[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]


                            OVERSIGHT OF THE
                    U.S. FOOD AND DRUG ADMINISTRATION

=======================================================================

                                HEARING

                               BEFORE THE

                              COMMITTEE ON
                      OVERSIGHT AND ACCOUNTABILITY
                     U.S. HOUSE OF REPRESENTATIVES

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             SECOND SESSION
                               __________

                             APRIL 11, 2024
                               __________

                           Serial No. 118-99
                               __________

  Printed for the use of the Committee on Oversight and Accountability
  
  
                  [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]  


                       Available on: govinfo.gov,
                         oversight.house.gov or
                             docs.house.gov
                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE
                    
55-452 PDF                 WASHINGTON : 2024                               
                             

               COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY

                    JAMES COMER, Kentucky, Chairman

Jim Jordan, Ohio                     Jamie Raskin, Maryland, Ranking 
Mike Turner, Ohio                        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                 Gerald E. Connolly, Virginia
Gary Palmer, Alabama                 Raja Krishnamoorthi, Illinois
Clay Higgins, Louisiana              Ro Khanna, California
Pete Sessions, Texas                 Kweisi Mfume, Maryland
Andy Biggs, Arizona                  Alexandria Ocasio-Cortez, New York
Nancy Mace, South Carolina           Katie Porter, California
Jake LaTurner, Kansas                Cori Bush, Missouri
Pat Fallon, Texas                    Shontel Brown, Ohio
Byron Donalds, Florida               Melanie Stansbury, New Mexico
Scott Perry, Pennsylvania            Robert Garcia, California
William Timmons, South Carolina      Maxwell Frost, Florida
Tim Burchett, Tennessee              Summer Lee, Pennsylvania
Marjorie Taylor Greene, Georgia      Greg Casar, Texas
Lisa McClain, Michigan               Jasmine Crockett, Texas
Lauren Boebert, Colorado             Dan Goldman, New York
Russell Fry, South Carolina          Jared Moskowitz, Florida
Anna Paulina Luna, Florida           Rashida Tlaib, Michigan
Nick Langworthy, New York            Ayanna Pressley, Massachusetts
Eric Burlison, Missouri
Mike Waltz, Florida

                                 ------                                
                       Mark Marin, Staff Director
       Jessica Donlon, Deputy Staff Director and General Counsel
            Dan Ashworth, Deputy Chief Counsel for Oversight
                 Reagan Dye, Professional Staff Member
                          David Ehmen, Counsel
                        Ryan Giachetti, Counsel
                Sarah Feeney, Professional Staff Member
      Mallory Cogar, Deputy Director of Operations and Chief Clerk

                      Contact Number: 202-225-5074

                  Julie Tagen, Minority Staff Director
                      Contact Number: 202-225-5051
                                 ------                                
                         C  O  N  T  E  N  T  S

                              ----------                              
                                                                   Page

Hearing held on April 11, 2024...................................     1

                               WITNESSES

                              ----------                              

Dr. Robert M. Califf, M.D., MACC, Commissioner of Food and Drugs, 
  U.S. Food and Drug Administration
    Oral Statement...............................................     5

Opening statements and the prepared statements for the witness 
  are available in the U.S. House of Representatives Repository 
  at: docs.house.gov.

                           INDEX OF DOCUMENTS

                              ----------                              

  * Letter, April 10, 2024, from Judge Rotenberg Center; 
    submitted by Chairman Comer.

  * Letter, April 9, 2024, from Taxpayers Protection Alliance; 
    submitted by Chairman Comer.

  * Statement for the Record; submitted by Rep. Connolly.

  * Editorial, The Reality of Radiation, by Reps. Donalds and 
    Brandon Williams (NY-22); submitted by Rep. Donalds.

  * Article, Wall Street Journal, ``Truth About Puberty 
    Blockers''; submitted by Rep. Gosar.

  * Article, ScienceDaily, ``Vitamin D Determines Severity in 
    COVID-19''; submitted by Rep. Gosar.

  * Statement for the Record, from Doctors of America; submitted 
    by Rep. Norton.

  * Article, Northwestern Now, ``Vitamin D Appears to Play Role 
    in COVID-19 Mortality''; submitted by Rep. Grothman.

  * Article, UChicago News, ``Vitamin D Deficiency May Raise Risk 
    of COVID-19''; submitted by Rep. Grothman.
  * Email, February 17, 2022, from FDA to the White House; 
    submitted by Rep. McClain.

  * Email, February 20, 2022, from FDA to the White House; 
    submitted by Rep. McClain.

  * Email, February 19, 2022, to FDA; submitted by Rep. McClain.

  * Email, February 4, 2022, to FDA; submitted by Rep. McClain.

  * Article, Politico, ``The FDA's Food Failure''; submitted by 
    Rep. Tlaib.
                      CONTINUED INDEX OF DOCUMENTS

                              ----------                              

  * Questions for the Record: to Dr. Califf; submitted by 
    Chairman Comer.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Gosar.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Foxx.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Grothman.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Cloud.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Higgins.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Sessions.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Donalds.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Burchett.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    McClain.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Langworthy.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Waltz.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Crockett.

  * Questions for the Record: to Dr. Califf; submitted by Rep. 
    Pressley.

The documents listed are available at: docs.house.gov.

 
                            OVERSIGHT OF THE
                   U.S. FOOD AND DRUG ADMINISTRATION

                              ----------                              


                        Thursday, April 11, 2024

                     U.S. House of Representatives

               Committee on Oversight and Accountability

                                           Washington, D.C.

    The Committee met, pursuant to notice, at 1:07 p.m., in 
room 2154, Rayburn House Office Building, Hon. James Comer 
(Chairman of the Committee) presiding.
    Present: Representatives Comer, Gosar, Foxx, Grothman, 
Cloud, Palmer, Higgins, Sessions, Biggs, Mace, LaTurner, 
Fallon, Donalds, Perry, Timmons, Burchett, McClain, Fry, Luna, 
Langworthy, Burlison, Waltz, Raskin, Norton, Lynch, Connolly, 
Krishnamoorthi, Khanna, Mfume, Porter, Bush, Brown, Stansbury, 
Garcia, Frost, Lee, Crockett, Moskowitz, Tlaib, and Pressley.
    Chairman Comer. The Committee on Oversight and 
Accountability will come to order. I want to welcome everyone 
here today.
    Without objection, the Chair may declare a recess at any 
time.
    Alright. I will recognize myself now for an opening 
statement.
    Again, welcome to the Committee on Oversight. We want to 
thank Commissioner Califf for his participation in today's 
oversight hearing of the U.S. Food and Drug Administration. 
There might not be a Federal agency that is more integral to 
Americans' day-to-day lives than the FDA. FDA is charged with 
regulatory oversight of the food and drug industries, 
industries that ensure Americans have food on the table by 
innovating safer and more stable crops, industries that provide 
Americans new medications to treat diseases, industries that 
create cutting-edge medical devices that can keep your heart 
pumping or replace a knee. These industries are vital to keep 
Americans safe, healthy, and happy. These industries provide 
millions of jobs and nearly $3 trillion in economic value.
    Unfortunately, the FDA under President Biden is suffering 
from dysfunction and is failing to do bare minimum to carry out 
its core mission, which is to make certain our Nation's food 
and drug products are safe and effective. Further, the FDA 
appears consistently unprepared for certain crises. That is why 
our Committee has conducted several investigations into areas 
of concern at the FDA. These investigations have identified a 
pattern of issues within the FDA.
    At the beginning of Congress, Subcommittee Chairwoman 
McClain launched an investigation into the infant formula 
crisis. Her Subcommittee revealed how the FDA attempted to hide 
behind the COVID-19 pandemic as an excuse for neglecting 
facility inspections and justifying poor performance. The FDA's 
telework policies and lax approach to oversight left it 
unprepared to address the shortages when Abbott's facility in 
Sturgis, Michigan was shut down. Additionally, the Biden White 
House and the FDA took 3 months to act to increase production 
of infant formula. The result of these failures? Barren 
shelves, leaving millions of young families unable to access 
the formula needed to feed their babies.
    We have also investigated the FDA's failure to prepare for 
and adequately respond to drug shortages for essential 
medications used to treat infection, heart disease, and cancer, 
just to name a few examples. FDA and Democratic policies, such 
as the Inflation Reduction Act, have dramatically diminished 
the profitability of manufacturing generic medications. This 
has resulted in fewer manufacturers and a greater risk of 
shortage. The FDA must improve coordination with manufacturers 
and Federal agencies, including DEA, DOJ, and DOD, to increase 
production. The FDA has failed to incentivize domestic 
manufacturing of pharmaceuticals, resulting in significant 
offshoring of these facilities. We conducted oversight of the 
FDA's failure to return to pre-pandemic levels of inspections 
of those manufacturing facilities for prescription drugs 
abroad. Inspections of foreign manufacturing facilities were 79 
percent lower in 2022 than 2019. Last year alone, this failure 
resulted in two separate recalls of eye drops manufactured in 
India that caused an outbreak of dangerous drug-resistant 
bacteria, killing four people.
    Through our investigation of tobacco products regulations, 
we learned the FDA is failing to consistently and effectively 
regulate tobacco products. According to the Reagan-Udall 
Foundation, the FDA has been reactive and overwhelmed in its 
tobacco products regulation. The FDA has delayed review of 
applications for products that can reduce harm for many 
Americans. Further, the FDA's failure to regulate has allowed 
unsafe and illicit products to proliferate. In fact, the United 
States Court of Appeals for the Fifth Circuit slammed the FDA 
for sending manufacturers of flavored e-cigarette products on a 
wild goose chase. Meanwhile, the FDA is also failing to prevent 
illicit-flavored tobacco products from China entering the 
country and harming Americans. The FDA is not implementing 
enforcement actions to address illicit-flavored tobacco 
products in stores across the country.
    Additionally, the Committee examined the FDA's refusal to 
regulate hemp-derived products, such as CBD. Instead of using 
its existing authority, the FDA is requesting new authorities 
and money that it does not need. This is the FDA putting its 
own bureaucratic priorities over the American people who can 
benefit from these products. The FDA's refusal to regulate hemp 
products is creating a significant confusion in the market and 
resulting in products with intoxicants that can be dangerous to 
Americans who use these products. It has also halted businesses 
trying, in good faith, to enter the market while bad actors 
continue to thrive. Finally, we found that the FDA ignored 
decades of research regarding the ineffectiveness of an over-
the-counter decongestant causing Americans to waste their hard-
earned money on a medication that is simply ineffective.
    These examples are just scratching the surface of the 
dysfunction and failures that are ongoing within the FDA. 
Today, I am hopeful we can take a deep dive to better 
understand how the FDA is responding and taking action to 
ensure a safe food and drug supply. I now yield to Ranking 
Member Raskin for his opening statement.
    Mr. Raskin. Thank you very much, Mr. Chairman, and thank 
you to Commissioner, Dr. Califf, for being with us here today.
    The FDA regulates everything from bottled water to infant 
formula, meat, poultry, and egg products, prescription and non-
prescription drugs, vaccines, medical devices, microwaves, 
personal care products, and tobacco. During the Biden-Harris 
administration, the FDA has made critical progress to ensure 
that we have access to safer food and to effective drugs.
    For example, last fall, FDA acted quickly to investigate 
reports of lead appearing in children's cinnamon applesauce 
packets for their school lunch. The cinnamon was adulterated 
with lead, which was added by the manufacturer in order to 
increase the weight of the product to make it more profitable 
in the process. However, the applesauce contamination issue 
could have been completely prevented if end-product inspections 
for food were required. The FDA asked Congress to amend the 
Food, Drug, and Cosmetic Act as part of the Fiscal Year 2024 
budget request to require that industry conduct testing of 
final products exactly for such contaminants and provide FDA 
immediate access to those results. This would greatly help to 
ensure the safety of all of our food products for kids and for 
everyone else, but the FDA needs these additional authorities 
to make that happen. And, Mr. Chairman, I was very pleased to 
hear your opening comments, and I hope you would join me in 
supporting giving the FDA additional regulatory authority, 
precisely to address the kinds of problems that both you and I 
have identified. The FDA itself has proposed multiple solutions 
that would address the problems we are talking about today. The 
Democrats support greater and more refined regulatory authority 
to make our food and drugs safer and we hope our colleagues 
will join us.
    In the wake of infant formula and prescription drug 
shortages, FDA also advanced legislative proposals earlier this 
year to strengthen notification requirements and data sharing. 
Right now, they do not have any authority to tell drug 
manufacturers to produce more drugs. One proposal they have 
offered would require manufacturers to notify the FDA--dealing 
with this first problem of the applesauce--would require 
manufacturers to notify FDA about pathogens that are discovered 
in certain critical foods. In the case of infant formula, this 
authority would help FDA prevent contaminated infant formula 
from reaching any more consumers and babies. A second proposal 
they have suggested would expand FDA's authority to gather data 
from industry about potential drug shortages and supply chain 
disruptions.
    FDA has improved access to contraception and protections 
for medication abortion access. In 2021, FDA advanced the 
accessibility of medication abortion by removing the in-person 
dispensing requirement for mifepristone and allowing it to be 
distributed by mail through retail pharmacies. In July 2023, 
FDA approved the first over-the-counter birth control pill, 
Opill. As a result, consumers' access to contraception has 
improved at a critical time when many states are enacting 
increasingly draconian and oppressive abortion restrictions.
    FDA has also made advancements to combat a range of life-
threatening diseases. In March of last year, FDA approved the 
first OTC opioid overdose reversal medication, naloxone nasal 
spray, a critical step toward reducing opioid overdose deaths 
in our districts. FDA also recently approved new genome editing 
technologies to treat sickle cell anemia, a disease that has 
ravaged a lot of communities, primarily African-Americans. This 
advancement is a crucial step toward treating sickle cell 
anemia and represents a breakthrough in gene therapy. FDA also 
secured additional supply chains in the wake of cancer drug 
shortages.
    It is crucial that FDA continue to carry out its mission 
and create meaningful regulations based on sound science and 
not conspiracy theories or ideological programs. Public attacks 
on FDA without any corresponding legislative solutions simply 
undermine its ability to effectively protect public health.
    Anti-abortion activists brought a case against FDA over its 
updated guidance on mifepristone, the first of a two-pill 
medication abortion. The activists claim that FDA did not 
properly collect data on drug risks and complications. However, 
this claim is contrary to the FDA's review of ``extensive 
research showing that mifepristone is safe, including to take 
it home.'' FDA followed its standard procedure in reaching that 
conclusion, and according to FDA, it must act reasonably based 
on the information available rather than act based on perfect 
data which seldom exists. If the objective of anti-abortion 
activists is to undermine FDA's authority, the consequences 
will be devastating to public health. An FDA that bases its 
decisions on political science rather than actual science is 
not in the best interest of consumers.
    Congress must ensure that FDA is empowered to rely on the 
facts rather than bend to the will of people pushing an 
ideological agenda. Thank you, Mr. Chairman, and I yield back.
    Chairman Comer. The gentleman yields back. Now pursuant to 
Committee Rule 9(g), the witness will please stand and raise 
his 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?
    Dr. Califf. I do.
    Chairman Comer. Let the record show the witness answered in 
the affirmative.
    We appreciate you being here today and look forward to your 
testimony. Now, let me remind the witness, who I am pretty sure 
you are an old pro at this by now, we have read your written 
statement, and it will appear in full in the hearing record. 
Please limit your oral statements to 5 minutes. As a reminder, 
press the button on the microphone in front of you, so that it 
is on and that 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 has expired, and we would ask that you please wrap up.
    I now recognize Commissioner Califf to please begin his 
opening statement. Dr. Califf?

