[Senate Hearing 116-488]
[From the U.S. Government Publishing Office]


                                        S. Hrg. 116-488

                             NOMINATION OF
                         STEPHEN M. HAHN, M.D.,
                        TO SERVE AS COMMISSIONER
                           OF FOOD AND DRUGS

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                                   ON

EXAMINING THE NOMINATION OF STEPHEN HAHN, OF TEXAS, TO BE COMMISSIONER 
       OF FOOD AND DRUGS, DEPARTMENT OF HEALTH AND HUMAN SERVICES

                               __________

                           NOVEMBER 20, 2019

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


        Available via the World Wide Web: http://www.govinfo.gov
        
                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
41-400 PDF                 WASHINGTON : 2021                     
          
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            COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming		PATTY MURRAY, Washington
RICHARD BURR, North Carolina		BERNARD SANDERS (I), Vermont
JOHNNY ISAKSON, Georgia			ROBERT P. CASEY, JR., Pennsylvania
RAND PAUL, Kentucky			TAMMY BALDWIN, Wisconsin
SUSAN M. COLLINS, Maine			CHRISTOPHER S. MURPHY, Connecticut
BILL CASSIDY, M.D., Louisiana		ELIZABETH WARREN, Massachusetts
PAT ROBERTS, Kansas			TIM KAINE, Virginia
LISA MURKOWSKI, Alaska			MARGARET WOOD HASSAN, New Hampshire
TIM SCOTT, South Carolina		TINA SMITH, Minnesota
MITT ROMNEY, Utah			DOUG JONES, Alabama
MIKE BRAUN, Indiana			JACKY ROSEN, Nevada        
                                     
                                     
               David P. Cleary, Republican Staff Director
         Lindsey Ward Seidman, Republican Deputy Staff Director
                  Evan Schatz, Minority Staff Director
              John Righter, Minority Deputy Staff Director
                           
                           
                           C O N T E N T S

                              ----------                              

                               STATEMENTS

                      WEDNESDAY, NOVEMBER 20, 2019

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening statement.........................     1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State 
  of Washington, Opening statement...............................     3
Cornyn, Hon. John, a U.S. Senator from the State of Texas, 
  Opening statement..............................................     5

                               Witnesses

Hahn, Stephen, M.D., Washington, DC..............................     7
    Prepared statement...........................................     9

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
    Letters supporting the Nomination of Stephen M. Hahn, M.D., 
      to be Commissioner of the Food and Drug Administration.....    42

                         QUESTIONS AND ANSWERS

Response by Stephen M. Hahn to questions of:
    Senator Sanders..............................................    56
    Senator Casey................................................    60
    Senator Baldwin..............................................    64
    Senator Murphy...............................................    68
    Senator Warren...............................................    71
    Senator Kaine................................................    89
    Senator Hassan...............................................    90
    Senator Smith................................................    92
    Senator Jones................................................    94
    Senator Rosen................................................    95
    Senator Murray...............................................    99
    Senator Collins..............................................   109
    Senator Scott................................................   111
    Senator Isakson..............................................   113
    Senator Braun................................................   114

 
                             NOMINATION OF
                         STEPHEN M. HAHN, M.D.,
                        TO SERVE AS COMMISSIONER
                           OF FOOD AND DRUGS

                              ----------                              


                      Wednesday, November 20, 2019

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:04 a.m., in 
room SD-430, Dirksen Senate Office Building, Hon. Lamar 
Alexander, Chairman of the Committee, presiding.
    Present: Senators Alexander [presiding], Isakson, Roberts, 
Murkowski, Scott, Romney, Braun, Collins, Murray, Casey, 
Baldwin, Kaine, Hassan, Smith, Jones, and Rosen.

                 OPENING STATEMENT OF SENATOR ALEXANDER

    The Chairman. The Senate Committee on Health, Education, 
Labor and Pensions will come to order, please. Today we are 
holding a confirmation hearing on the nomination of Dr. Stephen 
Hahn to serve as Commissioner of the Food and Drug 
Administration. Senator Murray and I will each have an opening 
statement, and then I will introduce Senator John Cornyn of 
Texas who will introduce Dr. Hahn. After Dr. Hahn's testimony, 
Senators will each have five minutes for a round of questions. 
And I will be glad to stay for second round if Senators want to 
do that. President Trump nominated Dr. Hahn on November 5, 15 
days ago. The Committee received his paperwork on November 6.
    The Office of Government Ethics paperwork came on November 
12, which was eight days ago. So we have all the paperwork. I 
met with Dr. Hahn on the 6th. I believe he is well qualified to 
lead the FDA. Dr. Hahn met with all but three Members of the 
Committee. I thank the Committee Members for making that time 
available and I thank him as well. And he has offered to meet 
with every Member. This timeline is consistent with the 
schedule the Committee followed for the nomination of Dr. 
Gottlieb to be President Trump's first FDA Commissioner.
    The Committee held a hearing for Dr. Gottlieb nine days 
after he was nominated and five days after we received his 
final paperwork. This is a critical time for the Food and Drug 
Administration. There is a lot the FDA needs to do, approve 
life-saving drugs, regulate tobacco and e-cigarettes, complete 
the ongoing lung injury investigation having to do with e-
cigarettes, and continue addressing the Opioid Crisis, 
implementing the various provisions of the 21st Century Cures 
Act. Dr. Hahn has both the perspective of a physician and the 
leadership of a well-respected, large healthcare organization 
with a large employee base and a diverse mission. He is Board 
certified in both medical oncology and radiation oncology, 
specializing over the course of his career on prostate, 
bladder, kidney, testicular, and lung cancers, and sarcoma. He 
has considerable experience with Federal health agencies.
    After graduating with his medical degree from Temple 
University, he completed a residency in Internal Medicine at 
the University of California. He was at the National Cancer 
Institute at the National Institutes of Health between 1988 and 
1995. There he completed a residency in radiation oncology, and 
a fellowship in medical oncology, and was a senior 
investigator. He also held the rank of Commander in the U.S. 
Public Health Service Commissioned Corps in 2005. From 1996 to 
2014, Dr. Hahn was at the University of Pennsylvania where he 
was a Professor and Chair of the Department of Radiation 
Oncology for nine years.
    In 2015, he became the Chair and Professor of Radiation 
Oncology at the University of Texas MD Anderson Cancer Center. 
Today, Dr. Hahn is the Chief Medical Officer at MD Anderson 
Cancer Center where he continues to treat patients. Dr. Hahn, 
you are nominated to lead this agency at a very important time. 
As an oncologist, you know firsthand the importance of bringing 
new life-saving drugs and devices quickly through the 
regulatory device--the regulatory process, as well as safely.
    As a successful Chief Executive, you will bring a guiding 
hand to an agency tasked with protecting the public's health. 
MD Anderson is a large organization. You have 21,000 employees 
there, revenues of $5 billion, the largest number of clinical 
trials in the United States. That experience should serve you 
well here. I believe those experiences as well as your 
experience with the National Institutes of Health and the 
Public Health Service Commissioned Corps made you well prepared 
to lead the FDA.
    In recent years, this Committee has taken a number of steps 
to ensure that the FDA can keep up with the rapid pace of new 
discoveries while continuing to ensure the safety of new drugs 
and devices. For example, in 2016 Congress passed the 21st 
Century Cures Act, giving the FDA new hiring authorities to 
help bring in the right experts and scientists to keep up with 
biomedical innovation. In 2017, we renewed the FDA's ability to 
collect user fees from drug companies so FDA can bring drugs 
and devices through the regulatory process more rapidly.
    Last October, we passed legislation to fight the opioids 
epidemic. That included proposals from 72 different Senators, 
proposals that would allow the FDA to require prescription 
opioids to be packaged in set amounts like a three or seven day 
supply in blister packs, and increased authority to help stem 
the flow of fentanyl at the border. And in June, Congress 
reauthorized the Pandemic and All-Hazards Preparedness Act 
which reauthorized the FDA's ability to help ensure our Nation 
is prepared for and able to respond to public health 
emergencies such as pandemic flu or a bioterror or nuclear 
attack.
    Looking ahead, the perspective of a physician and an 
executive is what the FDA needs to successfully implement the 
many new authorities and funding associated with the 21st 
Century Cures Act, to address the opioids crisis, at the same 
time to ensure that Americans with chronic pain can receive the 
medications they need, to protect our Nation's food supply, to 
appropriately regulate tobacco and e-cigarettes. Dr. Hahn, I 
enjoyed meeting with you in my office. You have an impressive 
medical and research background. You are a proven leader in a 
large health system with complex needs and a dynamic staff.
    I believe you are well qualified to lead the FDA. I am not 
the only one who thinks that. I ask unanimous consent to 
introduce seven letters of support for Dr. Hahn into the 
record, which includes a letter of support from five previous 
Commissioners under Democrat and Republican administrations, as 
well as letters from physician and research organizations. So 
ordered.
    [The following information can be found on page 42.]
    The Chairman. It is my intent to have the Committee 
consider your nomination when we return on December 3rd, and I 
hope that we can report you out on a bipartisan basis so that 
you can be confirmed by the full Senate before the end of the 
year. The FDA needs a permanent Senate-confirmed leader. I 
think you will do an excellent job.
    Senator Murray.

                  OPENING STATEMENT OF SENATOR MURRAY

    Senator Murray. Well, thank you very much, Mr. Chairman. 
Thank you, Dr. Hahn, for joining us today. I also want to 
welcome your wife and family who are with you today. And I want 
to welcome our colleague, Senator Cornyn. Thank you for being 
here today to introduce Dr. Hahn to our Committee. Each year 
$0.20 of every dollar Americans spend goes to products the Food 
and Drug Administration regulates. Every day people put the 
well-being of themselves, their families, and even their pets 
in the FDA's hands. When we sit down for a meal, we count on 
the FDA's efforts to ensure the safety of 80 percent of our 
food supply and provide us with the information we need to make 
healthy choices. When we get our prescriptions filled or turn 
to medical devices to stay healthy, we count on the FDA's work 
to uphold the gold standard of safety and effectiveness. We 
don't have to look hard for reminders of just how enormous the 
FDA's responsibility is.
    A few years ago more than 30 patients at a hospital in 
Seattle were infected with a superbug by contaminated medical 
devices and over a third of them died. The FDA eventually 
recalled the devices after an investigation by my staff found 
outbreaks linked to the devices worldwide. Over the last two 
years, several states including Washington State have faced an 
E. Coli outbreak from romaine lettuce, resulting in over 230 
illnesses and five deaths. This year the FDA announced millions 
of patients were exposed to blood pressure and heartburn 
medicines with carcinogens, and across the country FDA's 
failure to meaningfully regulate vaping products has allowed 
youth tobacco use to skyrocket driven largely by flavored e-
cigarette products.
    We need to make sure the FDA has strong experienced 
leadership who will uphold the agency's mission to protect 
public health, which is why this hearing is so important 
because President Trump has an incredibly poor track record 
when it comes to nominations from his cabinet, to the courts, 
to critical Government agencies. He has repeatedly put forward 
nominees with alarming ethical problems and conflicts of 
interest, nominees without any relevant experience or 
qualification, and nominees with long track records of putting 
ideology or partisanship ahead of science, data, and families' 
best interest. People are counting on us to do this vetting and 
to do it seriously, especially because the President won't.
    Given what I have seen so far, I have some reservations 
regarding Dr. Hahn's qualifications to lead the Food and Drug 
Administration. Dr. Hahn has almost no Government experience, 
no public record on policy issues related to the FDA, and no 
experience leading an organization anywhere near as complex as 
the FDA. So I want to be clear what I will be looking for from 
Dr. Hahn today. First and foremost, I will be looking at his 
commitment to putting science and data ahead of ideology. This 
is fundamental to the FDA's work, and when it doesn't happen 
people are put in harm's way, people are unable to get the care 
they need.
    A good example is emergency contraception known as Plan B. 
It is now available to people all over the country. But when 
FDA was considering whether to make Plan B more widely 
available, I had to fight really hard to make sure science and 
data would ultimately win out over ideology and political 
pressure so women across the country could finally get Plan B 
over the counter. And getting these priorities right is perhaps 
more important than ever given how much President Trump has let 
ideology drive policy decisions and putting family's needs 
first also means quickly following through on strong regulation 
of e-cigarettes.
    Right now we are in the middle of a public health crisis. 
Millions of children are becoming addicted to tobacco products. 
The Trump administration's 2017 decision to delay oversight of 
e-cigarette products was an absolute disaster. Instead of 
taking strong action to protect children's health, the FDA has 
instead allowed youth e-cigarette use to more than double among 
high school students and more than triple among middle students 
in just the last two years. And now over two months after 
President Trump promised strong action, he reportedly plans to 
back away from steps to clear unauthorized flavored e-
cigarettes from the market. He has shown he is more swayed by 
the tobacco industry and politics than by our children's 
health. We need an FDA Commissioner who will push back hard so 
children's health comes first, who have finally clear the 
market of all non-tobacco flavored e-cigarettes, including 
menthol, nationally instead of offering more delays or half 
steps, and who will take strong, decisive action to protect our 
kids from combustible tobacco products as well.
    I will also be looking at Dr. Hahn's commitment to putting 
families' needs ahead of company profits because the FDA 
absolutely must prioritize making sure drugs and devices are 
safe and effective. And it should also be doing whatever it can 
to make sure they are accessible and affordable too. For 
example, the FDA should do everything it can to facilitate the 
development and approval of biosimilar insulin, a life-saving 
drug that many patients struggle to afford, including ensuring 
a smooth transition of insulin products to the biologics 
pathway in March 2020. This is an important step to help 
cheaper follow-on versions come to market.
    Finally, I will be looking at Dr. Hahn's commitment to 
continue upholding the FDA's gold standard for safety and 
effectiveness in drugs and medical devices. I am alarmed by 
changes the Trump administration has proposed to FDA's medical 
device review program, including a proposal to pre-certify 
software developers and a decision to apparently break a 
commitment it made to me to limit a conditional approval 
pathway to certain animal drugs by expanding it to human 
medical products as well. I am concerned these proposals are 
not consistent with the FDA's gold standard and may compromise 
patient safety, and I expect Dr. Hahn to revisit them if 
confirmed.
    We need an FDA Commissioner who will unquestionably put 
data and science and families' best interests ahead of ideology 
or politics or companies' bottom lines. Who will uphold the 
gold standards that make sure drugs and medical devices are 
safe and effective, and who has the experience necessary to 
lead this massive agency and its over 17,000 employees in 
tackling a wide range of challenges like the ongoing opioid 
epidemic, drug shortages, the increasing risk of antimicrobial 
resistance, and much more.
    Dr. Hahn, I am going to be listening very closely to your 
testimony today and asking you about some of the issues I think 
are particularly important during questioning. And I hope all 
of our colleagues will continue to work with me to make sure we 
thoroughly vet your nomination. This role is simply too 
important for us to do anything less. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murray. We now welcome Dr. 
Hahn. We especially welcome his family. There are a large 
number of you here. We are glad that you are here. Dr. Hahn 
will be introduced by Senator Cornyn from Dr. Hahn's home State 
of Texas. Senator Cornyn is completing his third year in the 
U.S. Senate. He has been elected by his colleagues to the 
second ranking position on the Republican side of the aisle. We 
welcome him to the Committee.

                      STATEMENT OF SENATOR CORNYN

    Senator Cornyn. Thank you, Mr. Chairman, Ranking Member 
Murray, for allowing me to come before the Committee today to 
introduce Dr. Stephen Hahn, who has been nominated to serve as 
Commissioner of the Food and Drug Administration. Let me join 
you in welcoming Dr. Hahn and his family to this hearing.
    I am constantly in awe of Americans who are willing to step 
up and serve our country in important positions like this, 
people like Dr. Gottlieb, Dr. Hahn, and others, and I am proud 
to be here with him today. For the past five years, Dr. Hahn 
has helped lead the University of Texas MD Anderson Cancer 
Center, the world's leading Cancer Center. He has quickly risen 
through the ranks of a renowned institution that includes some 
of the most esteemed faculty in the Nation, including a Nobel 
laureate and more than a dozen members of the National Academy 
of Medicine and National Academy of Sciences among others.
    He went from Chair of the Department of Radiation Oncology, 
to Chief Operating Officer and Deputy President, to his current 
position as Chief Medical Officer. He brings both the 
experience of a talented and dedicated physician as well as 
that of a leader of a major healthcare and research 
institution. Like the FDA, MD Anderson is a large organization 
operating on more than a $5 billion budget. Just to give you a 
glimpse of the scope of MD Anderson's operations, last Fiscal 
Year it had more than 20,000 employees, 7,000 trainees, who 
treated 141,000 patients, and ran 1,200 clinical trials, and 
logged 1.5 million outpatient visits. I remember visiting MD 
Anderson with John McCain and Senator McConnell years ago and 
was astonished to learn that they treat patients from 90 
different countries. That was the number at the time.
    This is not just a crown jewel of American science and 
medicine, it is a gift to the world. In 2018, they received the 
most grants of any entity from the National Cancer Institute 
and have a proud history of working closely with the FDA to 
help test leading-edge drugs. If you think running an 
institution of that size sounds like a lot of work, consider 
the fact that Dr. Hahn is also a clinician and continues to 
treat patients.
    He is Board certified, as the Chairman noted, in both 
medical oncology and radiation oncology, and has devoted his 
career to cancer research and treatment. He has previously 
served as Chair of the Department of Radiation Oncology at the 
University of Pennsylvania, where he served for nearly a 
decade. He is also a Commander in the United States Public 
Health Service at the National Cancer Institute. I had a chance 
to meet with Dr. Hahn this last week and we spoke about a 
number of challenges, many mentioned by the Ranking Member 
Senator Murray, among them is something I am concerned about, 
and as she expressed, and I know this Committee has examined 
last week, the recent increase in tobacco and nicotine product 
used among children and teens primarily spurred by e-
cigarettes.
    This combined with varying state laws on marijuana, the 
rise in CBD, and other hemp derived products and our ongoing 
efforts to reduce prescription drug prices has only underscored 
the need for strong leadership at the FDA which I believe Dr. 
Hahn will provide. The agency needs a commissioner who has 
experience managing a large organization, which he does, who 
understands the drug development process, which he does, who is 
committed to swiftly bring life-saving medications to market, 
and who prioritizes the health and safety of the American 
people above all else. I firmly believe Dr. Hahn is the right 
man for the job.
    Throughout his career, he has proven that outstanding 
patient care is his top priority, as an oncologist providing 
top-notch care to each patient he saw, as a professor educating 
our next generation of physicians, and now as the Chief Medical 
Executive at MD Anderson where he oversees medical practice and 
patient care. I have no doubt that, if confirmed, Dr. Hahn will 
bring his patient-centric work ethic to Washington and lead the 
FDA with the same skill and determination we have seen him 
display at MD Anderson.
    Mr. Chairman, Ranking Member Murray, thank you for allowing 
me to introduce my constituent and somebody who I have come to 
admire greatly for his willingness to serve in a very difficult 
time in a very important position of public trust. So thank you 
for the opportunity to be here with you today.
    The Chairman. Thank you, Senator Cornyn, and you are 
welcome to stay as long as you would like but we know you have 
other hearings and a busy schedule so if you need to excuse 
yourself, we will understand that. I would say to Senators, we 
have votes at 11:30 a.m., but we will continue the hearing 
right through the votes and we will swap the gavel so that 
everybody can ask their questions, and if necessary, we will 
have a second round of questions so Senators can ask Dr. Hahn 
questions. Dr. Hahn, you are now recognized for five minutes of 
testimony. Welcome.

STATEMENT OF STEPHEN M. HAHN, M.D., TO BE COMMISSIONER OF FOOD 
                    AND DRUGS ADMINISTRATION

    Dr. Hahn. Thank you, Mr. Chairman. Chairman Alexander, 
Ranking Member Murray, Members of the Senate HELP Committee, 
thank you for inviting me to appear before you today. I am 
humbled to be here and I am very grateful for your 
consideration of my nomination by President Trump to serve as 
Commissioner of Food and Drugs. I sincerely appreciate the time 
that many of you and your professional staff have spent with me 
over the past several weeks as part of this very important 
confirmation process.
    Before I begin my statement, I would like to introduce my 
family, my wife Lota, my adult children Chris, Emma, Robert and 
Caroline, Chris's girlfriend Annie, and our son-in-law Mike, 
and would also like to point out my first grandchild is on the 
way. Emma and Mike are expecting. Maybe next week, who knows? 
It is truly a blessing and a real constant reminder of what is 
important in life. I am a scientist and a medical doctor. 
Science and fighting for the best interests of my patients has 
guided my entire professional career.
    I have been a frontline cancer physician, researcher, and 
leader of complex medical organizations. In my work, I have 
seen the joys of informing a patient of a successful treatment 
outcome and I have also seen the sadness in letting a loved one 
know that there are no further treatment options. Throughout my 
career, I have depended on and relied on the fact that the Food 
and Drug Administration had my back. Because of FDA, I had 
confidence for my patients in the treatments that I prescribed 
for them. As I reflect on the trust, I placed in FDA, I am now 
humbled that with your consent I may be in a position to lead 
that very agency I relied on and trusted for my entire career. 
If I am fortunate enough to be confirmed by the Senate, I 
promise to be guided by the core values of integrity and 
transparency, and I promise to put the interest of the American 
people first.
    As a front-line cancer physician, researcher, and executive 
at an academic medical center, I am profoundly aware of the 
importance of the FDA's role in the health and welfare of the 
American people. The FDA represents the gold standard for 
protecting the public health, is trusted by Americans, and 
admired around the world for its mission in ensuring the 
safety, security, effectiveness of medical products and 
ensuring the safety of our Nation's food supply.
    The professionals at the FDA have remarkable expertise and 
a deep commitment to the agency's mission. I believe strongly 
in the importance of science, data, and the law that have 
guided and should continue to guide FDA with their decision-
making. I also want to emphasize that I have deep respect for 
Congress, and its role in writing the laws that the FDA must 
enforce. If confirmed, I faithfully pledge to execute the laws 
written by Congress and be responsive to your questions 
regarding the agency. I believe strongly, very much, in 
collaborating with the Legislative branch to protect the public 
health.
    The role of the FDA is as vital today as it was when the 
Food, Drug and Cosmetic Act was first approved and became law 
in 1938. We are at a crucial and exciting time in American 
medicine and science, one in which the discoveries are dramatic 
and the translation of science into better medical products for 
patients is occurring at an ever more rapid pace. We are also 
approaching a time when new and improved ways of evaluating 
data will allow us to expedite innovation, better evaluate new 
products and ensure food safety, all with even greater accuracy 
and certainty.
    All of this, however, requires that the FDA have the 
appropriate talent, expertise, and infrastructure to keep up 
with progress in science and technology. It is crucial that the 
FDA encourage innovation and competition so that Americans have 
access to a continuously improving universe of treatments. The 
American people depend on a strong FDA, and if confirmed, I 
will work with Congress, the Administration, and stakeholders 
to ensure fulfillment of that vision as its leader.
    There are many issues that will likely come before the 
Commissioner that are perplexing and engender honest 
disagreement. When that occurs, I pledge to listen, study, and 
assess all viewpoints. It is true that the challenges are many 
and complicated, but it is also true that there are remarkable, 
and I mean remarkable solutions on the horizon and these 
solutions are within our grasp. As I have spent time meeting 
with each of you, I am increasingly optimistic and energized 
about the prospects of working toward data-driven and balanced 
solutions that are congruent with the law. It is my belief that 
regardless of our differences of opinion on any one issue or 
another, we all want what is best for the American people.
    The mission of the FDA is too important and the stakes are 
too high not to make the absolute best decisions, guided by 
science, data, and the law. Chairman Alexander, Ranking Member 
Murray, Members of the Senate HELP Committee, sitting behind me 
are my wife and our children. I want them, their children, and 
all of the American people to live in a world where they can 
trust in the safety and security of their food supply and where 
they have access to the most innovative, effective, and safe 
medical products in the world.
    If I have the honor of being confirmed by the Senate, I 
will uphold myself to the highest standards of integrity, 
transparency, communication, and teamwork at the FDA. I will 
collaborate closely with you in a bipartisan way, communicate 
about the FDA's programs, and will rely on your counsel to 
faithfully serve the American people. Thank you for your 
consideration of my nomination. I look forward to answering 
your questions.
    [The prepared statement of Dr. Hahn follows:]
                   prepared statement of stephen hahn
    Chairman Alexander, Ranking Member Murray, Members of the Senate 
HELP Committee, thank you for inviting me to appear before you today. I 
am humbled to be here and am very grateful for your consideration of my 
nomination by President Trump to serve as Commissioner of Food and 
Drugs. I sincerely appreciate the time many of you and your 
professional staff have taken to meet with me over the past several 
weeks as part of this very important confirmation process.

    Before I begin my statement, I would like to introduce my family 
who are here today. I am joined here by my wife Lota; our four 
children, Chris, Emma, Robert and Caroline; and our son-in-law, Mike. 
As you can probably see from your seats, Emma and Mike are expecting 
our first grandchild any day. This is a true blessing for our family 
and a constant reminder of what is important in life.

    I am a scientist and a medical doctor. Science and fighting for the 
best interests of my patients has guided my entire professional life. I 
have been a front-line cancer physician, researcher, and leader of 
complex medical organizations. In my work I have seen the joys of 
informing a patient of a successful treatment and the sadness in 
letting a loved one know that there are no further options. Throughout 
my entire career--I have depended on and relied on the fact that the 
Food and Drug Administration (FDA) had my back. Because of the FDA, I 
had confidence for my patients in the treatments I administered. As I 
reflect on the trust I placed in the FDA, I am now humbled that, with 
your consent, I may be in a position to lead that very agency I have 
relied on and trusted for my entire career.

