you. How do you think drug approval times may be affected by
cutting a blanket cut of 20 percent of the workforce?
Dr. Kessler. I think that drug approval times will
increase, but most importantly, important medicines that we
will depend on for our families, that is what I care about.
Mr. Min. That is right. Lifesaving medications are not
going to get approved now or will take longer to approve.
Dr. Kessler. I hope not. There are still dedicated people,
but I fear that those delays are going to happen.
Mr. Min. And when we talk about efficiency, I just want to
note another thing that is happening right now. The attacks on
immigrants, particularly in higher education, the cuts to NIH
are having massive impacts on universities around the country,
including UC Irvine, which I represent. They are very worried.
I know that many of the immigrants that are researching in
potentially groundbreaking efforts in new life sciences
products and drugs, that many of them are going back to their
countries of origin. They are going to other countries and
other top research institutions.
I just want to ask--this is my last question, Dr. Kessler--
if you can speak about the Administration's immigration actions
and how you anticipate they might affect our life sciences
industry here in the United States?
Dr. Kessler. Our competitiveness was enhanced by those
people coming to universities in your district.
Mr. Min. They made America great.
Dr. Kessler. Exactly.
Mr. Min. And now we are driving them out.
Ms. Greene. The gentleman's time has expired.
Mr. Min. Thank you. I yield back.
Ms. Greene. In closing, I want to thank our witnesses once
again for their testimony today. I now yield to Ranking Member
Subramanyam for his closing remarks.
Mr. Subramanyam. Thank you, Madam Chair. First, I would
like to enter into the record some articles without objection.
Ms. Greene. Without objection, so ordered.
Mr. Subramanyam. L.A. Times article February 13, ``Trump's
Assault on Science Will Make Americans Dumber and Sicker;
Washington Post article from April 2, ``Veterinarians Working
On Bird Flu, Pet Food Safety Are Fired in HHS Purge;'' article
from April 3 in The New York Times, ``FDA Layoffs Could Raise
Drug Costs;'' an Axios article from April 3, ``Drug Industry
Worries About FDA Delays;'' a Washington Post article from
April 6, ``Worries Grow Over Risks to Americans as Trump Cuts
Health Safety Agency;'' finally, an Axios article from
yesterday titled, ``FDA Cuts Threaten Medical Product Review
Programs.''
Ms. Greene. Without objection, so ordered.
Mr. Subramanyam. Thank you, Madam Chair. We have heard
today about the need to make sure our infant formulas and drugs
are safe and affordable, about the need to prevent youth
vaping, the need to stop illicit products from getting to kids,
and even the desire to have the FDA approve things faster. But
as our experts here today said, we cannot accomplish any of
this without the scientists, researchers, and staff in place,
and these are the people the Administration has started firing,
thousands of people at the FDA. Someone said that running the
FDA after these firings is like flying a plane with only a
copilot. I think it is like flying a plane with only a flight
attendant. It is such a difficult task already, and now you are
firing many of the people who make it happen.
And the title of this hearing is, ``Rooting Out Illicit
Products,'' but the very offices in charge of keeping us safe
and healthy have been gutted, and the foremost experts on
rooting out illicit products are being fired. We are worried
about products coming into our country across the border, but
170 people were fired at the Office of Inspections and
Investigations, and because of that, now the Agency will have
to ``reprioritize their workload for the rest of the year,
which would mean less surveillance, less inspections, and more
products that are illicit or bad for our health coming across
the border.''
We actually need more inspectors, 16 percent more,
according to the GAO, and all this is going to do is make it
harder for the inspectors who are still here to do their job,
but it does not end there. The Administration is also stopping
the work of Childhood Lead Poisoning Prevention Branch. Those
are the people who are making sure that our children do not get
lead poisoning, and just earlier this year, lead paint was
found in school buildings of a 68,000-student school district
in Milwaukee. The school district called this Lead Poisoning
Prevention Branch for advice, and they were getting advice up
until last Tuesday, but now the people who were giving them
advice have been fired. And as a dad of two girls, 5 and 3, I
can only imagine what is going through the minds of the parents
in Milwaukee.