               STATEMENT OF DR. ROBERT CALIFF, M.D., MACC

                     COMMISSIONER OF FOOD AND DRUGS

                   U.S. FOOD AND DRUG ADMINISTRATION

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Califf. Thank you, Chair Comer, Ranking Member Raskin, 
and members of the Committee. Thanks for the opportunity to 
testify about the Food and Drug Administration's work to 
protect and promote public health.
    In the United States, the safety of medical, food, and 
cosmetic products depends on the actions of both industry and 
the FDA. Industry bears the responsibility of creating a supply 
of medical, food, and cosmetic products that are safe and 
protect and promote public health. FDA guides an overseas 
industry to help ensure that Americans can have a confidence 
about the medical, food, and cosmetic products they are using 
and that they are duly warned about the risks of tobacco 
products. From that lens, I would like to focus on the Agency's 
work in four main areas today: first, addressing 
vulnerabilities in the supply chain; second, reversing the 
decline in our national life expectancy; third, accelerating 
effective treatment for thousands of rare genetic diseases; and 
fourth, undertaking the most significant reorganization in FDA 
history with a focus on human foods and improving oversight of 
all of our regulated industries.
    As we saw during the pandemic and continue to see, we have 
a significant global supply chain vulnerability, including lack 
of redundancy and resiliency and over-reliance on foreign 
sources for critical products, particularly medicines and 
devices. Preventing and mitigating supply chain issues in the 
industries we regulate have been a primary focus. In 2023 
alone, we worked with manufacturers to prevent over 230 
threatened drug shortages. During the infant formula shortage, 
FDA's use of temporary enforcement discretion enabled safe 
products to enter the U.S. market, which increased supply and 
doubled the number of firms producing infant formula for the 
U.S. from 2021 to 2022.
    FDA's continued oversight will be critical until supply 
chains are more resilient, particularly for infant formula. We 
will continue to promote competition in manufacturing quality 
and implement modernized systems to respond to shortages 
faster. It is why we have requested additional authorities that 
would provide more visibility into the supply chain.
    The trends in life expectancy and chronic disease in the 
U.S. are concerning. And while we are leading the world in the 
creation of new drugs and devices, our major causes of death 
and disability are driven by fundamentals: tobacco use, poor 
nutrition, and lack of adherence to inexpensive generic 
medications. Given the burden of tobacco-related diseases, it 
is encouraging that over the past year, we have seen a 
reduction in cigarette smoking in the U.S. and a significant 
decrease in overall tobacco product use among high school 
students, primarily driven by a decline in e-cigarette use. 
Despite these important wins, driven by a combination of 
education and enforcement actions, our work is not finished. We 
remain committed to reducing the health burden of tobacco 
product use in the U.S.
    Food safety and improved nutrition are essential to combat 
the epidemic of chronic disease and premature death. A 
healthier food supply, coupled with improvements in key 
nutrition information, will help consumers make informed health 
choices. This includes proposed actions to display simplified, 
at-a-glance, front-of-package nutrition information, to 
establish voluntary sodium targets, update the definition of 
the term ``healthy'' in advertising, and to create a nutrition 
center of excellence.
    Thanks to Congress' investment in the Human Genome Project 
decades ago, many of the approximately 10,000 rare diseases 
which impact at least 30 million Americans can now be treated 
with new gene editing and gene therapy technologies. We are 
preparing to navigate a large number of these exciting 
therapies that will require new clinical trial methods, deep 
scientific reviewer expertise, and development of reliable 
long-term follow up systems involving electronic health records 
for real-world evidence.
    Last, the Agency has made significant progress in its 
proposed reorganization. The proposal aims to unify human foods 
functions into the new Human Foods Program under the direction 
of the deputy commissioner for human foods, and to solidify the 
Office of Regulatory Affairs' role as a front line of FDA's 
field-based operations. This will enhance our outbreak response 
and fully realize the preventive vision of the FDA Food Safety 
Modernization Act. These proposed changes will strengthen the 
Agency, making it more efficient, nimble, and ready for the 
future with the ever-changing and complex industry we regulate.
    In conclusion, the essential work of the Agency continues 
in thousands of work streams that Americans and the world count 
on every day, thanks to the dedication and perseverance of FDA 
staff. We look forward to continuing to work with Congress on 
the Agency's mission and thank you for the opportunity to 
testify.
    Chairman Comer. Thank you very much, Commissioner. We will 
now begin the questioning phase. The Chair recognizes 
Representative Gosar from Arizona for 5 minutes.
    Mr. Gosar. I thank the Chairman. Now obviously, the FDA 
made a mistake in granting the Emergency Use Authorization and 
license of COVID-19 vaccines. It has been confirmed that the 
vaccines do not stop transmission. Moreover, 1,635,048 injuries 
due to COVID-19 vaccines have been reported to the Health and 
Human Services through the Vaccine Adverse Event Reporting 
System, including 37,382 deaths. Considering that under 10,300 
deaths have been reported due to all other vaccines combined, 
the harm due to COVID-19 vaccines is absolutely staggering, and 
not to mention that there is no accountability.
    Legally, it is impossible to sue COVID-19 vaccine 
manufacturers for the injuries caused by their products. Just 
last month, the Federal court forced the FDA to retract tweets 
and statements for its years-long smear campaign against 
ivermectin as an effective treatment for COVID-19. Now, let us 
enter Ozempic. J.P. Morgan predicts the market of Ozempic and 
similar drugs will exceed $100 billion by 2030. Concerningly, 
there is a plethora of Federal lawsuits, 18 in all so far, 
alleging serious side effects from this class of drugs, also 
known as glucagon-like peptide-1 receptor agonists, or GLP-1 
RAs. Gastroparesis, or simply stomach paralysis, and several 
severe indigestion, obstruction, and vomiting have been cited 
in the lawsuits. One woman claimed to have lost teeth from 
excessive and frequent vomiting. One law firm is investigating 
the claims of additional 10,000 people potentially harmed by 
this class of drugs. The plaintiffs predict 20,000 total people 
will be suing manufacturers of the GLP-1 RAs in the future. The 
European Medicine Agency is investigating Ozempic for suicidal 
ideation, according to Forbes. Also, according to Forbes, 
studies indicate that Ozempic and other GLP-1 RAs, like 
Rybelsus and Wegovy, may cause gallbladder disease.
    Furthermore, a recent study linked Ozempic to thyroid 
cancer. Ozempic is basically a synthetic hormone that tells 
your brain that it is full, therefore deactivating digestion, 
as well as causing the pancreas to increase insulin levels in 
order to lower blood sugar. Many Ozempic patients face 
blockages and obstructions. That makes sense as the body is 
being fooled into stopping that digestive pathway. Does 
purposely paralyzing the stomach strike you as a healing type 
of a remedy? It does not to me.
    It seems that the goal of Big Pharma is to get people 
hooked for life on their products, whether it be an annual flu 
or COVID-19 vaccines, perpetual statins to lower cholesterol, 
beta blockers for high blood pressure, expensive never-ending 
cancer treatments, yet all this intervention does not seem to 
yield much fruit. Chronic disease is skyrocketing. Fifty 
percent of American adults have a chronic disease. Forty 
percent have two or more. Are Ozempic and related drugs the 
next big thing Big Pharma is going to push on millions of 
people no matter what the harms are or lack of effectiveness?
    As the head of the FDA, you should like to take this 
opportunity to express your regret. As head of the FDA, would 
you like to take an opportunity to express your regret in 
failing to curtail the chronic disease epidemic in America?
    Dr. Califf. I would like to respond. You raised so many 
issues and I have got a minute and 20 seconds, so I will just 
start with the vaccine, which I think may be the most important 
one to talk about. So, here is the progression as I see it. 
First of all, I am pretty simple. I am from South Carolina, and 
I am a cardiologist. I am used to looking at life and death and 
seeing what the differences are. The question with any medical 
intervention, knowing that all interventions have risks and 
benefits, and the question is always do the benefits outweigh 
the risk. I will remind you, the initial vaccine trial that led 
to the EUA did show a dramatic reduction in the rate of 
infection in the two groups. The virus then mutated, but the 
good news is now we have a progression of overwhelming evidence 
in every country, including the United States.
    Mr. Gosar. So, would you----
    Dr. Califf. If you are up-to-date on your vaccine----
    Mr. Gosar. I understand this, but----
    Dr. Califf [continuing]. You are less likely to be dead. 
You are less likely to be admitted to the intensive care unit. 
If you live in a county with a higher vaccine rate, the 
mortality rate is lower. If you live in a country with a higher 
vaccine rate, the mortality rate is lower. So, when you compare 
the two, yes, vaccines have side effects. The risk of being 
dead is lower if you are vaccinated.
    Mr. Gosar. OK. This is my last question because I am 
running out of time. Do you not agree that the vaccine should 
have put into the fund or face liability issues because the 
people were used as guinea pigs? Do you believe in peer-
reviewed science because there is another part that did not get 
really reviewed very well?
    Dr. Califf. Well, I will remind you again, we always have 
to do studies or clinical trials to figure out the risks and 
the benefits. That is a normal part. In most of my career, I 
personally participate in clinical trials when I have the 
chance, so that we can have the data and the knowledge to make 
wise decisions, for example, and get vaccinated, so we are less 
likely to be dead.
    Mr. Gosar. I get that, but why did you have to retract 
everything you said about ivermectin? Because your office came 
out against ivermectin. Now, I agree that there are some 
problems in the manufacturing of that dosage, but if in doubt, 
leave it out.
    Dr. Califf. Well, we didn't retract everything we had to 
say about ivermectin, and, in fact, you know, possibly we had 
an attack against ivermectin. Drugs are not----
    Mr. Gosar. I hope the courts are watching this right now 
because they ordered you to.
    Dr. Califf. If you look at the randomized trials of 
ivermectin, and there are many of them now, there is no benefit 
of ivermectin in the treatment of COVID. That is a statement, 
just a fact, and any drug for which there is no benefit in 
their risk, people have to make their own decisions about what 
to do. What we are not doing is telling doctors what they have 
to do. Doctors have the right to prescribe off label.
    Chairman Comer. The gentleman's time has expired. The Chair 
now recognizes the Ranking Member for 5 minutes.
    Mr. Raskin. Mr. Chairman, thank you. I am going to follow 
up on this because this exchange to me was extremely 
illuminating because what we have here is the commissioner, who 
is the head of the Food and Drug Administration, and then we 
get a drive-by spray of propaganda, disinformation, and 
ideological attacks. So, let me try to sort some of this out, 
and maybe it will help to illuminate why we have a Food and 
Drug Administration rather than leaving it to politicians in 
state legislatures or in Congress to make decisions based on 
ideological whim.
    But let us start with ivermectin, which I believe is an 
animal deworming agent that some people were advocating for use 
to treat COVID-19. Has this been approved as a form of 
treatment or a cure for COVID-19?
    Dr. Califf. No, it has not. If I may, I should also point 
out it also has benefit for humans with worms, which is a huge 
problem in Asia. So, it actually won a Nobel Prize because it 
is an amazing drug both for animals and humans who have worms. 
And there was a good reason to think it may work in the case of 
COVID, and that is why, thankfully, the community, including 
the NIH, did a number of randomized clinical trials. There is 
just no benefit, and you know that is true of most things that 
we try. There is nothing wrong with thinking it might work. It 
just didn't.
    Mr. Raskin. Well, what about hydroxychloroquine, which was 
another thing that was advocated?
    Dr. Califf. Basically, the same story. There was really 
exciting preliminary work in the laboratory that said 
hydroxychloroquine may have activity against COVID, so the 
randomized trials were done. Unfortunately, no benefit. Again, 
nothing wrong with thinking it may work and trying it out in a 
randomized trial, but then we have the data now, so that leads 
you to the conclusion. So, we have not been able to grant 
occasion for those.
    Mr. Raskin. Yes. I mean, I am aware of a lot of political 
attacks and criticism against the FDA, but I can never figure 
out the coherence of it. Sometimes, they seem to be saying get 
out of the way and just let anybody advocate whatever they want 
and use whatever they want without any testing and without the 
various protocols you go through. And then other times they 
attack you because you do not have enough authority to do the 
things that we would want you to do in order to make kids' 
cinnamon applesauce clean, for example. So, let us take that 
one, which has caught my eye since we certainly ate a lot of 
cinnamon applesauce in our house when our kids were little.
    Let us see. Your FDA-regulated products are manufactured or 
handled at something like 275,000 or 280,000 different 
registered facilities across the land. So, what keeps you from 
inspecting every private manufacturing facility that produces 
things like cinnamon applesauce or peanut butter?
    Dr. Califf. Well, if I may, I will try this very quickly. I 
think the best way to think about FDA, in general, is that we 
are referees. You all in Congress actually write the rulebook, 
much like in any sport. It is the leadership that writes the 
rulebook. We enact what is in the rulebook. And in the case of 
food establishments, like most sports, the first line of 
defense are the players in the game, which is the industry that 
produces the products, and by and large they do a great job, 
but sometimes they do not. And as referees, we have to be 
really wise about where we step in because we do not have an 
unlimited budget.
    So, what keeps us from inspecting all 275,000? You do not 
have to be a brilliant mathematician to know how many people 
you would have to have. But what we can do, for example, in 
food for children is to have the manufacturers be required to 
do the testing, which is the way the drug system works. The 
manufacturers of drugs have to test every batch. And in the 
case of cinnamon applesauce, if there had been mandatory 
testing when it got imported into the U.S. from Ecuador, the 
stores that were selling it probably would have picked it up at 
that point.
    Mr. Raskin. And those kids ended up with lead poisoning, 
right?
    Dr. Califf. Right. Lead poisoning is a very serious 
problem, as you know, and it causes chronic issues.
    Mr. Raskin. So, you advocated mandatory testing. You would 
like us to give you that regulatory authority?
    Dr. Califf. Yes.
    Mr. Raskin. And I do hope that is something that our 
colleagues on the Republican side of the aisle would join us 
in. In the case of infant formula shortages, last Congress, we 
passed a bipartisan bill to help address those shortages, but 
nearly 200 House Republicans voted against a second bill to 
give FDA resources to strengthen its oversight and inspection 
of facilities to prevent shortages like that from happening. 
So, we cannot have it both ways. If we want an effective, 
strong regulator, we have got to give them the authority and 
the resources to get the job done. Thank you very much, Mr. 
Chairman. I yield back.
    Chairman Comer. The gentleman yields back. The Chair now 
recognizes Mr. Grothman from Wisconsin for 5 minutes.
    Mr. Grothman. Thank you much. I do not know if this is why 
you came over here, but we are going to give you another 
vitamin, another COVID-related topic. Throughout the COVID 
epidemic, I spoke multiple times on the floor with regard to 
the value of vitamin D. Now, the adequate level of vitamin D 
varies depending upon how you talk to, you know, 20 nanograms, 
30 nanograms, 50 nanograms, but whatever the study you look at, 
the number of lives saved if everybody had adequate levels of 
vitamin D is tremendous, OK? It is a relatively cheap vitamin, 
but for whatever reason it was not pushed by the medical 
establishment and resulted, in my opinion, in the deaths of 
hundreds of thousands of people. I mean, even the most moderate 
studies, I would say, would say that you were less than half as 
likely to die of COVID if you had adequate levels of vitamin D, 
and if you get up to around 50 nanograms, you have a very, very 
small population dying.
    Oh, by the way, another thing bothers me. If you went in 
for a medical checkup during that time, they would not even 
test you for vitamin D, which is not all that expensive because 
you get blood tests for other things you are doing. Could you 
comment on the lack of emphasis of the benefits of vitamin D, 
given that the evidence appears overwhelmingly helpful and very 
cheap, the lack of emphasis from the public health 
establishment on having vitamin D?
    Dr. Califf. Well, as I have already said, you know, as FDA, 
this is really not in our domain. The vitamin D is available on 
the market. We do not regulate the practice of medicine. That 
is determined by the medical profession, and other agencies may 
have more to say about that. But I would point out one key 
thing about vitamin D, just very basic in my role as a person 
who has done clinical trials all my life. There are many 
diseases for which if you measure vitamin D levels, the higher 
the vitamin D level, the lower the risk of the disease. But it 
turns out when randomized trials have been done, where you take 
equal people and give some vitamin D and others placebo, for 
most diseases, it turns out there is no difference, and that is 
because people with higher levels of vitamin D are different in 
many other ways. They tend to be healthier and spend more time 
in the sunshine and all sorts of other things that are 
different. And the randomized trials so far, and COVID, to the 
best of my knowledge have not been positive, but, again, I want 
to make the point. This is not something FDA regulates. It is a 
dietary supplement, basically a vitamin. It is on the market, 
it is freely available in your local store, and that is between 
the doctor and the patient.
    Mr. Grothman. I would like to submit a couple of columns 
here, and I will yield the remainder of my time to the 
Chairman.
    Chairman Comer. Without objection, so ordered.
    Chairman Comer. He yields me time. So Commissioner, I want 
to ask this question about tobacco. With tobacco and FDA's 
Center for Tobacco Products, I think it is safe to say the 
current regulatory process at the CTP is not at all what 
Congress envisioned when it passed the Tobacco Control Act 15 
years ago. From the Reagan-Udall Foundation report you 
commissioned and recent court rulings, I have to conclude that 
those seeking to play by the rules do not even know what the 
rules are because FDA will not tell them or FDA will not put 
information out, or they will put information out and then 
change it.
    So now, after 15 years, FDA has granted only 45 
authorizations out of some 26 million applications and only 
five authorizations for modified risk tobacco product. And 
while FDA rejects applications based on science and data from 
manufacturers who have spent untold millions to comply with 
what they think the rules are, American store shelves are 
overflowing with products from China, and your Agency does not 
seem to be doing anything about it. So, Commissioner, given 
what I just described, I have to wonder, do you even want a 
functional regulatory process for these products, or is it the 
objective to target the U.S. tobacco industry even if it means 
allowing a flood of Chinese products containing God knows what 
into this country?
    Dr. Califf. Mr. Chairman, you know, you are from Kentucky. 
I grew up in South Carolina, lived in North Carolina, and I was 
a cardiologist at a major medical center. I saw many, many 
people die from the ravages of tobacco. So, the basics here, 
first of all, the major cause of remediable death in the United 
States still today is tobacco-related illness. Four hundred and 
sixty thousand people will die from tobacco-related illness 
this year. So, we are very much intent on doing the very best 
job we can, starting with combustible tobacco, and the good 
news is, as I said in my opening statement, we have a decline 
in that. Well, it was not even present when the initial law was 
passed that you referred to, the presence of vaping or e-
cigarettes. No one anticipated there would be 26 million-plus 
applications of vaping products. That is a bit overwhelming. 
The good news here, we are 99 percent done, including almost 
completely done now with the major manufacturers.
    And so, the onus that Congress did give us is what is 
called a public health standard. When it comes to vaping 
products, does the benefit of helping adults reduce use of 
combustible tobacco, the major killer, outweigh the risk of 
teenagers and children getting addicted to nicotine, which is a 
brutal, fierce addiction that is almost impossible to shake 
once you have it. And so far, only 31 products, last I counted, 
have produced the evidence to meet that public health standard. 
All the others you refer to simply didn't produce the evidence.
    Now, if I could say a word about enforcement. I know that 
was the other issue. It bothers me as much it does you to see 
what is on our shelves, but I do want you to know that we 
really picked up our enforcement: over 600 warning letters to 
manufacturers, hundreds of civil money penalties now, and we 
have also now begun to do injunctions to stop. But every one of 
these cases is in an environment where every step we make ends 
up in court in complicated lawsuits and have to cause us to go 
back and take that into account, so it is a battle every day. 
We are engaged in it, and, yes, we do want to regulate it. The 
closer we can get to zero combustible tobacco, the better. The 
role of vaping is still something we are working on.
    Chairman Comer. And we will get back to that. My time has 
expired. I will have another round of questioning with that 
specifically because these products on the shelves that are 
getting the bad headlines are Chinese products that are not 
even regulated by the FDA. FDA regulates the American 
companies, but the Chinese companies are the ones that are the 
bad actors, so we will get back.
    My time has expired. I now recognize Ms. Norton from 
Washington, DC. We will get back on that. Ms. Norton?
    Ms. Norton. Thank you, Mr. Chairman. Dr. Califf, across the 
Nation and right here in the District of Columbia that I 
represent, drug shortages are negatively affecting patients and 
their families. Drug shortages can lead to daily challenges for 
patients, affecting every element of their lives as well as 
health outcomes. For example, because of shortages of ADHD 
medication, we have heard reports of previously capable 
students barely able to pass grades. Adults are forced to 
contact every local pharmacy to track down a medication that 
may be the difference between being productive and focused in 
the workplace or losing their livelihoods. Drug shortages have 
occurred for decades. And in the wake of recent shortages, the 
Department of Health and Human Services and the Food and Drug 
Administration developed new proposals to prevent and mitigate 
shortages. Earlier this month, HHS released a white paper with 
potential policy solutions to address shortages. Mr. Califf, 
what policies can the FDA execute to mitigate drug shortages?
    Dr. Califf. Thank you so much for the question, and I will 
try to go quickly here because we have spent so much time on 
this. This has been going on for decades, and most of what the 
FDA can do is to mitigate impending shortages when we know one 
is about to happen. But the way we do that right now is we have 
spotty pieces of information about what is going on out there 
from the manufacturers, and we spend a lot of time on the phone 
finding manufacturer B to make up for what manufacturer A 
cannot do. So, we have given you a comprehensive list of the 
information we need.
    Remember that most of the starting material now for our 
drugs is coming from China, the key petrochemicals that lead to 
drugs. India is a major player in the generic drug industry, 
and so the supply chains are complicated, and we only have bits 
and pieces of information. We need more of it. But you referred 
to several other kinds of drug shortages, and it may be worth 
just quickly going through this. I do not want to take all your 
time, but I think the most common shortages by orders of 
magnitude are inexpensive generic drugs.
    Well, believe it or not, the price is not supporting the 
cost of manufacturing and distribution and quality, and the 
white paper you referred to has a lot of detail about this in 
it that I would refer you to. Our supply chain pricing has hit 
a point where the price is below what keeps the manufacturers 
in the game. So, when we do an inspection and find a problem 
and a supply line shuts down, that company may very well go out 
of business. Now, that is very different than the shortage of 
Ozempic that you referred to and has been discussed. There, the 
manufacturer is making a huge amount of money with every dose. 
It is just that the demand is so much higher than they 
anticipated. That will take care of itself over time.
    We also referred to Adderall, which is the stimulants for 
ADHD, very important because these drugs are highly effective 
for this problem, and it is bad for students that have ADHD to 
not be treated. Unfortunately, the very same chemicals are 
showing up increasingly in overdose deaths. The over 100,000 
overdose deaths we have are typically a mixture of fentanyl 
plus something else, often a stimulant. The supply of these 
drugs is determined by the DEA, not by the FDA because it is a 
scheduled addictive substance, so it is a much more complicated 
issue.
    The generic one is the one that we hope that we have now 
solutions in this white paper that have to do with fixing the 
economics of that industry. Remember that it is not just 
Americans. The 8 billion people in the world need a reliable 
source of generic drugs. For the world, these drugs are really 
important to treat the chronic diseases that were referred to. 
And right now, in most low-income countries, we just heard from 
a foundation that 80 percent of antibiotics in one country were 
actually fake drugs. So, we have to have an industry that 
produces high quality at a low cost with a supply chain which 
is completely known, and we need the data, so that we can 
actually help intervene when there is an impending shortage 
like a supply line goes down or a company goes out of business. 
So, we have asked for that, and I hope we can get it.
    Ms. Norton. My time has expired.
    Chairman Comer. Thank you. The Chair now recognizes Ms. 
Mace from South Carolina for 5 minutes.
    Ms. Mace. Thank you, Mr. Chairman. Commissioner Califf, 
thank you for being here today, and thank you for your work on 
scheduling reform and your recommendation that cannabis should 
be moved to Schedule III. Well, I and many cannabis advocates 
believe this does not go far enough. This is a long-overdue 
start. So, my first question today, I understand this issue now 
rests with the DEA, and I am curious if you have an update on 
the timing of their decision.
    Dr. Califf. Now, we are both from South Carolina, we know, 
you know I cannot. I do not even know. But if I did, I could 
not tell you anyway. So, that timing of a regulatory decision 
is something that would be up to the DEA, not up to me.
    Ms. Mace. We think it will happen this year or have any 
idea?
    Dr. Califf. I know that there is no reason for DEA to 
delay. I think they just have to take into account all the 
regulations that are in play.
    Ms. Mace. OK. Thank you. If the DEA concurs with the FDA's 
recommendation, can you help me understand if the FDA will take 
on additional responsibilities or if your role will change as 
it relates to cannabis?
    Dr. Califf. This is a very complicated topic, but I will 
just say that cannabis, you know, remember, there are over 30 
different forms of cannabis now, different chemicals that are 
made, and it falls in this area where state regulation has been 
dominant. This is an area where I believe we would be better 
off if we had guidance from Congress about how to proceed. 
Medical marijuana is one thing where there is a medical 
purpose, and it is proven through traditional medical pathways, 
but when it is used for recreational purposes, there is no 
medical benefit in that case, so it does not fall under our 
typical regulation.
    But what is in play with this and several other things that 
I think we will probably talk with the Chairman about here 
shortly, like CBD, the question is how do we reduce harm that 
is done when it is used inappropriately or at a dose which is 
dangerous, or when it is packaged in a way to market it 