    If I am fortunate enough to be confirmed by the Senate, I promise 
to be guided by the core values of integrity and transparency, and I 
promise to put the interests of the American people first. As a front-
line cancer physician, researcher, and executive at an academic medical 
center, I am profoundly aware of the importance of the FDA's role in 
the health and welfare of the American people. The FDA represents the 
gold standard for protecting the public health, is trusted by Americans 
and admired around the world for its mission ensuring the safety, 
efficacy, and security of medical products and the safety of the 
Nation's food supply. The professionals at the FDA have remarkable 
expertise and a deep commitment to the agency's mission. I believe 
strongly in the importance of science, data, and the law that have 
guided and should continue to guide the decision-making at the FDA.

    I also want to emphasize that I have deep respect for Congress, and 
its role in writing the laws that the FDA must enforce. If confirmed, I 
pledge to faithfully execute the laws written by Congress, and be 
responsive to your questions regarding the agency. I look forward to 
collaborating with the legislative branch to protect the public health.

    The role of the FDA is as vital today as it was when the Food, 
Drug, and Cosmetic Act became law in 1938. We are at a crucial and 
exciting time in American medicine and science, one in which the 
discoveries are dramatic and the translation of science into better 
medical products for patients is occurring at an ever more rapid pace. 
We are also approaching a time when new and improved ways of evaluating 
data will allow us to expedite innovation, better evaluate new products 
and ensure food safety, all with even greater accuracy and certainty. 
All of this, however, requires that the FDA have the appropriate 
talent, expertise, and infrastructure to keep up with progress in 
science and technology. It is crucial that the FDA encourage innovation 
and competition so that Americans have access to a continuously 
improving universe of treatments. The American people depend on a 
strong FDA and, if confirmed, I will work with Congress, the 
administration, and stakeholders to ensure fulfillment of that vision 
as its leader.

    There are many issues that will likely come before the Commissioner 
that are perplexing and engender honest disagreement. When that occurs, 
I pledge to listen, study and assess all viewpoints.

    It is true that the challenges are many and complicated, but it is 
also true that there are remarkable solutions on the horizon and these 
solutions are within our grasp. As I have spent time meeting with each 
of you, I am increasingly optimistic and energized about the prospects 
of working toward data-driven and balanced solutions that are congruent 
with the law. It is my belief that regardless of our differences of 
opinion on any one issue or another, we all want what is best for the 
public health. The mission of the FDA is too important for the American 
people and the stakes are too high not to make the absolute best 
decisions, guided by science, data, and the law.

    Chairman Alexander, Ranking Member Murray, Members of the Senate 
HELP Committee, sitting behind me are my wife and our children. I want 
them, their children, and all of the American people to live in a world 
where they can trust in the safety and security of their food supply 
and where they have access to the most innovative, effective and safe 
medical products in the world. If I have the honor of being confirmed 
by the Senate, I will uphold myself to the highest standards of 
integrity, transparency, communication, and teamwork at the FDA. I will 
collaborate closely with you in a bipartisan way, communicate about the 
FDA's programs, and will rely on your counsel to faithfully serve the 
American people.

    Thank you for your consideration of my nomination, I look forward 
to answering your questions.
                                 ______
                                 