And so, you know, this Administration is also cutting food
testing labs in California, one that tests for contaminants in
baby food and for avian flu and other products. And so, America
has to lead the world in science, innovation, scientific
discovery, technological advancement. And the American people
deserve to live in a country where we can trust what is in our
food, what is in our medications, and what is in our products.
But cutting science funding and gutting the FDA, causing chaos
throughout the Agency is going to make every American man,
woman, and child less safe, less healthy. And the
Administration, if they do not reverse course, people will die.
I yield back.
Ms. Greene. The gentleman yields. I now recognize myself
for closing remarks.
The good news, ladies and gentlemen, the American people
are not going to die under President Trump and his great
Administration because the goal is to make America great again.
And as our new Administration is getting in place, we have to
talk about things that previously happened under the Biden
Administration, things like the failures with infant formula,
where mothers were desperately seeking formula for their
children and were blocked from ordering safe formulas from
overseas. That was a complete failure. I cannot believe that
any time in our country, mothers could not find infant formula
on the grocery store aisles and were blocked from getting
formula that they much needed for their babies.
We can also talk about how the FDA bans raw milk, which is
ridiculous. Raw milk is sold in countries all over the world,
countries like England, New Zealand, France, Italy, Germany,
Norway, Sweden, Finland, and Denmark. Raw milk has been here
since the beginning of time, and many Americans not only
produce raw milk, they would also like to sell it, and many
consumers would like to be able to buy it, but the FDA has
declared war on anything natural and good, and while it allows
many chemicals to be brought into America, put in our foods,
and distributed all over the country. No wonder obesity is at
all-time highs. No wonder Americans are sicker than most people
around the world.
The FDA's failure to approve new nicotine products, which
are safer than cigarettes, has spawned a massive and dangerous
illegal market of Chinese vapes. No one trusts many of the
products, especially anything laden with chemicals coming from
China, because China, after all, has been murdering Americans
for years now, and Americans are dying every single day from
fentanyl that comes in our country. And if China wants to be
serious about tariffs and its treatment and unfair treatment
against America, the first step they should do is stop sending
fentanyl in our country and poisoning our people.
The FDA has failed to effectively regulate hemp-derived
products, which the industry themselves desperately wants to be
regulated, and we heard that in testimony today. The FDA has
the authority to crack down on counterfeit drugs, which come
primarily from China and infiltrate our legitimate drug supply
chain, endangering American lives, and we heard our witnesses
today talk about how we cannot trust China to give us
lifesaving medications. President Trump's recent executive
order ending the de minimis package exemption for low-value
imports will bolster FDA's ability to restrict the flow of
illicit products from China, and I think that is a great thing
for every single American, no matter how they vote and how they
feel about the current President of the United States.
The reality today is, it is very sad that Americans do not
trust the FDA, and I will reiterate again for the many millions
and millions of Americans who are still angry and want
accountability, and they deserve it, for being forced to take a
vaccine they should have never been forced to take and all the
Americans that suffer from side effects and lost loved ones
from a vaccine that should lose its FDA approval. And I am
saying that, that is my own opinion, I believe that the FDA
approval of COVID vaccines should be revoked, and they should
be taken off the childhood vaccine schedule. Children do not
need a COVID vaccine. Children were one of the healthiest and
had the lowest hospitalization rates and deaths during COVID.
After all, our kids are resilient, and they should not be
forced and be injected with manufactured vaccines that their
parents disagree with.
I thank everyone for tuning into this hearing today. I
thank our witnesses for being here and thank you for your
testimony.
With that, and without objection, all Members have 5
legislative days within which to submit materials and
additional written questions for the witnesses, which will be
forwarded to the witnesses.
If there is no further business, without objection, the
Committee stands adjourned.
[Whereupon, at 1:19 p.m., the Committee was adjourned.]
[all]