specifically to children. We are seeing some of this stuff 
packaged in gummy bears that is easily mistaken for children's 
candy, but we are going to need help and a regulatory pathway, 
remembering that almost everything we do, there is a health 
benefit. Like, you create a new drug or a new device or a food 
for a health benefit. This is an area of harm reduction when it 
is used recreationally.
    Ms. Mace. Right. Well, and also, I mean, it reduces the 
morbidity and the addiction to opioids prescribed by doctors, 
too. I mean, there is just a huge amount of benefit. I have 
seen it benefit in my own life, and welcome to my world. I am a 
mom of teenage kids. I have seen packaging of things. I see 
what kids are bringing to school. Even in a state that 
prohibits cannabis, kids are doing it all over the place, and I 
have a bill called the States Reform Act. There is a balance 
between Federal regulation and also regulation amongst the 
states. One of the things you mentioned was about packaging. 
Myself, like my colleagues, we are concerned about the 
safeguards for our youth. And one of the things in the States 
Reform Act is it addresses the packaging that should not be 
marketed like it is candy, or candy bar, or chips, or whatever 
kind of candy is your favorite.
    In South Carolina, I understand these products, so I am 
concerned about safeguards for youths in intoxicating hemp-
derived products. So, in South Carolina, these products are not 
age-gated or appropriately tested, and many of the packages do 
resemble candy or snacks, and that sort of thing. For my 
family, it is an ongoing conversation about what looks cool and 
looks like it might be fun and exciting really is not, 
especially on a young brain.
    Dr. Califf. Without revealing too much about my age, I am a 
child of the 1960's. So, it would be nice if in my lifetime, we 
came up with a regulatory scheme where I think America, you 
know, whatever your belief is about use of the product, where 
the safety issues that you have referred to are written into 
law, so that we have a scheme whereby we can regulate it. As I 
said, we are referees. You write the rules. We need the right 
rulebook in order to play the referee role.
    Ms. Mace. I would encourage you and I would love for you to 
review the States Reform Act, a bill that I wrote last session, 
that takes into account, you know, the regulatory side and the 
Federal side, but also states being in the driver's seat. 
Again, one of the impositions in the bill is addressing and 
ensuring that we do not market to kids, things are not packaged 
to children, and that sort of thing.
    And then I only have 20 seconds left. While I firmly 
support the right of Americans to make choices about what to 
put in their body, we can all agree it is a desirable outcome 
for less people to smoke cigarettes, the negative health 
effects of which are well-known. Any comment on alternative 
non-nicotine products today while you are here, in 5 seconds or 
less?
    Dr. Califf. So, yes, there are several categories. 
Medications is one category where I hope we will see more in 
the pipeline. It is not robust. When it comes to chemicals that 
are synthesized that also activate nicotine receptors, they 
also cause addiction to nicotine, and the inventiveness of 
entrepreneurs in this area is profound right now because 
chemistry has gotten so much better. So, there are some things 
I am very concerned about in non-tobacco nicotine and even 
compounds that are one component removed from nicotine, which 
may even be more potent in terms of addiction.
    Ms. Mace. Thank you, and I yield back, Mr. Chairman.
    Chairman Comer. The gentlelady yields back. The Chair now 
recognizes Mr. Lynch from Massachusetts.
    Mr. Lynch. Thank you, Mr. Chairman. Dr. Califf, welcome. 
Thank you for your good work.
    Dr. Califf, in March 2024, the FDA issued a proposed rule 
regarding electrical stimulation devices that are intended to 
reduce or stop self-injurious or aggressive behavior in some 
patients. The proposed rule, if finalized, would remove ESDs, 
these electric stimulation devices, from the market, and the 
devices will no longer be considered legally marketed. I have 
tried to read as much as I can on these. As an attorney, I try 
to refrain from making medical decisions on my own, especially 
for my constituents. I do know that the Geneva Convention 
regards these devices as torture. But I also have a group of 
families in my district, who have children and loved ones who 
are undergoing these treatments, and they claim that those 
treatments help.
    Now, as a result of this rule, these treatments will go 
away, and my constituents have asked me to ask you and the FDA 
to meet with them to talk about the consequences of the FDA's 
rule. And so, as a Member of Congress, on behalf of my 
constituents, I am asking you and all your staff to provide an 
opportunity for those families to meet with you and to discuss 
their concerns.
    Dr. Califf. Well, thank you for bringing this up. I know it 
is part of your duty to do so. This is a very tough issue. And 
I have worked in psychiatric wards during my career, and I 
think most people cannot appreciate the anguish of families who 
have loved ones who are in a situation that might call for this 
or other serious mental health problems, but anyone who has 
been through it, I think, has a special feeling about it. As I 
think you know, there is a proposed rule that we have now put 
out there. There is a docket, and we do encourage everyone to 
submit their comments and views to that docket. I will 
definitely take this back to our staff. I know that our staff 
has met with these families before, but this has been going on 
for a while, so we will go back and reconsider.
    Mr. Lynch. It has. It has. It has, and it is heartbreaking. 
Let me ask you. So, shifting to something completely different. 
Last year, the FDA made nearly 200 additions to its public list 
of AI-and machine-learning-enabled medical devices currently 
marketed in the United States, and there has been some 
wonderful success. You know, Dana-Farber Cancer Center is near 
and dear to my heart, Mass General Brigham, that cancer center 
as well. Wonderful, wonderful progress in diagnosing breast 
cancer from mammograms. Clearly there are enormous potential 
benefits here, but there is also some concern around privacy 
and also the lack of explainability of some of these algorithms 
that are being used on the diagnosis or the predictive end.
    What are we doing to mitigate the negative aspects of the 
use of AI? And I know it is coming at us hot and heavy in so 
many areas, but I would like to hear what the FDA is doing 
about guarding against the dangers that might be present by 
this widespread adoption of AI.
    Dr. Califf. Thanks for the question. I will have to contain 
myself here because you may know that I worked at Alphabet, or 
Google, during the 5 years between my two FDA stints, and very 
heavily into this. And I think it is going to be a huge benefit 
but also with a huge risk on the other side if it is not 
regulated. And also, we have many mutual friends. I will be at 
Mass General next week as visiting professor and learning from 
the people in the Harvard system, you know, a lot about this 
stuff. Well, this is one of the topics.
    The thing I would emphasize is that I do not think it is 
explainability that is really the issue. And I think an easy 
way to think about this, think about yourself before you had a 
map in your car that you could talk to when you used to drive 
the car, and you get into an argument about which way to go and 
then you would have to pull out the map and look at it. Well, 
now you just talk to your car, and what is going on with the 
car is AI continuously, in real time, taking into account 
everything that is happening on the roads. The template of what 
is there and your personal preference is that it learns as you 
go along. And I think if AI works, we will take it for granted 
because there are many things we do in medicine. If you ask me 
how does aspirin work, we know a lot about aspirin, but exactly 
how it works for each disease, we are not so sure, but we know 
it does work for particular things.
    So, what we are really focused on is creating a community 
in our health systems and the industry that, like I have 
already said, we are referees. The first line is self-
regulation by the industries. And what is really important 
here, I think where AI is going, generative AI, it learns as it 
goes. The more information it has, either the better it gets or 
the worse it gets. You do not know which one, and if you just 
put it in place and do not tend to it and monitor it, it can go 
wrong in really bad ways. I saw that at Alphabet. It was 
something we were really worried about.
    And so, we have got to reformat our health system so that, 
as time goes on, you are constantly looking at what the 
algorithm is doing. Are its predictions accurate? That is 
really the key thing that we have to do, and right now, we are 
not configured to do that. So, we are working very much with a 
community of health systems and the industry to come up with a 
scheme of what is called assurance labs, and this would be you 
sell your AI thing to somebody, it goes out there, there has 
got to be a monitoring that says it is either working or it is 
not, in practice. And it also looks for this bias that we are 
all concerned about, that if you put the wrong information in, 
you end up with a prediction which is preferential to one type 
of person compared to another. That has got to be looked at. 
So, I will stop there, and I can go on a while on this.
    Mr. Lynch. Yes. Yes. Well, thank you for your answer, 
Doctor. Mr. Chairman, thanks for your indulgence. I yield back.
    Chairman Comer. The Chair recognizes Mr. Sessions from 
Texas for 5 minutes.
    Mr. Sessions. Mr. Chairman, thank you very much. 
Commissioner, thank you for taking time with us. As you have 
noted, a cardiologist also spending time in mental health 
stress units, I think that part of what I am going to talk with 
you about would come directly to observations that you may 
strongly identify with.
    In August of last year Assistant Secretary for Health 
Levine sent Drug Enforcement Agency director, Anne Milgram, a 
recommendation from the FDA to downgrade marijuana, also THC, 
from Schedule I, to Schedule III under the Controlled 
Substances Act. This recommendation made the claim that 
marijuana meets the criteria for control under Section III. In 
reviewing the FDA's recommendation, I believe that the FDA did 
not base its assessment in scientific fact or realities of how 
marijuana has been abused and used in our country today. The 
FDA's assessment relied on, I think, cherry-picked data, for 
example, concluding in the report that since the potential for 
abuse of marijuana is less than heroin, marijuana should be 
downgraded.
    This completely ignores the realities of a drug that is 
causing enormous consequences of children and adults in our 
country, high schools, middle schools, and communities. Just 
last week, Bloomberg editorial board published an article 
emphasizing the sharp rise in marijuana THC related traffic 
fatalities. One analysis, which is consistent with the HITDA 
report out of Colorado, a 10-percent increase in vehicular 
deaths, in California, the increase was 14 percent, in Oregon 
22 percent. During 50 percent of the deaths on a highway, the 
driver had THC in their blood, and those are only the 
marijuana-related traffic deaths that we know about. We know 
that there are other problems.
    In your Agency's analysis, you scrap the long-held five-
factor test for determining a drug's medical necessity to 
simply two factors. Two factors that relied on the fact that 
marijuana, as was reported, currently is accepted for medical 
use because it is prescribed by healthcare practitioners 
through medical marijuana programs. So, what I would ask you 
is, why did the FDA create a new, less rigorous two-factor test 
to determine this when you know the reams of data and evidence 
suggests it is not only addictive, but it is a contributory to 
not only death, but long-term stress of people who use this and 
confirmed by the medical community?
    Dr. Califf. Well, sir, I appreciate the question. I think 
you have already demonstrated, between you and the other 
representative, that there is not agreement in Congress about 
what should be done with this. And again, we would very much 
appreciate if Congress did come to a conclusion for the 
country. It would make our job better.
    Mr. Sessions. Well, I think Congress has not spoken----
    Dr. Califf. Right.
    Mr. Sessions--because we believe it is a dangerous product. 
We receive calls from thousands of parents every year about 
their children. We see drug-related not only instances in 
schools, but principals, teachers, people report the real 
problem, and the problem gets even worse as gummies are 
introduced into the system.
    Dr. Califf. I certainly appreciate those concerns.
    Mr. Sessions. So, I think Congress has spoken.
    Dr. Califf. Let me remind you that a Schedule III does not 
put marijuana on the market in the United States. It is still 
highly controlled.
    Mr. Sessions. No, it does not, but you do know exactly what 
it does do, and you have, through the FDA, suggested that it is 
not a dangerous product like heroin. Well, neither were 
cigarettes like heroin.
    Dr. Califf. Well, with all due respect, I think it is 
differentiable from heroin and cigarettes.
    Mr. Sessions. I think it is, too, that it is a dangerous 
product.
    Dr. Califf. Cigarettes directly cause death. I appreciate 
that you feel that way, and your colleague just gave exactly 
the opposite point of view.
    Mr. Sessions. No, she talked about the public opinion, not 
the medical opinion. You are a medical doctor----
    Dr. Califf. Yes----
    Mr. Sessions [continuing]. A cardiologist, and you are here 
to answer. And I thought you did do a fair job to answer that 
you do see where, when not used properly, it is a dangerous 
product, and it is a dangerous product. And I thank you very 
much, and I appreciate you being here today.
    Dr. Califf. All right. Thank you.
    Mr. Sessions. Mr. Chairman. I yield back my time.
    Chairman Comer. The gentleman yields back. The Chair 
recognizes Mr. Krishnamoorthi from Illinois for 5 minutes.
    Mr. Krishnamoorthi. Thank you, Mr. Chair. Dr. Califf, in 
February 2021 I was Chair of this House Oversight's 
Subcommittee, Economic and Consumer Policy Subcommittee. We 
studied the presence of toxic heavy metals in baby food at that 
time. And in March 2021, we issued a report with regard to the 
presence of lead, arsenic, cadmium, and mercury in astonishing 
levels in baby food products. For example, we found that baby 
food had, on average, 177 times the permissible amount of lead 
in drinking water. In response to public pressure coming off 
that report, FDA issued an action plan called Closer to Zero. 
This was the first time FDA would be regulating toxic heavy 
metals in baby food, which is obviously a good thing.
    When my Subcommittee issued its report in March 2021, FDA 
said that it would issue its initial draft guidance regarding 
permissible lead limits and baby food within 1 year, so roughly 
April 2022. Instead, it missed that deadline and issued its 
draft guidance in 2023. But let me talk to you about some of 
the other toxic heavy metals in baby food that are covered by 
the Closer to Zero Program. I want to throw up here a 
screenshot of your website from today.
    [Chart]
    Mr. Krishnamoorthi. And specifically, I want to talk about 
when you say final guidance will be issued with regard to 
permissible limit of other toxic heavy metals. So, in terms of 
when, for instance, arsenic in baby food would be examined and 
you would be issuing final guidance on permissible levels, your 
website says, and this is my red circle, ``no update.'' That is 
what it says, right?
    Dr. Califf. I cannot see it, but I will take your word for 
it. I cannot see it from this distance.
    Mr. Krishnamoorthi. Let me talk to you about cadmium 
levels. Again, screenshot from your website today. You say that 
we should expect final cadmium levels at some undetermined 
point, and, again, your website says, ``no update.'' You do not 
disagree with that, right?
    Dr. Califf. I am not up to date on the exact, but I will 
assume that you are telling the truth here.
    Mr. Krishnamoorthi. Thank you. Mercury, a dangerous toxic 
heavy metal in baby food, again, we go to your website, and 
with regard to when we should expect to hear from you with 
regard to permissible levels of mercury in baby food, you say 
``no update,'' right?
    Dr. Califf. You say it, it must be so.
    Mr. Krishnamoorthi. Dr. Califf, this is unacceptable, 
completely unacceptable. It has been 3 years since we issued 
that report. The public, the parents are outraged about the 
amount of toxic heavy metals that are present in baby food. And 
quite frankly, sir, I respectfully say that your Closer to Zero 
Program at this point is closer to zero update, and that is 
very, very disturbing.
    [Chart]
    Mr. Krishnamoorthi. I want to turn my attention to another 
topic, which is the youth vaping epidemic, and you and I have 
spoken about this before as well. Your own 2023 survey 
indicates that 10 percent of middle and high schoolers are 
vaping today, 90 percent of them prefer flavored vapes, and the 
vast majority, sir, the vast majority of those flavored vapes 
are illicit vapes coming from China. Here is one of those 
illicit vapes right here. It is a Strawberry Mango EBCREATE 
vape, and it is illegal, but you can buy it today because you 
folks have not cleared the shelves of these illicit products. 
On December 7, 2023, a dozen of us wrote to you asking for a 
comprehensive approach to dealing with these illicit Chinese 
vapes, and you didn't respond to me at that time, did you?
    Dr. Califf. I would have to go back and look, but we have 
had much correspondence about this issue, so I am not sure of 
that particular one.
    Mr. Krishnamoorthi. I know you are too busy to respond to 
us. Of course, it has been 5 months, sir. After that, we wrote 
you February 1, 2024, again, same issue. We want to know how 
you are going to deal with these illicit vapes coming from 
China. You didn't respond to that one either, right?
    Dr. Califf. I would have to go back and look.
    Mr. Krishnamoorthi. Sir, what bothers me about your 
answers, is this. The reason why you did not respond to us with 
your approach to clearing the shelves of these illicit vapes 
from China is perhaps because you do not have an answer. It is 
because you do not have an approach. And mark my words, the 
illicit vapes coming from China flooding our market, these kid-
friendly flavors such as the ones here or the ones I hold in my 
hand, is the next chapter in this youth vaping epidemic, and it 
is time you take this seriously. Thank you. I yield back.
    Chairman Comer. The gentleman yields back. The Chair now 
recognizes Dr. Foxx from North Carolina for 5 minutes.
    Ms. Foxx. Thank you, Mr. Chairman. Commissioner Califf, the 
Center for Tobacco Product, or CTP, must make timely decisions 
on whether products, especially tobacco harm reduction 
products, can be allowed for sale or not. However, stakeholder 
groups with pending premarket tobacco product applications, or 
PMTAs, have been waiting for several years for a decision, 
which far exceeds the 180-day review period written into law. 
Can you tell me in 25 words or less why has the CTP failed to 
comply with the statutory review period, despite the fact that 
the CTP staff has more than doubled in the last decade?
    Dr. Califf. You said less than 25 words. It has 26-plus 
million applications. We are now 99 percent done, and soon we 
will be within that timeframe.
    Ms. Foxx. But you know among those applications are very 
frivolous applications, and there are, like, a couple of dozen 
in there that are coming from legitimate places, and you all 
should have focused your attention on those. It is hard to 
believe that an Agency that has doubled its staff over a decade 
to over 1,200, receives over $700 million per year in funding, 
is still not meeting the deadline for these PMTAs, the serious 
ones, again, it is my understanding relatively few serious from 
legitimate companies. What steps are needed to bring more 
accountability to the CTP?
    Dr. Califf. I would remind you that the vaping industry 
right now pays no user fees, so all the money and people that 
are hired are hired off of the combustible product industry. 
There we have tremendous gains. So, in terms of the 
transparency, now the applications, people can track it. The 
information is published, and you are seeing continuous 
improvement in our efficiency.
    Ms. Foxx. So, what performance metrics does the CTP have to 
ensure they are being good stewards of the tobacco user fees?
    Dr. Califf. It is the numbers of applications, the time it 
takes to review them. The outcomes of the reviews are discussed 
by numerous watchdog groups that are looking at everything that 
we do.
    Ms. Foxx. Had the CTP done its job over the last decade, 
there should have been tobacco harm reduction products approved 
through the appropriate process. There is clearly a demand for 
these products. It is being filled by illicit-flavored 
disposable e-cigarettes, now make up more than 70 percent of 
the e-cigarettes or ends market, as my colleague is talking 
about, most of which are from China. What is the FDA doing to 
rectify this problem of illicit products in the market?
    Dr. Califf. If I may, ``tobacco harm reduction product'' is 
an industry term. I would say we are all in favor of reducing 
harm from tobacco, and as I went over with an earlier question, 
we have an increasing number of warning letters, civil money 
penalties and injunctions now, and seizures now at places of 
import. It is a very large number of products. There is no 
question about it, it is a big job, and we have a lot more work 
to do.
    Ms. Foxx. Commissioner, you have recognized the critical 
need for the public to have access to accurate medical and 
scientific information to help inform the decisions they make 
about their health. How does the FDA justify the decision to 
spend millions on ad campaigns and scare tactics, such as brain 
worms or metal dragons that are not based on verifiable facts? 
And when will the FDA focus on the facts about what can make 
cigarettes deadly as Congress intended in the Tobacco Control 
Act instead of relying on misunderstandings and outdated 
narratives?
    Dr. Califf. I am not sure I follow that question. I would 
just say we have seen dramatic progress and reduction in 
combustible pack tobacco use, significant reduction in the 
number of people dying, although it is still 460,000. I will 
just note that in my time at Alphabet, I learned a lot about 
advertising. I think our statements are based in fact, and they 
include a component to reach into the culture of people that 
need to receive the information. Simply stating a fact, when 
you are talking to a teenager, it is not necessarily the best 
way to reach that teenager. You need to have the mind prepared 
to absorb the information.
    Mr. Foxx. So, brain worms and metal dragons----
    Dr. Califf. I do not know about brain worm and metal 
dragons, but I will take your word that something alluding to 
that must exist somewhere in there.
    Ms. Foxx. Thank you, Mr. Chairman. I yield back.
    Chairman Comer. The gentlelady yields back. The Chair 
recognizes Mr. Khanna from California for 5 minutes.
    Mr. Khanna. Thank you, Mr. Chairman. Commissioner Califf, 
thank you for your service. So many Americans are frustrated 
that even with insurance, they are having to pay thousands of 
dollars for drugs for cancer, for multiple sclerosis, for 
getting inhalers, hundreds of dollars. I want you to help 
explain to the American people why this is happening and to 
start by giving two sentences on what the FDA's ``Orange Book'' 
is.
    Dr. Califf. Well, the ``Orange Book'' is a listing of 
patents that are relevant to drugs that are marketed.
    Mr. Khanna. Correct. And if something is listed on the 
``Orange Book,'' is it correct that for 30 months, a generic 
manufacturer cannot produce that?
    Dr. Califf. With some caveats, but, essentially, that is a 
fair statement.
    Mr. Khanna. So, let us take a couple of examples. You have 
a multiple sclerosis drug, Copaxone, produced by Teva. It costs 
patients between $3,000 and $50,000, and it is currently listed 
on this ``Orange Book.'' Now Teva, the company producing it, is 
going to come again to have it listed with no real changes to 
the drug, cosmetic changes. If they list it again, then no 
generic-manufactured drugs can be produced, correct, for 30 
months?
    Dr. Califf. It is a little more complicated than that. I 
mean, you left out one step before that, which is that you have 
to have a patent, which says it is a significant new thing.
    Mr. Khanna. Sure, but----
    Dr. Califf. Our role in the ``Orange Book'' is ministerial; 
that is, we list----
    Mr. Khanna. But you have discretion on whether to list it 
or not, correct?
    Dr. Califf. Not much discretion.
    Mr. Khanna. But technically, you have that discretion?
    Dr. Califf. Not really. We have to list them, and----
    Mr. Khanna. What would happen if you did not list them?
    Dr. Califf. We would get sued.
    Mr. Khanna. But what is happening is you have these 
companies that are getting you to list this and not have 
generic competition. And so then, as a result of it, the 
American people are paying $50,000 for drugs on multiple 
sclerosis, or in the case some--revumenib for leukemia
    --they are paying $17,000 because you are listing something 
in the FDA that is not allowing generic competition. Now, you 
can say the blame is with the Patent Office, but if those were 
not listed at the FDA, you would have generic alternatives. Is 
that not correct?
    Dr. Califf. You know, my grandfather was a Baptist 
minister, we are all sinners, so we will take our share of 
blame here. It is a point of emphasis between us and the Patent 
Office now to try to get rid of frivolous patents, which is 
what you are referring to, frivolous patents just to extend the 
time period in which a company----
    Mr. Khanna. Would you say that in the case of Copaxone 
where Teva is asking for more patents and multiple sclerosis 
patients are paying $3,000 to $50,000, that that could be 
frivolous, or with revumenib, which is where they have 27 
patents to treat leukemia, there could be some of those being 
frivolous?
    Dr. Califf. As FDA commissioner, that decision really is an 
FTC decision. I have personal opinions about parts of this----
    Mr. Khanna. What is your personal opinion on those two?
    Dr. Califf. There are too many efforts made to extend 
patents, but I will not comment on this specific one.
    Mr. Khanna. But what about for AstraZeneca and the inhalers 
with Symbicort?
    Dr. Califf. I cannot refer to a specific one. I will note 
that my mom got some extra life expectancy due to revumenib, 
so, and I am very familiar with what happened with the cost.
    Mr. Khanna. And so, my question I guess is, what can we do 
in Congress because this is what is frustrating people. And I 
am not blaming you, sir, but I am saying that you have got a 
system where you are listing these drugs--maybe you are saying 
your hands are tied--it is not bringing those costs down. From 
the American people's perspective, how do we solve this? And if 
you could give me 10 seconds because I have one more question, 
but do you have a 10-second recommendation?
    Dr. Califf. Maybe the analogy is worn out. Again, we are 
the referees, so it may be something where our staff will meet 
together with yours and the Patent Office and see if there is 
anything that can be done to tighten up the laws here.
    Mr. Khanna. The last question I want to ask, and it is not 
a ``gotcha'' or anything because I know when you were in the 
FDA, then afterwards, you got consulting fees from Merck, 
AstraZeneca, Biogen. I take you at your word that there were 
ethics reviews, and then you said that there were no ethical 
conflicts, but one of the things I proposed is Members of 
Congress should not become lobbyists. Would you commit today, 
that after your service as FDA chair, you will not take any 
money as consulting fees from Big Pharma going forward?
    Dr. Califf. I have a written record on this for 2 years. 
Beyond that point, you know, we will have to see. I will be----
    Mr. Khanna. But why not just make that commitment, so that 
the American people have confidence that you will not take? You 
can make plenty of money at Google or somewhere else. Why not 
just say I am not going to take Big Pharma money?
    Dr. Califf. I am not looking to make money. I am looking to 
contribute to the development of effective----
    Mr. Khanna. And why not say you will not take it after 
regulating it? Just make that commitment today.
    Dr. Califf. I certainly have made a commitment for a period 
of time, but I cannot speak for the rest of my life.
    Mr. Khanna. I think you should.
    Dr. Califf. I appreciate your opinion.
    Chairman Comer. The gentleman's time has expired. The Chair 
recognizes Mr. Fallon from Texas for 5 minutes.
    Mr. Fallon. Thank you, Mr. Chairman. I think we have some 
bipartisan agreement. Representative Khanna, I would love to 
co-author any bills you have for preventing Members of Congress 
from becoming lobbyists. I think it is good government, so 
thank you for that.
    Thank you, Mr. Chairman, and I am here today, Commissioner, 
not so much as a Member of Congress, but as a parent, and I 
just wanted to visit with you on a few things. Particularly, 
you know, I have two teenage boys, 17 and 14, and I see the 
teenage vaping, you know, skyrocketing, and I think that is an 
entry to some really nefarious habits moving forward. And I am 
particularly concerned about the use of illegal and unregulated 
Chinese vapes. I know it was touched on before and the FDA's 
role in contributing to this, I think, you know, proliferation 