    The Chairman. Thank you, Dr. Hahn. And we will now begin 
five-minute rounds of questions by Senators.
    Senator Scott.
    Senator Scott. Thank you, Mr. Chairman, Ranking Member. And 
thank you Dr. Hahn for being here today and especially thank 
you for spending the time yesterday. We had a good conversation 
about the importance of the generic market. So often we hear a 
lot of conversation about the prices of drugs, but we fail to 
appreciate the positive impact that generic drugs are having 
around the country. Speaking specifically of that, in 2019, 
Fiscal Year 2019, we saw a record-breaking 1,171 drugs, generic 
drugs, come to market.
    2018 was a record-breaking year. 2017 was a record-breaking 
year. So we are moving in the right direction. 90 percent of 
the prescriptions filled, of course, are generics, 90 percent 
of which have a copay of less than $20. This is all good news, 
especially when you compared to 1990 when fewer than a third of 
the drugs were generics. That being said, I have real concerns 
that we could see this trend slow down or even reverse. Earlier 
this year we voted in this Committee to report out the Lower 
Health Care Costs Act which contains dozens of good targeted 
policies that will benefit Americans.
    Unfortunately, one provision, Section 205 of the bill, 
could have an unintended consequence of deterring generic drug 
development and discouraging manufacturers for filing early. 
This would mean less competition and certainly higher prices 
for consumers. I filed an amendment that would have targeted 
Section 205 so as to deter the so-called exclusivity parking 
that it was strapped to combat, but without punishing good 
faith manufacturers who are actively pursuing final approval.
    Former Commissioner Gottlieb tweeted in support of the 
amendment and wrote an article suggesting that we should 
consider finding ways to strengthen rather than cheapen the 
180-day exclusivity period. Dr. Hahn, given that discussions 
with the FDA are still ongoing as to how we might better target 
Section 205, can you commit to engaging with my office on this 
issue as we seek to ensure strong and sustainable market 
competition?
    Dr. Hahn. Senator, nothing is more important than getting 
innovative products onto the market for the American people and 
providers. I think the generic pathway is an incredible way to 
do that and to introduce competition, and there are many 
virtuous effects of the generic pathway. As you mentioned, FDA 
has done a remarkable job over the last several years and I am 
very supportive of continuing that work and accelerating the 
approval and safe approval of generics. And pledge to work with 
your office, sir, and I look forward to doing that.
    Senator Scott. Thank you very much. When we talk about the 
importance of innovation, there is maybe no area where the 
conversation is more meaningful than the issue of rare and 
ultra-rare diseases. As you are familiar, I think we talked 
about it yesterday, there are like 7,000 rare diseases and only 
about 5 percent are set differently. 350 of those rare diseases 
have an FDA-approved treatment, which I think is challenging 
and certainly a real opportunity for the FDA to work on.
    Looking at the FDA, some review divisions seem to have much 
more experience than others with applications for rare and 
especially ultra-rare conditions. How can we work with you to 
create some transparency on which divisions these are, and how 
to support them as they evaluate drugs for what are often times 
the first in class treatments or treatments for conditions that 
have nothing--for patients?
    Dr. Hahn. Senator, I share your concern about the rare 
conditions. I think nothing is more important than that we 
don't forget any Americans who have serious illnesses, and I 
very much would, if I am fortunate enough to be confirmed, look 
into the issue that you described. I do know that the Oncology 
Center of Excellence has done a really terrific job in the area 
of rare tumors. It is something we specialize at MD Anderson, 
and I look forward to seeing how best practices can be spread 
across the agency.
    Senator Scott. Thank you, Dr. Hahn. We look forward to your 
successful vote and look forward to working with you on a 
number of these issues. I can't think of an area that is more 
important to the American community, our citizens than 
healthcare and frankly drug prices. We have so much negative 
news on drug prices that so often we forget the benefits that 
we are getting from the generic market. And the importance of 
stabilizing the generic market to me is in critical need and 
thank you very much for your commitment to do so. Thank you, 
Mr. Chairman.
    The Chairman. Thank you, Senator Scott.
    Senator Murray.
    Senator Murray. Thank you. Mr. Chairman. Dr. Hahn, the 
FDA's gold standard for product review ensures the safety, 
efficacy, and quality of our medical products. And patients and 
families place their trust every day in the FDA to make sure 
the products that they use meet that high standard. Yet, the 
Trump administration has repeatedly undermined the gold 
standard by prioritizing ideology over science. If you are 
confirmed, your duty as Commissioner would be to uphold that 
gold standard. Do you commit to upholding and protecting the 
gold standard for all medical products including drugs and 
devices?
    Dr. Hahn. Senator, as I mentioned in my opening statement, 
as a frontline physician who has come to depend upon the FDA, I 
very much commit to that gold standard. I believe that is very 
important in terms of assessing the safety and efficacy, and 
you are absolutely, right both patients, all of the American 
people, and the providers in this country very much depend upon 
that.
    Senator Murray. Thank you. Do you commit to making 
decisions based on science and not ideology and not bowing to 
political pressure from President Trump or the administration?
    Dr. Hahn. Senator, throughout my career whether it was at a 
patient's bedside or as a medical executive, I have made 
decisions based upon data and science congruent with the law. 
Nothing is more important for a patient than for them to trust 
that you are making a decision that is in their best interest 
and no one else's interest. And I commit to you that science, 
data, and the law will guide decisions that I would make if I 
am fortunate enough to be confirmed by this Senate as 
Commissioner of Food and Drugs.
    Senator Murray. Okay. Thank you very much. In September, as 
you know, the Trump administration announced plans to ban the 
sale of unauthorized, non-tobacco flavored e-cigarettes. I was 
really hopeful that the administration was finally taking the 
youth vaping epidemic seriously. And since then, as we all know 
now the President has reversed course all together choosing 
politics over children's health.
    A week ago, Mitch Zeller was here. He is the head of the 
FDA's Tobacco Center and I asked him if he is committed to 
finalizing that flavor ban that was announced, and he could not 
give me an answer. Instead, he referred questions to the White 
House. The President has chosen you now to run the FDA. So I am 
now asking you, are you committed to finalizing the flavors 
compliance policy that the administration announced on 
September 11th, yes or no?
    Dr. Hahn. Senator, thank you for your question. I am going 
to preface this Senator by emphasizing the point that I am a 
lung cancer doctor and I have seen the ravages of tobacco-
related cancers. It is all too real to me. I also know 
youngsters who are very close to me who use e-cigarette 
products. I am aware of the youth tobacco survey data, and I 
think this is an important, urgent crisis in this country. I do 
not want to see another generation of Americans become addicted 
to tobacco and nicotine, and I believe that we need to take 
aggressive action to stop that.
    Senator Murray. Is that a yes or no that you will work on 
finalizing that compliance policy?
    Dr. Hahn. I understand that the final compliance policies 
is under consideration by the administration. I look forward to 
their decision. I am not privy to those decision making 
processes, but I very much agree and support that aggressive 
action needs to be taken to protect our children.
    Senator Murray. Well, have you told the President that you 
disagree with his decision to back away from those actions.
    Dr. Hahn. I have not had a conversation with the President.
    Mr. Murray. Is failing to implement a flavor ban and 
ignoring the millions of children who are getting addicted to 
e-cigarettes consistent with your focus on science and data?
    Dr. Hahn. Senator, I look forward to hearing all of the 
data associated with this. As a scientist and a researcher and 
a doctor, seeing all the data and the complete set of data is 
important for making a decision. What I can promise you, 
Senator, is I will absolutely do that if I am fortunate enough 
to be confirmed as Commissioner of Food and Drugs. Nothing is 
more important than protecting our youth.
    Senator Murray. Are you willing to say to the President 
what you believe the science and data is on banning this or 
will you just take what the President tells you to do and 
implement it?
    Dr. Hahn. Senator, throughout my career using data, 
science, and the law, I have had conversations with people 
about what I think is best and I do look forward and will have 
those conversations.
    Senator Murray. Okay, let me ask you quickly about opioids 
because President Trump's commission on combating the opioid 
crisis identified the FDA's, ``inadequate oversight as one of 
the causes of that crisis and the commission found that for 
years the FDA accepted the pharmaceuticals industry's 
outrageous claims that newly formulated opioids were not 
addictive and failed to take action to mitigate that really 
critical public health crisis.''
    There is a lot more to be done to address the safety of 
opioids and the FDA plays a very critical role in monitoring 
and ensuring the appropriate use of prescription painkillers. 
If you are confirmed, can you tell us quickly what three steps 
you would take to make sure the FDA is doing what it can?
    Dr. Hahn. Thank you, Senator. Yes, I think continuing the 
great work that the Congress--the laws Congress passed with 
respect to packaging and labeling is important. I look forward 
very much to approaching this in a holistic way with 
accelerated approval or increased approval of non-opioid 
products as well as looking into potentially even medical 
devices to help.
    I believe based upon my experience at MD Anderson that a 
comprehensive holistic approach often without opioids can be 
very helpful in the treatment of pain including cancer pain. 
This is a significant problem and what we have to do is balance 
the relief of suffering with making sure that we prevent as 
much as possible misuse and addiction.
    Senator Murray. Thank you very much.
    The Chairman. Thank you, Senator Murray.
    Senator Romney.
    Senator Romney. Thank you, Mr. Chairman, and Ranking 
Member. And thank you, Dr. Hahn. It was good to meet with you. 
I am impressed by your credentials and experience. Your comment 
a moment ago that you have respect for Congress calls into 
question your judgment----
    [Laughter.]
    Senator Romney. But nonetheless, the great balance that you 
will have is to fulfill your responsibilities at the FDA where 
public health is of the ultimate significance versus the 
strength of politics and political donations, which have an 
enormous impact on the decisions that sometimes are made in 
Washington. And the stress that can come from politics and 
people who are driven by politics or political donations is 
wholly different than anything you have ever experienced in 
life and I can attest to that myself.
    This issue of vaping as it relates to this question is to 
whether you will put science and public health ahead of 
politics and political contributions? And they don't come to 
you directly, but they are the kind of people who will be 
telling you what to do. The question is how you will balance 
those things in which you put forward? For me, vaping is, if 
you will, the canary in the coal mine or better the child in 
the vaping room, and so how you will deal with this issue is a 
pretty good test case for how you would deal with this issue on 
an ongoing basis on matters not just relating to vaping.
    I mean, in September President Trump and Secretary Azar 
said they would regulate flavored e-cigarettes. We now know 
that over 5 million high schoolers are addicted to nicotine 
through vaping products. The Members of this body have been 
waiting for more than two months for the FDA to release a 
flavor ban. And while we have been waiting, 35 more people have 
died from lung injury, and I understand these death may be from 
adulterated products, but you can't decouple this and the fact 
that the flavors are what is luring kids in.
    Just three days after this Committee heard from the FDA and 
CDC officials that flavored e-cigarettes are driving youth 
vaping rates, we learned from news reports that the 
administration may no longer act on banning flavors. A number 
of us have bills that relate to banning these products, banning 
flavors, some include menthol some don't, some have a sunset 
provision some don't, but this is a really critical issue.
    The first question I would ask you is, is the FDA and your 
leadership able and willing to take action which will protect 
our kids whether or not the White House wants you to take that 
action?
    Dr. Hahn. Senator, thank you for the question. As a 
physician I took a pledge many years ago to uphold the ethics 
of medical practice, to always put the patient first. Senator, 
I take that pledge very seriously and I think if you ask anyone 
who has worked with me, they will tell you that I have upheld 
that pledge every time I have seen a patient but also as a 
medical executive and a leader of academic medicine. I take 
that incredibly seriously, patients need to come first, and the 
decisions that we make need to be guided by science and data 
congruent with the law.
    Senator Romney. There are many people who rely upon that 
oath and I have as a patient. And I certainly hope that will be 
foremost in your mind because this is a place where sometimes 
an oath of that nature takes a backseat. I would note that Dr. 
Schuchat last week in her testimony indicated that flavors are 
the key driver in leading us into this youth vaping epidemic 
where we have millions, millions of high schoolers and middle 
schoolers that are now addicted to nicotine and will be 
battling with that throughout the rest of their life. I can't 
imagine a reason for holding off on immediately banning these 
kinds of flavors. Do you see a reason for holding off on that?
    Dr. Hahn. Senator, I have also seen the data that you 
described suggesting the flavors are a significant positive 
effect--not positive but an effect for children using e-
cigarettes and I am alarmed by those data, completely alarmed. 
I think it is a serious issue and I think it requires bold 
action to keep these out of the hands of kids. I do not want to 
see another generation of children become addicted to tobacco 
and nicotine.
    Senator Romney. You recognize of course that there will be 
very strong lobbying efforts on the part of tobacco producers, 
tobacco companies, vaping shop owners, vaping shop employees, a 
lot of jobs on the line. There will be enormous political 
pressure which will say keep these products out there, and 
there is not a lot of money coming in the other side.
    From a political standpoint, there is no one coming to us 
and saying, hey, we are going to contribute to you all if you 
will make sure and ban these flavors. No, it is just moms and 
dads and millions of kids that need--basically it is going to 
be on your shoulders. As I understand it, you are the decider 
here. President Bush used to say, you are the decider. Are you 
willing and is there anything that is keeping you from making 
that decision to ban these flavored products?
    Dr. Hahn. Senator, as I mentioned to Senator Murray, I 
understand the final compliance policy is under consideration. 
I don't want to prejudge that and I don't have all the facts 
that they might have but I can tell you this for sure, sir. I 
will use science and data to guide the decisions if I am 
fortunate enough to be confirmed and I won't back away from 
that. I am a lung cancer doctor, I am a researcher, I am a 
father, and soon to be a grandfather and I take that incredibly 
seriously.
    Senator Romney. Thank you.
    The Chairman. Thank you, Senator Romney.
    Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman. I want to follow-
up on this line of questioning of Ranking Member Murray and 
Senator Romney. It strikes me that there are many areas in 
which the FDA could be active in this issue of vaping and e-
cigarettes and the lung injuries that we are seeing. We focused 
on some. I just came from a hearing where there was an 
exploration of other ways to be engaged.
    Let me just say that without decisive action from the FDA 
and the administration, we can bet that there is going to be 
more kids who will take up vaping. This leads to another 
problem that has been mentioned, nicotine addicted children. As 
you know, there are no FDA-approved cessation therapies for 
those under age 18. There are divisions other than the Center 
for Tobacco, there is the Drug Center that looks at--within the 
FDA--that looks at the potential development of effective 
treatments for things like nicotine addiction in children.
    If confirmed, how would you tackle this problem and ensure 
that the FDA is prepared to address the challenge of nicotine 
addiction among our Nation's young people?
    Dr. Hahn. Senator, thank you for your question. First, I 
would like to say Senator that I hope we have less and less 
nicotine addicted children in this country and hopefully zero 
in the future. And I am alarmed by the situation and what we 
are facing right now. Tobacco cessation and nicotine addiction 
are serious problems. I see that because many of my patients 
want to stop. Fortunately, there is great research, much of 
which has been funded by Congress, at NIH that has allowed us 
to look at this intersection between nicotine addiction, 
tobacco use, and what we might be able to do in the future.
    I am very supportive of taking measures and expediting 
those measures to try to find out what novel products we can 
use to help with the tobacco cessation problem that we have. 
The more that we can accelerate those products onto the market 
to help people, I think the less of a public health issue this 
will be and look very much forward to working with Congress and 
researchers around this country to help expedite that.
    Senator Baldwin. Right. This next question is on the food 
end of the FDA. As we discussed when we met, dairy farmers in 
Wisconsin pride themselves on producing high-quality milk that 
meets very specific requirements. In fact many of those 
requirements are set by the FDA standards of identity 
regulations. Despite the hard work that farmers do every day to 
meet these standards, there are many imitation products on the 
market today that get away with using dairy terms without 
meeting the same standards of identity for their products.
    Your predecessor was working on this issue and held a 
comment period for farmers, consumers, and food companies to 
provide input on the mislabeling that is going on in the 
marketplace. Now that the FDA has received that information, 
the FDA needs to finish the job. How will you enforce FDA 
regulations against all plant based imitation products that use 
dairy terms?
    Dr. Hahn. Senator, thanks for the question. I did very much 
enjoy hearing or having the conversation with you and hearing 
about this particular topic. I am in favor of clear, 
transparent, and understandable labeling for the American 
people. The American people need this so that they can make the 
appropriate decisions for their health and for their nutrition. 
I very much want to look at this issue when I get to the FDA if 
I am fortunate enough to be confirmed and I will work with you 
and your office to assess that.
    I would like to point out that this is consistent with what 
I said around science, data, and congruent with the law. It is 
a really important part of what FDA does.
    Senator Baldwin. I thank you for that. The agency should be 
enforcing this already. If confirmed, can you commit to me to 
begin enforcement within 60 days?
    Dr. Hahn. Senator, what I can commit to is that I will look 
at this as soon as I am confirmed, if I am fortunate enough to 
be confirmed, and then to get back to you as quickly as I 
possibly can.
    The Chairman. Thank you, Senator Baldwin.
    Senator Collins.
    Senator Collins. Thank you, Mr. Chairman. Welcome, Dr. 
Hahn. I first want to associate myself with my colleagues' 
comments on the vaping epidemic. You and I had a discussion 
about this problem in my office and I believe, as they do, that 
it is absolutely essential that the FDA act to ban the flavors, 
but I believe take a number of other actions as well.
    In that regard, I would commend to you an op-ed that was 
written by your predecessor, Dr. Gottlieb, on other actions 
that the FDA should take such as banning cartridges on e-
cigarettes that kids can use or others can use to refill with 
dangerous substances, which have led to this outbreak of 
serious lung diseases. Since you have discussed those issues at 
length, let me turn to two others. One is the issue of drug 
shortages and the other is the issue of drug pricing.
    Patients, pharmacists, physicians, and hospitals in my 
state are struggling with shortages of vital drugs. Maine 
Health, our largest healthcare organization is currently 
managing 40 such shortages. Northern Light Health Care in 
Bangor has had to hire four additional staff to manage ongoing 
shortages. We have had surgeries from patients in rural 
hospitals transferred to larger hospitals because of a shortage 
of injectable morphine.
    Cancer survivors are being denied additional preventive 
immunotherapy treatments, and now we are hearing about 
shortages of vincristine, which treats many childhood cancers 
as if cancer diagnosis weren't frightening enough to those 
children and their parents. Senator Tina Smith and I have 
introduced a bill to help lessen these drug shortages and that 
bill has the support of more than 50 healthcare organizations 
showing how widespread this problem is.
    You shared your personal experience as a physician with 
drug shortages. Today, will you commit publicly to all those 
patients who are affected by drug shortages and to this 
Committee that you will work with us on legislation and explore 
other ways to mitigate this very serious problem?
    Dr. Hahn. Yes, Senator. I very much enjoyed our meeting and 
the discussion regarding this very important topic. And yes, I 
commit certainly to working with Congress on this issue. As I 
mentioned to you, this is something that is very significant, 
telling parents and a child that you don't have enough 
vincristine to treat their cancer, something that no provider, 
no physician wants to be in that position. And so this is an 
incredibly serious issue and I look forward to working with 
Congress on this as there are things that I think we can do to 
help.
    Senator Collins. Thank you. I hope we can get our 
legislation through with your help. I wanted to turn to the 
issue of drug pricing. Dr. Gottlieb, your predecessor, has 
observed that if all the biosimilars that have been approved by 
the FDA were successfully marketed in this country in a timely 
fashion, Americans would have saved more than $4.5 billion in 
2017.
    Let me give you an example. Humira, the world's best-
selling drug is really a textbook example. The biosimilar 
version has been available in the European Union for more than 
a year but American consumers must wait until 2023 because of 
gaming of the patent system by the brand name manufacturer. 
Senator Kaine and I have sponsored legislation that would 
provide earlier and greater disclosure of patents surrounding 
biologics so that biosimilars can come to the market sooner and 
a version of our bill has been included in this Committee's 
Lower Health Care Costs Act.
    What role do you see the FDA playing in coordination with 
the FTC and the patent office to prevent the gaming of the 
patent system when we are dealing with biosimilars, and are you 
willing to have FDA play an aggressive role in using the purple 
book to publicize patents?
    Dr. Hahn. Senator, I really appreciated this conversation 
with you. We are all very fortunate that your passion is behind 
this because it is a significant problem across the country. As 
we have discussed, biologics represent an important treatment 
source for cancer patients, and their availability and also the 
upward pressure that they are causing on prices are 
substantial.
    The biosimilar pathway is crucial and very much in favor of 
transparency. And anti-competitive practices should be 
eliminated. So I pledge to work with you, Senator and the 
Congress, on those particular issues.
    Senator Collins. Thank you.
    The Chairman. Thank you, Senator Collins.
    Senator Hassan.
    Senator Hassan. Well, thank you Chairman Alexander and 
Ranking Member Murray, and welcome to our nominee----
    The Chairman. Senator Hassan, I made mistake. I should have 
called on Senator Murphy.
    Senator Hassan. It is all good. So I will yield to 
Senator--or we are going to follow----
    The Chairman. But having put him on the spot, he is a 
gentleman as always.
    Senator Hassan.
    Senator Hassan. Thank you. And thank you for your courtesy, 
Senator Murphy, and again, welcome doctor. Welcome to your 
family. Service is a family affair and we very much appreciate 
your family's support not only in this endeavor but on all the 
work you have already done. We can't overstate the importance 
of the FDA Commissioner as an advocate for public health, and 
as you have heard from all of us, fact-based decision making 
particularly at a time when we continue to grapple with the 
devastating impact of the opioid epidemic and the surge in 
youth e-cigarette use.
    Dr. Hahn, as we discussed in my office last week, eight 
months ago, Senator Markey and I sent a letter to the FDA 
asking basic questions about the approval and labeling of 
opioids, including the influence that drug manufacturers had on 
these decisions. We also asked in that letter about a 
problematic clinical trial design that FDA allows for opioid 
approvals. It is called the enriched enrollment randomized 
withdrawal study design, which is a mouthful, and some non-
experts like me think skew the results.
    As you know, FDA has not responded to our letter. This 
Committee has a track record of working on a bipartisan basis 
to address the devastating opioid crisis, and we need FDA to be 
a partner in those efforts. That includes being responsive to 
and transparent with Members of this Committee. I heard what 
you said in your opening statement and responses to other 
Senators here about working with Congress.
    My question to you is asking for the same commitment from 
you today that you gave to me in my office last week. If 
confirmed, will you respond to our letter within the first 30 
days of your tenure?
    Dr. Hahn. Senator, as I said in your office and I commit to 
this, within 30 days I will look into this issue and get back 
to you regarding your letter. I also want to emphasize that I 
very much appreciate your approach here. And that is always 
important to have a look back to see what happened, to see if 
you can have continuous improvement. I think that is a really 
strong effort.
    Senator Hassan. Well, I appreciate that and I take it from 
your answer that your update on the response will include 
specifics on where the response is held up and why, if you 
can't get me a full response.
    Dr. Hahn. Yes, Senator.
    Senator Hassan. Because a look back isn't particularly 
helpful if it takes too long to do, right?
    Dr. Hahn. Yes, Senator.
    Senator Hassan. Okay. I also appreciated our discussion in 
my office about balancing access to opioids for those who need 
them with policies that keep these highly addictive drugs from 
being overprescribed. Can you talk about how your views on 
opioids have evolved since medical school and how marketing 
efforts by opioid manufacturers may have influenced physicians 
and patients' initial understanding of the dangers of opioids?
    Dr. Hahn. Senator, yes. Thank you for the question. And it 
is a really interesting time in medicine regarding this issue. 
And congratulations to Congress for their excellent work as 
well as the administration on this because provider education 
has gone a long way to addressing the problems that we have 
seen.
    I mentioned in your office that when I first went to 
medical school and started taking care of cancer patients, the 
teaching was that cancer patients should be treated liberally 
with opioids and that they don't become addicted to pain 
medications. And we found out that wasn't the case, and in some 
instances with tragic consequences. We have totally changed 
based upon new information and education how we provide relief 
of pain for cancer patients. And as you can imagine as a cancer 
doctor in the front lines, this balance between relieving 
suffering but also making sure there is not misuse or abuse is 
critically important.
    A multidisciplinary approach has been instituted at MD 
Anderson as we talked about with certainly opioid therapy, but 
also non-opioid therapies, behavioral therapies, even 
potentially medical devices to help with pain. I am very much a 
supporter of the multidisciplinary approach to treating pain. I 
think it is something that we need to do more of and if I am 
fortunate enough to be confirmed as Commissioner or Food and 
Drugs, I look forward to furthering the education efforts for 
providers and patients.
    Senator Hassan. Alright. Well, thank you for that and I 
appreciated that conversation. And I look forward to you 
continuing to take that hard look at that risk-benefit analysis 
of these kinds of drugs and what they should be used for and 
what they shouldn't be. You have heard a lot of concern up here 
about fact-based decision making, about the influence of 
outside interests, whether their special interests or 
ideological ones on decision making at the FDA. Right now we 
are dealing with reports that the administration caved to 
special interest in reversing the e-cigarette flavor band and 
that is incredibly disturbing. You have talked a little bit 
about your concerns about the ban.
    But if you are confirmed you are going to be overseeing the 
FDA premarket tobacco application process for e-cigarettes. A 
whole lot of people are counting on the FDA to put public 
health first. Will you commit to public disclosure of all 
meetings between FDA and Juul that take place before and during 
the pre-market tobacco application process, including who 
attended and what was discussed?
    Will you commit to providing this Committee with any data 
you receive from companies like Juul that relate to youth e-
cigarette use including data on flavors and diversion?
    Dr. Hahn. Senator, so I am aware of the pathways that you 
are describing. I think they are important and I do think they 
need to be supported by science and data and congruent with the 
law. What I can promise you Senator because I am not at the 
FDA, I don't know the rules and regulation around disclosure, 
that I will look into that, understand what those rules are, 
and follow the law.
    Senator Hassan. Well, and just for the record here, Juul 
made a commitment that they weren't going to lobby on this and 
then their representatives come to my office and mention all 
the meetings they have had at the FDA and when I asked the FDA 
about what meetings they had, they said nothing to do with 
policy. They are either lobbying or they are not and the 
American public has a right to know how decisions that affect 
their children and our public health are made, and so I am very 
hopeful that we will get full disclosure from the FDA about 
their meetings with Juul and the information Juul has brought 
forward. It was an issue with opioid approval as well. And I 
thank you, Mr. Chairman, for letting me go over.
    The Chairman. We will have time for second round of 
questions if Senators wish. Dr. Hahn, several Senators have 
mentioned e-cigarettes and our hearing last week and the 
appearance of the Director of the Center for Tobacco Products. 
Just as a matter of record, there was some disagreement here 
about tobacco among Senators.
    We have got 23 Members, a lot of different points of view, 
libertarian, whole variety of points of view. But there was no 
disagreement on two issues, among the whole crowd that I heard. 
One was we are very concerned about the 2,000 Americans who 
have lung disease. You are a lung doctor. That is not 
completely explained and is related to e-cigarettes.
    What do we do about that? And very concerned about the 1 in 
4 high school students who apparently are using e-cigarettes. I 
didn't hear anybody on this Committee of any point of view 
advocate for that. And Mr. Zeller made it clear that the FDA 
has plenty of authority to deal with all of those things. 
Sometimes we tie the hands of the administration, but just for 
example, as Senator Romney and Senator Collins mentioned, 
requiring tamper-proof cartridges that couldn't be--so you 
couldn't insert a vitamin E or THC, for example, I believe you 
have the authority to do that now if you are the FDA 
Commissioner.
    Lowering the level of nicotine, FDA could do that now. 
Putting labels on the actual products, FDA could do that now. 
Regulating flavors, the FDA could do that now. Improving age 
verification methods, developing better standards for 
retailers, spending more the $5 plus billion you have collected 
from tobacco companies over the last several years, on a more 
effective way persuading young people not to use e-cigarettes, 
they have that authority now so I don't need an answer to the 
question from you today because you are not yet the 
commissioner.
    But my point is you have plenty of authority if you are the 
Commissioner to deal with the issues that almost everybody on 
this Committee is worried about concerning e-cigarettes. When 
we were working on the 21st Century Cures Act, I asked Dr. 
Caleb who was then Commissioner, what is your top priority? I 
said, this is a train that is likely to get to the station, 
meaning our bill, so what is the single most important thing we 
could do for the FDA? And he said it was having the flexibility 
to hire the right people and pay them enough to keep them 
working at the FDA yet late in 2017 Commissioner Gottlieb said 
that FDA's hiring process can take anywhere from 150 to 550 
days.
    What can you do to implement this new authority FDA has to 
make sure you have the right people at FDA to deal with 
speeding up approval of safe treatments and cures?
    Dr. Hahn. Senator it is striking--thank you for the 
question--on how much the similarities between MD Anderson and 
FDA exist. Both are large----
    The Chairman. How many employees do you have at FDA?
    Dr. Hahn. At FDA?
    The Chairman. Well at both.
    Dr. Hahn. MD Anderson is 21,700.
    The Chairman. At FDA?
    Dr. Hahn. 17,000 is my understanding, sir. Big complex, 
public health driven, research driven organizations. In the 
case of the University of Texas at MD Anderson is a state 
bureaucracy associated with hiring and obviously FDA with the 
Federal Government. I applaud Congress has inclusion in the 
21st Century Cures Act.
    The Chairman. What can you do about it? What can you do 
about hiring more talented people?
    Dr. Hahn. I think one of the first things, and I said this 
to many of you in meetings, that I believe it will be a top 
priority for me to make sure that all of the new authorities 
that were given to FDA through 21st Century Cures Act are in 
fact implemented. Nothing is more important than getting the 
right expertise in the agency to help adjudicate these 
decisions on these incredible new treatments that are coming 
down to help the American people. So I think there is that. I 
think also the experience I have had at MD Anderson with 
respect to recruiting and retaining the best and brightest to 
help with the mission will help with FDA.
    The Chairman. Well, this was a bipartisan priority and it 
was a top priority of FDA. It would seem to me that given our 
goals that would be a top priority of yours. I just have a few 
seconds left but regenerative medicine. On the one hand, FDA 
has taking enforcement action, which it should, against stem 
cell clinics and manufacturers that may be misleading people. 
On the other hand, we have diabetes advocates who come to me 
and say regenerative medicine may restore pancreas or put out 
of business a heart transplant surgeon by restoring a heart, or 
I had a friend from Tennessee who came and whose eyesight was 
restored by stem cell therapy.
    We gave new authority to the FDA to move ahead with real 
treatments and cures in regenerative medicine and new money to 
Dr. Collins at NIH to work with you on that. Will you commit to 
taking seriously the promise of regenerative medicine and stem 
cell therapy?
    Dr. Hahn. Senator, I certainly commit to that. I have had a 
chance to speak to Dr. Collins and I think the work that they 
are doing, particularly in the all of us project is so 
important and I absolutely commit to trying to accelerate that 
work.
    The Chairman. Thank you, Dr. Hahn. Now, Senator Murphy--
excuse me for skipping over.
    Senator Murphy. No problem at all. Thank you very much, Mr. 
Chairman. Good to see you again, doctor. A handful of 
questions. First, we had the chance to talk privately about two 
priorities of mine and I want to get your commitment on the 
record to continuing to work on them if you are confirmed for 
this post.
    The first is an FDA current proposed rule to ban electrical 
stimulation devices. These are devices that have been used in 
many cases on children with little efficacy and many long-term 
negative side effects. The second is the increasing propensity 
of children to show allergy to sesame and there is a 
conversation happening about labeling sesame as one of the 
regulated allergens through FDA. Can you just commit to me 
again in public to continue to work with us on both of these 
issues?
    Dr. Hahn. Senator, if I am fortunate enough to be 
confirmed, I commit certainly to working with you on both of 
those issues.
    Senator Murphy. Second, we have had a problem in other 
areas of the administration where information is often readily 
shared with Republicans but is withheld intentionally from 
Democrats. That was not the case with your predecessor. Scott 
Gottlieb was I think very good about making sure that both 
Republicans and Democrats were informed, a little bit easier on 
the FDA because there is not a lot of politics. That plays into 
the decisions that you make but I just want to make sure that 
you commit to this Committee to work with all Members, 
Republicans and Democrats, to share updates and to gather input 
without regard for party.
    Dr. Hahn. Senator, I commit to that. As you and I discussed 
in your office, many of these issues are not party based, they 
are bipartisan and I certainly commit to that, sir.
    Senator Murphy. Lastly, I certainly agree with your 
testimony, this is a really exciting time for American medicine 
and science but we have a drug and device manufacturing system 
that is rewarded really solely for bringing to market products 
that can lead to strong profits. And often we talk about this 
in the context of rare diseases that go unmet by drug 
discoveries. But, frankly the real scandal is that even in many 
common disease states, we have had very little innovation, and 
as someone who works a lot on mental health, it is remarkable 
how little innovation we have seen over the last 50 years when 
it comes to drugs that treat depression, for instance, which is 
a common disease state inflicted upon millions and millions of 
Americans.
    In fact, this year was the first time in decades that the 
FDA approved any new major depression drugs. And so you are in 
a really unique position as a physician to bring together 
clinicians and patients and other stakeholders to hear about 
how these gaps impact patient care. So if you are confirmed, 
what kind of things do you think you can do at the FDA to 
identify those areas of medicine where we just haven't seen 
advancements in treatment options, especially when it comes to 
mental health where people are crying out for additional 
treatments and drugs?
    Dr. Hahn. Senator, thank you for the question, and you are 
right, mental health, we have lagged behind in terms of 
innovations. I think the other area are the neurodegenerative 
disorders, ALS, etc., Parkinson's disease, and these are areas 
where there is fantastic research going on. I don't understand 
completely why there is this gap between that research and 
product development. I know that there are best practices at 
the agency with respect to some areas and I look very much 
forward to working with you and Congress finding how we can 
spread those best practices across all of the different units 
of the agency.
    Senator Murphy. I had one of the few major pharmaceutical 
companies that is investing some major money in mental health 
drug development pathways, and they identified patient and 
human testing as an area that they really saw opportunity for 
reform. And once you got a drug into those tests, it was much 
harder to prove efficacy than it was for other disease states. 
And that is certainly something that you at FDA can work with 
these companies on trying to reform and perfect.
    Dr. Hahn. Senator, this is an area of particular interest 
to me. As you know, I am a clinical trialist and what endpoints 
we use in clinical trials, which is exactly what you are 
getting, could help actually expedite some of this medical 
product development. We have to be pragmatic but we also have 
to make sure that they are validated endpoints. I am very 
interested in working with all stakeholders on this.
    Senator Murphy. I hope you will allocate sufficient time 
and attention to it. It could really use some leadership from 
the top. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murphy. And I would say 
Dr. Hahn, Senator Murphy and Senator Cassidy for example, and 
their work on mental health are an example of the opportunities 
we have to work in a bipartisan way on this Committee. So as 
you work with Congress, just because we make a lot of noise 
sometimes about politics, doesn't mean there are not plenty of 
opportunities for substantive progress. I would encourage you 
to work with the Members of this Committee on both sides of the 
aisle to try to--because that is usually the way we get a 
result.
    Senator Braun.
    Senator Braun. Thank you. Mr. Chairman. I enjoyed our 
meeting in our office. You are entering into an area of the 
economy, Warren Buffett calls it the tapeworm on the economy. I 
am recently a CEO and biggest challenge was how to control 
healthcare costs. And I know you don't get involved in that but 
I think part of what I am looking for with science and fact 
based is like taking a risk and changing the paradigm. So often 
I see the FDA, I see the HHS, have been a stodgy part of the 
problem.
    We have evolved to where the healthcare system is broken 
and every opportunity, I get to say it publicly I blame it on 
the industry. So in your own way when it comes to the other 
sectors, hospitals, insurance, practitioners, pharma will be 
what you focus on and I look at a particular issue of 
methodology. And I want to focus in and Senator Murphy 
mentioned it a moment ago, on diseases like ALS, DMD, where no 
real good remedies, narrow windows of survival once you are 
diagnosed, why would we be sticking with the old ways of doing 
things?
    Are you going to feel like any CEO would in running a 
business where you actually excel and do well when you take 
risks and stick your neck out, and in this case why wouldn't 
you want to change the process to advance drugs and therapies 
and treatments for diseases that have nothing going on for 
them?
    Dr. Hahn. Senator, I really appreciate our conversation, 
and you with your business background presented me with 
incredible pragmatic and interesting observations about the way 
the world works with respect to insurance and medical care. So 
I appreciate that very much. My experience at MD Anderson is 
with a large bureaucratic organization. I understand what you 
are saying about risk aversion.
    It is always a balance between making sure we ensure the 
safety of our patients and get the best treatments to them 
while at the same time making advances. My colleagues at MD 
Anderson say that the most risk-free clinical trial is one that 
doesn't happen and of course that is a really bad thing for 
patients because we don't actually--aren't able to figure out 
what is the right treatment for them. So sir, I do believe this 
is a balance.
    I do believe that we have to accelerate innovation and get 
those products into the hands of patients and the American 
people and the providers. And I very much appreciate your 
perspective and look forward to working with you on the 
subject.
    Senator Braun. That is good. Next week I am introducing a 
conditional approval bill where drugs can be provisionally 
approved after receiving promising early stage data. Could be 
transformational in my mind to address some of these diseases 
that, have no cures, nothing really working well.
    The FDA could grant limited marketing authorization to new 
drugs after successful phase 1 and phase 2 clinical trials 
establishing safety and a reasonable expectation of 
effectiveness, allowing patients in need of a treatment to 
benefit while allowing companies to generate a modest amount of 
revenue to help fund phase 3 trials. Does that sound like 
something that would be in your entrepreneurial framework 
heading this agency? Is that something that you think makes 
sense?
    Dr. Hahn. Senator, I am always willing to hear about 
science and data and new approaches. My career has been in 
clinical trials and clinical trial design, and understanding 
the novel approaches that we can use. I think it is important 
to expedite and to have innovation reach patients as quickly as 
possible. I do want to make sure that these approaches are 
validated so that we don't make huge mistakes that hurt 
patients, but I am open to conversation about all of those.
    Senator Braun. Rest assured after your confirmation I will 
be getting with you. Drug importation. Of all of the things you 
can do at the FDA, pharma is probably the most focused in place 
because everybody is involved with it. I know as representing 
the only financial stakeholder in healthcare, that would be the 
private insurance sector and the employers who pay all the 
bills that subsidize low prices across the rest of the world, I 
would hope that you will look at anything that, even though I 
know you can't get in the pricing but you can control some of 
the structure and processes.
    Drug prices and the fact that I listened to Senator Merkley 
a couple Thursdays ago highlighting an insulin drug, sales for 
$343 here, in average it is about $50 bucks across six other 
countries. I know you can't do anything about the mechanics 
that have evolved in such a way to give us such poor results 
but what about using the agency to speed up the process of 
getting drugs that are being produced elsewhere into this 
country and change the paradigm that is made so clumsy and then 
calling out the drug companies that in many cases do everything 
they can to restrict the process, including biologics.
    Dr. Hahn. Senator, as you point out, there are indirect 
things that FDA can do in this really important issue. Not a 
week goes by when I see a patient that doesn't comment on the 
stress, financial toxicities, how people refer to it, of high 
prescription drug prices. And the American people want urgent 
action and I support moving forward with action that makes 
sense. With respect to drug importation, as you know, the 
Secretary has the power under Section 804 to certify to 
Congress that importation will reduce costs for the American 
people and that it is safe and does not introduce additional 
risks. FDA's role in that is to actually to certify the safety 
and security of the Nation's drug supply which is the safest 
and most secure in the world. And that would be our job to look 
at the data and----
    Senator Braun. Keep the gold standard there but be 
entrepreneurial and push and hold the industry accountable. 
Thank you.
    Dr. Hahn. Thank you, sir.
    The Chairman. Thank you, Senator, Braun. The votes will 
begin 11:30 a.m. I am going to go vote quickly on the first 
vote. Senator Murray will preside. I will get back. We will 
continue the questioning as we go along.
    Senator Rosen.
    Senator Rosen. Thank you. And thank you for your 
willingness to serve and for what you have done throughout your 
career to support patients and their families through some of 
the most difficult times in any family's life. I really 
appreciate your dedication to your medical practice. And we 
talked a little bit about palliative care. As an oncologist, 
medical oncologist, a lot about that, especially a radiation 
oncologist. And so I want to make sure that patients with 
serious illnesses are treated in a comprehensive way that 
includes focusing on reducing stress and alleviating pain.
    I was glad to launch the bipartisan Senate comprehensive 
care caucus with Senators Barrasso, Baldwin, and Fisher, as my 
co-chairs. We are using this as a way to improve access to 
palliative care and care coordination and address issues 
impacting caregivers. And I know the importance of this 
firsthand. For example, near the end of her life, my mother 
suffered from a tumor on her spine and needed palliative 
radiation therapy. Not a curative. She was terminal but it was 
going to help reduce her pain for the rest of her life, and it 
was really important for the quality of life. So I have two 
questions for you.
    What else could the FDA be doing to advance options for 
palliative care? And how can we balance the variety of patient 
needs including that of palliative care when we look at how the 
FDA evaluates drugs and devices for safety and efficacy?
    Dr. Hahn. Thank you, Senator, for this question. As you 
know, I expressed in our meeting a very special, feeling toward 
the supportive care and palliative of our patients. As a cancer 
doctor, that is incredibly important and some of the best 
things that you can do for people as they end their life. So it 
is a really interesting question, Senator, particularly when 
you think about what are the end points that can be used in 
clinical trials for drug approvals.
    There is a lot of great work going around in this country 
looking at what those endpoints are, what endpoints matter to 
patients, and what are the most important in the palliative 
setting. And I think there is great opportunity for us to look 
at those endpoints and see how that can be incorporated in the 
drug and the device pathways to actually help in the palliative 
care setting. So I look very much forward to working with your 
caucus on that if I am fortunate enough to be confirmed.
    Senator Rosen. Thank you. I want to move on to a little bit 
more to the research area too. We all are aware of this 
successful research that led to cannabidiol, and I am probably 
not saying that right. It is used to treat seizures in children 
who suffer from a severe form of epilepsy. So we want to find 
new treatments that have fewer side effects or more effective. 
And so I have researchers at the University of Nevada Las 
Vegas. They are stymied and their scientific efforts because of 
the challenges to gain access to study marijuana legally, 
developed different strains like this one for epilepsy.
    Even in states like Nevada where marijuana is legal. And so 
given the great needs for alternatives, again, whether it is 
palliative care, pain management, we hear talk about opioids, 
depression, anxiety. What can we do to make it easier for the 
researchers not to take that one or two years to get Schedule 1 
license approval?
    Dr. Hahn. Senator, thank you for the question. The top line 
answer to that is clarity and transparency about what the rules 
of the road are. That is really important for all innovators as 
they try to bring new medical products to patients across 
America. The issue of CBD that you described, in fact, it is an 
active ingredient in this drug that was approved for a very 
serious childhood seizure disorder. I think that tells us that 
there is a pathway for medical products. There are also some 
indications cancer, palliative care setting where CBD might be 
of benefit, but there are some open and unanswered questions 
that have to be filled by research exactly as you described, 
Senator. What is the appropriate dosage and for what 
medication? What are the implications of long-term use 
Unsubstantiated claims like we see in the marketplace are of 
concern in terms of things like curing Alzheimer's or cancer. 
It needs to be supported by data.
    Senator Rosen. Can you help us speed up that process for 
researchers just to even get you this data so we can do what we 
need to do if you are lucky enough to be confirmed?
    Dr. Hahn. Senator, huge supporter of research and getting 
clarity and transparency around the processes to allow us to 
get the medical products to patients.
    Senator Rosen. Thank you.
    Dr. Hahn. Thank you.
    Senator Murray. [presiding] Thank you.
    Senator Isakson.
    Senator Isakson. Thank you, Senator Murray. I have been 
listening to everybody and decided I am not going to ask a 
question then probably make a 15 minute speech. I am not going 
to make a speech but I am going to tell you, what Ms. Rosen was 
just talking about and what has been talked about by other 
Members and a concern that I have as well and that is there 
seems to be almost an inhibitor to get drugs to market place 
because we get new developments take place, new drugs are 
found. We can't get enough time to approve them. We can't get 
enough authority over them. We don't get enough transparency to 
get things we need and it has been going on and on, and finally 
we don't solve a problem and then get another problem. But the 
people are sick and are not getting help. I want to talk about 
two or three things that happened to me while I have been a 
Senator and the specific thing that happened and ask you a 
little bit about it, one was on September 12, 2001.
    We all remember what happened the day before. It was the 
most tragic attack on the United States in America history. And 
in New York City we had more people affected by bad and 
debilitating burns than any place we had in history. And I had 
a phone call on my cell phone that ended up leading me to the 
FDA, that ended up leading me to Salve Pharmaceutical, which is 
now in Austria, but it was here in the United States, at time 
in my district, who had developed a drug called flamazine. 
Flamazine was used in burn cases. It was a salve of some type. 
It was not approved in the United States, it was approved in 
Europe.
    On September 11, 2001, 2002 when they called me up, they 
wanted to give it to us in the United States, give it to 
doctors and United States hospitals but they couldn't because 
they weren't approved to be used. I think that was an FDA 
decision if I am not mistaken. So I called FDA and one day, the 
next day, flamazine was on the way to the Northeast in New York 
and around for use in cases where they run out of every other 
preparatory salve type--and I don't know, I am not using the 
right terms--but medicine that there was. And I thought to 
myself, gosh, that we had all these things but we took so long 
to get to the patients because we never could get through all--
so before we got someone that was really bad, we got through in 
one day. And that shows you what you can do.
    I bragged about the FDA so many times for that because we 
would never get that done but we got it done in one day when 
the whole world was scared about what had happened. We need to 
improve--we don't need to get down to one day approvals. I 
don't think one day of rules on pharmaceuticals would be 
popular or possible, but we ought to get to a situation where 
it doesn't take an absolute emergency or death-defying 
circumstance to cause somebody to move. What can we do to get a 
more agile FDA in terms of getting those things to the 
marketplace and get them approved and through the process?
    Dr. Hahn. Senator, I share your enthusiasm from modernizing 
and making more efficient all of the approval processes. I am 
cognizant that as a physician I rely upon FDA to protect the 
public health and the standards can't be compromised. However, 
I believe in the new era where science is moving so quickly, 
the agency should be more efficient, and we should have more 
agility to actually do those approvals.
    Part of that is in fact getting the right people in place 
to help make the assessments that are needed to uphold the gold 
standard. But part of that is the possibility of using data, 
new ways of using data, data analytics to help us come to more 
accurate and precise conclusions about products. And those are 
two very important things to me that I would like to see, if 
fortunate enough to be confirmed, pushed forward at the agency.
    Senator Isakson. How much difficulty is getting things to 
the marketplace, do you find, from the trial but actually 
scaring off the development new drugs because it is getting 
approved without them. Just some of the manufacturers are 
fierce and they just don't do it. How much did you fear the try 
bar and cause you to get people to say well, we are not going 
to develop a drug. That would be too expensive, too big a risk. 
We are just not going to do it. So they don't do it because the 
fear of being sued or having a liability they couldn't afford.
    Dr. Hahn. Senator, it is a concern. I am not sure that it 
is a primary concern that I have seen from my perspective and 
very much be interested to hear what stakeholders say about 
that and address the problems to the extent that FDA could.
    Senator Isakson. I think you said the magic word on that 
particular case. I think it is to get the stakeholders to the 
table early in the advance of coming up with a solution. Have 
them committed to doing it. I love our system and I love the 
rights I have as a citizen. I love the constitutional 
protections. I respect everybody and every profession. I have 
nothing against law firms whatsoever. But I have seen in action 
the damage that can be done by out-of-control tort liability 
cases by out of control lawyers using that case to accomplish 
ends which aren't always good for the society no matter what 
happens.
    I think if we have a situation where they are blocking the 
expediting or even the tackling of trying to find a solution 
for a problem, that we ought to try everything we can to level 
the playing field, whether it is a waiver of liability because 
the manufacture agrees to do something or whatever might be. I 
think we need to be proactive on that end rather than operating 
in fear. It is my personal opinion.
    Dr. Hahn. Senator, I think being proactive in a lot of 
these fears makes sense. I look forward to working with you on 
it, sir.
    Senator Isakson. Thank you very much.
    Dr. Hahn. Thank you.
    Senator Murray. Thank you, Senator Isakson.
    Senator Casey.
    Senator Casey. Thank you, Ranking Member Murray, and 
doctor, welcome. Sorry I wasn't here earlier for your 
testimony. It is one of those days we are pulled in a couple 
different directions, but grateful that a native Philadelphian 
is here and someone who spent so much time at the University of 
Pennsylvania Medical School, School of Medicine I should say. 
And we are grateful you are willing to put yourself forward for 
public service. And I know your family is with you and they are 
part of that service were you to be confirmed. So thank you for 
that. I wanted to move and I know a vote is just starting so I 
will try to be as brief as I can.
    I wanted to move to a question about legislation that 
Senator Isakson and I have worked on for many years and I am 
grateful for his continuing help on this issue. And that is the 
over the counter monograph issue. We talked about that when you 
and I met. Senator Isakson, Chairman Alexander, Ranking Member 
Murray have worked closely with us for years on this 
legislation. We got it through this Committee recently. We had 
to work with several of your predecessors. We are trying to 
obviously protect public health and promote innovation in the 
OTC, the drug marketplace. And we believe that we are going to 
get this done and get it passed. It will be up to the FDA to 
swiftly implement the legislation. So first question is, if you 
are confirmed, will the OTC monograph reform still be a 
priority for the FDA and will you make it a priority as 
Commissioner?
    Dr. Hahn. Senator, thank you for that question. I am aware 
that it has been many years since there has been an update in 
the OTC monograph system and it, I believe it is in need. I 
believe the agency feels the same way of modernization and I 
commit to working with you. I will faithfully execute the laws 
passed by Congress.
    Senator Casey. I look forward to that and I look forward to 
having more discussions with you about it. Here is another 
version of that question regarding a plan because it is 
possible that if a bill were signed into law but language 
authorizing the collection of user fees is not included in this 
year's Appropriations legislation, basic question I have is 
would you have a plan to deal with that?
    Dr. Hahn. Senator, I think this is a resource issue and I 
would have to dig into the details. My personal belief is that 
the user fee program has been a success with respect to 
expediting products on the market. I have to understand more 
about the finances of the institution and how that would be 
affected by the legislation that you described with the lack of 
inclusion, but I would very much want to work with Congress on 
that.
    Senator Casey. The next and last question I have is on 
challenges facing the FDA. You have got a lot of them obviously 
as any agency does when you are coming in the door, drug 
shortages, lack of new antimicrobial drug development to combat 
growing resistance is the second, a third would be of course 
the ongoing opioid epidemic. How would you, if confirmed, use 
both FDA's capabilities and its regulatory authority to address 
these pressing issues?
    Dr. Hahn. Senator, I feel very strongly that FDA's role in 
protecting the public health on all of these issues is 
critically important to Americans. My general approach is to be 
guided by the principles of integrity and transparency and 
putting the interests of patients first. And if I am fortunate 
enough to be confirmed as Commissioner of Food and Drugs, I 
promise that we will use science data in the law in our 
decision making and that I will faithfully represent that.
    Senator Casey. Doctor, thanks. I am going to be cutting my 
time short so we can move forward but thank you very much.
    Dr. Hahn. Thank you, Senator.
    Senator Murray. Thank you, Senator Casey.
    Senator Roberts.
    Senator Roberts. Thank you, Ranking Member. Doctor, when 
you came to my office it was obvious to me that he was 
certainly qualified. I know here you are supported by the 
American Society for Radiation Oncology, American Association 
for Cancer Research, American Cancer Society Action Network, 
American College of Radiation Oncology, American Hospital 
Association National Organization for Rare Disorders, and the 
American Feed Industry Association. As chairman of the Ag 
Committee, I appreciate that very much. Just say to my 
distinguished friend that we ought to move his confirmation as 
fast as possible if we can talk to leadership to get that done. 
Thank you, sir, for your service.
    Dr. Hahn. Thank you, Senator.
    Senator Roberts. The United States quietly insists on the 
adherence to a risk-based science-based principles when 
evaluating standards for animal health, food, safety, and 
international trade. Last year the FDA received a five-year AMR 
strategic plan, a collection of activities for the stated 
purpose of addressing the potential risk for antimicrobial 
resistance, AMR, from agriculture production. However, her 
concern is that some parts of the FDA's plan take more of a 
hazard based approach where a risk-based approach would be 
better to achieve the best outcomes for animal health and human 
beings. How will you ensure the FDA will follow a risk-based 
approach when implementing all of the five-year AMR strategic 
plan in working, of course, with the animal health industry?
    Dr. Hahn. Yes, sir. Thank you for the question. I am a huge 
fan both in my previous career at Penn and now as a medical 
executive of using a risk-based approach to looking at problems 
and enforcement. I think there has been a long history at FDA 
and that I look very much forward to getting more information 
about the issues that you described and working with you on 
that to assess the role of a risk based versus a hazard based 
approach.
    Senator Roberts. I might add that Senator Baldwin brought 
up on the question on the efficacy of milk. If you just put a 
parenthesis after that in your memory and put meat in there 
too. And you might put impossible in front of it.
    [Laughter.]
    Dr. Hahn. Yes, sir.
    Senator Roberts. Thank you. Animal biotech. I understand 
the FDA is looking at revising its guidance under the 1992 
update to the coordinated framework for the regulation of 
biotech. I understand the need to update and examine the 
framework. Will the revised guidance be consistent with a 1992 
update and is it considering emerging technology such as animal 
gene editing? Do you commit to giving timely and meaningful 
information regarding upcoming update to the industry 
stakeholders?
    Dr. Hahn. I commit to giving timely and accurate 
information. Yes, sir.
    Senator Roberts. My last question is about hemp. Hemp is 
the latest thing with regards to farmers, ranchers, and 
growers, about the only thing we can get above the cost of 
production in a recession. And it has already been asked by 
Senator Rosen with regards to CPD. There are many questions 
about the safety of using these products including interactions 
with other drugs, dosing, even manufacturing standards to 
conform that what is in the bottle is the same as what it says 
and not contaminated with other substances. I have a personal 
interest in this and that I have--I don't know why I am 
bringing this up but I have football knees.
    My wife insists that this little bottle of CBD stuff, that 
if you can put that on your knees, it is going to work. It 
doesn't. Well at least for me it doesn't. But this is being 
used for everything. I am not unaware--or I was going to 
mention Bob Casey, myself, and then you sir, with the 
possibility of growth of hair.
    [Laughter.]
    Senator Roberts. I mean, this is ridiculous. This is the 
last thing since had a call and that really dates me way back 
in the day when that was being a product going across state 
lines. So I know you have started a process to develop a 
framework for how these products might continue to be marketed 
but understand that farmers really want to get into this crop 
because it is a positive thing in terms of price recovery.
    Dr. Hahn. Senator, I think you have described very well the 
balance that is needed here. As you know from a manufacturer 
survey, a significant proportion of Americans are using these 
products and a significant proportion of Americans that are 
using the products think that they are already judged to be 
safe and effective by FDA when they are not. So I think there 
are unanswered questions that need to be filled in my data and 
science and research. I also know that there are signals that 
CBD, for example, can be an effective medical product. And I 
think we have to have a clear and transparent framework for 
assessing them certainly on the medical products.
    Senator Roberts. Let me know.
    Dr. Hahn. Thank you.
    Senator Murray. Senator Smith.
    Senator Smith. Thank you. Thank you, Dr. Hahn, and thank 
you very much for coming in and speaking with me the other day, 
and thanks also to your family for being here. You know, you 
said a couple of times, if I were fortunate enough to be 
confirmed, and I have to say thinking about this job in the 
world we live in right now, I don't know if I would go right to 
fortunate.
    [Laughter.]
    Senator Smith. I think this looks like a really hard job to 
me. I also think that in this job you really are going to be 
between a rock and a hard place. You have said quite a few 
times and I believe you that you are a physician and a 
scientist ruled by science and data and the law, and yet 
colleagues on both sides of the aisle have acknowledged that in 
many circumstances that there are pressures, political 
pressures, political influence I would say, that is going to be 
brought to bear on you. And so I have to ask you, there is an 
open question here. I want to just go back to something that 
Senator Murray was asking you about earlier and ask you whether 
you can say yes or no, whether you would commit to finalizing 
the administration's proposal to clear the market of 
unauthorized flavored e-cigarettes?
    Dr. Hahn. Senator, as I mentioned before, I am aware that 
the final compliance policy is being considered and I just 
can't prejudge that decision at this point. I am not involved 
in that. I don't have the data. Senator, I want to stress to 
you how important I think this issue is and again say to you 
that throughout my career, as you probably know from my record, 
I have been put in situations where I found myself in positions 
of leadership where making tough calls needs to be done that 
aren't popular, that aren't being made in the best interest of 
Stephen Hahn, but in the best interest of the people that I am 
helping, the patients. And I can promise you that I will follow 
that.
    Senator Smith. Would you agree that as head of the FDA, 
that you would have the authority to advance that rule, to 
finalize that rule?
    Dr. Hahn. Senator, I am always hesitant to opine on the 
law, on regulation without having all the facts.
    Senator Smith. I am pretty sure you would have the 
authority. We could all check that but I am pretty sure you 
would. Let me just ask you, are you aware or can you imagine 
evidence on the other side that these candy flavored e-
cigarettes don't contribute to youth addiction to nicotine and 
if that is actually there? Are you aware of any evidence on the 
other side?
    Dr. Hahn. I am not aware of any evidence on the other side, 
Senator.
    Senator Smith. Nor am I. Dr. Hahn let me ask you something 
else. When we met earlier, also, as we were talking about the 
importance of following the science and the data and the 
evidence. We have this issue with the rising price of 
prescription drugs and the FDA has been under pressure to 
expedite the review and approval of generic drugs. And as the 
FDA has approved more generic drugs and more generic drugs have 
come to market, there has been some consequences to this.
    One is these drugs that are manufactured overseas and 
companies are reportedly falsifying data and failing to comply 
with good manufacturing practices. And all of this can lead to 
very adverse outcomes for patients. So let me ask you, how 
would you see following the science and the data to make sure 
that these record approvals don't place the public health at 
risk?
    Dr. Hahn. Senator. This is of critical importance to the 
American people as you have outlined. We must ensure that the 
products that are approved by FDA are safe and efficacious, and 
we must ensure the good manufacturing procedures are followed 
by industry. As part of this is enforcement, I am very 
interested also in looking at what technical assistance FDA can 
provide to manufacturers. I am very interested in advanced 
manufacturing techniques and the processes that are used in 
other Industries and actually how some of that can occur here 
in the United States.
    Senator Smith. Thank you. Well, I think I agree. I think 
this is a very important problem. Another issue I would like to 
quickly raise with you. In March 2020, the FDA will begin 
regulating insulin products as biologics rather than drugs. 
Many of my colleagues have talked about the importance of--
great concern about the price of insulin and this should help 
bring lower-cost insulin products to the market.
    But there is this issue which is that pending insulin 
applications that might not be approved by this deadline in 
2020 and if nothing is done to address this cliff, then these 
pending insulin applications would have to be withdrawn as the 
transition is made to regulating insulin as biologics. And 
Americans could easily be required to wait even longer for 
these medicines to come to the market. So Senators Durbin and 
Kramer and I have a bill that would address this insulin cliff 
and I would just like to ask if you should be so fortunate to 
be confirmed, whether you would be willing to work with us on 
this, what could be a big problem?
    Dr. Hahn. Absolutely, Senator Smith. This could be a big 
problem. Diabetic patients need this life-saving therapy. So I 
do commit to work with you.
    Senator Smith. Thank you very much. Thank you, Mr. 
Chairman.
    The Chairman. [presiding] Thank you, Senator Smith.
    Senator Murkowski.
    Senator Murkowski. Thank you, Mr. Chairman. And Dr. Hahn, 
thank you for the opportunity to visit with you on so many of 
these issues. Thank you for the very clear and open answers you 
have shared with the Committee Members today on a whole range 
of issues. I want to add my voice to that of so many on the 
Committee that have expressed the concern of what we are seeing 
with rising levels of nicotine addiction through e-cigs, 
through the vaping products. Just the dangers that we know with 
kids and nicotine. The fact that we are absolutely going the 
wrong way when it comes to nicotine addiction after making the 
turn if you will on that trend and now to see where we are is 
not only alarming, it is frightening.
    Knowing that you will do everything within your authorities 
should you be confirmed, which I certainly assume you will, you 
will have my support, but to make sure that we are taking off 
the table these products that are designed to entice young 
people. And as they do so, they are addicting our young people. 
So every effort that you make on that, I so appreciate. I also 
want to thank you for some of the comments that you provided to 
Senator Braun as he was asking about how we deal with those who 
are facing these terminal diseases like ALS and a pathway to 
maintain the integrity of the FDA process while also allowing 
our terminal patients access to drugs that help.
    You have given him a commitment on doing all that you can 
to work on these barriers that I think really do deprive so 
many that are terminally ill with the opportunity to try 
something that just might be promising and give them that 
little increment of hope that today might be the day. That with 
this we are going to find a cure. In that vein, one of the 
things that I have learned from all of my interactions with the 
ALS advocates is that patient partnership is really essential 
to move forward in the research and your predecessor had 
committed to the ALS community in meetings with patients that 
he would have patients in every investigational new drug 
meeting.
    I think that making that kind of commitment is important. I 
think that it is important that at these meetings the question 
be asked, who here is the patient at the table to ensure that 
those patient voices are heard throughout the trial process. So 
I would ask that you would make that same commitment with that 
focus toward the patients.
    Dr. Hahn. Senator, I commit with you very much to including 
the patients' voice in the decisions that FDA makes. As a 
cancer provider, we make so much better decisions when the 
patient's perspective is included in those decisions.
    Senator Murkowski. They know more than anyone. They and 
their families. I appreciate that. When we visited, I shared 
with you that most of my colleagues would talk about drug 
pricing and much of this but I want to talk about the food side 
that Senator Baldwin said. The food side for her included the 
dairy food side. For me it is seafood. And we talked about the 
seafood guidance. Back in 2014, FDA published this study on the 
net effects of seafood consumption for pregnant and for nursing 
women, but yet the FDA seafood consumption advice doesn't 
reflect this. Contrary to the Government's own finding, 
effectively FDA relied not on their own research, but on EPA's 
Mercury reference dose, which is a toxicology standard that 
ignores the benefits of seafood in my view and measures risks 
in isolation.
    I have been pushing on this to get the FDA to correct this, 
to reflect the FDA's own science instead of the EPA Mercury 
data. So I would like to know from you whether you are willing 
to put some focus and energy into ensuring that effectively the 
FDA follows its own guidance here, its own science and in 
making sure that we do not send conflicting or confusing 
messages or signals to those pregnant women and to children 
when it comes to proper seafood advice and guidance.
    Dr. Hahn. Senator, I promise to focus energy on it and also 
want to thank you. I enjoyed that discussion very much and had 
a very great discussion with my pregnant daughter about the 
brain food associated with seafoods. And thank you.
    Senator Murkowski. Well, I don't want to throw out 
statistics out here but an average 7.7 percent point increase 
in IQ for babies whose moms ate seafood during pregnancy. You 
want a smart baby, eat that seafood now and in good quantities 
there. And then finally I wanted to raise also with you the 
issue that we face with genetically engineered salmon FDA 
approved for human consumption back in 2015 through the new 
animal drug process, a process that is intended to regulate 
things like veterinary medicine and livestock animals. This is 
the first genetically engineered animal approved by the FDA for 
human consumption. We are in completely new territory.
    A couple of million Americans who have submitted comments 
to the FDA have opposed the approval of the GE salmon. We are 
kind of lost on that. But what we have argued for is that there 
be strong and consistent and clear labeling requirements. So I 
am asking whether you will agree to work toward establishing a 
regulatory system outside of the new animal drug approval 
process that is appropriate for approving genetically 
engineered animals for human consumption?
    Dr. Hahn. Senator, one of the most important things that 
the FDA can do is to ensure the safety of food products for 
Americans and I commit to working with you on this subject.
    Senator Murkowski. I appreciate that commitment to work 
with us on the regulatory system as well as on the transparency 
so that people know what it is that they are actually 
purchasing. With that, I thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murkowski. I think that 
boils down to pregnant women should eat seafood but not 
genetically modified seafood.
    [Laughter.]
    The Chairman. Thank you, Senator Murkowski.
    Senator Kaine.
    Senator Kaine. Thank you, Mr. Chairman. Dr. Hahn, great 
visiting with you the other day. You have big shoes to fill. I 
was a big fan of your predecessor Scott Gottlieb who I voted 
for and I was really impressed with the work he was doing. And 
one of the things that impressed me and it has been raised in 
the hearing so we don't need to go into it, but he was very 
proactive in looking at non-opioid based strategies for dealing 
with pain management. My concern about the FDA is that FDA is 
in sort of a receive mode. When an application comes in then we 
will consider whether to approve a drug or a technique or 
medical device, but I was worried that the FDA was not being 
proactive to look at what had been approved and whether there 
was a real spectrum of pain management strategies available. 
And Scott Gottlieb got right on that in a good way and we 
talked about it. I don't need to ask you about it here because 
others have but I was encouraged by your comments in that way.
    I do want to say an additional word about the e-cigarette 
issue and look you are a dad and you are a lung doctor and you 
have seen this and how debilitating lung disease, lung cancers, 
addictions are to the health, especially health of kids. And I 
am troubled by what my young people tell me about trying to do 
their own research online about the health effects of e-
cigarettes and then finding that the research they have done 
triggers algorithms and social media companies and then they 
get flooded with ads to buy e-cigarettes or talking to school 
administrators who kind of throw up their hands and say, gosh, 
we don't have the experience in dealing with how to help a 14 
year old break an addiction.
    We just have been dealing with that and now they are having 
to deal with it. So this is dire and the hearing last week made 
me deeply concerned that the Trump administration was going to 
do a 180 on the proudly announced policy from September that we 
were going to clear unauthorized flavors from market until 
there was a process by which they could be authorized if they 
were safe. You have been asked about that but here is what I do 
want to go into a little bit more, nicotine levels. Nicotine 
levels because we can learn from not only research that is 
taking that other place around the world but even the 
experience of other public policy positions.
    In 2016, the UK implemented an EU directive restricting the 
capacity of e-cigarette tanks, or the maximum volume of 
nicotine containing e-liquid for sale on a refill container and 
e-liquid nicotine strength to no more than 20 milligrams per 
milliliter. So that is an EU policy that the UK has embraced. 
And there is other labeling and packaging requirements as well. 
But just to compare that 20 milligram per milliliter limit, a 5 
percent nicotine Juul pod sold in the United States contains 59 
milligrams per milliliter and that is not because of some 
limit, it can contain 75, it can contain 150. There isn't a 
limit.
    The UK and EU have not seen the youth epidemic and they 
have not seen the vaping linked to illnesses to the extent that 
we have. I think I couldn't say that they have not seen any 
challenges but they have not seen them to the extent that we 
have and since nicotine is one of the most addictive substances 
there is, I think there is strong suggestion that the nicotine 
limitation that they put in place as one of the reasons that 
they may not have seen some of the problems that we are seeing. 
As Senator Alexander mentioned in response to testimony or his 
questions last week, the head of the program at the FDA 
indicates the FDA currently does have the authority to 
promulgate regulations setting standards for nicotine yields 
and other characteristics of the e-cigarette devices.
    You pledged here to focus on the science and go where the 
science goes. I would like your commitment to look at the 
science around nicotine levels and to consider whether 
limitations on nicotine to protect the public health are part 
of a comprehensive strategy that we should be embracing as we 
deal with this epidemic.
    Dr. Hahn. Senator, you have my 100 percent commitment to 
the science and data on the subject of nicotine levels. As we 
discussed, there is a lot of great research going on in this 
area and I think where the data and science take us, we should 
go.
    Senator Kaine. Thank you so much for that commitment. I 
have one more topic. We have a very unusual, to my way of 
thinking, a very unusual problem in this country that is 
getting more and more attention and it deals with maternal 
health. Our maternal mortality statistics, death of moms while 
they are pregnant or during the first year of a child's life 
are bizarre when compared with other nations. Given that we 
have wealth and we have some of the best medical institutions 
and some of the best medical professionals, we shouldn't be 
where we are in maternal mortality.
    Moreover, the gaps in those mortality statistics between 
Caucasian and minority populations are really, really 
frightening. Even if you control for income, you find that high 
income Latina and African-American moms are experiencing more 
maternal mortality at a just shocking rate. There is an 
organization, intergovernmental panel called the Task Force 
Specific to Research and Pregnant Women and Lactating Women, 
and the FDA is already a partner in this effort. Will you 
commit to continuing the FDA playing the role that it can in 
helping us solve this problem?
    Dr. Hahn. I commit. This is a terrible, and I agree, 
heartbreaking problem, and I commit to that.
    Senator Kaine. Thank you very much. Thanks, Mr. Chairman.
    The Chairman. Thank you, Senator Kaine.
    Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman. Thank you for 
allowing a second round of questions. Dr. Hahn you were asked 
by both Democrats and Republicans this morning about your 
ability to stand up to potentially the President in view of his 
reversal on policy related to flavored vaping products, your 
ability to stand up to powerful corporate interests who are 
going to be lobbying and cajoling around their bottom line and 
hope for profits. I know it is hard to answer a hypothetical 
about how you would pursue and advocate for children's health 
over these other interests. Can you describe an instance in 
your past management experience where you have had to stand up 
to a directive that you think is wrong and push for a data and 
science-based approach?
    Dr. Hahn. Senator, in my career as a physician and in my 
career as a researcher and then as a medical executive there 
have certainly been situations where recommendations have been 
made that in my opinion weren't always in the best interests of 
patients, for whatever the reason and the motivation. I am 
going to say this again, Senator, and I so appreciate your 
bringing this up. I am deeply, and I mean deeply committed to 
my patients and the public health of the American people. That 
is the most important and awesome responsibility of FDA and I 
commit to you that I will stand up for that.
    Senator Baldwin. Thank you. You have had some questions 
already about drug shortages. We had the opportunity to discuss 
a shortage of a different type of in this case a radioisotope 
that is used in imaging and diagnostics. I wonder if you can 
talk about what the impact would be if there were increased 
shortages in the supply of the medical isotope known as Molly 
99, molybdenum is I think how you accurately pronounce the 
longer title but Molly 99 is what it is referred to.
    It is used in 40,000 medical scans each day in the United 
States to diagnose urgent heart conditions and provide early 
detection and enable treatment of cancer. We have a very 
fragile supply chain for this critical medical isotope. As a 
radiation oncologist, can you describe how you have used Molly 
99 in your work and how a shortage could harm patient access to 
crucial diagnostic imaging and treatment?
    Dr. Hahn. Senator, thank you for that question. You are 
right. As a radiation oncologist and as an oncologist in 
general, this is an important compound, technetium. My personal 
practice experience has been on the imaging side of this and it 
is very interesting you bring that up because I have been in 
clinical situations where we have had to delay diagnostic tests 
because of a shortage of technetium. So it is critically 
important for decision making on the diagnostic side. I would 
love to have a conversation with you about maybe the pragmatic 
way of approaching this, the great research that was going on 
at the University of Wisconsin to help solve this problem, and 
I look forward to addressing these issues in a proactive 
manner.
    Senator Baldwin. Thank you. Lastly, we have had a lot of 
discussions about the high price of many prescription drugs 
that are life-saving or life-extending in nature. So, Dr. Hahn, 
do you believe that drug companies are setting prices too high?
    Dr. Hahn. Senator, I don't spend a lot of time on the price 
side as an oncologist. What I can tell you is that rarely a day 
goes by where this isn't an issue that is addressed by 
patients. But also in academic institutions, the pressure on 
the prices of drugs is substantial. I mean, it is an urgent 
issue and the American people want us to act on this. So I 
think there are some actions that FDA can do, particularly an 
indirect way of stimulating innovation and competition. And I 
am very interested in those because I think that is important 
to the American people, and ultimately this gets to an access 
issue. And sometimes an access issue for our most underserved 
and we have to address that.
    Senator Baldwin. The President has signaled a degree of 
support for importation. Do you believe that we should move 
forward with a plan to allow the safe importation of 
prescription drugs?
    Dr. Hahn. Senator, this gets back again to the issue of 
data and science. The FDA's role in this as, you know, Senator 
is to assess the safety and security of the Nation's drug 
supply, which is the best, safest, and most secure in the world 
and something we are all proud of. I look forward to looking at 
the data associated with that and giving that information to 
the Secretary who is responsible for certifying to Congress. I 
am open to all science and data that could potentially support 
that as a solution.
    Senator Baldwin. Thank you.
    Dr. Hahn. Thank you.
    The Chairman. Thank you, Senator Baldwin. Senator Jones is 
trying to come back so we are going to wait on him. In the 
meantime, I have got a couple of areas I would like to explore. 
Let me go back to the vaping issue. Assuming you are confirmed, 
hopefully that will happen before the end of the year, and you 
will be on the job, you will be in the midst of a--the FDA will 
be in the midst of a review with the Center for Disease Control 
on why these mysterious diseases have been occurring in lungs 
around the country as related e-cigarettes, and there is some 
evidence of THC, there is some evidence of vitamin E oil, but 
it would seem to me that is one area that there should be no 
hesitancy about the administration moving ahead rapidly to deal 
with this.
    I mean nobody on this Committee, Republican or Democrat, 
who doesn't want to see that problem related to e-cigarettes 
resolved. And second, I think it has been emphasized by many of 
the Senators here both Republican and Democrat that the FDA 
already has the authority to take significant steps to more 
effectively combat the use of e-cigarettes by high schoolers 
and middle schoolers. Already this Committee by a vote of 22 to 
3 has agreed to increase the tobacco buying age from 18 to 21, 
which should be of some help.
    We are talking about teenagers all of whom shouldn't be 
able to buy tobacco products at all. So I would hope that there 
would be some sense of urgency by the FDA under your leadership 
to use the authority you already have to deal with the epidemic 
that we have seen of young people using e-cigarettes and of the 
lung diseases that are occurring related to e-cigarettes. Now, 
two other areas that--one is pain. You should be an expert in 
pain giving your background.
    We worked through the opioids legislation here and as I 
mentioned earlier, we had 70 Senators with 72 proposals. That 
was a huge response to the epidemic. Many ideas and I did my 
best and Congress ended up agreeing generally with it to resist 
having the Federal Government establish a lot of hard and fast 
rules that would override what states would decide or what 
doctors or hospitals would decide about prescribing opioid 
medicine. The Centers for Disease Control came out with some 
guidelines that many doctors and hospitals apparently found it 
convenient just to automatically adopt both for acute people 
who had acute pain and people who had chronic pain.
    That concerned me a lot because it seemed to me that in 
some cases, I mean I am sure some of your patients--and I guess 
I shouldn't put words in your mouth. Let me just ask you a 
question, in your practice, was it true that some of your 
patients were prescribed opioids as a painkiller and for more 
than three days or five days?
    Dr. Hahn. Absolutely, Senator.
    The Chairman. What was the policy that you used in your 
leading cancer organization to deal with these?
    Dr. Hahn. To relieve human suffering, Senator.
    The Chairman. What would be typical of a prescription of 
opioid? Can you give me an example or two of how a physician 
might appropriately prescribed opioids that might be 
inconsistent with the Center for Disease Control guidelines?
    Dr. Hahn. Senator, I can't speak to practices that would be 
inconsistent per se with the guidelines. What I can tell you is 
that most of us in oncology are using an evidence-based 
approach which is a multidisciplinary. So behavioral 
approaches, opioids, non-opioids, pain medicine now is a very 
sophisticated practice. We had experts at MD Anderson that I 
refer many of my patients to and there are many different 
options that are available now to give----
    The Chairman. Rather than your person? Having that you have 
a specialist who makes the decision about----
    Dr. Hahn. Correct. And they are experts in this and they 
use opioid and non-opioid. And they are very cognizant of the 
addictive and the misuse and the diversion aspects to this. 
Every patient is an individual and these treatment decisions 
are individualized by our experts.
    The Chairman. What would be based upon your background and 
experience, what is your estimate of the potential for the 
discovery of treatments for non-addictive pain medicine? This 
Committee and Congress put a lot of money and encouragement 
behind the research on non-addictive pain medicine. What about 
that? Is that practical? Is that likely to happen?
    Dr. Hahn. Mr. Chairman, definitely practical and definitely 
I believe likely to happen. Great research is being done in 
pain. I think it will allow us to use the precision medicine 
techniques we use on other diseases for pain. So we will have 
targeted therapies in the future for this. I am not a pain 
expert by training but I have seen much of this research and I 
am really very optimistic about the path forward.
    The Chairman. My fear was that the, in our country when we 
get a fever, we all go one way until we do something and that 
usually creates a counter action. And my fear was that the need 
we had to deal with opioids, fentanyl, and other medicines like 
that would somehow interfere with the ability of physicians to 
prescribe pain medicine to patients who really needed that and 
that we would go too far. I have one other question and then I 
will go to Senator Jones. Do you--often in this Committee we 
ask the FDA, is there any way we could use the work that is 
done by other countries whose processes we respect, Japan, 
Great Britain, Canada, others, for example, to shorten the 
period of time that it takes for treatments and cures to go 
through our FDA system and still have the gold standard? In my 
opinion, we talked about imported drugs in a misleading way 
because we import all kind of drugs all the time.
    The key is not whether medicines are made in other parts of 
the world, plenty of them are, but as you pointed out in your 
testimony, if they are manufactured anywhere, they have to have 
an FDA approval at the manufacturing place and the supply chain 
has to be approved by the FDA. So we import that--couldn't we 
shorten the period of time that it takes to gain approval of 
the life-saving treatment or cure by taking more advantage of 
the work done in other countries on the same subject?
    Dr. Hahn. Senator, I believe it is possible. I would like 
to know more about this because as you point out we need to 
make sure that the gold standards maintained, but I am open to 
having conversations that science and data would provide to go 
in that direction.
    The Chairman. Senator Jones.
    Senator Jones. Thank you, Mr. Chairman, and also, I would 
be remiss if I didn't recognize the Chairman's very skillful 
use of rope-a-dope to try to get me back here to ask these 
questions. I very much appreciate that. Dr. Hahn, thank you. 
Thank you for all you have done. Thank you for your willingness 
to serve. I have got one question and I want to make a comment 
before I close.
    We talked about data and you have mentioned that a whole 
bunch about the use of big data to help in this job should you 
be confirmed. We seem to be collecting more and more data in 
everything we do these days. I think that FDA has made great 
strides in that but from your perspective, how can the use of 
big data--where do you see that going and how can it help us 
and help the job of the FDA getting drugs to market quicker, 
getting the appropriate drugs to market? How can that help you?
    Dr. Hahn. Senator, thank you for that question. I am 
incredibly enthusiastic about the big data efforts that are 
going around the country as we discussed many places, including 
in your home state, are looking at these approaches to actually 
help patients. I believe there is great value there. We need 
expertise at the FDA, if I am fortunate enough to be confirmed. 
And we need the advanced data analytics to let us do that. I 
think there is a balance as you describe make sure that the 
data are accurate, that there is a lot of fidelity around them, 
but let's try to use those to expedite the processes to get 
innovative products in the hands of Americans. I am 
enthusiastic about that, sir.
    Senator Jones. Great. Well, thank you for that. I am going 
to forego some of the other questions I have got on biosimilars 
and others and I may submit them for the record, but I feel 
compelled to make a comment, Dr. Hahn, because I was very 
impressed with you. I told you that your enthusiasm for this 
job is very infectious sometimes and I appreciate that and I 
appreciate all you have done in your career. But I will tell 
you that I was less than happy with many of the answers you 
gave to Members of this Committee with regard to vaping and the 
potential ban on flavored e-cigarettes and those things. I 
thought that was very--I just don't think that was you. I think 
it was prout from handlers that kept going back to science and 
data.
    I think you could tell from the questions of so many 
Senators that is one of the biggest issues that the U.S. Senate 
and the Congress is facing right now. It is at the top of our 
agenda. It is with this Committee. We want to see something 
happen. From where I sit the data is in, the evidence is in. It 
is really strong. You are a lung cancer doctor.
    You have been in this position before and I am really 
concerned that the administration has prepped you in a way that 
is not you to give you an out of dodge and bob and weave a 
little bit and I am just being candid with you, sir. I thought 
the, if you are basing things on evidence and science, I think 
that is great. You should be doing that. But it seems pretty 
clear to me and I think the administration has pulled back on 
this right now. It is not a good thing for the health of young 
people and the health of Americans.
    I think we have seen it before, though. I think we have 
seen the pullback on potential issues concerning gun violence 
that the administration said that they would support following 
mass shootings in the killing of a lot of Americans and then 
all of a sudden when a lobbyist and people get to them, they 
seem to pull back instead of finding common sense and the 
courage to do things, it actually goes out the window. This is 
going to require some courage. This is a big industry out there 
that has got a lot of money invested and it is going to require 
some courage to pull back and say you are damaging the health 
of so many children in this country, much less adult. You are 
damaging that and I think you know that. And I think the 
question becomes not how we go about banning these, it is just 
a question--the question is how we go about doing it, it is not 
a question of if we go about doing it.
    I am going to submit another question for the record, sir, 
and that question is simply going to be to get you to review 
your answers and ask you to give a more thoughtful and 
opinionated--personal opinion, not about the details of a rule 
but about whether or not that this opinion, that what the 
administration has pulled back now is right or wrong and 
whether or not these flavors should be banned right now in 
order to protect the health of our children and the health of 
many Americans.
    I am not asking for a comment or an answer now but given 
what I thought was a really good meeting with you and my 
wanting to support this, I just felt compelled to tell you how 
disappointed I was in the answers to at least five or six 
Senators, and maybe more. So with that, thank you for being 
here. Thank you for your willingness to serve. And Mr. 
Chairman, thank you very much for giving me the opportunity to 
scoot back from those folks.
    The Chairman. Thank you, Senator Jones. Dr. Hahn, I think 
this will--I think we will wrap up the hearing. This has been 
from my point of view a very good exchange of views. You can 
see we have 23 Members of very different points of view here on 
this Committee. We don't agree on everything but we work pretty 
hard to find those things that we do agree on and I would 
encourage you, if you are confirmed which I believe you will 
be, to work with both the Democratic and Republican Members of 
the Committee to look for areas of agreement. I too am 
concerned about the vaping epidemic among high school students 
and middle school students. Just speaking as one Senator, I 
don't expect you to be able to state the position of an 
administration of which you are not yet a part.
    I mean, I don't see how you could do that. And from my 
point of view, I am glad to have as a candidate for the head of 
the Food and Drug Administration someone with as distinguished 
a background in clinical medicine, oncology, the science of 
cancer and lungs, and tobacco as a voice that would be in the 
highest councils of an administration on what to do about the 
vaping epidemic.
    I am glad you are willing to be there and look forward to 
supporting you. If Senators wish to ask additional questions to 
the nominee, those questions for the record will be due by 5 
p.m. on Friday, November 22d. It is my intent to schedule a 
markup of Dr. Hahn's nomination on December 3d, after we return 
from Thanksgiving.
    For all other matters, the hearing record will remain open 
for 10 days. Members may submit additional information for the 
record within that time.
    [The information referred to an be found on page 42]
    The Chairman. Thank you for being here. The Committee will 
stand adjourned.