that we see across the country.
    So, the Tobacco Control Act of 2009 created pre-market 
review process allowing for new tobacco products to enter the 
market. Yet, as myself and nearly 60 of my colleagues pointed 
out in a letter we sent to the President last month, a letter 
led by my good friend, Congressman Richard Hudson, despite the 
FDA's receiving over 26 million smoke-free applications since 
this law, the FDA has authorized fewer than 50 product 
applications, with less than 10 being commercially available. 
During this time, however, they have authorized thousands of 
combustible cigarette product applications, but as of January 
2024, there were only 23 authorized e-cigarette products and 
all by three manufacturers.
    The FDA's inability to produce, or to process rather, the 
PMTAs in a timely manner has resulted in the proliferation of 
illegal Chinese vapes flooding the market all over the country 
to meet the consumer demand, often in flavors that, I am sure 
you hopefully agree, are horrific insomuch as they appeal to 
kids. Peach, mango, watermelon, which is a flavor currently 
offered by EBCREATE, a wildly popular brand formerly known as 
Elf Bar, this is a Chinese company whose vapes are illegally 
here yet easily purchased at local stores. In fact, a local 
smoke shop over in Virginia, this picture was taken 2 days ago.
    [Chart.]
    Mr. Fallon. And you can see in the yellow up there, those 
are all displayed. They are illegal Chinese vapes along the 
wall, and we are not speaking about hypotheticals or back-alley 
deals. This is flagrant noncompliance, and this was just 
randomly discovered. By the inaction of the FDA, what we 
essentially see is almost a prohibition on legal products with 
unregulated and illegal products rushing in to meet the demand. 
Then by further weak action on enforcement, U.S. stores have 
seemingly no concerns about openly selling the products all 
over the place. So, Commissioner, by law, how long does the FDA 
have to review PMTAs and take action on?
    Dr. Califf. I believe it is 180 days as legal.
    Mr. Fallon. You are correct, and how long on average is it 
actually taking?
    Dr. Califf. It is hard to calculate an actual number. There 
are 26-point-something million applications, so, and some still 
outstanding. So, you know, we are obviously not meeting 180-day 
timeline, although it is getting better as we are plowing 
through, and 99 percent complete, which still leaves hundreds 
of thousands to go.
    Mr. Fallon. The industry stakeholders have told us that 
they are claiming it is 3 years. Is that feasible?
    Dr. Califf. You know, remember the history, and when I was 
commissioner in 2016 was right when vaping was starting and 
then went immediately to millions of products. There were some 
laws in between. And it is the case that there was such a flood 
of products, it could be if you went back, you know, 3 or 4 
years ago, you would say OK, 3 years until now, but you look at 
applications coming in now, it is much shorter than that.
    Mr. Fallon. Because the FDA's website shows that they 
approved PMTs for 2023 took roughly 2-and-a-half to 3 years for 
each one.
    Dr. Califf. There was a bolus effect that had to be dealt 
with. As one of your representatives already pointed out, 
millions were taken care of by getting rid of the ones that did 
not have useful data in them.
    Mr. Fallon. I think that it would behoove you all to have a 
regulatory framework in place, and warning letters are one 
thing. How many seizures have we had at retail shops across 
country?
    Dr. Califf. We have only had a few seizures. We have had 
32,100 civil money penalties, and those are ramping up 
considerably as we go. As I think you know, seizures require a 
whole different order of magnitude of legal work both before 
and----
    Mr. Fallon. So, we only have a few seconds left. These are 
all over the place. So, what do you think that the FDA can do 
to, you know, mitigate this?
    Dr. Califf. Well, given the fact that there is a vape shop 
in almost every neighborhood, it would take a lot more people 
to do what you are saying of clearing the shelves. So, we have 
an action plan. It is going to get better and better. As I have 
already said, if user fees were paid by the vaping industry--
that will be about $100 million--we could hire a lot of people 
and spend a lot more time out there in the shops.
    Mr. Fallon. And I am not trying to suggest that every 
illegal Chinese vape is going to be taken from the shelves, but 
you know as well as I that you can set examples and make 
examples, and then word gets out that if you have these 
products, you are going to heavily fine and they are going to 
seize them as well. Thank you, Mr. Chair. I yield back.
    Chairman Comer. The gentleman yields back. The Chair now 
recognizes Mr. Mfume from Maryland.
    Mr. Mfume. Thank you very much. Mr. Chairman, I want to 
thank you and Ranking Member Raskin for convening this hearing. 
And before I go into my observations, Dr. Califf, let me go 
back to something that the Ranking Member said earlier that I 
do not want to get lost in all of this. And that is that maybe 
what we ought to be doing in addition to this is trying to find 
a way to create more regulatory pathways, giving the FDA the 
ability to do many of the things that you said you could not do 
here today.
    Dr. Califf, I am deeply concerned about the over-
prescribing of ADH medications, particularly Ritalin and 
Concerta, as it relates to kids in poor neighborhoods as a 
means of dealing with their ``hyperactivity in school,'' and 
that so many studies have shown that whether they are poor 
Black, poor White, poor Latino, this over-prescription seems to 
take place. And I am not a conspiracy theorist. I just do not 
think Humpty Dumpty fell. I think he was pushed. And so, moving 
under that premise, I think that unless we do have greater 
regulations over the over-prescribing of these medications, it 
will continue.
    Now, let me just flip that around to the other side. I am 
also deeply concerned about children who are unable to focus on 
things and are given these medications and where all the 
protocols have been followed, and I am concerned about that 
because, in many instances, those drugs, unfortunately, have 
been part of the shortages. I am concerned about cancer 
patients who are forced to delay treatment, as you know because 
many of the required medications are out of stock.
    So, those are just a couple of things that I am hearing 
from my constituents in Baltimore on a regular basis. I know 
that supply chains were disrupted during COVID, and that there 
had been intermittent and sometimes not intermittent drug 
shortages occurring throughout the U.S., but I would be less 
than honest if I did not just tell you from my perch some of 
the things that I hear. And I recognize you do not carry your 
magic wand in your back pocket. The only thing you can do is to 
help guide us, listen to us, and suggest to us ways that we can 
help you.
    The FDA serves as an important regulator, to say the least, 
and it is well-positioned to assess potential supply chain 
disruptions. Can you tell us and this Committee and the people 
around the country who may be watching these proceedings, how 
is FDA working now currently with manufacturers to mitigate the 
ongoing drug shortages? And have those manufacturers, in your 
opinion, been transparent with the FDA about potential 
shortages and the real root causes of those shortages?
    Dr. Califf. Thank you for that. First of all, just a 
comment you made about the under-prescribing and the over-
prescribing. I think it exemplifies a major problem that we 
have in the intersection of the responsibilities of the FDA and 
the practice of medicine. There is no doubt that people that 
need these drugs are not getting them and people that do not 
need them are getting them, and that equilibrium, of course, is 
not set by the FDA. I am also a physician. It is a clinical 
quality issue that we need to work on, and we are trying to 
help as best we can with that.
    But your main question about the manufacturers, we work 
every day with the manufacturers. They are required to give us 
certain information, but, frankly, they have resisted giving us 
some of the crucial information that we really need. When there 
is an impending shortage, we are finding that they are very 
cooperative to work together to try to fix it. But it would be 
better if we had all the data we needed to put together 
predictive algorithms that would allow us to intervene 
preemptively much, much earlier and prevent the shortage. So, 
we have a list that you all have a copy of that list the areas 
where the correct information would make a difference.
    But, I also want to point out that while there is a 
shortage of the stimulants for ADHD, the biggest shortages are 
occurring in inexpensive generic drugs where the less expensive 
the drug, the more likelihood of shortage because of the way 
the market is not succeeding in rewarding high-quality 
manufacturing. And that is a point I think we really need to 
address over the next few years.
    Mr. Mfume. And any guess on your part as to what factors 
affect non-generic drug shortages?
    Dr. Califf. For non-generic drug shortages, there are 
really only two major types. Because a non-generic drug, as we 
have already discussed, in general, the manufacturer is making 
a handsome profit once the product is on the market.
    Mr. Mfume. That is my point.
    Dr. Califf. So, they are pretty good at figuring out how to 
make it.
    Mr. Mfume. Yes.
    Dr. Califf. The exception, as I said, is Ozempic or the 
weight loss drugs where the demand is just so high they have 
not been able to keep up.
    Mr. Mfume. Yes. Thank you very much. Mr. Chairman, I yield 
back.
    Chairman Comer. The Chair now recognizes Mr. Biggs from 
Arizona for 5 minutes.
    Mr. Biggs. Thank you, Mr. Chairman, and thank you, 
Commissioner Califf for being here today.
    The University of Arizona has been engaged in research that 
would advance pain and addiction research to help combat the 
opioid crisis. They are looking for ways to expedite known drug 
candidates through the Phase 2 and Phase 3 trials to take non-
addictive pain relief medications to the market. U of A has 
informed me that they have found if they can repurpose 
clinically available medications that are proven to be non-
addictive and have also shown to be effective for treating 
different types of chronic pain. They think they are ready to 
go forward in these trials. But they also report that there is 
a need to repurpose some of the medications specific to sex 
differences because pain is differentiated based on sex, and 
that would have an impact on how they develop this drug.
    So, the question is, during the COVID era, FDA was able to 
expedite clinical trials. U of A tells me that they are 
struggling to obtain approval for Phase 2 and Phase 3 clinical 
trials on something that could alleviate chronic pain and help 
reduce the risk of opioid addiction that we see so rampant in 
the society today. So, I guess my question is, could this be a 
statutory problem, a regulatory problem, a resource problem? 
What might we be looking at? And I realize I am giving you a 
very specific example but hoping that you can give us some 
information.
    Dr. Califf. Well, you know, the way it works at FDA on the 
drug side is there are user fees that are paid, and we have 
statutory or agreed-upon, passed by Congress every 5 years, for 
the user fees timelines. We are meeting those timelines which 
are agreed to between the industry, the FDA, and then put into 
law by your passing the law.
    I am not aware of the particular circumstance you are 
giving. There is a thing that we say at FDA: ``In God we trust. 
All others must bring data.'' So, I would have to know the 
specific data coming from University of Arizona to know if 
there may be some issue that is causing a back and forth that 
would not fall within the usual timeline, but when that 
happens, it is very much noted that that is the case, so.
    Mr. Biggs. We would love the opportunity to present you 
with additional information, whatever we need to----
    Dr. Califf. Sure.
    Mr. Biggs [continuing]. Find out what may be the hitch in 
the get-along, if we could.
    Dr. Califf. That will be fine.
    Mr. Biggs. With that, I will yield to the Chairman.
    Chairman Comer. Thank you for yielding. Commissioner, it is 
FDA's responsibility to ensure the safety and efficacy of all 
drugs marketed and sold in United States regardless of where 
the drugs are manufactured. Yet the number of inspections 
conducted annually has been declining since 2013. At the same 
time, Chinese and Indian manufacturers have received the most 
FDA warning letters by far. These violations include 
contaminated medicines, non-sterile manufacturing, and 
falsified data. So, how is the FDA working to keep foreign 
manufacturers accountable?
    Dr. Califf. I really appreciate that question. As I have 
already established, we are doing a major reorganization 
because I agree with you that we need to pick up the pace of 
the inspections that we are doing, but, again, as I have 
already said, the first line of defense is the manufacturers 
themselves. And so, here is where modernization of our data 
systems is important because the more we can keep up with what 
is going on, not just in U.S. facilities, but all around the 
world, the better we are able to target our inspections and to 
have the frequency that is needed to keep the manufacturer in 
shape.
    One of the big areas that we are working on now is India, 
where we have completely redone our inspectional system, and I 
have personally gone to India to meet with the Indian 
Government to work on the relationship, so that the inspections 
can proceed, and I believe they are acting in good faith in 
India right now, as one example. So, think of it as a layer of 
data and information that should be constantly coming in now 
that all manufacturing is digitized. And on the human side 
where the inspector actually shows up, the investigator in the 
facility, those are being increased, and it has been a major 
point of emphasis in our reorganization.
    Chairman Comer. There are not a lot of bipartisan agreement 
on controversial issues in this Congress, but one thing I think 
there is overwhelming bipartisan agreement on is the fact that 
we need to have more domestic manufacturing of our 
pharmaceuticals. In your medical opinion as commissioner of 
FDA, what can we do in Congress to encourage an environment 
where all of our essential, or much more at the very least, of 
our essential pharmaceutical production is manufactured in the 
United States?
    Dr. Califf. As one of your colleagues pointed out through 
the Socratic method of asking the question, I do not think it 
is a big issue for innovator drugs because that industry does 
not experience much in the way of shortage. But for this 
generic area, it is an area where we do need to reshore 
significant----
    Chairman Comer. But, it is a national security issue as 
well.
    Dr. Califf. Absolutely.
    Chairman Comer. Right.
    Dr. Califf. And when the raw material is coming from China, 
it is an issue that we need to take seriously. So, as you know, 
FDA does not deal with the prices and the market per se. I 
would refer you to the HHS white paper that just came out with 
a large input from us. And basically, we need to create an 
economic market situation where the price is fair, so that the 
manufacturer can produce a product, but also invest in the 
technology of manufacturing and can be done using American 
labor, which is more expensive than labor in other countries. I 
would also say, I am not talking about 100 percent reshoring. I 
do not think we need that, but we need enough of a footprint in 
the U.S. and in nearby countries that we are assured that if 
something goes wrong anywhere in the world, we keep this up. 
Ninety-five percent of our prescriptions are now generic.
    Chairman Comer. And we will touch on that later. My time 
has expired. The Chair now recognizes Ms. Bush from Missouri 
for 5 minutes.
    Ms. Bush. Thank you, Mr. Chairman. St. Louis and I are here 
today, Dr. Califf, to first thank you for the work that the FDA 
has done to eliminate cumbersome restrictions on mifepristone, 
one of two drugs used for medication abortion. As Ranking 
Member Raskin mentioned at the top of the hearing, mifepristone 
is subject to a risk evaluation and mitigation strategy, also 
known as REMS. During the peak of COVID-19, the FDA suspended 
enforcement of a REMS requirement that mifepristone be 
dispensed in person. Due to the success of this trial run, we 
know that in January 2023, the FDA permanently updated the 
strategy to remove the in-person dispensing requirement. This 
has proven that the in-person dispensing requirement was never 
actually medically necessary.
    I have a bill called the Protecting Access to Medication 
Abortion Act, which would assure that mifepristone, one, does 
not have an in-person dispensing requirement; two, allows 
patients to access prescriptions for mifepristone via 
telehealth; and three, authorizes all pharmacies certified to 
dispense mifepristone to patients to do so via mail. So, thank 
you to the FDA for your commitment to your evidence-based care 
that serves patients and not politicians.
    Next, I want to turn to sickle cell, a disease that affects 
approximately 100,000 people across our country, the majority 
of whom are Black people, and about 2,000 people across my 
district. In fact, according to the CDC, 1 out of every 365 
Black children in the United States are born with sickle cell 
disease. It cuts at least 20 years from life expectancy. And 
so, as a nurse, I have treated people with sickle cell disease. 
Patients experience totalizing pain, and it is debilitating. 
This illness completely takes over your life and it is heart 
wrenching, and we do not speak enough about it.
    So last year, the FDA issued a groundbreaking approval of 
the first gene therapy to treat sickle cell disease, and so 
this new technology is the first-time genetic editing has been 
used to treat any disease. As a result, patients who face 
excruciating pain and even death from sickle cell disease will 
now be able to better manage this life-threatening condition 
for many who may have been unable to hold steady employment, 
spend time with friends and family, or otherwise participate in 
everyday life because of this illness. This is truly life 
altering and is life sustaining. This technology would be 
impossible without the diligent and the science-driven work of 
the FDA.
    So, Dr. Califf, what did the FDA consider when determining 
the new sickle cell treatment, determining that it is safe and 
effective?
    Dr. Califf. As I believe you probably know, there are 
actually two treatments approved, one using gene editing per se 
and another using a viral vector, and in both cases, human 
clinical trials were done. Taking sickle cell patients, as you 
well know being a nurse, people with sickle cell disease, even 
though the genetic issue is essentially the same area of the 
human genome, the manifestation of the disease is quite 
different.
    So, what was done in these trials were to take people who 
are having the worst outcomes--that is, many attacks, painful 
crises--and then doing the gene effort, and then following them 
after and showing that those crises abated almost completely. 
It was quite a remarkable result but in a small group of 
patients. And so, there is a lot yet to learn, but it was 
important to give access to that treatment to those who would 
benefit.
    Ms. Bush. OK. OK. Is there potential for this new treatment 
to be used to treat other genetic diseases?
    Dr. Califf. It is very exciting, and I alluded to it in my 
opening comments. You know, I was around for the Human Genome 
Project, and people for decades said, ``where is the beef'', 
you know. We put all this money into $3.2 billion base pairs 
and knowing what they are. Now we are here because thanks to 
the science, we can go in with molecular scissors and snip out 
the gene that is causing the problem and put in a new one, or 
snip out the gene that is causing the problem if we do not need 
to put in a new one. There are 10,000 rare diseases with no 
treatment right now.
    You are talking about parents of children who have terrible 
outcomes. And so, this is such a revolution in terms of 
therapeutics, that we are making major changes within the FDA, 
but it has got to go further than that because you are aware 
that the cost of these treatments is quite high. So, I think 
there is going to be a lot for you in Congress to work with the 
administration on here to figure out, you know, if you are a 
parent of a child with a rare disease, now there is hope that 
within a few years, we could have an effective treatment. But 
if we have hundreds to thousands of effective treatments, the 
environment in which this is done has got to look different 
than it does right now. I hope that was helpful.
    Ms. Bush. Yes. Yes. And, Chairman, can I? OK. Thank you. 
One last question. How can we ensure that people who require 
these genetic therapies are not priced out because like you 
started to allude to?
    Dr. Califf. Well, I can take these out and say, you know, 
as FDA commissioner on a hearing about FDA, it is definitely 
not in our remit. But I can assure you there are many 
discussions going on across HHS where, as you know, for 
example, in sickle cell disease, the majority of patients are 
on Medicaid----
    Ms. Bush. Right.
    Dr. Califf [continuing]. Because their medical costs are so 
high and the difficulty with jobs in a case where you are sick 
a lot, that we got to come up with new pricing schemes. And I 
am an academic, a health policy person, but I should not opine 
on that here at this hearing, but I would be glad to talk with 
you separately.
    Ms. Bush. OK. I will reach out. Thank you. Thank you, Mr. 
Chairman. I yield back.
    Chairman Comer. The Chair now recognizes Mr. Higgins for 
Louisiana for 5 minutes.
    Mr. Higgins. Thank you, Mr. Chairman. Mr. Califf, thank you 
for being here. Your authority is vast and your responsibility 
is great, and you are a gentleman of distinguished stature, so 
I appreciate you being here today. You have to give serious 
answers to hard questions, and I do indeed have some hard 
questions to submit to you, and, Bob, we are submitting the 
more interesting questions in writing for the record after the 
hearing.
    Mr. Higgins. For legislative purpose, I have a specific 
line of questioning regarding imported seafood, so it is what I 
am going to be discussing with you. Just as a matter of 
background, according to my research and investigations, about 
60 to 65 percent of seafood consumed in America is imported. 
And generally speaking, given the limited resources that you 
have at your avail, you are able to supervise the inspection of 
about one-tenth of 1 percent of imported seafood. Is that 
generally correct, sir?
    Dr. Califf. Well, we settle it all differently. First, and 
by our account, it is more than 65 percent of seafood, if you 
are asking me.
    Mr. Higgins. This is the Republican side, so I am being 
conservative.
    Dr. Califf. OK. But much as I described on the drug side 
just a few minutes ago, it starts with a digital inspection. 
That is, we have information about these facilities from----
    Mr. Higgins. And then the shipper and the owner and the 
input.
    Dr. Califf. And as it comes in, we use artificial 
intelligence now to look at the characteristics of the shipment 
to pick out, so it is not just the small number you referred to 
out of overall. It is the high-risk part of the import that we 
are also looking at.
    Mr. Higgins. Yes, and I appreciate that level of expertise 
and, of course, the dynamics of illegal imports or would 
include inspections beyond the biological and chemical realm. 
But according to a September 2017 GAO report titled, ``Imported 
Seafood Safety: The FDA and USDA Could Strengthen the Efforts 
to Prevent Unsafe Drug Residues in Imported Seafood,'' a 
whistleblower has come forward indicating that a company called 
Choice Canning, an Indian shrimp exporter, has knowingly 
shipped antibiotic contaminated shrimp to the United States. 
Despite this, FDA data shows that only 21 shrimp samples from 
this company have been tested since 2003.
    Just to put this in perspective, again, respectfully, sir, 
you have a massive job to do and limited resources. I respect 
that and I want to help. This company that I am referencing, 
the Choice Canning Company, which is a known violator, imported 
24 million pounds of shrimp to the United States last year 
alone. So basically, imported seafood is coming into our 
country, and the billions and billions of pounds, very little 
of it is being actually inspected at the laboratory level for 
biological and chemical contaminants. And the reason we are not 
getting sick is because we cook the seafood, basically. That is 
the reality. So, I would like to ask you, if you had 
legislation from this body that gave you teeth in your 
enforcement, like the authority and mechanisms to destroy 
shipments that had been found to be contaminated, would that 
power be helpful for FDA enforcement of imported seafood that 
violates American standards for biological and chemical 
contaminants?
    Dr. Califf. You ask the question in a specific way that I 
am reluctant to say just yes.
    Mr. Higgins. Yes, you can say just yes.
    Dr. Califf. What I would say is in the general direction 
you are going, I would say, in general, including this arena, 
the industries have, by and large, followed our ability to do 
what you described. It is not just true in the area that you 
mentioned, but, in general, I believe we would exercise our 
authorities responsibly and could more quickly take care. I 
mean, there is stuff which sits there for a long time given all 
the things we have to do in order to stop while it is coming 
in.
    Mr. Higgins. Roger that. Thank you, sir. I am going to 
close by saying that my intention is to legislatively empower 
the FDA to have very aggressive responses to shipments of 
contaminated seafood that enter our country. Mr. Chairman, I 
yield.
    Dr. Califf. Let me thank you for that. And I am a South 
Carolinian, and I think our shrimp is better than yours, but in 
any case, there is nothing I would like better than to see a 
resurgence of the seafood industry in the United States.
    Mr. Higgins. Well, I have learned from a young man not to 
argue with a gentleman in a bow tie, so I will let you have 
that, sir.
    Chairman Comer. The Chair now recognizes Ms. Stansbury from 
New Mexico for 5 minutes.
    Ms. Stansbury. Thank you, Mr. Chairman, and thank you, Dr. 
Califf, for being here today. It is wonderful to have you. I 
want to thank your staff for being here today as well, and I am 
grateful for the opportunity to highlight the importance of 
science and science-based decisionmaking in this hearing and 
all that you are doing to protect the American people to ensure 
that we have access to medicines that work, that we have food 
that does not harm us; and to ensure that every American can 
get lifesaving care, and also for your work and the 
Administration's support of our work this last Congress to pass 
once-in-a-generation legislation to expand access to 
healthcare, to invest in science and innovation, and, of 
course, to expand access to prescription drugs for our seniors.
    The FDA is truly on the front lines of that battle every 
single day, and we are really grateful for the work that you 
do. And I will say on a personal note, I have a family member 
who was formerly an FDA employee, and you represent the best of 
the best that our country has to offer. And nowhere is this 
more important than in the realm of reproductive care where we 
have to continue to follow the science and ensure reproductive 
freedom, especially in the face of unprecedented attacks.
    You know, as we have seen, Republicans in this body, in 
fact, in this room and across the country, have been working to 
ban abortion, first through Donald Trump's Supreme Court, which 
overturned Roe vs. Wade last summer, and then chipping away 
state by state to implement abortion bans, including where in 
Arizona, just this week, the Court has upheld a Civil War-era 
abortion ban. That is right. For folks that do not know this, 
this ban was put in place in 1864 before an end to slavery had 
been ratified by this body, before women could vote, and before 
Arizona was even a state. Let us be clear. No judge, no 
politician, no person should be able to tell any woman in 
America or anywhere in the world what she can do with her own 
body. And nowhere is this more important right now than in the 
U.S. Supreme Court, which we are all watching very carefully in 
the wake of their hearing of oral arguments in a case in which 
the FDA has been involved since the last couple of years over 
Mifepristone.
    So, Dr. Califf, I want to ask you a question, if you could 
talk to us a little bit, not only about the implications of the 
decision by the Supreme Court, which we are expecting this 
summer, for women to access reproductive care through medicated 
abortion, but also what are the wider implications for FDA's 
ability to use science to approve medicines?
    Dr. Califf. Well, thank you for the question. I have to 
note that since this case is under consideration by the Supreme 
Court, I am very limited in what I can say. I will say that we 
stand by our decisions. They are still in play today, and I 
will add that, you know, we do have concerns if judges start 
second guessing FDA decisions, about what that means for the 
broader area of having a rational system of availability of 
medications and devices for the American public.
    Ms. Stansbury. Right. So, the FDA approved Mifepristone to 
be used as a totally appropriate medicated way of addressing 
issues around reproductive care, and the broader implications 
are that if judges start legislating from the bench on this 
kind of medicine, it could be anything. It could be cancer 
treatments. It could be any kind of medication or intervention 