                          ADDITIONAL MATERIAL

                  letters of support for stephen hahn
       The American Society for Radiation Oncology,
                         251 18th St. South, Arlington, VA,
                                                  November 6, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    The American Society for Radiation Oncology (ASTRO), \1\ on behalf 
of our 11,000 members of the radiation oncology team, strongly supports 
the nomination of Stephen Hahn, M.D., FASTRO, as Commissioner of the 
Food and Drug Administration.
---------------------------------------------------------------------------
    \1\ ASTRO members are medical professionals practicing at hospitals 
and cancer treatment centers in the United States and around the globe. 
They make up the radiation treatment teams that are critical in the 
fight against cancer. These teams include radiation oncologists, 
medical physicists, medical dosimetrists, radiation therapists, 
oncology nurses, nutritionists and social workers. They treat more than 
one million cancer patients each year. We believe this multi-
disciplinary membership makes us uniquely qualified to provide input on 
the inherently complex issues related to Medicare payment policy and 
coding for radiation oncology services.

    Dr. Hahn is highly qualified to be the next FDA Commissioner, and 
---------------------------------------------------------------------------
he enjoys the strong support of his specialty and other stakeholders.

    A culture of safety is woven into the fabric of radiation oncology, 
making Dr. Hahn uniquely suited to further FDA's mission of protecting 
the public health. At the same time, Dr. Hahn's experience using some 
of the most sophisticated medical devices in health care gives him 
insight and expertise to drive progress for the benefit of patients and 
consumers. He is also extremely well-versed on the drug, biologic and 
device development pipeline, demonstrated by his role in developing 
multiple medical products.

    Dr. Hahn, who obtained the rank of Commander in the U.S. Public 
Health Service, is trained in radiation oncology, medical oncology and 
internal medicine, and he has broad knowledge as a clinician, 
researcher, educator and administrative leader. In his roles as a 
physician leader and executive at premier medical centers, Dr. Hahn has 
proven himself as a remarkably talented physician and cancer 
specialist. He is exceptionally versatile in his understanding of 
medicine and public health and would bring enormous energy and 
creativity to the role of FDA Commissioner.

    Dr. Hahn previously served on the ASTRO Board of Directors, 
spearheading innovative educational initiatives, such as the creation 
of a leadership development program focused on diversity and steering 
the selection of top science for ASTRO's Annual Meeting, the leading 
meeting dedicated to radiation oncology and patient care in the world.

    The public health of United States citizens faces incredible 
challenges, and the FDA needs a strong leader who can inspire the 
agency and confront difficult and controversial matters directly. Dr. 
Hahn has demonstrated the impressive ability to do both. He has the 
ability to make great institutions greater and drive measurable 
cultural change when it's needed most. Dr. Hahn asks the tough 
questions and builds consensus, bringing to bear intelligence and 
expertise in an engaging style.

    His clinical expertise and international recognition in treating 
lung cancer gives him the ability to tackle some of the toughest issues 
faced by the FDA. His familiarity working with Federal grantmaking 
agencies gives him the understanding necessary to navigate the 
regulatory environment to advance important initiatives that balance 
innovation and safety.

    Dr. Hahn has an extraordinary track record of patient-centered 
leadership and service. He is the right choice to accelerate the 
critical work of the FDA.

    To take a major step forward in protecting the public health of 
Americans, we urge you to vote in favor of Dr. Hahn's nomination.

            Sincerely,
                                         Laura I. Thevenot,
                                   Chief Executive Officer,
                       The American Society for Radiation Oncology.
                                 ______
                                 
                     American College of Radiology,
                                                  November 7, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    The American College of Radiology (ACR) \1\ urges the Senate to 
confirm the nomination of Stephen Hahn, M.D., to serve as Commissioner 
of the Food and Drug Administration (FDA). With his broad knowledge as 
a clinician, researcher, and educator, Dr. Hahn is uniquely qualified 
to lead the agency.
---------------------------------------------------------------------------
    \1\ The American College of Radiology is a professional 
organization representing more than 38,000 radiologists, radiation 
oncologists, interventional radiologists, nuclear physicians, and 
medical physicists.

    His research spans topics including lung cancer, cancer 
immunotherapies, and brain tumors, positioning him at the forefront of 
topics affecting the FDA. Dr. Hahn's experience with sophisticated 
medical devices in healthcare also provides an insight to its 
---------------------------------------------------------------------------
utilization and safety for patient care.

    His role as Chief Medical Executive at the University of Texas MD 
Anderson Cancer Center and his prior service at the National Cancer 
Institute makes him an asset to the FDA's mission of advancing public 
health.

    For the aforementioned reasons, Dr. Hahn would make an astounding 
FDA Commissioner and ACR fully supports his nomination.

            Respectfully,
                                   William T. Thorwarth Jr.
                                             MD, FACR, CEO,
                                     American College of Radiology.
                                 ______
                                 
          American College of Emergency Physicians,
                          2121 K Street NW, Washington, DC,
                                                 November 15, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    On behalf of the American College of Emergency Physicians (ACEP) 
and our 40,000 members, I would like to express our strong support for 
the nomination of Stephen Hahn, M.D., FASTRO, to become the next 
Commissioner of the U.S. Food and Drug Administration (FDA).

    Dr. Hahn's appointment comes at a time when emergency physicians, 
emergency departments, and emergency medical services are facing 
substantial challenges obtaining essential medications for our 
patients, which is significantly hindering our ability to deliver high-
quality care. The shortage crisis in emergency medicine affects drugs 
across all classes of medications. As of September 2019, there were 92 
preparations of 45 emergency care medications that are in shortage, 
including most forms of adenosine, atropine, bicarbonate, calcium, 
dextrose, dopamine, epinephrine, fentanyl, furosemide, labetalol, 
lidocaine, magnesium, lorazepam, and paralytic agents. These shortages 
have resulted in delayed care, higher costs, reduced time for patient 
care, and increased risk to patients when alternative medications and 
dosages must be used.

    While important strides have been made since the height of the drug 
shortage crisis in 2012 and the subsequent enactment of the Food and 
Drug Administration Safety and Innovation Act (FDASIA), physicians are 
still experiencing a greater intensity of current shortages. Because of 
our first-hand involvement with this issue, ACEP was proud to take a 
lead role is supporting the efforts by Senators Bill Cassidy (R-LA) and 
Chris Murphy (D-CT), as well as Representatives Brett Guthrie (R-KY) 
and Mike Doyle (D-PA), in obtaining the signatures of 31 Senators and 
107 House members urging the FDA to establish a task force that would 
identify the root causes of drug shortages and develop subsequent 
recommendations to address them.

    When the FDA's Drug Shortages Task Force released its report on 
October 29, 2019, it identified three primary causes of drug shortages 
and recommended specific solutions to address these underlying 
concerns. ACEP believes that Dr. Hahn will make a great partner in 
working through these issues and helping us to obtain the medications 
that our patients so desperately need.

    ACEP appreciates Dr. Hahn's dedication to patients, his 
understanding of the FDA's complex regulatory issues, and his 
commitment to working with the relevant stakeholders to ameliorate 
essential medication shortages.

            Sincerely,
                                         William P. Jaquis,
                                          MD, MSHQS, FACEP,
                                                    ACEP President.
                                 ______
                                 
                           The University of Texas,
                         MD Anderson Cancer Center,
                      1515 Holcombe Boulevard, Houston, TX,
                                                 November 15, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    On behalf of the faculty and staff of The University of Texas MD 
Anderson Cancer Center, I am writing to express my full support of Dr. 
Stephen Hahn to be the Commissioner of the United States Food and Drug 
Administration (FDA) at the Department of Health and Human Services. I 
am confident in Dr. Hahn's ability to successfully lead the FDA as the 
U.S. Senate considers his nomination.

    Throughout his career, Dr. Hahn has proven to be a trusted leader, 
with the highest integrity, committed to both caring for patients and 
advancing his field through scientific research. As a physician 
scientist, Dr. Hahn knows the importance of protecting public health 
and ensuring that new discoveries rapidly translate into safe and 
effective products that enhance and improve overall health, reduce 
health burdens and save lives.

    Dr. Hahn's experience at MD Anderson includes leading more than 
1,700 faculty members working in a clinical enterprise that sees over 
one million patients a year. Additionally, during a time of leadership 
transition at the institution, Dr. Hahn led the largest cancer center 
in the country, with 21,000 employees, 1,250 clinical trials, greater 
than $800 million in research expenditures and an operating budget of 
more than $4 billion at the time. Dr. Hahn boldly took on these 
challenges and demonstrated success offering our entire community the 
opportunity to see him as a resilient leader with the intellect, 
emotional intelligence and drive necessary to succeed in a dynamic, 
multi-dimensional organization, similar to the FDA.

    I respectfully request your full consideration of Dr. Hahn, and 
would be happy to discuss my support at length with you and your 
colleagues in the U.S. Senate.

            Sincerely,
                                          Peter WT Pisters,
                                                         President.
                                 ______
                                 
                       Alliance for Aging Research,
                          1700 K Street NW, Washington, DC,
                                                 November 18, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    On behalf of the Alliance for Aging Research (Alliance), I am 
pleased to offer our strong support to Dr. Stephen Hahn for his 
nomination to serve as Commissioner of the U.S. Food and Drug 
Administration (FDA). The Alliance is the leading non-profit 
organization dedicated to accelerating the pace of scientific 
discoveries and their application to improve the experience of aging 
and health. For more than 30 years, the Alliance has guided efforts to 
substantially increase funding and focus on aging at the National 
Institutes of Health (NIH) and FDA; built influential coalitions to 
guide groundbreaking regulatory improvements for age-related disease 
clinical development and access to care; and created award-winning, 
high-impact educational materials to improve the health and well-being 
of older adults and their family caregivers.

    The Alliance is confident that Dr. Hahn possesses the 
qualifications that make him the right person for the esteemed role of 
FDA Commissioner. In his leadership roles as chief medical executive at 
The University of Texas MD Anderson Cancer Center, chair of the 
Radiation Oncology at the University of Pennsylvania School of 
Medicine, chief of the Department of Prostate Cancer Clinic at the 
National Cancer Institute at the NIH, Commander in the U.S. Public 
Health Service, researcher--and, perhaps most importantly as a 
clinician--Dr. Hahn has shown outstanding dedication to improving and 
protecting the health of patients.

    As chief medical executive at The University of Texas MD Anderson 
Cancer Center, the largest cancer center in the U.S., Dr. Hahn oversees 
hundreds of clinical trials as well as clinical care for more than 
141,000 patients annually. He is well-versed in, and has published on, 
the importance of involving representative populations, including older 
adults, in research studies in order to truly understand the impact of 
a potential drug or medical product on the primary groups likely to use 
the product under study. Dr. Hahn has been a vocal advocate for 
comparative effectiveness research, which is a top priority for the 
Alliance. He recognizes the importance of identifying what treatment 
approach works for which patient and under what circumstances and 
conditions. He has additionally been outspoken with colleagues about 
the value of research that predicts or enhances treatment response--
innovation that will significantly benefit patients and society. The 
Alliance is confident that given the opportunity as FDA Commissioner, 
Dr. Hahn will continue to advocate for and prioritize patient-centered 
research.

    Throughout his career, Dr. Hahn has prioritized transparency in the 
implementation and evaluation of medical research, development, and 
treatment. A broad openness to transparency at the top level is 
critically important for the Federal agency in charge of assessing the 
safety and effectiveness of new medical products that may harm or heal.

    The FDA Commissioner is a public servant, who must be committed to 
improving the health of the public. This is a role with which Dr. Hahn 
is very familiar. He held the rank of commander in the U.S. Public 
Health Service Commissioned Corps while working at the National Cancer 
Institute, a position dedicated to protecting and improving public 
health. The rapidly aging population deserve to have allies in top 
roles within the Federal Government who will advocate for their health 
and well-being and inclusion in the process. The Alliance is confident 
that Dr. Hahn is this ally.

    If you have any questions about our support for Dr. Hahn, please do 
not hesitate to contact me. We thank the Committee for your 
consideration of his nomination.

            Sincerely,
                                             Susan Peschin,
                                                       MHS,
                                                 President and CEO.
                                 ______
                                 
                          Former FDA Commissioners,
                                                 November 19, 2019.
Hon. Mitch McConnell, Majority Leader,
U.S. Senate,
Washington, DC.
Hon. Charles Schumer, Democratic Leader,
U.S. Senate,
Washington, DC.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Leader McConnell, Leader Schumer, Chairman Alexander and 
Ranking Member Murray:

    As former Commissioners of the Food and Drug Administration, we are 
writing to provide our perspectives on the Committee's consideration of 
the nomination of Dr. Stephen Hahn as Commissioner of Food and Drugs.

    We appreciate the Committee's prompt consideration of Dr. Hahn's 
nomination. As four of us previously wrote to the President and 
Secretary Azar in urging a timely nomination, the FDA urgently needs a 
well-qualified permanent Commissioner. The FDA regulates up to one-
quarter of the US consumer economy, including potentially life-saving 
therapies and most of the Nation's food supply, and is constantly under 
pressure to adapt to changes in science and public health threats. The 
agency has a dedicated and talented professional staff to carry out its 
mission, but a permanent Commissioner provides the support needed to 
enable that work. The absence of a confirmed Commissioner complicates 
their ability to undertake and sustain the FDA's continuously evolving 
role in protecting and promoting the health of Americans.

    We believe Dr. Hahn has the experience and commitment to public 
health and public service needed to provide this leadership. He has 
extensive public-sector experience in clinical research, serving at the 
National Cancer Institute for seven years, including as an officer in 
the US Public Health Service. He also has significant expertise in the 
conduct of the biomedical research that FDA regulates, with more than 
200 peer-reviewed publications and multiple patents from his career in 
academic medicine. Finally, he has extensive executive leadership 
experience at both the University of Pennsylvania School of Medicine 
and at the M.D. Anderson Cancer Center.

    This is a critical time for public health and for leadership on the 
many challenging issues and opportunities facing the FDA and the 
Nation. We hope that Dr. Hahn will be able to bring his clinical 
expertise, leadership experience, and commitment to public service and 
science to the FDA as soon as possible.

            Sincerely,
                                          Robert M. Califf,
                                                M.D., MACC,
                                        FDA Commissioner 2016-2017.
                                            Scott Gottlieb,
                                                      M.D.,
                                        FDA Commissioner 2017-2019.
                                          Margaret Hamburg,
                                                      M.D.,
                                        FDA Commissioner 2009-2015.
                                            Mark McClellan,
                                                      M.D.,
                                       FDA Commissioner, 2002-2004.
                                  Andrew C. von Eschenbach,
                                                      M.D.,
                                        FDA Commissioner 2006-2009.
                                 ______
                                 
                      American Medical Association,
                AMA Plaza, 330 N. Wabash Ave., Chicago, IL,
                                                 November 20, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    The American Medical Association (AMA) is very pleased to offer our 
strong support for the nomination of Dr. Stephen Hahn, M.D., FASTRO, to 
serve as the Commissioner of the Food and Drug Administration (FDA).

    As you know, Dr. Hahn's impressive resume shows significant 
leadership experience in academic medical settings. Dr. Hahn has been 
widely praised for his work at MD Anderson Cancer Center, one of the 
Nation's premier oncology providers, where he assumed the role of Chief 
Medical Executive after several years leading MD Anderson's radiation 
oncology unit. Throughout his career, Dr. Hahn has held numerous 
management positions and has positively navigated a number of 
challenges. Dr. Hahn is credited with ``righting the ship'' at MD 
Anderson during a time of financial strain. Furthermore, while at MD 
Anderson, Dr. Hahn has been well regarded for his handling of several 
high-profile controversies. Such leadership and management experience 
at such a renowned institution as MD Anderson is excellent training for 
leading the FDA.

    Dr. Hahn specializes in radiation oncology, receiving his medical 
degree from Temple University, with residency training at the 
University of California San Francisco and the National Cancer 
Institute in Bethesda, Maryland. He is board certified in both 
radiation oncology and medical oncology. Dr. Hahn spent a significant 
portion of his career at the University of Pennsylvania, serving as 
division head and ultimately department chair of the university's 
radiation oncology unit. He has played an active role in organized 
medicine; he is an AMA member, and is affiliated with the American 
Society of Radiation Oncology and the American Society of Clinical 
Oncology.

    The AMA believes Dr. Hahn's expertise makes him well suited to be a 
successful Commissioner of the FDA. We look forward to his prompt 
consideration and confirmation in the Senate.

            Sincerely,
                                       James L. Madara, MD,
                                     Executive Vice President, CEO.
                                 ______
                                 
                      Seattle Cancer Care Alliance,
                         825 Eastlake Ave., E. Seattle, WA,
                                                 November 19, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    On behalf of the Seattle Cancer Care Alliance, I am writing to 
express support for the nomination of Dr. Stephen Hahn to serve as the 
commissioner of the United States Food and Drug Administration. If 
confirmed, we believe Dr. Hahn will be a thoughtful advocate for cancer 
patients.

    Dr. Hahn has devoted his career to caring for cancer patients, 
discovering breakthrough radiation oncology treatments, and teaching 
the next generation of physicians and caregivers. As a clinician and 
teacher, he has demonstrated an understanding of the value of advanced 
cancer therapies, the promise of breakthrough anti-cancer drugs, and 
the impacts they can have on cancer patients. As an administrator, Dr. 
Hahn is equally mindful of balancing the value proposition of 
innovative treatments with appropriate cost-containment policies.

    Dr. Hahn's clinical and research expertise, administrative 
experience, and commitment to patient care make him an excellent choice 
to lead the FDA. For these reasons, we respectfully urge the Committee 
to confirm his nomination.

            Sincerely,
                                            Nancy Davidson,
                      MD, Executive Director and President,
                                      Seattle Cancer Care Alliance.
                                 ______
                                 
                          Cancer Support Community,
                        734 15th Street NW, Washington, DC,
                                                 November 21, 2019.
Hon. Mitch McConnell, Majority Leader,
U.S. Senate,
Washington, DC.
Hon. Charles Schumer, Democratic Leader,
U.S. Senate,
Washington, DC.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Leader McConnell, Leader Schumer, Chairman Alexander and 
Ranking Member Murray:

    The Cancer Support Community (CSC), an international nonprofit 
organization that provides support, education, and hope to people 
impacted by cancer, supports the nomination of Dr. Stephen M. Hahn as 
the next Commissioner of the Food and Drug Administration (FDA) and 
urges the Senate to vote in favor of his confirmation.

    As the largest direct provider of social and emotional support 
services for people impacted by cancer, and the largest nonprofit 
employer of psychosocial oncology professionals in the United States, 
CSC has a unique understanding of the cancer patient experience. CSC's 
Research and Training Institute (RTI) has contributed to the evidence 
base regarding the cancer patient experience through its Cancer 
Experience Registry, various publications and peer-reviewed studies on 
distress screening, the psychosocial impact of cancer, and cancer 
survivorship. We look forward to sharing our knowledge and working with 
Dr. Hahn to ensure that clinical trials measure not just a patient's 
physical experience in a clinical trial but also the psycho-social 
experience. We applaud Dr. Hahn's pledge to make science based, 
patient-centered decisions if confirmed and support his commitment to 
put patients first.

    The Cancer Support Community believes that Dr. Hahn, a radiation 
oncologist who specializes in the treatment of lung cancer and sarcoma, 
has both the professional background and clinical experience to succeed 
as FDA Commissioner. We trust that Dr. Hahn will successfully lead the 
FDA at a time when it is critical to find the balance between medical 
innovation, stakeholder responsiveness, and patient safety.

            Sincerely,
                                     Elizabeth F. Franklin,
                                   MSW, Executive Director,
                                           Cancer Policy Institute,
                             Cancer Support Community Headquarters.
                                 ______
                                 
          Hematology/Oncology Pharmacy Association,
                         8735 W. Higgins Road, Chicago, IL,
                                                 November 22, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    On behalf of the Hematology/Oncology Pharmacy Association (HOPA), I 
am writing to writing to express HOPA's support for the nomination of 
Dr. Stephen Hahn to be the Commissioner of the Food and Drug 
Administration (FDA).

    HOPA is a nonprofit professional organization launched in 2004 to 
help hematology and oncology pharmacy practitioners and their 
associates provide quality cancer care. HOPA's membership is 
predominantly oncology pharmacists, but also includes pharmacy interns, 
residents, nurses, technicians, researchers, and administrators 
specializing in hematology/oncology practice. The roles of our 
membership span from direct patient care, to education, to research. 
HOPA represents approximately 3,400 members working in hundreds of 
hospitals, clinics, outpatient oncology practices, home health 
practices, community pharmacies, and other healthcare settings.

    Some of us have worked with Dr. Hahn for years as a result of his 
leadership at MD Anderson, his volunteer leadership of cancer 
organizations, and others of us have more recently become acquainted 
with him. We support him because of his focus on patients, commitment 
to public health, and pledge to honor science-based decision making. 
His record in cancer clinical care, clinical research, and 
institutional leadership prepares him well to lead FDA. We are 
concerned about attracting and retaining a stellar FDA staff, and we 
believe that Dr. Hahn can provide leadership on FDA staffing matters.

    Because of the significant responsibilities of FDA, there is never 
a time that the agency does not face challenges. However, the agency 
confronts especially daunting trials now, including regulation of 
increasingly complex therapies, addressing the critical issue of drug 
shortages, contributing to efforts to address the opioid epidemic, and 
maintaining an outstanding staff to manage all of these issues. We 
trust Dr. Hahn to lead the agency through these challenges.

    Please know HOPA stands ready to work with Dr. Hahn should the 
Senate confirm him at the new FDA Commissioner. If you have any 
questions about our letter, please feel free to contact me or HOPA's 
Health Policy Associate, Jeremy Scott.

            Sincerely,
                                            Susanne Liewer,
                            PharmD, BCOP, FHOPA, President,
                          Hematology/Oncology Pharmacy Association.
                                 ______
                                 
          Association of American Medical Colleges,
                           655 K Street NW, Washington, DC,
                                                 November 27, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    The Association of American Medical Colleges (AAMC) urges the 
Committee on Health, Education, Labor and Pensions, to favorably report 
out the nomination of Stephen M. Hahn, MD, to serve as Commissioner of 
the US Food and Drug Administration (FDA). The AAMC is a not-for-profit 
association dedicated to transforming health care through innovative 
medical education, cutting-edge patient care, and groundbreaking 
medical research. Its members comprise all 154 accredited U.S. and 17 
accredited Canadian medical schools; nearly 400 major teaching 
hospitals and health systems, including 51 Department of Veterans 
Affairs medical centers, and more than 80 academic societies. Through 
these institutions and organizations, the AAMC serves the leaders of 
America's medical schools and teaching hospitals and their 173,000 
faculty members, 89,000 medical students, 129,000 resident physicians, 
and more than 60,000 graduate students and postdoctoral researchers in 
the biomedical sciences.

    The FDA plays a pivotal role in the public health continuum by 
regulating products consumed by all Americans including drugs, 
biologics, and the Nation's food supply. A permanent and skilled 
Commissioner is key to FDA's ability to keep up with the rapid pace of 
scientific progress and public health threats. The AAMC believes that 
Dr. Hahn's experience in research, patient care, and administration at 
institutions that are among the Nation's foremost venues for cancer 
treatment and research, as well as his public service as an officer in 
the US Public Health Service and at the National Cancer Institute, 
provide invaluable qualifications to lead the FDA. He is intimately 
experienced with and understands the processes for discovery and 
refinement of new therapies, the complex environment in which medical 
innovation takes place, and the centrality of patients' and families' 
needs. As a physician scientist, Dr. Hahn is also committed to data and 
evidence-based analysis at all levels of medical decision making, and 
he has stated that he is committed to advancing evidence-based 
policymaking at the helm of the FDA.

    The FDA has a profound influence, both immediate and lasting, in 
shaping the environment for public health, safety, and medical 
innovation. The AAMC therefore strongly believes that Dr. Hahn's 
experience, leadership, public service and dedication are ideal 
qualifications for the role of FDA Commissioner, and we hope that the 
Senate will move expeditiously to his confirmation. The AAMC is 
grateful for your attention and the opportunity to provide these 
comments in support of Dr. Hahn's nomination. We are also deeply 
grateful to Ned Sharpless, MD, and Adm. Brett Giroir, MD, for their 
leadership of the FDA during this process of identifying a permanent 
Commissioner.

    Please contact me if you believe the AAMC can be of assistance or 
provide further information in the confirmation process.

            Sincerely,
                                      David J. Skorton, MD.
                                 ______
                                 
          American Association for Cancer Research,
                          1401 K Street NW, Washington, DC,
                                                  December 2, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    On behalf of the Board of Directors of the American Association for 
Cancer Research (AACR), and the 44,000 laboratory researchers, 
physician-scientists, other health care professionals, and patient 
advocates who constitute our national and international membership, I 
urge you and your colleagues on the Senate HELP Committee to approve 
the nomination of Stephen M. Hahn, MD, to lead the Food and Drug 
Administration (FDA).

    Dr. Hahn possesses an extraordinary dedication and commitment to 
cancer patients, and the AACR is extremely confident that he will be an 
outstanding leader for the FDA. Dr. Hahn is board certified in both 
radiation and medical oncology, and he has consistently advocated for a 
drug review process at the FDA that is both science-directed and 
patient-focused.

    Dr. Hahn has been a member of the AACR since 1999. He served as an 
inaugural member of the AACR Radiation Science and Medicine Working 
Group Steering Committee and the AACR Radiation Oncology Task Force. 
Dr. Hahn has also served as a member of other AACR committees. He also 
served with distinction in 2018 as co-chair of the Workshop on Clinical 
Development of Drug-Radiotherapy Combinations held in partnership with 
the FDA, the AACR, and the American Society for Radiation Oncology 
(ASTRO).

    The unprecedented research opportunities that exist today, coupled 
with our rapidly improving ability to translate these scientific 
advances into improved treatments for patients, require an experienced 
and highly effective scientific administrator, as well as a visionary 
and innovative leader. Dr. Hahn's impressive qualifications make him 
ideally poised to succeed at the FDA.

    I urge you to vote in favor of Dr. Hahn's nomination so that the 
full Senate can vote to confirm him before the end of the year.

            Respectfully,
                                             Margaret Foti,
                                              PhD, MD (hc),
                                           Chief Executive Officer.
                                 ______
                                 
                         Cancer Leadership Council,
                       2446 39th Street NW, Washington, DC,
                                                  December 2, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    The undersigned cancer organizations, including patient 
organizations, professional societies, and research foundations, are 
writing to express support for the nomination of Dr. Stephen Hahn to be 
the Commissioner of the Food and Drug Administration (FDA).

    Some of us have worked with Dr. Hahn for years as a result of his 
volunteer leadership of cancer organizations, and others have more 
recently become acquainted with him. We all support him because of his 
focus on patients, commitment to public health, and pledge to honor 
science-based decision-making. His record in cancer clinical care, 
clinical research, and institutional leadership prepares him well to 
lead FDA. We are especially concerned about attracting and retaining a 
stellar FDA staff, and we believe that Dr. Hahn can provide leadership 
on FDA staffing matters.

    Because of the significant responsibilities of FDA, there is never 
a time that the agency does not face challenges. However, the agency 
currently confronts an especially daunting agenda, including regulation 
of increasingly complex therapies, addressing the teen vaping epidemic, 
contributing to efforts to address the opioid epidemic, and maintaining 
an outstanding staff to manage these issues. We trust Dr. Hahn to lead 
the agency through these challenges.

            Sincerely,
                                 Cancer Leadership Council,
                   American Society for Radiation Oncology,
                     American Society of Clinical Oncology,
                                                CancerCare,
                                   Children's Cancer Cause,
                                   Fight Colorectal Cancer,
                          International Myeloma Foundation,
                                      LUNGevity Foundation,
                              Lymphoma Research Foundation,
                National Coalition for Cancer Survivorship,
                     National Comprehensive Cancer Network,
                          Ovarian Cancer Research Alliance,
                                 Prevent Cancer Foundation,
                             Sarcoma Foundation of America,
                                            Susan G. Komen.
                                 ______
                                 
                                                  December 2, 2019.
Hon. Mitch McConnell, Majority Leader,
U.S. Senate,
Washington, DC.
Hon. Charles Schumer, Democratic Leader,
U.S. Senate,
Washington, DC.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Leader McConnell, Leader Schumer, Chairman Alexander and 
Ranking Member Murray:

    The undersigned organizations, representing millions of patients, 
advocates, caregivers, and health care providers, would like to affirm 
our support for President Trump's nomination of Dr. Stephen Hahn as 
Commissioner of the Food and Drug Administration (FDA). We urge the 
Senate HELP Committee to swiftly advance his nomination and the full 
Senate to vote to confirm Dr. Hahn.

    The United States is at a pivotal moment in terms of public health. 
A confirmed commissioner is critical to ensure FDA is best positioned 
to continue to carry out the agency's important mission for millions of 
Americans.

    Dr. Stephen Hahn is well qualified and has received broad-based 
support. As Chief Medical Executive at The University of Texas MD 
Anderson Cancer Center, he not only has the knowledge and experience 
gained by managing the cutting-edge research and medical practices of 
one of the world's most innovative teaching hospitals, but also 
firsthand expertise of patient needs and a deep understanding of the 
breadth of work that needs to be achieved on their behalf.

    Due to his knowledge and experience, Dr. Hahn is the right person 
to ensure the FDA keeps pace with science and innovation without 
sacrificing the safety and efficacy gold standard established by the 
agency.

    Additionally, we know that Dr. Hahn can maximize value for patients 
through the FDA. Congress must ensure that FDA continues its important 
mission to provide patients with safe and effective treatments. We ask 
the Senate to do what is right for patients and swiftly confirm Dr. 
Stephen Hahn as FDA Commissioner.

            Sincerely,
                                 Acromegaly Community Inc.,
      Adenoid Cystic Carcinoma Research Foundation (ACCRF),
                               Alliance for Aging Research,
           American Association for Cancer Research (AACR),
   American Cancer Society Cancer Action Network (ACS CAN),
              American Society of Clinical Oncology (ASCO),
                 Association of American Cancer Institutes,
  Bridge the Gap--SYNGAP Education and Research Foundation,
                                  Cancer Support Community,
                                                CancerCare,
                                     CARES Foundation Inc.,
                                   Children's Cancer Cause,
                    EveryLife Foundation for Rare Diseases,
                                               FasterCures,
                                   Fight Colorectal Cancer,
                                Friends of Cancer Research,
                                          Genetic Alliance,
                            GO2 Foundation for Lung Cancer,
                                    Grandparents in Action,
                                                 KidneyCAN,
                                      LUNGevity Foundation,
               Lupus and Allied Diseases Association, Inc.,
                              Lymphoma Research Foundation,
                          Melanoma Research Alliance (MRA),
                              Melanoma Research Foundation,
                                      Men's Health Network,
                                            MLD Foundation,
                                    MRSA Survivors Network,
                       National Alliance on Mental Illness,
           National Organization for Rare Disorders (NORD),
                          National Osteoporosis Foundation,
                                NBIA Disorders Association,
                                       NTM Info & Research,
                          Pancreatic Cancer Action Network,
                           Personalized Medicine Coalition,
                                 Prevent Cancer Foundation,
                                Prostate Cancer Foundation,
                                         PXE International,
                                         Research! America,
                                      Solving Kids' Cancer,
                              The Nicholas Conor Institute,
                          United Leukodystrophy Foundation.
                                 ______
                                 
           National Organization of Rare Disorders,
              1779 Massachusetts Avenue NW, Washington, DC,
                                                  December 2, 2019.
Hon. Mitch McConnell, Majority Leader,
U.S. Senate,
Washington, DC.
Hon. Charles Schumer, Democratic Leader,
U.S. Senate,
Washington, DC.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Leader McConnell, Leader Schumer, Chairman Alexander and 
Ranking Member Murray:

    On behalf of the 25 to 30 million Americans with one of the over 
7,000 known rare diseases, the National Organization for Rare Disorders 
(NORD) and the undersigned NORD member organizations write to support 
the nomination of Dr. Stephen Hahn as Commissioner of the Food and Drug 
Administration (FDA). We urge the Senate Health, Education, Labor, and 
Pensions, (HELP) Committee to swiftly advance his nomination and the 
full Senate to vote to confirm Dr. Hahn.

    NORD is a unique federation of voluntary health organizations 
dedicated to helping people with rare ``orphan'' diseases and assisting 
the organizations that serve them. NORD is committed to the 
identification, treatment, and cure of rare disorders through programs 
of education, advocacy, research, and patient services.

    Ensuring the continuation of FDA's work in support of the rare 
disease community is more important now than ever. There are over 7,000 
rare diseases that afflict almost 30 million people in the United 
States alone. More than 90 percent of these diseases still have no FDA-
approved therapy. Dr. Hahn has demonstrated, in both his own experience 
and in the recent HELP Committee hearing, that he understands and has 
the tools to support the critical public health mission of the agency, 
including helping deliver innovative, safe, and effective therapies to 
rare disease patients.

    As a practicing oncologist most recently at the University of Texas 
MD Anderson Cancer Center, Dr. Hahn has first-hand knowledge of 
patients' experiences and has demonstrated his understanding of the 
importance of keeping these needs front and center in his work. At MD 
Anderson, Dr. Hahn also served as the Chief Medical Executive, which 
allowed him to acquire the requisite skills to lead a large 
organization like FDA. Further, Dr. Hahn has overseen many clinical 
trials, providing him with valuable experience and insight into FDA's 
regulatory science pertaining to innovative clinical trial designs.

    During the HELP Committee hearing, Dr. Hahn repeatedly affirmed his 
commitment to identifying and employing best practices within the 
agency to facilitate medical product development for diseases with 
unmet needs, including rare diseases. He emphasized the need to 
accelerate innovation and get treatments to patients. Finally, Dr. Hahn 
demonstrated during the hearing that he appreciates the critical role 
FDA plays in the stimulation of robust generics and biosimilars 
pathways, which promote accessibility and affordability of drugs for 
many rare disease patients.

    For these reasons, NORD and its undersigned member organizations 
support the swift confirmation of Dr. Hahn as FDA Commissioner. Dr. 
Hahn has shown that he is committed to ensuring that FDA's 
appropriately high safety and efficacy standards for medical products 
are both upheld and balanced with the critical need for innovation, 
particularly in the rare disease space. Dr. Hahn will keep the patient 
at the center of this work.

    FDA needs strong leadership, and we believe Dr. Hahn will provide 
it. We urge the Senate to swiftly confirm Dr. Stephen Hahn as FDA 
Commissioner.

            Sincerely,
                                         All Things Kabuki,
                     American Behcet's Disease Association,
             American Multiple Endocrine Neoplasia Support,
                                  APBD Research Foundation,
                     Association for Creatine Deficiencies,
                                         Avalon Foundation,
                                    Children's PKU Network,
                  Congenital Hyperinsulinism International,
                                                  Cure CMD,
                                          Cure VCP Disease,
                               Dreamsickle Kids Foundation,
                                   FamilieSCN2A Foundation,
                Fibromuscular Dysplasia Society of America,
                      Foundation for Prader-Willi Research,
              Friedreich's Ataxia Research Alliance (FARA),
                               Glut1 Deficiency Foundation,
 International Fibrodysplasia Ossificans Progressiva (FOP) 
                                               Association,
             International Pemphigus Pemphigoid Foundation,
   Li-Fraumeni Syndrome Association (LFS Association/LFSA),
                                Lung Transplant Foundation,
                                         Marfan Foundation,
                                 Mila's Miracle Foundation,
                                            MLD Foundation,
                               Moebius Syndrome Foundation,
            National Eosinophilia Myalgia Syndrome Network,
           National Organization for Rare Disorders (NORD),
                                         National PKU News,
                                NBIA Disorders Association,
                  PTEN Hamartoma Tumor Syndrome Foundation,
                                         SSADH Association,
              Turner Syndrome Society of the United States,
                          United Leukodystrophy Foundation.
                                 ______
                                 
                      Natural Products Association,
                         440 1st Street NW, Washington, DC,
                                                  December 2, 2019.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Senate Committee on Health, Education, Labor, and Pensions,
428 Dirksen Senate Office Building,
Washington, DC.
    Dear Chairman Alexander and Ranking Member Murray:

    On behalf of the Natural Products Association (NPA) we ask for your 
vote of approval in President Donald Trump's nomination of Dr. Stephen 
Hahn to lead the Food and Drug Administration (FDA). Dr. Hahn's medical 
and science background and expertise make him the ideal candidate to 
use current statutory authority in the Dietary Supplement Act of 1994 
(DSHEA) and other amendments in the Federal Food, Drug, and Cosmetic 
Act to regulate dietary supplements. NPA asks for the speedy approval 
of his appointment so that we can begin working with his staff under 
his oversight to address much-needed regulation for cannabidiol (CBD) 
products and enforcement for adulterated dietary supplements.

    Inaction to date in the CBD marketplace has created a scenario that 
may lead to the next vaping-like health crisis. With more than 1,500 
CBD products on store shelves across the country and 1 in 7 Americans 
using CBD, it is past time for consumers to have accurate information 
on CBD and time for producers to be properly regulated.

    Dr. Hahn recently told the Senate Health, Education, Labor and 
Pensions, Committee that ``a significant proportion of Americans are 
using [CBD] products, and a significant proportion of Americans who are 
using the products think that they're already judged to be safe and 
effective by FDA when they're not.'' We share Dr. Hahn's concerns and 
that is why NPA supports legislation that would require the FDA to set 
a safe level for CBD consumption and create an urgently needed legal 
pathway for regulation of CBD products.

    In addition to regulating CBD, action is needed in FDA's new 
dietary ingredient (NDI) notification process. Adulterated ingredients 
that have not completed the NDI notification process are entering our 
country at an alarming rate and it's been roughly 6 years since the FDA 
provided dietary supplement import alerts to prevent this. This puts 
American consumers at risk and compliant U.S. supplement-makers at a 
terrible disadvantage. It is our hope that with Dr. Hahn as its next 
Commissioner, the FDA will take on these much-needed actions to protect 
American consumers.

    NPA is the largest trade association for the natural products 
industry, representing since 1936 the interests of manufacturers, 
distributors and retailers of foods and dietary supplements as well as 
health and beauty products. NPA represents more than 650 member 
companies including more than 10,000 retail storefronts as well as 
suppliers, manufacturers and related natural products industry leaders.

    As a leader in both the natural products and dietary supplement 
industries, NPA has witnessed firsthand the nationwide economic growth 
in creating good-paying industry jobs for over 80 years. According to 
an independent analysis, the dietary supplement industry alone serves 
as both a barometer of economic health in the country and an engine to 
drive jobs as this $43.4 billion industry presently employs more than 
750,000 Americans nationwide.

    Over 200 million Americans consume a dietary supplement daily and 
we look forward to discussing the positive role supplements can play in 
public health for all Americans. NPA supports Dr. Hahn and regulatory 
agencies to enforce laws already on the books, to ensure a 
comprehensive and fair enforcement strategy, and to implement all tools 
at their disposal, including but not limited to misdemeanors in order 
to keep this marketplace the safest in the world.

    Natural products, including foods, beverages, dietary supplements 
and cosmetics, are manufactured and sold in every state as well as the 
District of Columbia and Puerto Rico. NPA asks you to please consider 
your constituents who are employed in the natural products and dietary 
supplement industries when voting on the FDA nomination of Dr. Hahn. We 
look forward to the opportunity to meet with yourself and members of 
your staff to speak about this and other important issues effecting 
both industries in greater detail.

    Thank you for your time and consideration,

                                          Daniel Fabricant,
                                    Ph.D., CEO & President,
                                      Natural Products Association.
                                 ______
                                 

                         QUESTIONS AND ANSWERS

Responses by Stephen M. Hahn, to Questions of Senator Sanders, Senator 
Casey, Senator Baldwin, Senator Murphy, Senator Warren, Senator Kaine, 
 Senator Hassan, Senator Smith, Senator Jones, Senator Rosen, Senator 
 Murray, Senator Collins, Senator Scott, Senator Isakson, and Senator 
                                 Braun.
                            senator sanders
    Question 1.

    President Trump has directed FDA, on behalf of states like Florida 
and Vermont, to implement a prescription drug importation plan. If 
confirmed, how will you, as the head of FDA, collaborate with HHS to 
implement drug importation from foreign markets? What specific policies 
and regulations will you pursue? Additionally, how will you ensure that 
safe personal importation continues?