in your health, and I think the American people need to 
understand the implications of this case, the potential impacts 
for public health and the ability for it to impact every 
American's opportunity to access life-saving care.
    So, we appreciate your work. And I am personally thankful 
to be from a state, from New Mexico, that has worked to protect 
reproductive care. But, if the Supreme Court does overturn 
FDA's decision to approve that medication this summer, we could 
see a ban on medicated abortion across the United States, 
including in places like New Mexico, where it is protected. So 
that is why this body has to urgently take action, it is why we 
have to defend the science, it is why we have to sit here and 
defend our agencies who are making sure that American women and 
all people have access to the care that they need. And it is 
why we have to do everything we can to defend our institutions 
because the lives of our communities literally depend on it. 
Thank you.
    Dr. Califf. Just a quick comment, if I may. Everywhere I go 
in the world, our system of drug development and decisionmaking 
is the envy of the rest of the world. They all want to be like 
us in that regard. As I have already commented, our use of 
generic drugs in public health is falling a little short now 
with our drop in life expectancy. But the system that you 
described is one that it is very important that we preserve in 
general, in addition to the topic you are specifically talking 
about.
    Chairman Comer. The Chair now recognizes Mr. Perry from 
Pennsylvania.
    Mr. Perry. Thank you, Mr. Chairman. Thank you, Dr. Califf. 
I want to talk to you about the World Health Organization. And 
the----
    Dr. Califf. I am sorry. My name is called all kinds of 
things. It is Califf.
    Mr. Perry. Califf, sorry. I am sorry. Sorry.
    Dr. Califf. I have gotten a lot of different pronunciations 
here, but I am used to that.
    Mr. Perry. That wasn't an incorrect pronunciation. That was 
just plain damn wrong.
    Dr. Califf. OK.
    Mr. Perry. I want to talk to you about this treaty, I think 
185, maybe, plus nations, including places like Yemen, Iran, 
Iraq, Afghanistan, Cuba, Haiti, and some terms in that, we have 
not seen it. We have not seen the 30-plus amendments, so we are 
kind of shooting in the dark here. And I do not know that you 
know any more than any of the rest of it about it, you know, 
than we do, but there was another draft just last month that 
created a multilateral system for sharing pathogens with 
pandemic potential. I already listed some of the countries 
involved. It also commits each party, which would include us if 
we were signatories, to promote timely access to credible and 
evidence-based information on pandemics, and the aim there, I 
guess, is to combat misinformation and disinformation, I guess, 
as you see it or as they see it.
    So, my question is, with the potential threat to U.S. 
sovereignty for decisionmaking on whether a pandemic even 
exists and the prescribed remedies, including lockdowns and 
maybe even medicating, would you commit before the Committee 
today to pledge not to adopt policies included or pursuant to 
the treaty until such time and if such time as that treaty 
would be ratified by the U.S. Senate?
    Dr. Califf. I am not sure how to answer that question given 
the complexity of what you said, but it is hard for me to 
imagine that we would do something at FDA that is not a 
government policy. Now, you refer to the Senate in particular. 
I am just not familiar enough.
    Mr. Perry. Well, if the Senate does not ratify it, it would 
not be a treaty that we would be signatories to, or at least 
not legally. And I just want some or to know if there is any 
intention on the FDA's part to institute any of the provisions 
within the treaty without the proper ratification from the U.S. 
Senate.
    Dr. Califf. I do not think that particular issue would fall 
within our purview, so, and I do not know enough about it to 
make a commitment. But I will comment that----
    Mr. Perry. Sure.
    Dr. Califf [continuing]. You know, if we just look at the 
avian flu situation we are in now, the knowledge of the 
molecular structure of whatever the pathogen is turns out to be 
really, really critical to come up with countermeasures to 
treat it, and so I hope we can work out a way. And then also, 
even for food safety, we talked about the imported food that we 
get the genetic composition of the pathogen turns out to be 
really important. So, I sure get what you are saying. We got to 
do this carefully, whatever we do, but I hope there will be a 
way that, for example, we do not get exposed to a new pandemic 
where we know nothing about the organism until it is too late.
    Mr. Perry. I think most people in America want to maintain 
their medical sovereignty, the individual medical sovereignty 
that we all enjoy. Regarding censorship, the CDC was involved 
in media companies taking down social media posts regarding 
misinformation and disinformation, again, terms that I think 
are loosely defined. But the FDA has been involved in this 
process in the past, having awarded several grants in the range 
of hundreds of thousands of dollars to places like the 
University of Maryland College Park, Texas Woman's University, 
regarding, again, misinformation and disinformation. 
Commissioner Califf, has the FDA coerced social media companies 
to take down users' social media posts regarding the pandemic 
or any other topic due to what they describe as myths or 
disinformation?
    Dr. Califf. Not to my knowledge.
    Mr. Perry. Not at all to your----
    Dr. Califf. Not to my knowledge.
    Mr. Perry. So, would you consider you are paying--If the 
FDA is granting-organizations, like the University of Maryland 
or Texas Women's University, to mitigate the spread of 
misinformation or disinformation, that is, essentially, 
subcontracting out that duty. You are saying the FDA has not 
done it, particularly, but have they done it indirectly through 
their surrogates or their subcontractors via the grant program?
    Dr. Califf. I am not aware of the particular contract you 
are talking about, but let us remember that throughout the 
entire history of the FDA, the FDA considers data and 
information, makes a decision about a product, puts together 
the risks and benefits into a judgment as to whether it should 
go on the market. It is put in the label. The label is then 
transmitted to clinicians all over the country, who then work 
with their patients to make decisions about what to do. The 
sovereignty that you refer to is typically a patient-doctor 
relationship based on that information. Places like University 
of Maryland has a major, first-rate medical center. They are 
intermediaries in this process of relaying useful information. 
Now, if someone is saying something that is flat out wrong, you 
know, how that is dealt with by University of Maryland, that is 
their business.
    Mr. Perry. But, it also has the imprimatur of your 
approval, and when they are found out to have been wrong in the 
past for coercing social media companies to take down so-called 
posts that then were later found to be incorrectly done, where 
is the remedy, and is there an apology from the FDA? Is there 
an admonishment from the FDA to these universities that have 
been fast on the trigger and coerced and changed the narrative 
or changed behavior based on things that are not true?
    Dr. Califf. Far be it from me to apologize for a 
university. I am a longtime university person before coming to 
FDA, but I think what the university does is the university's 
business.
    Mr. Perry. Well, understand it also is a reflection on the 
FDA. Mr. Chairman, I yield.
    Chairman Comer. The gentleman yields back. The Chair now 
recognizes Representative Brown from Ohio.
    Ms. Brown. Thank you, Chairman, and thank you, Commissioner 
Califf, for coming before us today.
    On March 15, 2023, Congresswoman Pressley and I wrote to 
you urging an investigation into the link between chemical hair 
straighteners and uterine cancer. I would personally like to 
express my gratitude to the Food and Drug Administration for 
your rapid response and dedication to addressing this matter. I 
am pleased the FDA has already taken immediate steps with the 
proposed rule to limit the use of harmful chemicals found in 
many hair straightening products. As you know, Black women 
experience scrutiny and discrimination regarding our hair, 
which has led to widespread use of these products. Black hair 
should not restrict our ability to learn in school or advance 
in the workplace, nor should our haircare products come with 
health risk. As the FDA finalizes this rule, I look forward to 
working together to ensure our consumer products remain safe 
for everyone.
    Furthermore, I know you are hard at work to protect 
Americans in other ways, too. The Biden-Harris Administration 
and Democrats continue to fight to protect and preserve women's 
reproductive rights. The FDA's recent landmark approval of 
over-the-counter birth control moves us one step closer to 
reproductive freedom, even amid brutal, backward, and barbaric 
abortion bans like Arizona's and other attacks in reproductive 
health, including my own state of Ohio. Women must have the 
right to control when, if, and how to start a family. Increased 
access to safe and reliable contraception provides space for 
that decision to be made while putting control back in the 
hands of women. So, Commissioner Califf, what have been the 
impacts so far of over-the-counter birth control hitting 
shelves across America?
    Dr. Califf. Well, we are in the early phase of it, 
obviously, and there is always a lot to work out when something 
goes commercially because of pricing and all. But the 
availability, I think, as more manufacturers come on the 
market, given the precedent, we should see much more widescale 
availability so that people can use the products as indicated.
    Ms. Brown. OK. Thank you. And finally, one last issue I 
would like to touch on concerns a disease impacting far too 
many in the Black and Brown community. Roughly one in 8--1 in 
8--Black Americans live with diabetes, while in my district of 
Cuyahoga County, the Black diabetes rate is over 25 percent, 
over 1 in 4. Certain FDA-approved weight loss drugs aid in 
obesity management for adults with weight-related conditions, 
like type 2 diabetes. For many, these drugs are lifechanging 
and lifesaving. Unfortunately though, these medications are 
often too unaffordable and inaccessible for those who need them 
most, especially uninsured individuals. So, Commissioner 
Califf, how is the FDA working to ensure these new, highly 
effective treatments are reaching populations who need them 
most?
    Dr. Califf. Well, first of all, I appreciate your 
description of the problem, and there are special populations 
at much higher risk. You have referred to one. I would say 
rural people, in general, are also suffering greatly, and it is 
one of the main reasons that we are seeing this very 
troublesome decline in life expectancy. Right now, despite the 
fact that we are producing the majority of the innovations in 
medical products, we are almost in last place among high-income 
countries in terms of life expectancy and the disability and 
multiple chronic diseases that go along with it.
    Unfortunately, our tools at FDA specifically are very 
limited for what you described because we are limited by law in 
dealing with price or of products when they come to market. 
This is a policy issue, though, for all of the administration 
and for Congress to consider. The one thing that we do that 
when we have a product, like a set of products like this, that 
looks so effective, so far, is working with the manufacturers 
to get more products on the market because the competition does 
bring the price down, but what you are referring to is most 
unfortunate in many ways. There is a saying that I love. It 
makes you feel bad in a way, but it was in the Atlantic during 
the pandemic, and technological solutions drift into societies, 
penthouses. Diseases seep into societies' cracks, and the 
problem is, here we have a highly effective treatment. Who is 
getting most of it? The wealthy and highly educated people. Who 
needs it the most? It is the people that you described who may 
have lower income and are in the need. So, this is a major 
policy problem. I am sorry, the FDA is limited in what it can 
specifically do, but I can assure you that, for example, CMS is 
thinking hard about what am I to do about this.
    Ms. Brown. Well, I thank you for your thoughtfulness, and I 
thank you for this work that you are doing, and I look forward 
to continuing and staying in a good contact with you. And with 
that, I yield the balance of my time.
    Chairman Comer. The Chair now recognizes Mr. Palmer from 
Alabama for 5 minutes.
    Mr. Palmer. Thank you, Mr. Chairman. Commissioner Califf, 
in your testimony, you said the use of CBD raises safety 
concerns, especially with long-term use. And you mentioned a 
couple of things that were problematic, including harmful male 
reproductive system exposure, particularly concerning for 
children during pregnancy. The FDA is engaged in monitoring the 
use of CBD. Is that correct?
    Dr. Califf. It is a little complicated because CBD does not 
fall directly under any particular regulatory scheme that we 
have.
    Mr. Palmer. Should it?
    Dr. Califf. So, when people do report things to us, we note 
it, and we have had funding from Congress to study the problem 
from independent studies that have been----
    Mr. Palmer. I appreciate that, but my question is, should 
the FDA be more involved in monitoring CBD because it is 
becoming extremely popular throughout the country.
    Dr. Califf. We would very much like Congress to establish a 
regulatory pathway for CBD.
    Mr. Palmer. Well, I have an article from the National 
Institute on Drug Abuse, and it talks about vaping. We also 
talked about vaping. I am not going to get into that, but I do 
have major concerns about the products coming in from China, 
but also have concerns about the lethality of vaping, whether 
it is tobacco or marijuana. And is that something that the FDA 
is actively engaged in monitoring?
    Dr. Califf. To the extent that we can. Again, as we 
discussed earlier today, the regulation of marijuana is another 
area where we would benefit greatly from Congress reaching 
agreement on a regulatory pathway that enables the prevention 
of harm from being done.
    Mr. Palmer. I am glad you brought that up because I agree 
with you. This body in the 1990's recognized that the tobacco 
industry had worked to increase the amount of nicotine in 
tobacco. Nicotine is not the carcinogenic that causes people to 
get lung cancer. It is the smoke, the tar, and the other things 
from inhaling the smoke. You have some of the same issues with 
marijuana, that there is tar and other things that are ingested 
into the lungs.
    But the thing that concerns me about this as well is, and 
this Congress acted, I think, effectively in dealing with the 
tobacco industry in the 1990's. But what concerns me right now 
is that we are not doing anything, to my knowledge, to regulate 
what is going on in the marijuana industry and, particularly, 
the genetically modified products. In the 1960's, 1970's, 
1980's, as I reminded my colleagues, THC content was about 2 
percent. Now it is anywhere from 17 percent to 28 percent, and 
that is the addictive part of marijuana that affects the 
frontal lobe that impacts judgment. And what we are starting to 
see now, again, it comes in different forms. You do not just 
smoke it. You could take it as a gummy. You could get it as an 
oil.
    And what is happening is more and more children are coming 
in contact with it. And there is a report from the National 
Center for Biotechnology Information that are found in one of 
the medical publications that says that in terms of addiction, 
9 percent of those people who just experiment with it become 
addicted, 17 percent of those who start as teenagers become 
addicted and anywhere from 25 percent to 50 percent of daily 
users. Is that another area where the FDA needs to engage 
because we see more and more states legalizing this? So, it is 
not a DEA problem. It is a consumer problem.
    Dr. Califf. I believe that this is a similar area where 
harm reduction through a regulatory strategy is probably our 
best approach, and we need more research on exactly what the 
facts are. Remember that the tobacco industry was engaging in 
genetic manipulation, basically, going way back just through 
the old-fashioned Mendelian radiation of the plant, and then 
development of mutations that will lead to more and more 
nicotine in the product. And now we have chemical synthesis, 
which can imitate almost any of these in a highly efficient 
way, to produce the kind of effects that you described.
    Mr. Palmer. Increase addiction.
    Dr. Califf. So we are concerned and we would like see a 
regulatory pathway. We talked earlier about the fact for the 
most part, the FDA is a referee, and we need a rulebook and you 
guys write the rulebook, so we would really like to see a 
rulebook in this area.
    Mr. Palmer. Commissioner Califf, I appreciate your answers. 
I yield back.
    Chairman Comer. And I have to comment on that. We write a 
lot of rule books, that we have trouble with this 
administration complying with the rules like they sing to their 
own drummer there, but anyway, march to their own drummer. 
Anyway, the Chair now recognizes Mr. Frost from Florida for 5 
minutes.
    Mr. Frost. Thank you, Mr. Chairman, and good afternoon, 
Commissioner. Like many of my constituents, I am deeply 
concerned with the H5N1 avian flu outbreak. It has impacted 
birds, livestock. At least one person in Orlando lost several 
of our Lake Eola swans, which is in the center of my district. 
It is a symbol of our city. While it does seem clear that the 
avian flu is not currently able to spread easily among people, 
folks are still wondering about how safe they are. It is 
brought up a lot in my district. Commissioner, how is the FDA, 
in coordination with the Department of Agriculture and the CDC, 
ensuring that Americans have access to reliable and up-to-date 
information about this?
    Dr. Califf. Well, thanks for bringing this up. It is a very 
important issue today. As you have noted, avian flu has been 
around for a while, but it is only recently that it has now 
infected cattle and now cattle and multiple cows in multiple 
states, and so this is really an all-of-government effort. 
There are Zoom conferences multiple times a day now involving 
FDA, CDC, Agriculture, as you said, but also many other areas 
of government that have a stake in the game of interstate 
commerce and Department of Justice and issues that are related. 
So, we are all working together, and you should see frequent 
communications as we work through this, remembering that the 
most recent episodes with the cows is a relatively new thing, 
so we are starting with a lot of uncertainty and working our 
way through it.
    Mr. Frost. And since 2006, the Federal Government 
stockpiled antivirals designed to prevent severe illness and 
death from the flu. Will this medication be effective against 
avian?
    Dr. Califf. Well, this relates to the discussion that we 
just had. It is very useful to know the molecular or genetic 
composition of the virus and in this case, if you look at the 
composition of this virus, there is nothing in it that should 
confer resistance to the current antivirals that we have 
stockpiled, so we feel good about that. I should note it is 
always the case when you have an actual illness, you have to 
empirically prove that it works, and so fortunately, right now, 
there is really only one infected human that we know of. So, it 
is not something that we can test, but it looks good at this 
point.
    Mr. Frost. Thank you. I appreciate it, Commissioner. 
Another subject that is really important to me and it is 
personal to me are allergies. I am a survivor of anaphylactic 
shock just a few years ago that almost killed me. I also want 
to make sure that the other 20 million Americans with food 
allergies know that what they are taking or what they are 
eating is safe. A recent study found that 93 percent of all 
medicines contain an allergen, and many popular over-the-
counter allergy drugs contain lactose. Do you believe that the 
FDA has the power to require labeling of prescription and over-
the-counter medicines for food allergens and gluten?
    Dr. Califf. We definitely have the power to require 
labeling when it is indicated.
    Mr. Frost. Three years ago, President Biden signed into law 
the FASTER Act requiring labeling of sesame as a food allergy, 
and also requiring HHS to submit a comprehensive government 
report on food allergies within 18 months. That report has not 
yet been submitted, and it is very frustrating to Americans 
with food allergies and their families. Does this report fall 
under the responsibility of the FDA, and, if so, would you be 
able to provide an update on the status of it?
    Dr. Califf. I will have to get back with you on that 
because I am not familiar with that particular report. But we 
are very familiar with the fact that allergies in the U.S. are 
apparently growing and that there is a great need to make sure 
we get this right.
    Mr. Frost. OK. Yes, we would love to follow up on that. I 
think we even gave a heads up about that question so you could 
be prepared, but it is all right. We will follow up about it.
    Mr. Frost. Thank you. I yield back.
    Mr. Palmer. [Presiding.] The gentleman yields. The Chair 
now recognizes the gentlelady from Michigan Representative 
McClain for her 5 minutes of questions.
    Mrs. McClain. Thank you, and thank you for being here 
today. Commissioner Califf, you assumed the Office of the 
Commissioner of the FDA in February 2022, correct?
    Dr. Califf. That is correct.
    Mrs. McClain. Thank you. When you assumed office, were you 
aware that a manufacturer who made more than 40 percent of the 
country's infant formula was voluntarily recalling all the baby 
formula it made at its Sturgis plant?
    Dr. Califf. I was very familiar because it happened on the 
day I was confirmed, so I did not know before----
    Mrs. McClain. So yes, thank you. So, I will take that as a 
``yes.'' In the days and weeks that came after you assumed 
office, were you aware that there was a shortage of infant 
formula across the country?
    Dr. Califf. Well, in the first days and weeks, there was 
not a shortage, but as the shortage evolved, I was very much 
aware of it.
    Mrs. McClain. So yes, thank you. Were you aware that 10 
states reached rates of over 90 percent of out-of-stock and 
nationwide, 74 percent of stores had no infant baby formula?
    Dr. Califf. Those numbers do not sound right to me, but 
there was a lot of out-of-stock and absence of formula.
    Mrs. McClain. Directionally, what do you think they were? 
Could you say we were reaching crisis mode, or we were just 
like short one or two cans?
    Dr. Califf. It is closer to crisis and sure wanted to----
    Mrs. McClain. OK. Thank you. Mr. Chairman, I would like to 
enter into the record two internal email exchanges within the 
FDA, the first dated February 4, 2022, in which the FDA 
officials are discussing the potential for infant formula 
supply issues and asking for media support from the White House 
to educate the public; the second on February 19, 2022, in 
which the FDA officials were discussing the supply issue that 
were already happening.
    Mrs. McClain. Now, despite these discussions within the 
FDA, media reports, the President was not aware of the problem, 
even though it was headlining in nearly every news channel and 
every paper across the country for 3 months. So, my question 
is, did the FDA not raise concerns about the potential shortage 
even before the recall?
    Dr. Califf. As you know, there is a record that says there 
was a supply disruption task force that was put up during the 
COVID crisis. It was also used for this purpose, working to----
    Mrs. McClain. So, it was elevated?
    Dr. Califf [continuing]. To the task force which has----
    Mrs. McClain. Did the FDA raise concerns about a potential 
shortage even before the recall? Yes or no.
    Dr. Califf. I cannot speak for before the recall, but at 
about the time of the recall.
    Mrs. McClain. OK. Well, let me help you because I can tell 
you the FDA did, in fact, raise the issues to at least nine 
different White House officials, and President Biden took no 
action. So, I would like to enter into the record an email 
between the FDA and the nine White House staff, including 
members of the National Security Council, Domestic Policy 
Council, and the Special Assistant to the President for Public 
Health.
    Chairman Comer. [Presiding.] Without objection, so ordered.
    Mrs. McClain. Thank you. This email dated February 17, of 
2022, which was the day of the voluntary recall, shows the 
White House in communication with the FDA about the recall. So, 
I am just helping you out there.
    Mr. Chairman, I would like to enter another email into the 
record, an email dated February 20, 2022, just 3 days after the 
voluntary recall, which shows the FDA Chief of Staff already 
raising concerns about infant formula shortages and 
communicating this concern with the White House.
    Chairman Comer. Without objection, so ordered.
    Mrs. McClain. Commissioner, here is my question. Why did it 
take 3 months for President Biden to invoke the Defense 
Protection Act?
    Dr. Califf. I cannot speak for President Biden and that 
particular decision. I will note, as I have already said, you 
know, I do not have the emails that you are referring to, but--
--
    Mrs. McClain. I will get them to your office, and I will 
promise you I will get them to you in a timely fashion. I 
guess, my question is----
    Dr. Califf. But this evolved over time, so the exact timing 
of when the DPA should have been brought in is something that 
is a matter of discussion.
    Mrs. McClain. ``A matter of discussion.'' That is your 
answer. I mean, so your office has been in communication with 
nine White House staffers. Either the FDA did not tell him or 
he did not act. Which is it?
    Dr. Califf. Yes. I think you have the emails, and I cannot 
really comment beyond that.
    Mrs. McClain. Well, you know, what baffles me is you make 
about $200 grand. You are supposed to be in charge, but when 
the you-know-what hits the fan, everybody runs for the hills. I 
am going to switch topic.
    Dr. Califf. Well, just hold on a minute. I----
    Mrs. McClain. It is my time, sir, when asking about its 
handling of this is unbelievable. I mean, you do not have an 
answer. I would love to have an answer, but I am going to 
switch gears.
    Dr. Califf. Well, you overestimated my salary, which is----
    Mrs. McClain. It is about $191,000, so that is pretty 
close. But, Commissioner Califf, it costs millions of dollars 
to prepare premarket tobacco product applications, ``PMTAs.'' 
Manufacturers have had products pending at your facilities for 
years. I know we have talked about this, and you know the 
concern of all the illicit and illegal products coming over 
from China. When do you anticipate getting some results from 
these American companies that have actually been waiting for 
over 4 years on their tobacco products?
    Dr. Califf. As we have already discussed, we are 99 percent 
done with almost 27 million applications. We have, you know, 1 
percent left to go. These are big decisions, and they are going 
to be rolling out. We expect to be caught up, for example, with 
the ones that are largest from the American Pediatric Group 
that follows us by the end of this year.
    Mrs. McClain. Wonderful. Thank you, sir. I yield time.
    Chairman Comer. The Chair now recognizes Representative Lee 
from Pennsylvania.
    Ms. Lee. Thank you, Mr. Chair. As we have discussed today, 
the FDA has a critical responsibility to ensure that our food 
supply, medications, and medical products are safe and 
effective, but the FDA does not hold this responsibility alone. 
The Agency does not have the resources to singlehandedly ensure 
the integrity of every product produced by every food, drug, 
and device manufacturer. The private sector also has a critical 
role in ensuring that their products are safe, a responsibility 
that they need to take seriously.
    Recent reporting has uncovered how Philips Respironics, a 
Pittsburgh-based company and one of the largest medical device 
manufacturers in the world, received hundreds of complaints 
about its CPAP machines and ventilators prior to issuing a 
recall in 2021, a recall that ended up being one of the largest 
in history. Not only did the company receive hundreds of 
complaints from hospitals, providers, and patients as far back 
as 2010, but its own internal evaluations indicated their 
machines were toxic, yet the company withheld this information 
from the FDA and the public for more than a decade. They 
continued to sell these hazardous machines enabling their stock 
prices to soar to the highest levels in decades while the most 
medically vulnerable in our communities--our infants, our 
seniors, our veterans--suffered. In Pennsylvania, there are now 
more than 700 personal injury lawsuits and class actions 
against the company due to irreparable harm its devices caused 
patients. Philips is one of the most egregious examples of what 
can occur when corporations do not take their responsibility to 
public health seriously.
    From COVID-19 vaccine manufacturing failures to dangerous 
levels in children's applesauce products, we have seen the 
private sector repeatedly fall short. Dr. Califf, what is the 
private sectors' responsibility in ensuring that medical 
devices that are brought to the market are safe and effective?
    Dr. Califf. As we have discussed multiple times today, the 
primary first line responsibility is with a regulated industry. 
This is a situation in which we oversee the industry, but the 
industry has that primary responsibility to produce safe and 
effective products, whether it is a device, a drug, or a food.