    Answer 1. High prescription drug prices and affordability are a 
significant problem and addressing this issue through a variety of 
means has been a priority of Congress, the administration and the 
Department. The American people have made it clear that this is an 
urgent issue for them and I intend for this to continue to be a top 
priority of the Agency if fortunate enough to be confirmed. I have seen 
first-hand at MDACC the impact of this financial toxicity on patients 
and the institution. Although pricing of prescription drugs is not a 
direct FDA responsibility, I agree that strong action is needed and 
appreciate their consideration of all options to address the problem 
including drug importation. I understand that the central issue is how 
to establish a program of drug importation to relieve high drug prices 
without risking patient safety and health or eroding the US 
pharmaceutical drug supply chain. As you know, FDA is responsible for 
determining whether any product offered for importation is in 
compliance with or in violation of a law enforced by FDA. Section 804 
of the FDCA allows for the Secretary of HHS to certify to Congress that 
a drug importation program from Canada poses no additional health and 
safety risk and would substantially reduce the cost of drugs in the US. 
FDA has a critical role to play in assessing drug importation programs 
including issuing regulations permitting wholesalers and pharmacists to 
import drugs from Canada. I look forward to working with career staff, 
Congress and the department and pledge that science, data, and the law 
will guide all decision making.

    Question 2.

    As you may know, multiple studies, including one in the New England 
Journal of Medicine from March 2017, have found that an overwhelming 
number of patient advocacy organizations have received financial 
support from the pharmaceutical industry. In 2015 alone, pharmaceutical 
companies gave $116 million to patient advocacy groups. As you know, 
patient advocacy groups play an important role in FDA Advisory 
Committee meetings and the product approval process. During the hearing 
on your confirmation, you committed to including the patient voice in 
the decisions that FDA makes and to having science and data guide your 
actions. If you are confirmed, will you commit to requiring patient 
advocacy groups to disclose their industry donors and donation amounts 
prior to participating in Advisory Committee meetings? Further, if you 
are confirmed, will you make it a priority to seek out patient advocacy 
groups, when they exist, that do not receive funding from industry?

    Answer 2. I commit to continue the very important practice of 
including the patient voice in the decisions that FDA makes. As a 
cancer provider, I have seen firsthand that better decisions are made 
when the patient's perspective is included.

    Nothing is more important for a patient to trust that you are 
making a decision that's in their best interest and no one else's 
interest. I also believe strongly that transparency is a critical 
factor to maintain the public trust. I commit to you that science, data 
and the law will guide decisions that I would make if I'm fortunate 
enough to be confirmed by the Senate as Commissioner of Food in Drugs. 
I promise to be guided by the core values of integrity and 
transparency, and I promise to put the interest of the American people 
first.

    Question 3.

    On September 5 of this year, FDA issued a recall for the drug 
Natpara due to a potential issue with rubber particulates from the 
injector pen contaminating the medicine. More than 2,000 patients in 
the U.S. rely on Natpara to manage hypoparathyroidism, a rare disease 
affecting blood calcium levels--for most of these patients, there is no 
alternative treatment. FDA has not shared any substantive information 
with patients regarding how long the recall may last or if other 
treatment options were available. The Vermont congressional delegation 
wrote to FDA on October 18, 2019, expressing deep concern for patients 
with hypoparathyroidism in Vermont and around the country impacted by 
the recall. Without this medicine, patients can get very sick, and 
patient advocates have informed me that more than 170 patients have 
visited emergency rooms around the country due to not having Natpara. 
Some of these patients have been hospitalized and admitted to intensive 
care units. If confirmed, will you provide patients with an immediate 
update about the status of the Natpara recall and a projected timeline 
for its resolution?

    Additionally, it is my understanding that FDA does not currently 
track adverse events following a drug recall caused by a lack of the 
drug itself. If hundreds of people got sick because a medicine was 
contaminated, that would be big news. But when hundreds of people get 
sick because the medicine they need was taken off the market, FDA keeps 
no such records. If you are confirmed, will you commit to reviewing 
FDA's internal process for making recall determinations and evaluating 
adverse events caused by the recall itself, particularly in cases where 
the recalled product is a sole source product?

    Answer 3. As a physician, I understand how important timely and 
consistent access to medication is, and all Americans should be able to 
count on FDA to ensure the drug supply is safe. If confirmed I will act 
promptly to ensure the American people have the most current 
information available pertaining to the recall of Natpara. I will also 
undertake a full review of the agency's processes related to recalls as 
well as adverse event tracking because I agree this is an important 
public health issue.

    Question 4.

    Should you be confirmed, and upon concluding your tenure at the 
agency, do you commit to not taking a position within or on behalf of 
the pharmaceutical or medical device industries?

    Answer 4. If confirmed, I will abide by all of the commitments set 
forth in my ethics agreement and will comply with all applicable laws 
and regulations. I will also be bound by the requirements and 
restrictions set forth in this administration's Ethics Pledge (EO 
13770).

    I am a scientist and a medical doctor. Science and fighting for the 
best interest of my patients has guided my entire professional career, 
and will continue to do so in any role I undertake in my career.

    Question 5.

    In August 2019, FDA's Center for Devices and Radiological Health 
(CDRH) finalized guidance on when the agency may accept inconclusive 
data that result in uncertainty of a device's benefit-risk 
determination.

          Do you commit to upholding CDRH's mission ``to 
        protect and promote the public health'' and ensure that 
        patients have access to safe and effective medical devices?

    Answer. Yes, if confirmed I commit to upholding the mission of FDA 
and the mission of CDRH.

          How will you ensure that this guidance allowing 
        incomplete clinical evidence to inform device approvals does 
        not result in unsafe devices reaching the market?

    Answer. FDA guidance documents do not establish legally enforceable 
requirements or change the standard for approval in any way. I think it 
is important that FDA regularly examines its thinking to ensure its 
approval pathways keep pace with innovation in science and technology 
so that patients have timely access to high-quality, safe, and 
effective medical devices. While this guidance provides insight to the 
agency's current thinking on the risk-based framework for FDA approval 
of medical devices, patient safety must remain a top priority and will 
if I am confirmed.

          How will you ensure that the medical device industry 
        does not take advantage of the ability to submit inconclusive 
        clinical evidence and force new devices onto the market without 
        doing complete research?

    Answer. Upholding the Gold Standard of FDA's assessment of medical 
products is fundamental to FDA's ability to protect and promote public 
health. I commit to ensuring that all medical devices approved for 
marketing authorization meet the applicable standards before such 
authorization is granted by the agency.

          How will you quell concerns that CDRH is putting too 
        much focus on speeding device approvals and not prioritizing 
        high quality pre-market and post-market research and 
        surveillance?

    Answer. If confirmed, it will be my top priority to ensure that FDA 
makes sound regulatory decisions based on science and data and that all 
products regulated by FDA continue to be subject to rigorous scrutiny 
even after marketing authorization.

          Knowing that many patient-advocacy groups receive 
        financial support from industry, how will you ensure that 
        patients' perspective on probable benefits and risks, as 
        outlined in the guidance, are provided without influence from 
        industry?

    Answer 5. Nothing is more important for a patient to trust that you 
are making a decision that's in their best interest and no one else's 
interest. I also believe strongly that transparency is a critical 
factor to maintain the public trust. I commit to you that science, data 
and the law will guide decisions that I would make if I'm fortunate 
enough to be confirmed by the Senate as Commissioner of Food and Drugs. 
I promise to be guided by the core values of integrity and 
transparency, and I promise to put the interest of the American people 
first.

    Question 6.

    The FDA recently issued Nutrition Facts Label guidance for ``added 
sugars'' which will require a ``percent Daily Value'' to be placed 
without explanation on a blank line below the quantity of total sugar 
in the Nutrition Facts Label. The FDA then suggested that producers can 
voluntarily explain this confusing orphaned percent Daily Value as the 
quantity of ``Added Sugars'' in the otherwise pure product. Vermont 
producers work hard to guarantee the integrity of 100 percent pure 
maple and honey products. This suggestion by FDA that producers of pure 
maple syrup and honey incorporate the ill-conceived reference to 
``Added Sugars'' on a footnote of the Nutrition Facts Label is not only 
confusing for consumers, it likewise calls into question the quality of 
these excellent products. Our producers compete for shelf space with 
cheap imitation products that do, in fact, rely on added sugars. The 
Nutrition Facts Label for pure maple syrup and honey should clearly 
reflect that no sugars are ``added,'' in the conventional meaning of 
the term, but that these products do contain sugar.

          Did FDA complete any market research on this topic to 
        quantify consumer understanding and perception of labeling 
        terminology?

          If not, do you commit to ensuring that the agency 
        performs this research prior to mandating, or even suggesting 
        in guidance specific terminology on product labels?

          If the agency finds that the phrase ``added sugars'' 
        on single-ingredient sugars is misleading for consumers, do you 
        commit to reopening the rulemaking process for added sugars to 
        identify alternative terminology that is truthful and not 
        misleading for consumers of single-ingredient sugars?

    Answer 6. Although I am not currently a part of the administration 
and cannot speak to the specifics of what FDA considered in designating 
the requirements for the updated Nutrition Facts Label, I agree that 
consumers should be provided with accurate information about the food 
they buy and eat; and industry should compete on a level playing field. 
This is true for pure maple and honey products just as it is true for 
other foods. I personally make decisions on the food I buy based on the 
Nutrition Facts Label and rely on FDA to ensure that information is 
accurate and meaningful. I will commit that, if confirmed, I will 
support the Agency in updating the Nutrition Facts Label requirements 
and ensuring that the rules make sense for pure maple and honey 
products.

    Question 7.

    FDA met with the International Maple Syrup Institute on October 10, 
2019. The Institute is still waiting for a response from the agency on 
whether their proposed additions to the footnote are sufficient to meet 
FDA's standards. If confirmed, will you respond to the Institute's 
inquiry and verify that their proposed changes to the footnote are 
acceptable to FDA?

    Answer 7. I commit that I will look into this issue if I am 
confirmed.

    Question 8.

    As you know, the most recent farm bill legalized hemp cultivation 
and products. The new law also classifies hemp as a crop, moving 
jurisdiction of its production to the Department of Agriculture, 
including production of hemp derivatives like cannabidiol (CBD). The 
same month the farm bill became law, then-FDA Commissioner Gottlieb 
announced CBD and other hemp derivatives are drug ingredients. That 
means that while production of CBD is governed by USDA, companies that 
create products containing CBD must seek approval from the FDA before 
selling their products. While I understand the need to ensure product 
safety, this process can be an insurmountable hurdle for small 
businesses, to the benefit of the pharmaceutical industry. FDA's 
position is concerning to many who believe it will make CBD 
unattainable for consumers, restrict its use for therapeutic purposes, 
and limit the economic benefit of hemp production for struggling 
farmers and small businesses. If confirmed, will you commit to working 
with USDA on regulations related to CBD that prioritize the needs of 
farmers, small business owners, and consumers?

    Answer 8. Thank you for your question. As you know, CBD is widely 
available throughout the United States. It can be purchased in many 
places across the country. There are open questions and knowledge gaps 
about these products such as: `What is the appropriate dosage and for 
which health claim?' What are the potential interactions with other 
drugs? What are the health effects of long term usage particularly 
among youth. On the other hand, we need to recognize that there are 
potential therapeutic benefits from CBD. In fact, FDA approved a CBD-
containing product for the treatment of a serious childhood seizure 
disorder. There are signals that CBD might be useful for other 
conditions. However, I am concerned about the unsubstantiated claims 
that CBD can be useful for conditions like cancer and Alzheimer's 
disease. It is important to ensure that any claims made to treat a 
disease are supported by the appropriate safety and efficacy data. I 
look forward to reviewing the data on the safety of CBD with career 
staff and to work with the Agency and all appropriate Federal partners 
to determine if there is a clear and transparent pathway for consumer 
products (e.g. food additives and dietary supplements) that can be used 
by manufacturers, including small businesses.
                             senator casey
                             Rare Diseases
    Question 1.

    According to the National Organization for Rare Disorders, about 
25-30 million Americans are living with a rare disease. I frequently 
hear from constituents who suffer from rare diseases, such as 
amyotrophic lateral sclerosis (ALS), regarding the lack of FDA-approved 
treatments for their conditions. Many of these constituents are 
extremely ill, and are concerned that they may not live long enough to 
see final FDA approval of a new drug to treat their condition. I 
applaud the FDA for the work it has done to speed approval of new drugs 
for rare diseases, but I also believe that this is an issue that 
deserves continued attention. If confirmed as FDA Commissioner, will 
you:

        a. Commit to ensuring that the agency remains engaged with 
        these patients during the drug development and approval 
        process? Please provide details on how you would strengthen the 
        FDA's engagement with patients;

        b. Commit to ensuring close coordination within the agency, 
        particularly within the Center for Drug Evaluation and Research 
        and the Center for Biologics Evaluation and Research, to 
        develop policies informed by rare disease regulatory experts, 
        such as those who work in the Office of Orphan Products 
        Development?

        and

        c. Commit to working with Congress in continuing to implement 
        and improve the Rare Pediatric Disease Priority Review Voucher 
        Program?

    Answer 1a. I am and will be deeply committed to engaging patients 
in the drug and device approval process. This has been a priority for 
FDA and I look forward to continuing their work. I look forward to 
working with your office and other stakeholders on the details of how 
we can expand this work. As Secretary Azar, Commissioner Gottlieb, and 
Acting Commissioner Sharpless have all emphasized in speaking to rare 
disease groups, this is a key commitment for FDA and all of HHS.

    Answer 1b. I will be strongly committed to having CDER and CBER 
develop policies that are focused on and informed by advancements in 
how we can research rare diseases, including ways we can bring more 
patients into clinical trials.

    Answer 1c. I am committed to working with Congress on the Rare 
Pediatric Disease Priority Review Voucher Program, which helps to 
accelerate development of therapies, bringing patients hope. I am 
committed to ensuring that this and other Priority Review Voucher 
Programs are effectively implemented.
                                Vaccines
    Question 2.

    The overwhelming scientific consensus is that FDA approved vaccines 
are safe for the vast majority of the public, and that they save lives. 
However, the public is routinely exposed to a great deal of misleading 
information on the safety of vaccines, much of it from online sources.

        a. What role do you feel the FDA should play in pushing back 
        against this misinformation?

        b. What additional efforts do you feel the agency should 
        undertake to push back against vaccine hesitancy and anti-
        vaccine sentiment?

    Answer 2. As a public health agency that always strives to use the 
best available scientific evidence to promote and protect the well-
being of individuals, FDA has a critical role to play, with its many 
key partners and stakeholders, in building and maintaining the trust 
and confidence of parents and healthcare providers in the safety and 
effectiveness of vaccines. It is an institution that does not and 
should not take lightly its responsibility to ensure the safety and 
effectiveness of vaccines, and must work diligently with its many 
partners to:

          Provide timely, understandable, accurate, relevant, 
        and actionable information to the public, partners, and health 
        professionals about the importance of staying up to date on 
        vaccinations across the lifespan.

          Emphasize vaccines are the best and safest ways 
        parents can protect infants, children, and teens from 16 
        potentially harmful diseases, including measles.

          Support healthcare professionals with the tools and 
        resources needed to talk to parents about vaccines and answer 
        questions.

          Recognize that parents are working to make the best 
        health decisions for their children, and increase their 
        awareness that vaccine-preventable diseases can be very 
        serious, may require hospitalization, or even be deadly--
        especially in infants and young children.

    But simply providing the facts is not enough.

    Trust is one of the most important factors associated with vaccine 
confidence. Trust is the willingness to rely on someone else's 
expertise and advice (e.g., their vaccine recommendation). For 
vaccinations, trust comes into play in a number of ways and with 
respect to a number of stakeholders. For example, parents need to have 
trust in the pharmaceutical companies that produce vaccines, trust in 
the healthcare system that delivers them, trust in the healthcare 
providers that recommend and administer vaccines, and trust in the 
organizations and policymakers that decide which vaccines are needed 
and when. Trust also extends to the safety and effectiveness of 
vaccines, including a belief that the system has adequately evaluated 
the safety and effectiveness of recommended vaccines. The level of 
trust parents have in government, the healthcare system and their 
healthcare providers are often associated with their ultimate decision 
to accept or refuse vaccinations for their children.

    The public has long looked to and trusted the FDA to ensure the 
drugs, devices and other medical products it regulates are safe and 
effective. FDA should leverage that trust by working with its partner 
agencies and stakeholders, the health care community, and, most 
importantly, parents, to rebuild the Nation's confidence in one of the 
greatest public health achievements of all time
                             Drug Shortages
    Question 3.

    The number of drug shortages has increased over the past two years. 
Last year, there were 54 drug shortages, which affects patients' 
ability to get the care they need and even could cause them to lose 
their lives. These shortages appear to be linked, in part, to 
complexities in the manufacturing supply chain, particularly with 
respect to the safety and quality of products being imported from 
overseas. While we should be doing everything we can to keep drug 
prices from skyrocketing, we also need to ensure that drugs, their 
ingredients, and all products related to their delivery are safe and 
effective. If confirmed;

        3a. What specific steps will you take to ensure that quality 
        manufacturing practices are enforced, both in the United States 
        and abroad?

    Answer 3a. FDA plays an important role in promoting manufacturing 
processes that result in quality medical products. As a physician, I 
relay on FDA to ensure that the products I prescribe to patients are 
not contaminated and contain the amount of active ingredient specified. 
One important aspect is recruiting and retaining the appropriate 
workforce with the necessary knowledge and experience and I commit to 
supporting the Agency in these efforts if confirmed.

        3b. In addition, please describe how you will work with the 
        Department of Defense (DOD) and the Assistant Secretary for 
        Preparedness and Response (ASPR) on drug quality management and 
        the medical supply chain to ensure our national security with 
        respect to public health emergency response medical 
        countermeasures.

    Answer 3b. Medical countermeasures are essential to protect our 
citizens, including our military personnel from a range of threats, 
including chemical and biological hazards. I am committed to 
collaborating with ASPR and with DOD as part of the critical medical 
and public health preparedness and response efforts to protect our 
Nation.

    Question 4.

    The recent report by the FDA on drug shortages suggests 
implementing financial incentives for manufacturers who continue to 
produce those lower-profit drugs to ensure they experience lowered risk 
on their continued investment, thereby assuring continuity of important 
older and less profitable drugs. In addition to the above responses, 
please describe other ways in which FDA can, if you are confirmed, 
provide incentives to companies to ensure that manufacturers continue 
to produce lower-profit drugs.

    Answer 4. I applaud FDA's efforts to involve a range of 
stakeholders to investigate and report on the root causes of drug 
shortages. But the Agency must continue its work to reduce the 
instances of drug shortages, especially those that are critical to the 
treatment of patients. I understand that although some of these root 
causes, such as financial incentives, are not directly under FDA 
control that we must be creative in our approaches.
                         Antibiotic Resistance
    Question 5.

    According to the Centers for Disease Control and Prevention, more 
than 35,000 Americans die from infections caused by antibiotic-
resistant bacteria each year. However, there are few new antibiotics on 
the market, and manufacturers are hesitant to invest in the development 
of antibiotics. Public health experts are warning of a potential future 
without antibiotics, when currently treatable infections could become 
deadly. Under the Generating Antibiotic Incentives Now (GAIN) Act, FDA 
has the authority to review and approve certain antimicrobial drugs 
that are designated as a qualified infectious disease product under a 
fast track or priority review designation, and certain products could 
also receive extended exclusivity. As of 2018, the agency had approved 
12 such qualified products. Further, the 21st Century Cures Act 
authorized the Limited Population Pathway for Antibacterial and 
Antifungal Drugs (LPAD); to date, two drugs have been approved through 
LPAD pathway. In addition to the GAIN Act and the LPAD pathway, what 
other actions can the agency take immediately to combat antimicrobial 
resistance?

    Answer 5. This is a top public health priority and I believe the 
Agency is a global leader in combating antimicrobial resistance (AMR). 
The Agency is working strategically across all medical centers and with 
key offices, including the Office of the Chief Scientist to implement 
the 2019 Strategic Approach for Combatting AMR. \1\ This comprehensive 
approach addresses the many critical components of AMR, including use 
of antibiotics in food producing animals, innovative diagnostics for 
identifying infections and appropriate treatment, innovative 
antibiotics for both animals and humans, innovative clinical trials 
that include appropriate breakpoints and post market studies, and 
finally stewardship.
---------------------------------------------------------------------------
    \1\ https://www.fda.gov/emergency-preparedness-and-response/mcm-
issues/antimicrobial-resistance-information-fda.

    One immediate step the agency could take is leverage this cross 
agency working group to partner with physicians to revise utilization 
and reporting of antibiotics. The Agency could potentially use a 
similar approach that was used for addressing prescribing patterns with 
---------------------------------------------------------------------------
opioids and apply it to antibiotics.

    I also understand this is a high priority for this Committee and 
many Members of Congress and the public health community and I would 
welcome the opportunity to partner on potential actions and solutions 
to AMR.
                                Opioids
    Question 6.

    Several concerted efforts to combat the ongoing epidemic have 
helped lead to a decline in opioid over-prescribing. However, despite a 
recent decline in opioid prescribing, Americans continue to die due to 
opioid overdoses, and people continue to become addicted. In June 2019, 
the agency released a draft guidance for assessing the risks and 
benefits of opioid analgesic drugs. The guidance states: ``FDA also 
considers the broader public health effect of opioid analgesic drugs; 
this involves consideration of the risks related to misuse, abuse, 
opioid use disorder, accidental exposure, and overdose, for both 
patients and others. Likewise, FDA considers any properties of a drug 
expected to mitigate these risks.''

        a. If confirmed as FDA Commissioner, will you ensure that the 
        broader public health and safety is taken into account when 
        approving new opioid products?

        b. If you are confirmed, when will FDA finalize its guidance on 
        opioid analgesics under your leadership?

        c. As FDA Commissioner, how would you prevent future abuse/
        misuse of opioids prescribed for long-term use?

        d. A recent set of guidelines from the Veterans Administration 
        and the Department of Defense warns against the use of opioids 
        for treating mild, chronic pain. If confirmed, what additional 
        steps will you take to reduce over-prescribing of opioids, 
        particularly regarding the approval of alternative pain 
        medications and treatments, especially for chronic pain?

                i. In your confirmation hearing, you mentioned we need 
                to take action on packaging, increased approval of non-
                opioid products, and take a holistic approach to pain 
                medication. Please provide specific examples of how FDA 
                will address each of these approaches in its response 
                to the opioid epidemic.

        e. Will you commit to promote the use of medication-assisted 
        treatment in the treatment of substance use disorder, 
        particularly opioid use disorder?

        f. What steps will you take to increase the availability of 
        naloxone, such as extending the shelf-life of naloxone products 
        and promoting co-prescribing practices?

    Answer 6a-f. Thank you for your question. The opioid crisis is one 
of the largest and most complex public health tragedies that our Nation 
has faced. This is a top priority for the administration, the 
Department and Congress. It will be a top priority for me if I am 
fortunate enough to be confirmed. My own personal experience with this 
issue is as a cancer doctor. I have known patients who have survived 
cancer only to become addicted to opioids. For many years, our medical 
education was that addiction did not occur in cancer patients and we 
were encouraged to use opioids liberally. This turns out not to be the 
case and unfortunately, there have been tragic consequences. There has 
been a significant change based upon doctor education efforts in the 
prescribing habits for opioids. An evidence-based holistic approach to 
treating pain with non-opioid medications, behavioral therapies, and 
when appropriate, opioids is now being used effectively in many medical 
settings to effectively treat pain. We have new ways of prescribing 
pain medications that create a balance between relief of suffering and 
preventing addiction. There is outstanding research being performed on 
addiction and the causes of pain. I am optimistic that even better 
approaches will be developed in the future. That being said, we are 
still dealing with a devastating and urgent crisis with opioids. FDA 
was given important authorities by Congress in the SUPPORT act to 
assist in the prevention of misuse of opioids. Actions by FDA such as 
changes to packaging, labeling, the REMS program and efforts to stop 
the illegal importation of opioids are all important steps forward. I 
promise, if confirmed as FDA Commissioner, to make combating the opioid 
crisis a top priority of the agency and I look forward to continuing 
and enhancing those efforts, if I am fortunate enough to be confirmed. 
I understand that FDA is also evaluating other activities that could be 
helpful including setting standards for new opioid approvals, 
additional doctor education, and revising regulatory procedures for 
mandatory recall authority of opioids that have a substantial risk for 
adverse health consequences or death. I am supportive of efforts by the 
agency to help innovators of non-opioid alternatives for pain control 
and abuse-deterrent formulations because we cannot forget the 
importance of safely helping Americans with pain syndromes. I am also 
supportive of efforts to advance the development and use of safe and 
effective medication-assisted therapy or MAT in a holistic therapy 
setting. I have cared for numerous patients with serious and 
debilitating pain, and understand that we must strike a balance between 
maintaining patients' access to effective opioid drugs and non-opioid 
alternatives, while reducing misuse and abuse of opioid drugs.

    Question 7.

    Standards of identify (SOI) for food products are important because 
they ensure consumers are assured a minimum level of quality. They also 
establish required and/or prohibited ingredients and ensure that 
packages contain the correct amount of food. The United States is the 
only country that still uses a ``pressed weight'' SOI for tuna, while 
all other countries use a ``drained weight'' SOI for canned tuna. I 
urge FDA to retire the outdated standard of ``pressed weight'' and 
harmonize with the rest of international community's SOI of drained 
weight for canned tuna. This reform would ensure that all U.S. canned 
tuna companies and importers use a consistent and quality tuna, thus 
benefiting consumers and regulators. It would also help to achieve 
FDA's goal of modernizing its own SOI portfolio.

        a. What are FDA plans to move toward adopting the drained 
        weight SOI for canned tuna fill of container?

        b. When do you expect this reform to be completed?