    Ms. Lee. So, what investigative action or enforcement 
actions does the FDA have, or does the Agency need to hold 
companies like Philips accountable for regulatory noncompliance 
and to deter future wrongdoings?
    Dr. Califf. This has come up with regard to almost every 
commodity now, that it would be better for public health, I 
believe, if we had direct recall capabilities across the 
spectrum of products that we regulate when we find problems, 
such as you are referring to. I would also like to see a 
bulking up of our post-market surveillance capabilities. After 
all, every American has an electronic health record now, and 
there is a lot that we can do so that we find out about these 
problems earlier than we currently are. And we need to make 
sure the manufacturers actually report in a timely fashion when 
they do get problems that they are aware of.
    Ms. Lee. So, over the years, the FDA has promised to 
overhaul the way that it detects dangerous medical devices by 
allowing more real-time data and medical registries. What 
progress has the FDA made toward those goals?
    Dr. Califf. Well, you know, this is actually work that I 
have been involved in, in my academic life, for 30 years. So, 
if you just think about it, everyone has an electronic health 
record. Every important medical transaction essentially is 
digitally captured now. We have multiple blocks in the system 
that keep us from putting the data as best we can, so we are 
very dependent on voluntary registries where either companies 
pay for it or health systems pitch in, and then the FDA buys 
the data.
    I am pleased to say there is a lot of discussion with NIH 
and other parts of HHS now about having better data pooling 
capabilities, so that we know about these things in real time. 
And we now have a model globally where it is happening in 
Israel, where 100 percent of the population has real-time 
electronic health record accessibility to detect problems but 
also, importantly, to find advantages. Sometimes there are 
surprises where something works better than expected, but right 
now we do not know about it in real time.
    Ms. Lee. OK. Looking at the time, I already know that I am 
not going to get through this next question, so I want to 
respect yours and my colleagues' time and yield back.
    Chairman Comer. The Chair now recognizes Mr. Burchett from 
Tennessee for 5 minutes.
    Mr. Burchett. Thank you, Mr. Chairman. Thank you, 
Commissioner. I appreciate you doing all of this without a 
bathroom break, so it is great admiration for you there. I have 
a question about the 2018 Farm Bill. It is about the 
cultivation, sale, and transportation of hemp-derived products. 
Since 2018, what regulations has the FDA put in place regarding 
hemp-derived products?
    Dr. Califf. Well, I mean, we have a law from you all 
defining hemp as less than 0.3 percent THC, and you have given 
us money to study the problem, and our conclusion, as it 
relates to human health, is they are not safe enough to be 
called a dietary supplement or a food. And so, we have asked 
Congress to put together a regulatory pathway that will be 
appropriate so these products are available, but they are 
labeled, they are identified. And in cases, for example, gummy 
bears packaged for children, there is a way for us to take 
action quickly in those situations.
    Mr. Burchett. Have any outside groups requested that the 
Food and Drug Administration regulate hemp-derived products?
    Dr. Califf. Yes, we have had multiple citizens petitions, 
but as I have said, the requests have been to regulate these as 
dietary supplements, and they do not meet the definition of a 
dietary supplement because of elevated liver enzymes and other 
health problems that we believe make them unsafe as 
supplements. But they could be regulated in other ways and made 
available if Congress thinks that is the right thing to do.
    Mr. Burchett. Are you an M.D.? It is not in my notes, but 
you were saying some medical things there, and I am curious.
    Dr. Califf. I am a board-certified cardiologist, 35 years 
of intensive care unit and outpatient practice, sadly, not 
practicing right now.
    Mr. Burchett. Yes, sir. So, you would question whether we 
have a heart then if you are a cardiologist. Is that correct?
    Dr. Califf. Let us just say the heart and the brain are two 
different things.
    Mr. Burchett. Let the record reflect that our commissioner 
is punch-drunk from being up here so long, but thank you, 
brother.
    I am concerned about hemp, and I will tell you why. It is 
not in my notes, and it always makes my people nervous when I 
do this, go off the thing. My daddy fought in the Second World 
War, and I can remember and I have seen videos of, you know, 
``help us grow hemp to save the world.'' You know, they have 
made rope out of it, and then, of course, it is a cousin of 
marijuana, but it does not have the THC level. And they come 
down here and we passed this thing in the Farm Bill, and all of 
these folks that want to grow hemp, they all say, ``Oh, we have 
got the greatest thing in the world.'' But dadgummit, I am a 
United States Congressman, and I have got a little farm, and I 
checked into growing hemp. It is not going to make you a 
fortune, but I have to get a dadgum fingerprint to do it.
    It just seems to me that the big boys in the cotton 
industry, and I am sure they will be rushing up to my office 
right after I say this, but they wrote these dadgum 
regulations. You and I both know it. They do not want the 
competition. They do not want hemp in there. You can watch the 
videos. You know, these people say it is not the miracle that 
they claim it is because there is a huge labor factor involved 
in it, and it really ticks me off that these folks have been 
fed this bill of goods, and, you know, it is just not 
happening. It is not happening like it should. And I am 
wondering, have you, anyone, you and your office had any 
meetings with the cotton industry officials in which hemp-
derived products were mentioned?
    Dr. Califf. I am not aware of any meetings for the cotton 
industry. That would be an unusual industry for us to meet 
with, but----
    Mr. Burchett. Due to the fact that you are not ingesting 
it, correct? OK. Well, you see that is another problem with the 
product. It goes to two different, separate groups, and so I 
think that is by design actually, the way, so that it keeps it 
more complicated. Are you aware in the first 2 years of the 
Biden administration that the value of hemp production in the 
U.S. decreased by 71 percent? No?
    Dr. Califf. Not aware.
    Mr. Burchett. OK. I will get away from the hemp thing, and 
I have only got 30 seconds. The Center for Tobacco Products, I 
feel like they have continued to not tell the truth in some 
cases to the American people. They tell us that vaping is 
harmful or more harmful than cigarettes, yet--let us see--Dr. 
Nancy Rigotti of Harvard concluded U.S. health agencies and 
professional medical societies should reconsider their 
cautioned position on e-cigarettes for quitting smoking. The 
burden of tobacco-related disease is too big for potential 
solutions such as e-cigarettes to be ignored. Would you say 
that that is--I am out of time, but you get where I am going 
at--is it more harmful than cigarettes if is not over-used, if 
it is not abused?
    Dr. Califf. Here is what I would say. Combustible tobacco 
kills people. I was just over in the U.K. because we are having 
a regulator. I went to Oxford, where Sir Richard Doll did the 
British doctor study, the doctors who smoke died 10 years 
earlier than the ones who did not. Vaping--if combustible 
tobacco didn't exist, you would be horrified by what is in the 
residue from vaping. When you think about that going into your 
lungs----
    Mr. Burchett. Sure.
    Dr. Califf [continuing]. Over the course of decades, it is 
pretty horrifying, but it is much less toxic in terms of all 
the things that cause cancer and heart disease, the vaping, 
then the combustible tobacco. So, that is why the term has been 
used, ``harm reduction,'' to say if you have got someone using 
combustible tobacco, they are a lot better off if they are 
vaping, at least by those criteria, but compared to using 
neither, there is no question that there is no benefit of 
vaping other than if it helps you get off of combustible 
tobacco.
    Mr. Burchett. Tobacco is the one product, if you use as 
directed, will kill you. So, I apologize, Mr. Chairman. I went 
way over. Mr. Raskin, I apologize to you, too, brother. Thank 
you, guys. Thank you, sir.
    Chairman Comer. The Chair now recognizes Mr. Garcia for 5 
minutes.
    Ms. Garcia. Thank you, Mr. Chairman. Well, thank you, Dr. 
Califf. I appreciate you being here and all your work and the 
work of the FDA. I was going to talk a little bit about a 
different topic, but I just want to clarify some of the truly 
insane attacks on vaccines and just what happened during the 
pandemic that we heard a little bit earlier today, which I 
found to be really wild. I just want to reiterate that during 
the pandemic, we lost 1.3 million American lives. In my city 
alone, we lost almost 1,300 lives back home in California in 
the city of Long Beach, and we know that many of the folks that 
we lost would have lived if they had had access to the vaccine 
or had been vaccinated. We know that for a fact. We know the 
success of vaccines, and certainly, today, with more data, we 
know how effective they have been.
    What is concerning now, as we know, is early childhood 
vaccinations are reaching new lows. We are having other 
diseases come forward, like measles and other diseases, that we 
are now not addressing because all of this vaccine denial that 
is happening, unfortunately, not just across this country, but 
also here in Congress and in this chamber. Vaccine hesitancy 
outside of what happened to COVID-19 is going to cause this 
country great harm. And instead of doing the responsible thing, 
earlier today, we had folks on the other side attack vaccines 
with, in my opinion, conspiracy theories and with treatments 
that we know are ineffective and have shown not to work.
    We also know this is not just a matter of personal choice. 
Across the country, there are millions of people who do not 
have the choice, who cannot get vaccinated because it might be 
too young, they might be immunocompromised or have other 
underlying health conditions. And so, America's high 
vaccination rates is something that has helped our country for 
so long that the FDA has been so involved with, and it is very 
concerning that our vaccination rates and our vaccine process 
is being attacked. I also want to note that there have been 
comments made over and over again about vaccines, about somehow 
vaccines causing turbo cancers or vaccines causing miscarriages 
or that the COVID vaccine somehow has no effect on healthy 
people, that are all false. And I know that you know this, your 
team knows this, and I just want to reiterate that for the 
public.
    What I did want to say, and I have less time to do so, but 
I want to just to transition and just thank you and your team 
for what you are doing as it relates to listening to the LGBTQ+ 
community, myself as an openly gay person. I really appreciate 
the FDA's move and decisions allowing particularly gay men to 
be a part of the solution. When it comes to health, when it 
comes to blood donations, when it comes to other forms of 
surrogacy, the FDA has really stepped forward and especially on 
the recent change in guidelines as it relates to the LGBTQ+ 
Americans and gay men being able to donate blood. I think that 
as a gay person, it is comforting to know that if there was an 
emergency where my blood or other blood was needed, that we 
would have that same right, and thanks to all of you.
    Dr. Califf, in the time I have remaining, could you 
describe the FDA's draft proposal and how this helps advance 
equality while also expanding the donor pool as relates to the 
recent changes you are all making?
    Dr. Califf. All right. Simply, first of all, let me just 
say I appreciate your comments. Just back on the vaccines, just 
one point I want to make, all medical interventions have risks 
as well as benefits. In the earlier discussion, if you want to 
be alive and not be in an intensive care unit, you are better 
off getting vaccinated. There are some people that have side 
effects, I just want to note that because it is important to 
take care of those people also, but the benefits far outweigh 
the risks.
    Simply put, the question that you asked, people had raised 
this issue about donation for many years, and we did a study 
which showed that a questionnaire about behavior can do much 
better than just the time-based thing related to the LGBTQ 
community. So, we are well along in that now, and it looks like 
it is really going to work, and we will be consistent with what 
other countries are doing. So, we are really glad we were able 
to come to this conclusion.
    Mr. Garcia. Great. Well, thank you very much for your work 
and for your team's work. I yield back.
    Chairman Comer. The Chair now recognizes Mr. Fry from South 
Carolina.
    Mr. Fry. Thank you, Mr. Chairman. Commissioner, thank you 
for being here. Congress enshrined harm reduction as a kind of 
a pillar in the 2009 Tobacco Control Act. The FDA's 2017 
strategic plan embraced that harm reduction with the former FDA 
commissioner, noting that successfully implementing harm 
reduction could dwarf the introduction of any new medical 
technology and its positive impact on our public health. 
Unfortunately, the Center for Tobacco Products' current 
leadership under the Biden administration seems to have 
abandoned harm reduction as a foundational principle of its 
tobacco policy by refusing to authorize other tobacco products 
that have been pending before your Agency for years. Your 
Agency is failing to acknowledge the need for real change to 
provide better options for 28 million American smokers.
    A recent study from Yale University found that for every 
0.7 milliliters of e-cigarette, e-liquid that goes unsold due 
to flavor restrictions, 15 additional cigarettes are sold. It 
was also found that e-cigarette flavor restrictions in place 
for at least a year yielded 20-percent increases in sales of 
cigarette brands disproportionately used by underage smokers. 
Can you explain why the FDA and the CTP have authorized 900 new 
cigarettes in the time that it has authorized only a handful of 
vapor products?
    Dr. Califf. First of all, we have not abandoned the 
principle that you described, but it is a little more 
complicated than that. It is the responsibility of the company 
to produce a data set that shows that the benefits of 
combustible tobacco reduction exceed the risks due to getting 
teenagers addicted. Vaping products get people addicted to 
nicotine if it is a new user, so we have always got to balance 
that risk of getting millions of teenagers addicted to the 
benefit to adults with combustible tobacco. So, there are 23 
products now in the market that have met that standard, and 
other companies are welcome to submit their data and produce 
the data showing that they meet that public health standard.
    Mr. Fry. Does CTP still believe in the continuum of risk of 
nicotine products, and does the FDA think it is helpful for 
adult smokers who would otherwise continue smoking cigarettes 
to switch from combustible cigarettes to smoke-free 
alternatives? Yes or no.
    Dr. Califf. There is not a ``yes'' or ``no'' answer to that 
because for adults, the best thing to do is to stop using 
tobacco products altogether. The second best would be to switch 
to a vape, but the very best would be, as we already discussed, 
if you look at the residue from vaping relative to no use of 
any tobacco product, it raises a number of issues over the long 
term.
    Mr. Fry. I think the concern that I have, sir, and I think 
the concern that many people share is that there seems to be an 
abandonment of a congressional, not only a directive, that we 
are going to pursue harm reduction as an actual strategy in the 
country. And if you have 900 cigarettes that have been approved 
and only a handful of vape or other products, that seems to be 
divergent to what Congress has outlined for your Agency. Would 
you not agree with that?
    Dr. Califf. I am not familiar with the 900 term, so I would 
have to go back and look at that, but we have not abandoned the 
idea that the company should show that it can successfully 
transition people from combustible tobacco to vaping in a way 
which does not increase the risk to teenagers of getting 
addicted to nicotine and, therefore, being susceptible to 
switching to tobacco.
    Mr. Fry. So, in addition to vaping, you have other products 
like Zyn or something similar to that. Would you consider that 
to be a harm reduction product?
    Dr. Califf. You know, we discussed this earlier. The term, 
``harm reduction,'' tends to be used by industry to cover a lot 
of different areas, but if there is a product that can cause 
someone to stop using combustible tobacco and not get teenagers 
addicted to nicotine, that is a benefit.
    Mr. Fry. Commissioner, you know, reading about the FDA, 
there seems to be some pretty heavy backlog within the Agency. 
How are you utilizing your workforce to innovate the FDA, and 
what type of metrics are you using to make sure that you are 
being productive not only for companies that have products that 
go before you, but for the American people?
    Dr. Califf. As we discussed earlier today, I think everyone 
was surprised by the over 26 million applications that came in, 
and there was a big backlog, and we have now cleared 99 percent 
of that backlog. But just like all other parts of FDA, when 
applications come in, we keep track of where we are, and as we 
are employing better technology and we are just going through 
some organizational changes, you are welcome to read the 
Reagan-Udall report that we commissioned to guide us there. So, 
we are hard at work. We want to meet the timelines like we do 
in all the other product areas, and we are going to do that as 
fast as we possibly can. You make a good point there.
    Mr. Fry. Thank you, Commissioner, and thank you, Mr. 
Chairman. I yield back.
    Chairman Comer. The Chair now recognizes Ms. Pressley from 
Massachusetts for 5 minutes.
    Ms. Pressley. Thank you, Commissioner, for joining us 
today. First, let me just also acknowledge and thank you for 
your responsiveness and your swift action on my outreach to you 
regarding formaldehyde in chemical hair relaxers, also the 
shortage of children's Tylenol and Motrin. Personally, as 
someone living with alopecia totalis, I also appreciate your 
efforts in that regard, and finally, for the purposes of my 
question line today, reproductive justice.
    Dr. Califf, last year the FDA took pivotal steps to protect 
medication abortion access, including by allowing abortion 
pills to be prescribed by telehealth and distributed by retail 
pharmacies. Medication abortions accounted for 63 percent of 
all abortions performed in the United States last year. If 
mifepristone is pulled from the market, access to routine 
medical care would be jeopardized for people across the 
country. As part of their draconian, unpopular goal for a 
national abortion ban--let us call it what that is--forced 
birth, which for many will result in forced death, Republicans 
continue to try to block access to medications, like 
mifepristone, by spreading baseless conspiracy theories. The 
fake news is rampant.
    I have a teenage daughter, and we like to play a game 
called ``Two Truths and a Lie''. So, if you will indulge me, we 
are going to do some variation of that right now. I want to use 
my platform to clarify some of this disinformation by playing a 
game called ``Fact or Fiction''. Dr. Califf, I will say a 
statement and you will reply with just one word stating if it 
is fact or fiction. Let us start with this. Fact or fiction: 
the FDA conducted a rigorous review of extensive research on 
mifepristone.
    Dr. Califf. Fact.
    Ms. Pressley. Correct. That is a fact. Mifepristone has 
been on the market for almost 24 years, and more than 100 
studies have affirmed its safety since. Fact or fiction: judges 
know better than public health experts if medication abortion 
is safe.
    Dr. Califf. I cannot comment directly on that because the 
Supreme Court is currently adjudicating a case that involves 
it. But I am on record, and so are all of us, that it would be 
bad for the entire system of drug development and availability 
of medications in the United States if judges begin overruling 
the FDA as a matter of routine.
    Ms. Pressley. Thank you. So that is fiction. The FDA, not 
the courts, determines the safety of drugs. Fact or fiction: 
mifepristone as a form of medication abortion is safe and 
effective.
    Dr. Califf. Fact.
    Ms. Pressley. Correct. That is fact . Research shows that 
less than 1 percent of patients experience serious side 
effects, posing fewer risks even than Advil or Tylenol. The 
facts are adding up. Mifepristone is a safe, effective, and 
routine form of healthcare that remains necessary and legal 
across the Nation. Now, this may be a game for today's hearing, 
but unlike Republicans, I have no interest in playing games 
with people's lives, and this is gravely serious. For many, 
especially black women, pregnancy and childbirth can be life 
threatening.
    Now, I know this is a shock to the far-right extremist old 
white men making these decisions, but there are hundreds of 
reasons why someone might want or need to terminate a pregnancy 
with medication abortion, and policymakers and judges should 
not be the ones making decisions for them. If Republicans and 
anti-abortion extremists have their way, access to mifepristone 
will be cut in every state, blue or red, even in my district, 
the Massachusetts 7th, where abortion care is legally 
protected. Since I have been elected to Congress, I have been 
proud to lead the Abortion Rights and Access Task Force under 
our Pro-Choice Caucus, fighting alongside my colleagues for 
mifepristone access. I will continue to fight to affirm 
abortion care as the fundamental human right that it is, and I 
urge my colleagues to do the same. Thank you, and I yield.
    Chairman Comer. The Chair now recognizes Mr. Burlison from 
Missouri for 5 minutes.
    Mr. Burlison. Dr. Califf, in May 2022, you made an 
appearance on CNN and claimed that the leading cause of death 
in the United States is ``misinformation.'' Do you recall being 
on that interview? Do you recall making that statement?
    Dr. Califf. Yes.
    Mr. Burlison. OK. You are right because the claim that you 
went on to say that in COVID, that you need to get vaccinated, 
saying, ``Somehow the reliable, truthful messages are not 
getting across, and it is being washed out by a lot of 
misinformation, which is leading people to make bad choices.'' 
Now I would like to draw your attention to a tweet that I know 
that you are familiar with. On the post forward, it says, ``You 
are not a horse. You are not a cow. Seriously, you all, stop 
it.'' Another sarcastic tweet from the FDA read, ``Hold your 
horses, you all. Ivermectin may be trending, but it is not 
authorized or approved to treat COVID-19.'' The FDA put out 
these messages in 2021 and made similar posts on the other 
platforms to discourage people from using ivermectin to prevent 
or treat COVID. In January 2022, the FDA was sued by a number 
of doctors who claimed that you are practicing medicine as an 
organization. As part of that settlement, you were forced to 
delete these. Is that correct?
    Dr. Califf. That is correct.
    Mr. Burlison. So, in fact, the U.S. Court of Appeals said 
the FDA is not a physician, and even tweet-sized doses of 
personalized medical advice are beyond your statutory 
authority. Is that correct?
    Dr. Califf. That is what the court said.
    Mr. Burlison. Pretending that ivermectin is dangerous or 
claiming that it is horse medicine, would you not agree that 
that is the exact definition of misinformation?
    Dr. Califf. I would not agree with that. There are very 
well-done randomized trials showing no benefit of ivermectin.
    Mr. Burlison. And you knew that in 2021?
    Dr. Califf. I was not at the FDA.
    Mr. Burlison. No, you did not know that in 2021.
    Dr. Califf. I mean, I was not at the FDA in 2021.
    Mr. Burlison. Dr. Califf, I will ask the questions. Even to 
this day, you have to correct misinformation about ivermectin. 
Let me ask this. Ivermectin won the Nobel Prize, did it not?
    Dr. Califf. It won the Nobel Prize for the treatment of 
worms.
    Mr. Burlison. In humans. In humans, right? And next to 
penicillin and aspirin, it is considered one of the wonder 
drugs for use and its effectiveness in humans, correct?
    Dr. Califf. For treating a variety of infections that would 
commonly be known as worms, not for COVID, and it is a medicine 
for animals also. Both are valid uses.
    Mr. Burlison. Yes. At the end of the day, you created, in 
my opinion, and I think that it is obvious because you are 
still to this day having to correct people who think that a 
form of treatment that has been used how many times would you 
say, historically, has ivermectin been successfully used in 
medical treatments?
    Dr. Califf. Successfully used for worms, but no effective 
treatment for ivermectin----
    Mr. Burlison. It has been administered in humans billions 
of times over the last, what, 30 years, correct?
    Dr. Califf. Again, for the treatment of worms.
    Mr. Burlison. Dr. Califf, let me ask this. Do you think 
that tweets like this garner credibility to an organization 
like the FDA? Do you think that snarky tweets that I would 
think that my teenage daughters might write, do you think that 
that garners credibility with the FDA and the American people?
    Dr. Califf. I cannot really comment on that, and, again, I 
wasn't at the FDA when that tweet was put out.
    Mr. Burlison. Well, I am glad that the courts told you to 
remove these tweets because it is snarky. I think it is 
demeaning to the American people and certainly demeaning to 
people, I believe, in my district. Thank you, Mr. Chairman. I 
yield the rest of my time.
    Chairman Comer. I am going to try to get a quick question 
in here, Commissioner. You had mentioned in a previous 
question, talking about hemp-derived CBD oil, that is non-THC 
or 0.3 or less. You mentioned that you didn't think the FDA 
could ever approve that as a nutraceutical. Is that the FDA's 
position or not because there are a lot of people in the 
industry, in the hemp-derived CBD industry, that believe that 
CBD should be treated as a nutraceutical just like supplements 
and vitamins at GNC and Vitamin World and places like that.
    Dr. Califf. You are correct, and we have had a number of 
citizens' petitions from people that have had that belief. But 
the research shows, for example, elevation of liver enzymes, 
which are very concerning, that if people take this over time, 
that there is going to be damage to the liver, which could lead 
to things like liver transplants.
    Chairman Comer. And I have to say this, and I have seen 
this in Kentucky with many different CBD manufacturers, there 
is a big difference. They are CBD entities. Because it is the 
wild west because the FDA will not regulate this product, there 
are companies with labs that would be as good as anything that 
Merck or Johnson & Johnson would have, and then there are 
people operating out of the garage of their house. So, the 
reputable CBD manufacturers in America, I believe, strongly 
hope that the FDA will come in and not just take samples 
because these companies are not all the same. You agree with 
that, right?
    Dr. Califf. I would say that is a characteristic of every 
industry that we regulate, and often the good players are 
penalized because of things that the bad players do. I come 
back to the referee analogy. That is where a good referee can 
be very helpful, but the referee needs a rule book that says 
here are the rules, and you guys write the rules, so we would 
really like it if we had a set of rules.
    Chairman Comer. I am trying to play a small role in that 
moving forward, but thank you. Now, the Chair recognizes Ms. 
Crockett from Texas for 5 minutes.
    Ms. Crockett. Thank you, Mr. Chair, and Dr. Califf, thank 
you so much for being here. You are a brave man. I do not know 
who would want to sign up for your job, especially in a time in 
which it seems like we do not believe in science or we do not 
know what data is or we are just going to ignore it. I am not 
really sure. I do not know how long you were asked about 
ivermectin. And let me tell you something. I do not know if you 
have ever testified in court, but you will be a great witness 
because you refused to answer the way that he wanted you to, 
which would have been, again, putting out misinformation 
because I do want to do a quick level set on something, and I 
do not know how we continue to come back to this, but let me 
just ask you a few questions. Was COVID-19 real?
    Dr. Califf. Yes. I had it myself twice. I think twice, once 
or twice.
    Ms. Crockett. Did people die?
    Dr. Califf. Just in the U.S. alone, over a million people. 
It was in the top three causes of death for many months. You 
know, I was an intensive care unit doctor. When I came to FDA, 
I stopped practicing, but my friends in ICUs were overwhelmed. 
Hospitals had to have trucks backing up to the hospital because 
there wasn't enough room for all the dead people.
    Ms. Crockett. And did vaccines save lives?
    Dr. Califf. Yes. Thank you for asking that again. People 
that are up to date on their vaccines have a significantly 
lower risk of being dead or admitted to an intensive care unit 
compared to those who are not up-to-date on the vaccine, and 
worst of all are people not vaccinated at all. That is true on 
the individual level. If you look at counties in the U.S., the 
counties with a higher vaccination rate have lower death rates 
from COVID. If you look at countries, you see the same general 
relationship. So, the vaccines have been highly effective.
    Ms. Crockett. Thank you so much.
    Dr. Califf. Not perfect, but highly effective.
    Ms. Crockett. I understand. I do not know that there is any 
perfection. I know that there is none in this chamber. 
Nevertheless, as a result of an administration that believes in 
science and data, we now have ARPA-H, which ARPA stands for 
Advanced Research Projects Agency for Health, and my district, 
luckily, was the recipient of an ARPA-H customer experience 
centers. And I am so excited because this means that as we are 
looking at trials, as we are looking at diversifying them, we 
will have a great opportunity right there in Texas 30. It is a 
huge investment in science to make sure that we can save lives 
and when the next pandemic arrives, we will actually be 
prepared and have science so that we can stay on top of this 
because the last time I checked, and, Doctor, correct me if I 
am wrong, having a leader suggest that we should inject bleach, 
are you aware of anyone being cured of COVID-19 because they 
injected bleach into their body?
    Dr. Califf. I am unaware of any such thing. If I might 
comment in general, and this relates back to the discussion 
about ivermectin, I came along when no one knew what caused a 
heart attack. That was what I focused on. We tried 100 
different things for the treatment of heart attack. Only a 
couple of them worked. The others did not. And the only reason 
we knew what worked is we went from the idea to doing a well-
conducted study, a randomized trial, and then if it worked, 
then all the practitioners began to adopt it and use it. So, we 
now treat heart attacks by going to the cath lab, opening the 
artery, and some medicines that work.
    Ivermectin has been studied multiple times in randomized 
trials. No benefit, but it is highly effective for the 
treatment. I use the word ``worms'' as a generic term for the 
kinds of infections that typically occur in places like Asia 
that can be devastating. It got a Nobel Prize because it is 
effective for those, and it has been a lifesaver, but it has 
been ineffective in COVID.
    Ms. Crockett. I completely understand. The last area that I 
am going to touch on in my last 45 seconds, because I am a 
woman out of the state of Texas, there is no way that I am 
going to have a conversation and not talk about reproductive 
access. So out of curiosity, would you consider the medical 
management of a miscarriage to be potentially a lifesaving 
usage. Yes or no.
    Dr. Califf. I have to decline to answer that because it is 
currently under adjudication by the Supreme Court.
    Ms. Crockett. That is perfectly fine. That is perfectly 
fine. I am going to tell you yes, but I am going to give you 
another question that you can answer. Would you consider 
erectile dysfunction as a lifesaving usage for Viagra?
    Dr. Califf. Not lifesaving.
    Ms. Crockett. Not lifesaving. OK. Well, I am going to tell 
you that based on my research, that mifepristone actually has 
lifesaving characteristics, yet Viagra does not, and for those 
that do not know, Viagra, from my understanding, is actually 
nearly 10 times greater as it relates to risk of death, yet for 
some reason, it is not sitting in the court right now. And I do 
appreciate the fact that you laid out that when it comes down 
to getting drugs approved, they actually go through trials. It 
is not just randomness.
    You take the randomness, you then say maybe there is some 
evidence here, and then you put it through the wringer. After 
putting it through the wringer for decades, women's lives have 
been saved, and as a representative from the area that Roe v. 
Wade actually initiated, I am appalled because for whatever 
reason, some people want us to go back to horse and buggy in 
this country. And I think, since now maybe we have the 
internet, maybe we should take advantage of it, and we should 
not say that we should remain in the times of horse and buggy.
    And so, with that, thank you for the work that the FDA 
does. I respect your research. I recognize that the courts do 
not do research. I also recognize that this chamber seemingly 
does not care about research, but because of the work that you 
do, there are lives that are being saved, and I need you to be 
funded to the fullest extent to make sure that we can continue 
to save American lives. Thank you.
    Chairman Comer. The Chair recognizes Mr. LaTurner from 
Kansas.
    Mr. LaTurner. Thank you, Mr. Chairman. Commissioner, thank 
you for being here today. FDA holds the responsibility of 
ensuring the safety and integrity of our Nation's food, drugs, 
and consumer products, a responsibility that not only impacts 
our economy, but also the health and well-being of every 
American citizen. However, this FDA has failed to meet its 
mission statement and is defined by crisis from persistent drug 
shortages to the most significant disruption to the infant 
formula market in history. We cannot afford to overlook these 
critical failures. The well-being of all Americans depends on 
it. Commissioner, I look forward to hearing from you today on 
how to address these pressing issues.
    Despite the backdrop of food and product safety issues 
plaguing your organization, FDA continues to chase nutrition-
related policies like front-of-pack labeling, which are 
arguably outside of FDA's purview. Can you explain to the 
Committee what authority you feel FDA has to pursue nutrition-
labeling policy while heavy metals exist on our food supply, 
illicit Chinese tobacco products remain accessible, and 263 
drugs remain in shortage?
    Dr. Califf. We actually have a law that instructs us about 
food labeling that we are adhering to in this case, and I would 
remind you, we have a shortened life expectancy in this 
country, particularly in rural areas that is largely driven by 
diet and poor nutrition. I am just from South Carolina. It 
seems to me that putting the information on the front of the 
package is probably more likely to get the useful information 
so people can make wise choices. That does not seem to me like 
something that should be that hard to get to. If you put it on 
the back, if you are like me, when you go to the store, you are 
unlikely to look at it. If it is on the front, you are going to 
see it.
    Mr. LaTurner. Can you tell me where you derive the 
authority to do it, though, specifically?
    Dr. Califf. Yes. We are glad to get with your staff and go 
through the details of that, but we believe we do have that 
authority.
    Mr. LaTurner. I look forward to seeing that.
    Mr. LaTurner. Do you feel it is a best use of taxpayer 
dollars to shape American eating patterns in lieu of addressing 
these other critical issues? I listed a few issues that seem 
like a pretty big deal.
    Dr. Califf. Certainly, tobacco is a huge one, but I would 
have to say if we look at the fact that we have the lowest life 
expectancy of any high-income country, it is being driven by 
chronic diseases, which are being driven by diet, and so to say 
that we should pay no attention to diet is a mistake. Now, 
shaping what we are doing is proposing to give people the 
information they need so that they can make healthy choices and 
reduce these alarming rates of obesity, diabetes. I am a 
cardiologist, vascular disease. I tell my cardiology colleagues 
we have got no problem with business in the future in 
cardiology.
    Mr. LaTurner. I would only have a limited amount of time. I 
pointed to front-of-pack labeling as an example, but it appears 
the Agency has a number of outstanding rulemakings and goals 
that are not related to food safety: the definition of 
``healthy,'' a symbol for healthy, the dietary guidelines for 
Americans, dietary guidance statements. The list goes on. Can 
you please tell the Committee and consumers how all of these 
pieces fit together? My concern is that not only are you 
pursuing actions that you do not have the authority for, but 
you are also painting a terribly confusing landscape of rules 
and advice about what to eat.
    Dr. Califf. Well, I would be happy to work with your staff 
on going through this in more detail. But in short, what we now 
know about diet, it is a pattern of eating over time that is 
important in how long people live and whether they are burdened 
by chronic diseases. It is not one specific thing. It is 
multiple constituents of the diet when eating regularly in a 
pattern create the kinds of health problems that are really 
ravaging our country right now. If you look at rural areas in 
particular, we are seeing alarming premature death rates that 
are going in the wrong direction, actually, for the first time 
in 50 years.
    Mr. LaTurner. You said that earlier. My question is 
specifically all of these different initiatives, how they work 
together, and I look forward to getting an answer on that to my 
actual question. It has been brought to my attention that 
illicit flavored disposable e-cigarettes now make up a majority 
of the entire e-cigarette market, which most of these products 
are coming from China. Can you speak to the factors that have 
allowed this issue to materialize and what your Agency plans to 
do to rectify the situation?
    Dr. Califf. Yes. Thanks. I mean, we have been over this 
several times already this afternoon, but in brief, no one 
anticipated 27 million applications for vaping products when 
the door was open for applications. It has been a problem that 
is quite large and that we are gradually making progress in.
    Mr. LaTurner. What are you doing about it?
    Dr. Califf. Warning letters, civil money penalties, 
injunctions, and seizures, all of the above, and I hope that we 
will continue to be able to increase our presence out there in 
the field. Right now, we get no user fees from the vaping 
industry, and that money would enable us to put a lot more 
people in the field to take down these operations that you are 
talking about.
    Mr. LaTurner. It sure feels like warning letters are not 
getting the job done. Can you walk us through whether and how 
you personally have communicated these concerns to DOJ and 
Customs?
    Dr. Califf. We have had direct meetings, and I have 
personally gone to several places of import to meet with the 
Border Patrol and Customs people who are there when the stuff 
comes in. By the way, if you want to get an education on this, 
go to the International Mail Facility.
    Mr. LaTurner. What about the DOJ?
    Dr. Califf. Direct person-to-person meetings with DOJ. I 
have the key person's cellphone number to call in off hours.
    Mr. LaTurner. I am over time. I yield back, Mr. Chairman. 
Thank you.
    Chairman Comer. The gentleman yields back. The Chair now 
recognizes Ms. Tlaib from Michigan.
    Ms. Tlaib. Thank you, Mr. Chair. Thank you, Commissioner. 
We are almost done. I am really pleased that you are here. I 
had, in the last 2 weeks, a handful of community events, and 
FDA issues did come up. I want to start with this. You know, 
how much of what FDA is doing covering specifically food 
safety? I mean, how much of your resources right now is 
dedicated to food safety?
    Dr. Califf. For detail, I would refer you to the Reagan-
Udall report that we commissioned last year that has the 
detailed information.
    Ms. Tlaib. Is it like 50 percent or?
    Dr. Califf. Nowhere near 50 percent.
    Ms. Tlaib. OK.
    Dr. Califf. Although the ``F'' in ``FDA'' stands for food.
    Ms. Tlaib. Yes.
    Dr. Califf. On the medical product side, we have had very 
good funding because of the user fees, but not on the food 
side.
    Ms. Tlaib. Mr. Chair, I do want to submit for the record an 
article, ``The FDA's Food Failure.''
    Chairman Comer. Without objection, so ordered.
    Ms. Tlaib. I need to talk about this because it comes up a 
lot. FDA right now has the authorization to regulate water to 
keep deadly toxin out of produce, right?
    Dr. Califf. The water is actually mixed. We regulate 
bottled water. The water supply itself is regulated by EPA, as 
just noted. Water on farms as it goes from where cattle may be, 
for example, the plants, that is an area----
    Ms. Tlaib. Yes, Commissioner. So, I am going to read from 
the article--I think this is important--just as background, and 
I know it was, like, a couple of months maybe after you got 
confirmed. ``By the time FDA officials figured out it was 
spinach that was making people sick in 10 states, sending three 
people into kidney failure, it was too late. It was mid-
November 2021, and the package salad's short shelf life had 
passed. There was no recall. By the time FDA officials got 
inspectors on the ground, spinach season was over, the fields 
in the production facilities were empty, which made it 
impossible to pinpoint the source of contamination. The cause 
of the outbreak was likely never fixed.'' Have we fixed this 
kind of issue, again, what was suspected because of previous 
kind of contamination, it could be the water that touches the 
food, used to clean the produce?
    Dr. Califf. You know, when you say is it fixed, you know, 
what I would say is the economist rated the U.S. Food Safety as 
tied for first in the world----
    Ms. Tlaib. I know, but, Commissioner----
    Dr. Califf [continuing]. But is it completely fixed? Of 
course not.
    Ms. Tlaib. Yes. Look, I work on Get the Lead Out Caucus, 
and my colleagues know I am a leader on this issue on quality 
of water. I want to help you. This is more me trying to show my 
colleagues that if we really cared about food safety, which 
every single one of our constituents does not use every single 
medication that everybody talked about, but they sure had 
gathered produce, touch the food industry in every way. And so, 
I just want to get to the bottom of what we can do together to 
ensure that you have authorization to oversee water quality 
that touches our food.
    Dr. Califf. All right. We are just finalizing now. You 
know, there are 10 rules of FSMA, Food Safety Modernization.
    Ms. Tlaib. Yes.
    Dr. Califf. The agricultural water rule is one that is very 
pertinent, and it has to do with what farms should do, for 
example, if there are cattle upstream from where the produce 
is. And so, you know, there is a list of things we need. We can 
be in touch with your staff.
    Ms. Tlaib. So, we do not really have anything right now 
that gives you any authority over the use of water on produce?
    Dr. Califf. Only in reaction to what happens, but not----
    Ms. Tlaib. So, after contamination?
    Dr. Califf. Yes, not preemptive.
    Ms. Tlaib. OK. Well, that is important for us to know, and 
I hope the Chair and I and others can work on this. The other 
question I have, and it is regarding food, too, and I am sorry, 
I know your medical background, but food is so incredibly 
important here. Does the FDA have authorization to oversee food 
packaging, right? How about PFAS, the use of PFAS? What are we 
doing about the use of packaging around PFAS, which is----
    Dr. Califf. As PFAS relates to the surfaces of food 
containers, and, like, I was surprised to hear that we even 
regulate dishwashers when I came in because of this, yes, and 
it is a big----
    Ms. Tlaib. So, how do we do it?
    Dr. Califf. We have studies that sample but at very low 
rates because the funding is quite low.
    Ms. Tlaib. We do not really enforce it?
    Dr. Califf. Not to the extent we could. Let me just say, 
you know we are going through, as we have discussed, the 
largest reorganization in the history of the FDA food is the 
entire focus of----
    Ms. Tlaib. Yes, Commissioner. I mean, I hear that we have 
some of the highest rates of cancer in the world. Is that 
correct?
    Dr. Califf. We do.
    Ms. Tlaib. Yes. I really think we should really prioritize. 
So, when we talk about reorganization FDA, I do hope we can 
work all together in a bipartisan way to make sure that food 
safety is at the center of making sure that we have resources. 
Again, this is just me highlighting to my colleagues and really 
educating the American public that we need to do more around 
food safety.
    Dr. Califf. I appreciate that. I do want to point out, our 
new head of the Human Foods Program is Jim Jones, who had a 
career at EPA. He is an expert on the kinds of things that you 
have raised, and our reorganization plan would call for really 
beefing up the chemical safety part of FDA because we have had 
a very small staff historically in that area.
    Ms. Tlaib. Yes, and I agree. I mean, I think the EPA is 
moving, you know, it is slow, but they are moving toward trying 
to, again, prevent exposure of PFAS through other rightways. 
But the fact that we are trying to stop it within water within, 
again, contamination on our environment, earth, and so forth, I 
think we have to really be as aggressive when it comes to our 
food quality. Last question, if I may, and I promise this last 
question you gave somebody else. Do you believe our country is 
experiencing a vaping epidemic?
    Dr. Califf. To the extent, ``epidemic'' is defined as 
millions of people. yes.
    Ms. Tlaib. OK. What do you think we need to do as a 
Congress to protect our residents, especially our children 
right now? And I know we got questions about it, But, like, 
what do you think we should do because vaping comes up so much 
for all of us, no matter for a Republican, Democrat?
    Dr. Califf. Well, I think it has to be prioritized. We need 
more resources.
    Ms. Tlaib. Is it the disposables? We are not authorizing--
--
    Chairman Comer. That will be the last question. Feel free 
to answer that.
    Ms. Tlaib. Thank you, Mr. Chair.
    Dr. Califf. The vaping industry does not pay user fees, and 
so we have a limited staff dedicated to this. We really need to 
ramp up our staff. That would be the most important thing you 
could do, and you are doing a good job of staying on our case. 
I will say that, so that needs to continue. It is part of the 
process.
    Chairman Comer. The Chair now recognizes Mr. Cloud from 
Texas for 5 minutes.
    Mr. Cloud. Thank you, Chairman, and thank you, 
Commissioner, for sticking with us through the day. I 
appreciate you being here. Your Agency, of course, is 
responsible for the evaluating the safety and effectiveness of 
medications that millions of Americans rely on, and I am sure 
that your scientists and those working there view themselves as 
committed public servants. I wanted to talk to you though, 
about something that is concerning, I think, to a lot of 
Americans, and that is potential conflicts of interest.
    In 2018, the Journal of Science found that 11 out of 16 
medical examiners who left the FDA ended up working for 
companies they were previously responsible for regulating. That 
is roughly two-thirds or more than two-thirds. These wealthy 
and powerful pharmaceutical companies recruit former FDA 
employees with lucrative job offers in order to leverage their 
connections. Existing law imposes only a very limited 
restrictions on this revolving door. Former employees are only 
prohibited from lobbying the FDA for very few specific matters, 
and they are only subject to a 2-year cooling off period. 
Meanwhile, you know, former FDA employees can go and collect, 
you know, pretty substantial paychecks from companies once 
regulated.
    Just 2 months after leaving the government service, the 
lead medical officer for the FDA's Office of Vaccine Research 
and Review took a high-level job at Moderna. There is another 
one. Recently, the medical officer who decided on behalf of the 
FDA whether the clinical data from Moderna vaccine medicine 
approval standards also took a job shortly after that with the 
company just months after the vaccine received license. And so, 
I think you can see why many of Americans can look at history 
of this and be very, very concerned about what is going on. 
Especially, you know, coming out of COVID FDA, along with a 
number of agencies, I think we can all look back and see there 
were a lot of lessons learned and was not handled really in the 
best. And so, right now, we are trying to restore the American 
populace's faith in a lot of these institutions that you are 
now leading and have just taken up the mantle on recently with 
again.
    Can you speak to that issue? You know, with regard to these 
two FDA officials specifically, did either of these recuse 
themselves from any matter at the FDA while seeking these jobs 
that you are aware of?
    Dr. Califf. Well, I mean, this last point you made is a 
very important part of the system regardless of how you feel 
about the other parts of people moving from FDA to industry or 
industry into FDA. You are prohibited from seeking a job in the 
area that you are regulating unless you recuse yourself. So 
that is something that----
    Mr. Cloud. The FDA has refused to acknowledge on these two 
individuals, Dr. Doran Fink and Dr. Jaya Goswami, I believe is 
the pronunciation, whether or not these two recused themselves 
of their involvement in these areas that they were leading 
before going to Moderna. So, why has the FDA refused to provide 
the information?
    Dr. Califf. I am unaware of what you are describing. I will 
certainly go back and look into that. Again, if they were not 
seeking employment while they were regulating, then they did 
not violate anything.
    Mr. Cloud. Do you know that they sought guidance on 
approval with the FDA--I am sorry--the FDA's Ethics Office 
before taking those jobs?
    Dr. Califf. I would expect that they would have, but I do 
not know that. You know, we will have to go back.
    Mr. Cloud. Can you understand the concern, and what 
recommendations would you provide? I think it was 1981 to 2019, 
9 of the 10 commissioners went into work for pharmaceutical 
companies from leaving their office. You were one of those as 
well. I am not suggesting any impropriety at this point, but 
you can certainly see, I think, how this would create a huge 
concern, a conflict of interest, when the American people are 
looking at this. What recommendations would you suggest that we 
bring up to make sure that the American people can know that 
the decisions being made because here is the thing. You are 
supposed to give oversight to these companies, whether you are 
in food or drug industry, and you know that you are not going 
to get a job. Not you specific. I am speaking, you know, 
someone who wants one of these high-paying jobs, after leaving 
the Department knows that, you know, they are not going to be 
hired by someone who was very strict on them, and so there is a 
built-in incentive, of course, to be lax in these things. And 
so, what can we do in Congress to provide a level playing field 
that will help restore the public's trust in this area?
    Dr. Califf. Glad to engage in a discussion with you on 
that, but I do want to point out something about this. Inside 
the FDA, we are dealing with highly technical issues that 
require a lot of expertise. There are many people who work in 
industry and then volunteer to come to FDA for a much lower 
salary because they are attracted to the issue of understanding 
the science and making good decisions based on it. By the same 
token, there are people who work within the FDA for a period of 
time. They have skills and knowledge about an area. And, you 
know, it is an issue to say, well, they could never work in an 
industry where they might develop a cure for cancer or whatever 
the thing may be. So, this is a delicate area and needs to be 
looked at. You are perfectly right to raise----
    Mr. Cloud. I am not saying that there is no legitimate 
reason. This is why I am asking what are your recommendations 
as someone who is actually running, you know, the Agency right 
now. What recommendations would you provide that would not be 
onerous? But you know, 9 out of 10 going straight to the 
pharmaceutical companies straight out of office is, you know, 
pretty circumspect when the American people are looking at 
that. So, what would you recommend for us as Congress that 
would be reasonable provisions that would allow us to bring the 
full faith of these agencies back to the United States?
    Chairman Comer. His time has expired, but please answer the 
question.
    Dr. Califf. Yes. I mean, it is a complicated area. I would 
say, No. 1 is just making sure we adhere to what we already 
said. You have raised some questions about this.
    Mr. Cloud. Exceptions are given all the time to these is my 
understanding, you know. So, there are rules, but hey, we waive 
them all the time because it is a self-check kind of thing.
    Dr. Califf. I do not think that is true at all. I would 
speak very highly of our Ethics Office. Two-thousand-sixteen, 
the first time around, I spent a lot of time bringing in new 
people, and I do not think exceptions are given all the time to 
these, but we can always do better and happy to engage on it.
    Mr. Cloud. So, no recommendations so far?
    Dr. Califf. Well, it is a very broad area, so I am 
reluctant to just off the cuff make a specific recommendation.
    Mr. Cloud. OK. Well, I look forward to working with you.
    Chairman Comer. They have called votes, but we are going to 
try to get go to Mr. Connolly and then Mr. Donalds, and then 
just two votes will not take long. We will be right back. We 
will recess.
    Mr. Connolly. Chairman, I think Mr. Moskowitz is ahead of 
me.
    Chairman Comer. We will go to Moskowitz then.
    Mr. Moskowitz. Do not worry, Mr. Chairman. It will not be 
the usual, and I will try to use some time back, but first of 
all, thank you for coming today, Commissioner. I think you have 
established that if any of my colleagues get worms, you will 
make sure that they get ivermectin, so we do not have to, like, 
rehash all of that nonsense.
    I want to turn your attention, though, to a little bit of 
the aftermath of COVID in the pharmaceutical space. I mean, do 
you think it is appropriate that with all the supply chain 
issues that America had during COVID, that we have not really 
fixed in a broader sense, but in the medical sense, in the 
pharmaceutical space, I mean, should we still be getting a 
majority of our own or counter drugs from Wuhan? Should they 
still be produced there? Should we still be depending upon 
Wuhan, China, to be making drugs that we sell in a significant 
basis on shelves in this country?
    Dr. Califf. Well, I mean, I would say I am not sure it is 
specifically Wuhan, but the key starting materials for drugs 
are mostly coming from China, and I do not think that is good 
for us. We do not need to have no drugs from China, but we need 
to have a firm manufacturing base that we can be confident 
about in these times of stress.
    Mr. Moskowitz. I know you were not necessarily there, but 
during the two bills, one in the Trump administration, one in 
the Biden administration, where we spent $7 trillion or $8 
trillion combined after COVID, how come the FDA was not 
advocating, or if they were--I would love to hear it
    --with all that government money was spent, why were we not 
establishing that we should start manufacturing those products 
here?
    Dr. Califf. I was not there at the time. I would just say, 
you know, pretty much the time I came in February 2022, we 
really saw how stark the problem was, and we started advocating 
then, but, you know, we live in a country where the 
pharmaceutical industry is for profit. If people are not 
getting the prices they want or the purchaser is getting a 
lower price overseas, that is where they go. So, to fix this, 
it is going to take some kind of intervention, which is well 
beyond the FDA. We are certainly advocating that intervention 
is needed.
    Mr. Moskowitz. All right. Let me turn your attention. I 
know you got a bunch of questions on cancer drugs. My dad was 
diagnosed with pancreatic cancer. He lived 18 months, and he 
passed away about a month before I ran for office. He was on 
cisplatin. At that time, there were no issues. Do you think it 
is acceptable in America that families would get told by their 
doctors that we are going to have to push off a treatment 
because there is a shortage of a chemotherapy that is helping, 
extending the lives, keeping people alive? Do you think that is 
acceptable in this country, and why is it that we are not 
better prepared to handle when there are these manufacturing 
issues, whether it is in India or China? Why are we not better 
prepared to handle these things?
    Dr. Califf. Here is what I would say. First of all, it is 
unacceptable. I mean, I have a close relative with pancreatic 
cancer right now. I know how frightening it is. I would just 
say, you know, what has happened is we have health systems, 
hospitals, pharmacies, and we have manufacturers who are mostly 
overseas now. If we take cisplatin as an example, 5 years ago, 
it was $400 a dose. It is a generic drug. I gave it as an 
intern in 1978. Now, it was $13 a dose. You cannot make 
cisplatin for $13 a dose and maintain quality. So, people 
running the company say, why should I make it? And we do not 
have a system in place that says this is an essential drug. We 
are going to put something into effect which causes the market 
to behave.
    Mr. Moskowitz. Well, I do not want to interrupt. I mean, 
you are the FDA, you know, perhaps, you know, that is something 
you guys should be looking at. I mean, there are all sorts of 
ways to be working with manufacturers all day long on trying to 
incentivize them to make lifesaving drugs that may not be----
    Dr. Califf. Well, I mean, if I may, we have no authority to 
give incentives. We are prohibited by law from dealing with 
pricing. But I would refer you to the HHS report that came out 
last week with our heavy input that goes through all the 
details here. So, I am completely in tune with your concern, 
and I think people around the Administration know every time I 
am on a call I bring it up.
    Mr. Moskowitz. There has been reports in some of the vaping 
products in Florida seeing fentanyl in them, you know. What are 
we doing about some of these things coming in from China, some 
of the illegal vaping products?
    Dr. Califf. I am very concerned about what you raised. We 
just had an annual meeting in Atlanta, mostly parents of 
children who have died from overdose. Anne Milgram, the DEA 
administrator, was there and gave the details about how these 
products are getting into the mainstream of America through 
cartels predominantly. This is really a combined effort. FDA 
has a role that has now become mostly a law enforcement issue 
with DEA and we are working together as closely as we can, but 
I am not pretending that we have this problem solved at this 
point. It is a big deal.
    Mr. Moskowitz. Thanks, Mr. Chair.
    Chairman Comer. The Chair now recognizes Mr. Donalds from 
Florida.
    Mr. Donalds. Thank you, Chairman. Commissioner, thanks for 
being here. Listen, I support the FDA's efforts to reduce youth 
smoking rates under their current authority granted by 
Congress. However, I do not support the unnecessary and 
unfounded regulations, like the FDA's proposed tobacco product 
standard for characterizing flavors in cigars rule, which is 
purely based on, frankly in my view, far more politics than 
science. What are some of the examples of the unintended 
consequences that might arise out of this rule?
    Dr. Califf. Well, first, the intended consequences will be 
reduction in death rates, which is a pretty important one, in 
my view. In terms of unintended consequences there is always 
going to be some illicit market when rules like this are put 
into effect.
    Mr. Donalds. So, then do you think it is wise for the FDA 
to proceed?
    Dr. Califf. I think it is very wise to reduce the death 
rates and population----
    Mr. Donalds. But, Commissioner, you did also acknowledge, 
and we are seeing it, frankly, in a lot of markets associated 
with smoking, but right now we are focused on flavored cigars. 
So, your contention is that it is OK to put in this rule around 
flavors in premium cigars because you have adults who are 
choosing to smoke flavored premium cigars.
    Dr. Califf. Now, if you want to talk about flavored cigars, 
I would just say youth right now are smoking cigars more than 
they are smoking cigarettes. Flavored cigars are highly 
attractive to youth, and so it is a major concern that we have. 
Premium cigars is a different issue that is in the courts right 
now, so I cannot comment on it.
    Mr. Donalds. All right. So secondarily, California enacted 
a flavor ban on all tobacco products at the end of 2022. 
California already suffers from the second highest rate of 
cigarette smuggling where nearly 50 percent of all cigarettes 
used by consumers are purchased out of state. Further, in 2020, 
1 in 6 cigarette packs in California were smuggled into the 
state from international markets. In which ways does an illicit 
tobacco market impact the United States of America?
    Dr. Califf. You know, I just was out in California about 4 
months ago, and I met with the Public Health Department there. 
Their longevity is so much higher than the average of the 
United States. Largely, due to the reduction in things like the 
use of tobacco, they have very low rates of use of tobacco 
compared to the rest of the U.S. So overall, it is a net 
positive.
    Mr. Donalds. But, Commissioner, we are going to acknowledge 
the fact that, yes, there are black markets propping up, 
whether it is illicit cigarettes or, if we want to go back to 
the previous topic of premium cigars, in part because of the 
policies of the United States. Do we acknowledge that?
    Dr. Califf. You know, as I have already discussed, I am a 
cardiologist. I am used to life and death. Almost everyone 
prefers to be alive. I would rather reduce total mortality and 
deal with the illicit market than to tolerate 460,000 Americans 
dying of tobacco-related illness per year, which is what our 
current rate is, and that is at lower from what it used to be. 
I am taking care of these people. We also have people dying. It 
is not good.
    Mr. Donalds. Commissioner, we also have to acknowledge the 
fact that you are not omnipotent. You cannot control the 
actions of people. Do you truly believe that you have the 
ability to control the actions of Americans, if they choose? 
Adults, now, move away from children for a moment. Adults, if 
they choose to smoke a cigar or if they choose to smoke a 
cigarette. And by the way, I do not agree with smoking 
cigarettes. I am not a cigarette smoker, but at the same time, 
do we acknowledge the reality that when you put up these 
barriers, what you also do is create an illicit market for 
these products, which could be more harmful to the users that 
use them?
    Dr. Califf. I would never pretend to be able to control the 
behavior of people but imagine if we had taken that attitude. 
When I started out as a cardiologist, the average patient I 
took care of was 50 years old, typically a man smoking 
cigarettes, dying at a rate of 30 out of every 100 people with 
a heart attack in the first 30 days. Now the typical patient 
with heart disease is in the 70's because the rates of use of 
tobacco dropped so much, not because someone----
    Mr. Donalds. Commissioner, do you think it is because of 
informing the public, or do you think that is because of 
government regulation?
    Dr. Califf. I think it is a combination of both of those.
    Mr. Donalds. Commissioner, I would argue it is far better 
to get people to change behavior by informing them of the 
consequences of said behavior as opposed to putting up 
arbitrary rules from the FDA or anywhere else.
    Dr. Califf. I like that in general, but this is a highly--
--
    Mr. Donalds. It is not in general, Commissioner. That is a 
reality of the human condition.
    Dr. Califf. When you are dealing with people suffering from 
addiction, nicotine is a terrible addiction, very difficult to 
beat. This is an entirely different issue.
    Mr. Donalds. Commissioner, we have not got to a 
conversation about addiction. We are just talking about FDA 
rules around, frankly, flavored cigars and also some of the 
California, which are on cigarette bans.
    Dr. Califf. Nicotine is a highly addictive substance that 
we are talking----
    Mr. Donalds. I am well aware that it is, Commissioner, but, 
again, I would argue that information and education is far 
better than regulation and elimination. I yield.
    Chairman Comer. The gentleman's time has expired. Pursuant 
to the previous order, the Committee stands in recess, subject 
to the call of the Chair. The Committee will reconvene 10 
minutes after the floor vote. The Committee stands in recess.
    [Recess.]
    Chairman Comer. The Committee will come back to order.
    The Chair now recognizes Mr. Waltz from Florida for 5 
minutes.
    Mr. Waltz. Thank you, Mr. Chair, and thank you for your 
patience, Commissioner Califf. I want to talk about kind of 
your current policies in terms of hybrid telework. We have 
here, just for American people watching from your website, that 
says the White Oak Campus, your main campus, is open but yet is 
open with maximum telework flexibilities. And Mr. Commissioner, 
I sent you a letter back in January. I haven't received a 
response yet, so I will just ask you these questions today. And 
it is essentially, can you just talk about your telework policy 
and why we are still teleworking, and when you plan to bring 
everybody back in in-person?
    Dr. Califf. Well, thanks for the question, and I think to 
answer this question, it is useful to start from before the 
pandemic because when I was Commissioner in 2016, we had a 4 
out of 5 days on-campus policy because we did not have enough 
offices for the number of people that we had. So, it is 
actually a requirement, and we had our Zoom capabilities and 
all that built up well before the pandemic.
    But, you know, when I arrived in 2022, the pandemic was 
well underway, and we had instituted a policy of measurement. 
Now the primary accountability of the American public is 
getting the work done. We are meeting all of our metrics and 
our user fees quite well. That is a matter of public record. 
And when you look at the output of the employees, it is quite 
high. Now, within that, we have a number of people who work in 
laboratories. They have always gone to the facility to work 
because that is where the laboratory is. We actually have 270 
facilities all around the U.S. because we have a large 
inspectorate and other activities and labs that are located all 
around the U.S., those people are obviously going to work every 
day in-person.
    Mr. Waltz. Just in the interest of time, Mr. Califf, my 
understanding, and I am hearing consistently from industry, No. 
1, that the FDA granted in-person meetings without a hybrid 
component prior to COVID. So, have we gone to more hybrid 
because of COVID? And are you back to pre-pandemic levels in-
person, because the concern is and the concern in my letter, 
and I would appreciate an answer to some of the questions in 
it, is that lifesaving drugs--I am getting this from chief 
medical officers, I am getting this from providers and others--
cannot get the same type of due diligence. You cannot have the 
same type of meeting. And in fact, I have talked to a number of 
companies that said their meetings have been delayed because 
they did not have the right type of Zoom capabilities when you 
could just come in and have the meetings. So, it is actually 
delaying the approval process.
    Dr. Califf. Well, first of all, I know that----
    Mr. Waltz. These are, like, people are dying, and the 
pandemic is over. The Administration declared it over last 
year.
    Dr. Califf. The approval process is definitely not being 
delayed because those metrics are kept, and we have got a 
record number of approvals and our timelines have been met. We 
offer the option of in-person or hybrid meetings now. Many 
times, the industry chooses hybrid because to have an in-person 
meeting, they got to fly everybody to White Oak to be there, 
and it is more convenient and they get a better attendance 
themselves from hybrid.
    Mr. Waltz. I am hearing from industry that they would 
prefer in-person, and then those are delayed because of 
investments. We need more investments in Zoom, more investments 
in those kinds of meetings, more investments in your 
infrastructure.
    Dr. Califf. That may be true of some of the industry, but 
it is definitely not true of all of the industry. And I would 
expect that in the future there will be much more in-person 
from both sides wanting it, FDA and the industry. But I would 
be shocked if we did totally away with hybrid because often 
that is what the industry----
    Mr. Waltz. Why in the future would there be more in-person?
    Dr. Califf. Because people like to be in-person when they 
can.
    Mr. Waltz. So why are we not there now?
    Dr. Califf. Because often, people really find it more 
convenient to not have to fly everybody to White Oak, so there 
is a transition, you know, period going on.
    Mr. Waltz. And can you describe what is the transition 
issue?
    Dr. Califf. Well, you know, there are a limited number of 
meeting rooms that are completely up to speed, that is, you 
know, coming in the place for----
    Mr. Waltz. Up to speed for?
    Dr. Califf. For the hybrid meetings that we often have to 
have because, often, industry people on both sides of that 
equation, people who want to be there in-person and others who 
want to participate.
    Mr. Waltz. So, you are saying it is industry really driving 
the demand for hybrid that you are making the investments?
    Dr. Califf. I would not want to say that. I would say often 
it is both sides. The industry, you know, would like to have 
either option is what I would say.
    Mr. Waltz. I think that from what I am hearing 
consistently, and I would implore you to take a deeper look 
into this, the industry just wants to have meetings, however 
they have to happen. They certainly do not want them delayed 
because of a lack of rooms that have been upgraded for hybrid, 
especially for things like ALS where people are literally dying 
month to month with these delays.
    Dr. Califf. I am not arguing with your basic points other 
than to say was from everything I can see, we are meeting our 
timelines, and we have got a record number of approvals that 
have occurred. So, by any metric you would use, the place is 
pretty darn efficient right now.
    Mr. Waltz. Just on the time I have remaining, I think maybe 
we need to relook at the metrics. I do not know. But I am just 
telling you what we are consistently hearing, and if they were 
being improved and you were having in-person meetings, and they 
were not being delayed----
    Dr. Califf. You can evaluate it, so let us be clear about 
that. Our job is to evaluate, not just to approve. I mean, we 
approve it when the data supports approval.
    Mr. Waltz. But you cannot get to really have those 
conversations about the data if you are delaying because of 
meeting rooms.
    Dr. Califf. Again, I would be surprised if there are delays 
occurring because of meeting rooms.
    Mr. Waltz. OK. Thank you, Mr. Chairman. If you could please 
ask your team to look at the letter. I am on four committees 
and I have never had to wait 4 months for a response just to 
some basic questions.
    Dr. Califf. All right.
    Mr. Waltz. Thank you.
    Dr. Califf. I appreciate that.
    Mr. Waltz. Thank you, Mr. Chairman.
    Chairman Comer. The Chair now recognizes Mr. Langworthy 
from New York.
    Mr. Langworthy. Thank you, Mr. Chairman. Commissioner 
Califf, my constituents, many of whom do not have the same 
access to a doctor's office as my colleagues in urban or 
sprawling suburban areas, often they are the ones most impacted 
by the FDA's inaction and lack of clarity on prescription to 
over-the-counter, or in other words, Rx-to-OTC switch. What 
this can often result in is a lack of expanded over-the-counter 
access for medicines that have already gone through an approval 
process at the FDA and deserve serious and timely consideration 
so that constituents, our taxpayers can have more easy access 
to the care into the help that they need. Commissioner Califf, 
can you explain why we only see a small percentage of the 
prescription to over-the-counter switch annually, and what can 
we do to increase that number?
    Dr. Califf. Sure, appreciate that, and I also appreciate 
the importance of rural people, especially, of having access to 
medications. I mean, what the regulations require is that the 
company that wants to make that switch has to produce the 
evidence that if they go to over-the-counter, that the person 
purchasing the product can understand the instructions and use 
it appropriately, and therefore, does not need an intermediary 
to do the prescribing and the interaction with a person as a 
patient. So, I would say whenever a manufacturer produces that 
evidence, you know, we are anxious to get it and to take 
action, if they have got the data to support what they want to 
do. So, it is really a matter they actually cannot just make 
the switch because they have to show that a consumer can 
actually understand the instructions and apply the medication 
appropriately.
    Mr. Langworthy. No. Unfortunately, what we are hearing, Dr. 
Califf, is that for too long the switch process has been 
muddled by, you know, moving goalposts, challenges, engaging in 
a dialog with the FDA, and a culture at the FDA that seems to 
reward denying reviews and approvals rather than trying to get 
things done. But I have limited time, so I would like to move 
on.
    Essentially, pharmaceutical companies are disclosing their 
inventions to the FDA years before disclosing them to the 
Patent Office, which can elongate commercial monopolies 
inappropriately by 10 years. Due to inconsistent filing with 
both the FDA and the Patent and Trademark Office by branded 
companies, many of the most expensive drugs on the market are 
artificially blocked from generic competition. Now this leads 
to billions of dollars in lost savings to patients and to 
taxpayers.
    President Biden released the pharmaceutical competition 
executive order that encouraged the FDA and the patent 
tradeoffice to collaborate on this issue, and FDA has also 
conducted listening sessions where the issue was apparently 
discussed extensively. However, there seems to be no recent 
progress on this front. So, what real solutions is FDA in fact 
considering to address this problem, and when can we expect to 
receive an update?
    Dr. Califf. We would be happy to give your staff an update 
any day. I disagree with the view that there is no progress 
being made. There is a very active collaboration with the 
Patent Office in an effort to reduce the number of 
inappropriate patents that get in there and block the generic 
competition. So, we will give you an update on what has 
happened with that. We had a long discussion about this earlier 
this afternoon but let me just say that the Patent Office as a 
primary responsibility for determining if there is something 
unique that merits a patent. That is not an FDA call.
    You are correct that we see the pipeline of what is coming 
from Pharma. That is commercial confidential information that, 
by law, we cannot release to anyone else. But what we want to 
do is make sure that there is good communication so the Patent 
Office understands when it is actually a valid new patent that 
would extend that protection from competition.
    Mr. Langworthy. OK. Thanks. In my remaining time, I really 
want to switch gears here. According to the American Academy of 
Pediatrics, numerous studies have linked the range of health 
issues with the consumption of plant-based beverages by 
children. Furthermore, there is considerable confusion and 
misinformation about the substitution of non-dairy products for 
cow's milk. The FDA itself determined that based on 13,000 
public comments, ``Consumers do not understand the nutritional 
differences between milk and plant-based milk alternatives.'' 
So, Commissioner, can you comment on the FDA's efforts to 
enforce dairy product standards of identity, particularly the 
use of the term ``milk'' and the actions your Agency is taking 
to mitigate the risks posed by the chronic mislabeling of non-
dairy products using established dairy terms?
    Dr. Califf. Well, I am glad you referred to the nutritional 
content because that is a primary deficit here, and we are 
requiring that that nutritional information be prominently 
displayed as part of the effort. What we are not doing is 
specifying exactly what can be called milk because--how do I 
say--the cow is out of the barn already. It has been decades 
that terminology has been used, and whenever those kinds of 
issues, when we make a rule to require it, we call it something 
when it has been different, we have lost such cases in core. 
But what I think is really important is when people purchase 
something, they actually understand the nutritional content, 
and that is heavily emphasized in what we are currently putting 
forth.
    Mr. Langworthy. Thank you very much. I appreciate you 
answering my questions, and, Mr. Chairman, I yield back.
    Chairman Comer. The gentleman yields back. Now I recognize 
myself for 5 minutes. I have had a lot of members yield me 
time, but now I will ask my questions.
    Commissioner, in this hearing, you have said that the term, 
``harm reduction,'' is an industry term or a term that industry 
uses, but to be clear, the Institute of Medicine used this term 
in the title of its report titled, ``Clearing the Smoke: 
Assessing the Science Base for Tobacco Harm Reduction.'' So, it 
is not just the industry that uses this term. The Institute of 
Medicine uses it, and the concept of harm reduction has been 
embraced in other countries. That is, they accept and 
communicate that there are options that are less risky than a 
traditional cigarette. Are we ever going to get to that point 
in this country? Do you accept this idea?
    Dr. Califf. I definitely accept the idea. Your point is 
well taken, and industry is not the only entity to use it. But 
what I want to avoid in speaking of harm reduction, we have 
talked about combustible tobacco kills people. Neither using 
vaping or combustible tobacco is the healthiest thing you can 
do. Vaping compared to none of the above has residues that are 
quite concerning for long-term use. So, if you are a 
combustible tobacco user, if you switch to vaping, that is less 
harm. That is good as long as the product is not packaged in a 
way that is encouraging you to get addicted to nicotine. One of 
the main harms I want to get away from is millions of youth 
being addicted to nicotine by vaping products. So, we got to 
find that middle ground, and I accept there is a point here. I 
am just worried that when we use the term, ``harm reduction'' 
now, it is often part of a vast advertising campaign. That is 
not taking account of the addiction side in youth.
    Chairman Comer. But you admit that vaping is less harmful 
than cigarettes. I mean, we all----
    Dr. Califf. ``Admitting.'' It sounds like I am confessing 
of something. No, I agree. I agree.
    Chairman Comer. So, let us talk about all the applications 
that have been submitted, millions of applications. I think you 
have approved 25 or something?
    Dr. Califf. Almost 27 million.
    Chairman Comer. Have been applied?
    Dr. Califf. Right.
    Chairman Comer. Have requested application, but you have 
not approved but just a handful. The reason for the backlogs, 
are you working on it? Are you trying to approve more, or you 
just throw in the towel in and say we are just not going to 
have anything or?
    Dr. Califf. No, no. We are working every day and----
    Chairman Comer. So, you think there will be more approvals?
    Dr. Califf. As a Commissioner, I meet with the Center for 
Tobacco Products leadership every week and we go over this, but 
again, we can only approve a product by law. If the company 
produces the data that demonstrates that they meet the public 
health standard, that is the reduction in risks that we just 
talked about, to adults who use combustible tobacco offsets the 
addiction risk.
    Chairman Comer. Right. And you have heard a lot of people 
ask this question. On both sides of the aisle, we do not agree 
on a whole lot in this Committee in a bipartisan manner, but 
the FDA's refusal to approve these new tobacco products has 
created a thriving market for illegal and unsafe products, 
primarily from China. These products received warning letters 
from FDA, but I do not think China loses a whole lot of sleep 
over a warning letter from a U.S. Governmental Agency, 
especially in the Biden Administration. So, a lot of people 
have questions as to why there are so many of these Chinese 
products, counterfeit products on the market, they ask us. That 
is why so many different members have asked you about it. What 
is the reason? What are we supposed to say? We say it is FDA's 
responsibility, so why is the FDA enabling these Chinese 
products? I believe there is a solution here.
    Dr. Califf. I would not use the term, ``enabling,'' but I 
would say that this is a huge production issue coming out of 
China into our ports. We need to stop the use of illegal 
products.
    Chairman Comer. But this Administration has proven it is 
unable to do anything at the border with respect to security, 
but would a foreign manufacturer rule not address this problem, 
a rule that pertains to foreign manufacturers from the FDA for 
this?
    Dr. Califf. I mean, as we have said many times today, you 
are the referees, you make the rules, so if you choose to do 
that, you may. I would also say a lot of profit is being made 
in the vaping industry. If they had user fees, we would put a 
lot more----
    Chairman Comer. Are these Chinese companies paying the user 
fees?
    Dr. Califf. Whoever sold the product would have to pay the 
user fee.
    Chairman Comer. Last question with respect to CBD. What do 
you foresee over the next 12 months from FDA with respect to 
CBD? Do you see any action? You know, you mentioned you are 
close, you are communicating on the Center for Tobacco, but 
what about the shifting gears here with CBD oil, industrial 
hemp and things like that? Is FDA close to making any decision 
on anything?
    Dr. Califf. I think it is Congress' decision to make. So, 
we would really look forward to working with you all as quickly 
as possible to come up with a regulatory pathway that you think 
is reasonable and enables us to take action.
    Chairman Comer. Well, my time has expired, and I am going 
to yield to the Ranking Member. This concludes the questioning 
phase, unless Mr. Connolly is on his way back or anything. OK. 
Well, we appreciate you being here, and I am going to let yield 
to Ranking Member Raskin if he has any closing remarks.
    Mr. Raskin. Thanks, Mr. Chairman, and, Commissioner Califf, 
I just want to thank you for your great devotion to the task 
here and you are a model public servant trying to advance the 
public interest at every turn. The scope of issues that you 
have to address on daily basis is staggering, and the 
challenges faced by the FDA are mammoth. And we should not be 
adding to your burdens by beating you up for pet ideological 
causes, and I was disappointed that some of our colleagues went 
that direction today.
    I just wanted to clear up a couple of little things. One is 
the Inflation Reduction Act is not responsible for drug 
shortages, and contrary to Republican claims, it has already 
substantially lowered costs for lifesaving medications even as 
it is projected to reduce the deficit by $237 billion. And you 
ask how we pulled off the feat of reducing to $35 a month where 
people have to pay for insulin shots if they are diabetic, 
while at the same time saving hundreds of billions of dollars 
for the taxpayers. It is simple. We took a strong stand that 
the Federal Government should be able to negotiate with Big 
Pharma for lower drug prices. And so, we have saved hundreds of 
billions of dollars, at the same time that we have dramatically 
reduced the cost of prescription drugs despite the unfortunate 
and categorical partisan objection of our Republican 
colleagues.
    So, the shortages we are seeing today are primarily in 
generic medications, and Republican opponents of the Inflation 
Reduction Act claim it has already stifled the production of 
brand name drugs, which is just false. HHS recently published a 
white paper with multiple recommendations for what needs to be 
done to address drug shortages, none of which involve repealing 
the Inflation Reduction Act. Rather, they focus on ways in 
which the private sector can work with the FDA to shore up drug 
supply chains. And the commissioner has laid out a number of 
other ideas here today, and we would do well to defer to his 
expertise and to take it to heart.
    We would also be remiss not to clarify that ivermectin is 
not effective against COVID-19, and there is no reason to think 
anything wrong of people who wanted to check it out for those 
purposes, as the good commissioner testified today, but it did 
not work. The Fifth Circuit never said otherwise. And it is not 
the role of the Fifth Circuit to determine whether a drug is 
safe and effective, be it ivermectin or mifepristone. That is 
FDA's job, and it is a job that relies on the quality and the 
integrity of the science and the research.
    Some of our colleagues chose to blame the FDA exclusively 
for infant formula shortages when they could have joined us on 
our side of the aisle in our investigation into Abbott 
Nutrition and its role that it played. Democrats never received 
all the documents we were promised by Abbott, and our friends 
across the aisle could choose to help with that and provide the 
American people the accountability and the transparency we all 
deserve. Across the aisle, we share concerns about the illegal 
vapes coming into the country from China. I hope our colleagues 
will join the Democrats in supporting a whole-of-government 
approach to counter smuggling of illicit substances and 
products including adequately funding Federal law enforcement 
agencies. We should be concerned not just about illegal 
substances coming in from China, but from any country and every 
country of concern.
    So, we thank you for your patience and your seriousness 
today. Mr. Chairman, I thank you for calling the hearing, which 
I think has been very productive, and I yield back to you.
    Chairman Comer. The gentleman yields back, and I will 
conclude by again, Commissioner, thank you for being here 
today. I think this was a very substantive hearing. We covered 
topics from seafood inspection, all the way to just about every 
other topic that I think could be imaginable throughout the 
past five-and-a-half hours.
    I will attempt to correct my colleague across the aisle. 
The Inflation Reduction Act was the title, but I think it will 
be known throughout history as the Inflation Creation Act, and 
that is why I do not believe a single Republican voted for it. 
And with respect to transparency that Mr. Raskin said that we 
deserve, I agree. We deserve transparency. Hopefully, in our 
investigations, the administration will turn over the pseudonym 
emails, and the tapes, and all the other items have relevance 
to our other investigation that we have ongoing. With respect 
to----
    Mr. Raskin. But is that one still ongoing? I was not sure.
    Chairman Comer. Yes. Oh, it is. Yes, I know you need to 
stop watching CNN. You need to go to Main Street and ask 
people.
    But at the end of the day, we appreciate your attendance. 
We have requested a lot of information, and hopefully, we will 
follow up with each individual member that asked questions. As 
I travel America and travel Kentucky, we have a lot of people 
in the private sector that are concerned with the pace at which 
FDA moves to approve medical devices. There is a lot of 
concern, as I have stated to you in the last 2 days, with 
respect to the uncertainty around the tobacco products, the 
lack of enforcement of the Chinese illegal vape products that 
are the ones that are creating so much havoc with our young 
people and across America, and so much uncertainty in the CBD 
industry as well. So, we look forward to working with you on 
that.
    With that, and without objection, all members will have 5 
legislative days within which to submit materials and to submit 
additional written questions for the witnesses, which will be 
forwarded to the witnesses for their response.
    Chairman Comer. If there is no further business, without 
objection, the Committee stands adjourned.
    [Whereupon, at 5:43 p.m., the Committee was adjourned.]

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