    Answer 7a-b. Although I cannot speak to the specifics of FDA's work 
in this area as I am not currently a part of the administration, I 
recognize the importance of ensuring consumers have access to accurate 
and useful information about the food they buy, including canned tuna. 
I think FDA should also strive to harmonize rules with foreign 
requirements to the fullest extent possible.
                              Food Safety
    Question 8.

    How will you ensure the Agricultural Water Requirements of the 
Produce Safety Rule (from the Food Safety Modernization Act) are 
rewritten in a manner that ensures both realistic options for farmers 
who rely on a variety of water sources and accurate results that will 
identify the pathogens that are most likely to cause foodborne 
illnesses? How will you ensure actual progress is being made to rewrite 
the agricultural water requirements before the 2022 compliance date for 
the recently delayed agricultural water requirements?

    Answer 8. It is critical that FDA find the appropriate balance in 
issuing rules to ensure the safety of the food supply in the United 
States while not unnecessarily burdening American farmers. I am also a 
proponent of regulating based on a risk-based approach focusing on the 
most likely sources of contamination and those that pose the biggest 
risk to the public health. Farmers should be provided the appropriate 
amount of time to comply with any new rules and also be supported with 
sufficient learning opportunities to assist their ability to comply. I 
commit that, as Commissioner, I will review FDA's efforts around food 
safety and the implementation of the Food Safety Modernization Act.

    Question 9.

    The FDA was recently required by court order to write a proposed 
rule for the Food Safety Modernization Act Section 204 by September 
2020. FSMA Section 204 requires recordkeeping for any product FDA deems 
to be ``high risk.'' Within this section of FSMA, there is an exemption 
within FSMA for farms that have labels that preserve the identity of 
the farm through the supply chain to the consumer (farm identity 
preserved marketing). Farms are also exempt from keeping records of 
food that are direct marketed (to stores or individual consumers) by 
the farmer. How will you ensure the proposed rule includes these 
exemptions, which are required by FSMA?

    Answer 9. As mentioned above, I commit that if fortunate enough to 
be confirmed, as Commissioner, I will review FDA's implementation of 
the Food Safety Modernization Act to ensure a balanced approach and 
FDA's adherence to the law.

    Question 10.

    How will you encourage FDA officials to evaluate the first few 
years of Produce Safety Rule inspections on farms to ensure inspections 
are not decreasing conservation and biodiversity? The Produce Safety 
Rule requires monitoring and addressing any potential contamination 
from wildlife and domestic animals, which has led some farmers to 
destroy wildlife habitats, remove domestic animals from their 
diversified operations, among other actions. However, the Food Safety 
Modernization Act requires that the new regulations, including the 
Produce Safety Rule, do not undermine beneficial on-farm conservation 
and wildlife practices.

    Answer 10. I agree that it is important to ensure that FDA's rules 
around produce safety do not have unintended consequences on the 
environment. If confirmed, I will support the Agency as it solicits a 
range of stakeholder feedback on the Produce Safety Rule and all rules 
implementing the Food Safety Modernization Act.
                     Nutrition Innovation Strategy
    Question 11.

    FDA's Nutrition Innovation Strategy, unveiled in 2018, can play a 
critical role in reducing preventable deaths and diseases related to 
poor nutrition. This is an extremely important process looking at a 
wide array of issues, and while there is certainly a lot of good work 
that is already underway, I believe that there also a lot still to be 
done. As the incoming Commissioner, how do you plan to move forward 
FDA's food and nutrition work, and what are your priorities in terms of 
what issues the agency will move forward on next?

    Answer 11. I support FDA's efforts to promote food safety and sound 
nutrition for the country. In all the decisions we make, we must follow 
the best and most current science and engage in stakeholders who can 
provide the necessary information to inform the best course of action.
                            senator baldwin
    Question 1.

    Wisconsin has long been a leader in advancing new technologies to 
better diagnose and screen for disease, including tests used to promote 
earlier detection of cancer. As a practicing oncologist, you are no 
doubt familiar with the array of clinical diagnostic tests, which are 
becoming more and more complex. However, the regulatory system for 
these tests have not kept up.

    Both the FDA and Congress are devoting efforts to modernize the 
regulation of all diagnostic tests. How should FDA balance the desire 
for lab developed test reform with preventing barriers to the 
development of and patient access to life saving diagnostic tests? As 
FDA Commissioner, will you work to ensure continued progress is made on 
updating the regulatory system for clinical diagnostics?

    Answer 1. As an oncologist, I am very aware of the need to ensure 
that in-vitro clinical diagnostics provide patients and physicians with 
accurate diagnostic information to guide treatment decisions, 
particularly some of the newer more complicated testing procedures. I 
also recognize that any approach needs to promote innovation and not 
put unnecessarily burdens on developers. If confirmed as Commissioner, 
I will bring this perspective to the discussion and work closely with 
Congress and other stakeholders to modernize FDA's regulatory approach.

    Question 2.

    As we discussed when we met, dairy farmers in Wisconsin pride 
themselves on producing high quality milk that meets very specific 
requirements. In fact, many of those requirements are set by the FDA's 
standards of identity regulations. Despite the constant work farmers do 
to meet these standards, there are many imitation products on the 
market today that get away with using dairy terms without meeting the 
standard of identity for that product. FDA has now held a comment 
period for farmers, consumers, and food companies to provide input on 
the mislabeling in the marketplace, but action is needed.

    Do you agree that it is unfair that dairy alternatives have been 
allowed to proliferate in the marketplace without proper labeling 
enforcement, while dairy products have been abiding by numerous FDA 
regulations to ensure consumers have accurate information? Do you 
believe that standards of identity play a role in promoting health and 
consumer confidence?

    If confirmed, how will you enforce FDA regulations against all 
plant-based imitation products that use dairy terms? What is the status 
of the review of comments and stakeholder feedback at FDA and will you 
commit to beginning enforcement within 60 days of your confirmation?

    Answer 2. As I said during my confirmation hearing, I am in favor 
of clear, transparent and understandable food labeling for the American 
people. The American people need this so that they can make the 
appropriate decisions for their health and their nutrition. I 
understand that FDA has already collected stakeholder comment on this 
issue and I commit that, if confirmed, I will ensure that FDA follows 
the scientific evidence to guide actions in this area.

    Question 3.

    The Institute of Medicine, the Patient-Center Outcomes Research 
Institute, the American College of Surgeons Commission on Cancer, the 
American Society of Clinical Oncology, and the Community Oncology 
Alliance all recognize psychosocial care as the standard of care in 
oncology. Currently, there is no such standard at the FDA, despite the 
fact that between one-third and one-half of cancer patients report 
distress is a ``significant'' problem. In the 21st Century Cures Act 
and FDARA, Congress made clear to the FDA the importance of 
incorporating insights from the patient experience in its decisions on 
new drug approvals and post marketing surveillance. And, the FDA now 
recognizes that patient-focused drug development is applicable 
throughout the drug development process, and acknowledges that trials 
should measure more than just patient-reported symptoms and physical 
function.

    As an oncologist, do you believe including the assessment of a 
patient's psychosocial status in clinical trials would help to achieve 
a better understanding of the patient experience with the 
investigational agent? How would you work to ensure that FDA works with 
manufacturers to include comprehensive and reliable measures on patient 
experiences that capture physical and psychosocial symptoms in clinical 
trials?

    Answer 3. Thank you for your question. I am aware that the 21st 
Century Cures Act and FDARA required the FDA to advance patient-focused 
drug development. The FDA announced it is developing a series of four 
methodological patient-focused drug development guidances to implement 
these provisions. As an oncologist, I recognize the importance of 
patient psychosocial status assessment in clinical care and research. I 
am committed to continuing to implement the requirements of 21st 
Century Cures and FDARA as well as work with FDA staff to determine 
additional steps that can be taken to advance patient-focused drug 
development.

    Question 4.

    During the 2004 and 2009 flu seasons, including the H1N1 pandemic, 
the Nation experienced a dangerous shortage of influenza vaccines due 
in part to insufficient domestic production capabilities. Although 
domestic production and infrastructure of flu vaccine and other drugs 
and vaccines has partially improved since then, supply chain 
vulnerabilities and a lack of domestic production of various drug 
components may continue to place the Nation at risk.

    How can we continue to improve domestic manufacturing and reduce 
the future likelihood of drug shortages? What do you believe is the 
role of the FDA in mitigating drug and vaccine shortages that result 
from supply chain and production issues, and how can the FDA work to 
expedite the development and approval of novel vaccines? How will you 
work to incorporate advanced techniques and technologies such as cell-
based manufacturing processes in the development of new vaccines?

    Answer 4. I agree that advanced manufacturing will play a key role 
in preventing and mitigating drug and vaccine shortages in the future. 
I also believe that we may see an increasing role of domestic 
manufacturing if we move toward broader adoption of these technologies. 
Influenza vaccines could particularly benefit from advancement since 
reducing the required time needed can result in more accurately 
predicting the strains prevalent in a given flu season.

    Question 5.

    In August, public reports emerged that AveXis, a subdivision of 
Novartis, had knowingly submitted falsified data to the FDA to obtain 
approval of Zolgensma, the most expensive medication in history. AveXis 
also benefited from a number of Federal taxpayer-funded benefits and 
incentives for Zolgensma, including Fast Track, Breakthrough Therapy, 
and Priority Review designations, and had benefited from taxpayer-
funded NIH research before setting its staggering $2.1 million price.

    How will you ensure drug data accuracy and hold pharmaceutical 
companies accountable if confirmed as Commissioner? Will you commit to 
using the FDA's full regulatory, civil, and criminal authorities to 
hold pharmaceutical companies accountable when they mislead the FDA and 
the public?

    Answer 5. Throughout my career I have relied on the trust and peace 
of mind the gold standard the Food and Drug Administration provides. 
The gold standard requires accuracy of data. Because of FDA, I had 
confidence for my patients in the treatments that I prescribed for 
them. As I reflect on the trust I placed in FDA, I'm now humbled that 
with your consent, I may be in the position to lead that very agency I 
relied on and trusted for my entire career. If confirmed, I promise to 
be guided by the core values of integrity and transparency and I 
promise to put the interest of the American people first, and hold 
accountable to the fullest extent made possible by the law, those who 
violate that standard.

    Question 6.

    Even in the midst of the opioid crisis, the FDA has continued to 
approve new and stronger opioid drugs. Raeford Brown, MD, the Chair of 
the FDA's Anesthetic and Analgesic Drug Products Committee, called one 
of these recently approved medications, Dsuvia, ``an extremely 
divertible drug,'' with significant potential for abuse and overdose. 
In a statement, former Commissioner Gottlieb described a need to 
examine the agency's broader risk-benefit framework for approval of new 
opioid analgesics, and the agency put out draft guidance in June.

    What is the FDA's role in examining the larger context of the 
opioid crisis and mitigating potential harms in approving new drugs? 
What additional steps to address the opioid crisis, beyond what the FDA 
is currently taking, will you pursue if confirmed as Commissioner?

    Answer 6. Thank you for your question. The opioid crisis is one of 
the largest and most complex public health tragedies that our Nation 
has faced. This is a top priority for the administration, the 
Department and Congress. It will be a top priority for me if I am 
fortunate enough to be confirmed. My own personal experience with this 
issue is as a cancer doctor. I have known patients who have survived 
cancer only to become addicted to opioids. For many years, our medical 
education was that addiction did not occur in cancer patients and we 
were encouraged to use opioids liberally. This turns out not to be the 
case and unfortunately, there have been tragic consequences. There has 
been a significant change based upon doctor education efforts in the 
prescribing habits for opioids. An evidence-based holistic approach to 
treating pain with non-opioid medications, behavioral therapies, and 
when appropriate, opioids is now being used effectively in many medical 
settings to effectively treat pain. We have new ways of prescribing 
pain medications that create a balance between relief of suffering and 
preventing addiction. There is outstanding research being performed on 
addiction and the causes of pain. I am optimistic that even better 
approaches will be developed in the future. That being said, we are 
still dealing with a devastating and urgent crisis with opioids. FDA 
was given important authorities by Congress in the SUPPORT act to 
assist in the prevention of misuse of opioids. Actions by FDA such as 
changes to packaging, labeling, the REMS program and efforts to stop 
the illegal importation of opioids are all important steps forward. I 
promise, if confirmed as FDA Commissioner, to make combating the opioid 
crisis a top priority of the agency and I look forward to continuing 
and enhancing those efforts, if I am fortunate enough to be confirmed. 
I understand that FDA is also evaluating other activities that could be 
helpful including setting standards for new opioid approvals, 
additional doctor education, and revising regulatory procedures for 
mandatory recall authority of opioids that have a substantial risk for 
adverse health consequences or death. I am supportive of efforts by the 
agency to help innovators of non-opioid alternatives for pain control 
and abuse-deterrent formulations because we cannot forget the 
importance of safely helping Americans with pain syndromes. I am also 
supportive of efforts to advance the development and use of safe and 
effective medication-assisted therapy or MAT in a holistic therapy 
setting. I have cared for numerous patients with serious and 
debilitating pain, and understand that we must strike a balance between 
maintaining patients' access to effective opioid drugs and non-opioid 
alternatives, while reducing misuse and abuse of opioid drugs.

    Question 7.

    Personal care products and cosmetics are among the least regulated 
consumer products on the market. Currently, the Food and Drug 
Administration (FDA) oversees the marketing and labeling of cosmetics, 
but does not have the authority to approve the safety of cosmetics 
before they go on the market. Yet, research suggests that chemicals 
contained in many of the personal care products we use every day are 
linked to serious health problems, and FDA recently issued a number of 
alerts advising consumers not to use certain cosmetic products because 
of concerns related to asbestos exposure.

    If confirmed, what additional steps will you take to monitor and 
enforce the safety of cosmetic products? What specific authorities do 
you believe the FDA needs to enforce a high safety standard for 
cosmetics, and will you work with Congress to modernize and expand 
oversight of personal care products?

    Answer 7. Thank you for your interest in this issue. I commit that, 
if confirmed, I will work with staff at FDA, industry, consumers, and 
members of the scientific community to understand what needs to be done 
to take a proactive stance to monitoring the safety of the cosmetics 
market for consumers. I will also work to better understand the risks 
to public health presented by cosmetics products. It is important that 
consumers be able to trust that the cosmetics they buy are not 
contaminated by harmful substances or manufactured under substandard 
conditions.

    Question 8.

    There is a persistent shortage of donated blood products in the 
United States, and blood donation policies that encourage as much 
healthy donation as possible are critical to secure our Nation's blood 
supply. It is important for donor deferral policies to be based on an 
individual's risk of transmitting infection, rather than blanket, non-
risk-based criteria that discourage healthy donation. In 2015, the FDA 
finalized guidance to update the deferral criteria for men who have sex 
with men (MSM) from a lifetime ban to a one-year deferral. While this 
was a step in the right direction, this policy is not based on 
individualized risk, and is not driven by science and continues to be 
discriminatory.

    If confirmed, will you commit to reviewing FDA's donor deferral 
policies to ensure that they are based on the most up-to-date 
scientific knowledge, and working toward criteria based on individual 
risk of infection transmission?

    Answer 8. I know how important it is to make sure there is a safe 
and ample donated blood supply. It is absolutely critical and life-
saving to the American people. If confirmed, I will continue the work 
of the FDA to implement policies that ensure that we have access to a 
safe and adequate blood supply. I will also commit to continuing to 
work with FDA staff to review the donor policies to ensure they are up 
to date, and reflect current science and data.

    Question 9.

    On November 19, 2019, the Center for Veterinary Medicine at FDA 
issued draft guidance for industry #256, ``Compounding Animal Drugs 
from Bulk Substances.'' In May 2015, FDA published draft guidance on 
this issue, which was later withdrawn based on feedback from the 
veterinary community and compounding industry, as well as other 
stakeholders. The new draft GFI #256, like the withdrawn GFI #230, 
contains a clinical need standard and a bulk ingredient positive list 
for certain animal drug compounding, similar to provisions that apply 
to section 503B outsourcing facilities for human compounding.

    If confirmed, will you commit to actively engaging with 
stakeholders to gather feedback on this guidance, and can you provide 
more information on the statutory provisions that allow the agency to 
expand these provisions to animal drug compounding?

    Answer 9. I recognize the importance of gathering stakeholder input 
on all issues, including in the area of animal drug compounding. 
Compounded drugs play a critical role in providing patients, human or 
animal, with the appropriate therapy when filling a medical need. I 
commit that, if confirmed as Commissioner, I will work to ensure FDA 
makes progress in implementing the authorities over compounded products 
taking into account the range of stakeholder needs.

                             senator murphy
                        Sesame Allergen Labeling
    In late 2018, the FDA solicited comments to inform agency action to 
require food manufacturers to label for sesame as a priority allergen 
and received more than 4,800 comments in response. I previously wrote 
to the FDA on this topic and am pleased they took action in this year. 
This year, I secured language in the Fiscal Year 2020 Senate-passed 
Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Act encourages the FDA to continue 
action in this area and require sesame allergen labeling.

    Question 1.

    Do you agree that sesame should be labeled as a major allergen? 
What is your timeline to review the comments and data sets submitted to 
the docket and take action on sesame allergen labeling?

    Answer 1. American consumers should be alerted to potential 
allergens in their food to the extent practicable. I am glad to hear 
that Congress and FDA have already begun looking at whether it would 
benefit the public health to include sesame as a major allergen. I 
cannot give a timeline as I am not currently at the Agency but I commit 
that I will support the Agency in moving this work forward as 
expeditiously as possible.
                             Drug Shortages
    In June 2018, Senator Cassidy and I led a letter with 29 other 
Senators to ask the FDA to convene the Drug Shortage Task Force to 
develop a report and recommendations regarding the root causes of drug 
shortages. In response, last month the FDA released the report Drug 
Shortages: Root Causes and Potential Solutions that outlined some 
prominent obstacles and recommendations to address the drug shortage 
issues affecting patient care nationwide.

    Question 2.

    Would you outline the steps you would take to implement the 
recommendations, as well as a timeline? Also, would you commit to 
keeping HELP Committee Members abreast of any major steps that your 
agency undertakes on this issue?

    Answer 2. I applaud your leadership on this issue and believe FDA's 
recent report on drug shortages is a significant step forward in 
addressing this problem. I will make preventing and alleviating drug 
shortages one of the highest priorities of the Agency should I be 
confirmed as Commissioner. I have seen first-hand how shortages affect 
patient care. I also commit to be proactive in my communications with 
you and other Members of the HELP Committee.
                                Opioids
    As you know, opioid prescribing in the U.S. has declined in recent 
years. However, Americans continue to consume far more opioids per 
capita than any other country, which may lead to more people becoming 
newly addicted.

    Question 3.

    What would you do as Commissioner to reduce the overprescribing of 
opioids, while maintaining access for those who have a genuine need?

    Answer 3. Thank you for your question. The opioid crisis is one of 
the largest and most complex public health tragedies that our Nation 
has faced. This is a top priority for the administration, the 
Department and Congress. It will be a top priority for me if I am 
fortunate enough to be confirmed. My own personal experience with this 
issue is as a cancer doctor. I have known patients who have survived 
cancer only to become addicted to opioids. For many years, our medical 
education was that addiction did not occur in cancer patients and we 
were encouraged to use opioids liberally. This turns out not to be the 
case and unfortunately, there have been tragic consequences. There has 
been a significant change based upon doctor education efforts in the 
prescribing habits for opioids. An evidence-based holistic approach to 
treating pain with non-opioid medications, behavioral therapies, and 
when appropriate, opioids is now being used effectively in many medical 
settings to effectively treat pain. We have new ways of prescribing 
pain medications that create a balance between relief of suffering and 
preventing addiction. There is outstanding research being performed on 
addiction and the causes of pain. I am optimistic that even better 
approaches will be developed in the future. That being said, we are 
still dealing with a devastating and urgent crisis with opioids. FDA 
was given important authorities by Congress in the SUPPORT act to 
assist in the prevention of misuse of opioids. Actions by FDA such as 
changes to packaging, labeling, the REMS program and efforts to stop 
the illegal importation of opioids are all important steps forward. I 
promise, if confirmed as FDA Commissioner, to make combating the opioid 
crisis a top priority of the agency and I look forward to continuing 
and enhancing those efforts, if I am fortunate enough to be confirmed. 
I understand that FDA is also evaluating other activities that could be 
helpful including setting standards for new opioid approvals, 
additional doctor education, and revising regulatory procedures for 
mandatory recall authority of opioids that have a substantial risk for 
adverse health consequences or death. I am supportive of efforts by the 
agency to help innovators of non-opioid alternatives for pain control 
and abuse-deterrent formulations because we cannot forget the 
importance of safely helping Americans with pain syndromes. I am also 
supportive of efforts to advance the development and use of safe and 
effective medication-assisted therapy or MAT in a holistic therapy 
setting. I have cared for numerous patients with serious and 
debilitating pain, and understand that we must strike a balance between 
maintaining patients' access to effective opioid drugs and non-opioid 
alternatives, while reducing misuse and abuse of opioid drugs.

    Question 4.

    Currently, there is a citizen petition from public health officials 
and doctors that is pending before the FDA asking for the removal of 
ultra-high dosage opioids--opioids that come in doses so strong a 
single pill can cause an overdose in someone without a tolerance to 
opioids. One example is the 80mg OxyContin tablet that is the 
equivalent of 24 Vicodin tablets in a single pill.

    Answer 4. Thank you for your question. While I do not have access 
to non-public information from the FDA, if I am confirmed, I will work 
with agency staff to determine the status of the citizen's petition. 
Addressing the opioid crisis is a top priority for the administration, 
the Department and Congress. It will be a top priority for me if I am 
fortunate enough to be confirmed.

    Has the agency reviewed this petition to remove ultra-high dosage 
opioids?
                              Medical Gas

    The FDA has yet to formally begin the rulemaking process for 
medical gas, despite having the authority to do so since 1978 and being 
given a statutory deadline in the fiscal year 2017 Consolidated 
Appropriations Act to do so by July 2017. In 2018, the FDA convened 
three public meetings with stakeholders and announced in the fall 2018 
Unified Agenda that it intended to issue a proposed rule on medical 
gases by April 2019. That date was pushed back in the Fall 2019 Unified 
Agenda that now projects a September 2020 publication date for a 
proposed rule on medical gases.

    Question 5.

    What is causing the delay in rulemaking on medical gases that 
already is 41 years overdue? When will the FDA issue the NPRM on 
medical gas?

    Answer 5. If confirmed, I am committed to implementing all laws 
passed by Congress, including Section 1112 of FDASIA. I look forward to 
working with you on this issue.

    As you know, in 2017, FDA circulated a draft guidance on this 
matter that is intended to provide more clarity around good 
manufacturing processes for medical gases, and I look forward to 
continuing work on this issue.
                     Electrical Stimulation Devices
    The FDA released a proposed rule to ban electrical stimulation 
devices (ESDs) in April 2016 but has not yet finalized the rule. 
Evidence indicates that the use of ESDs in individuals with 
intellectual or development disabilities are associated with a number 
of physical and emotional risks including depression, posttraumatic 
stress disorder, burns and tissue damage. In 2016, I wrote a letter 
with five other Senators in support of agency action to ban ESDs. 
Meanwhile, ESDs continue to be used on children and young adults with 
developmental disabilities. Last year former FDA Commissioner Dr. Scott 
Gottlieb expressed support for a ban saying, ESDs ``present an 
unreasonable and substantial risk to public health that cannot be 
corrected or eliminated through changes to the labeling.''

    The Fall 2018, Spring 2019, and recently released Fall 2019 Unified 
Agenda include finalizing a ban on electrical stimulation devices that 
are used on individuals with intellectual or developmental disabilities 
but so far this hasn't moved from FDA to OMB.

    Question 6.

    When does the agency plan to complete its work to issue a final 
rule to ban electrical stimulation devices?

    Answer 6. I am committed to working with your office on this issue 
and working to protect American patients. I cannot speak to a proposed 
timeline, as I am not part of the administration yet. I look forward to 
working with FDA's professional staff to study this issue and 
understand the most efficient path forward that protects patients.
                              Maple Syrup
    The FDA is currently debating changes to nutrition panel labeling, 
one of which is more prominently listing added sugars. While the FDA 
defines this term as the sugars that are added to someone's diet, 
consumers often interpret it as sugars added to the product. Producers 
of pure maple syrup are concerned about how their products will be 
viewed under this label because consumers will think that if a bottle 
of maple syrup lists ``added sugars'' it means there are other 
processed sugars added to the product--even when it's pure maple syrup.

    While the FDA has attempted to address these concerns by publishing 
non-binding guidance, producers must now publish an unidentified 
percent daily value on a blank line below the amount of total sugar on 
the nutrition facts panel. Producers remain concerned that the 
orphaned, floating percent daily value would suggest to consumers that 
pure maple syrup producers, and other single ingredient sugar producers 
included a typographical error on their labels, thus exposing producers 
to consumer complaints. To address this concern the FDA offered in 
guidance that producers could voluntarily use an obelisk by the orphan 
percent daily value and include an explanatory footnote explaining that 
this refers to a percent daily value of ``added sugar''. Producers are 
now requesting an answer from FDA on whether the following phrase would 
suffice as that footnote, ``One serving adds 24g of sugar to your diet 
and represents 48 percent of the Daily Value for sugars added to your 
diet.''

    Question 7.

    Can you work with producers to confirm that this explanatory 
footnote will be recognized by the FDA as truthful and not misleading?

    Answer 7. Yes, I commit that if confirmed, I will prioritize FDA's 
interactions with stakeholders including on the issue of Nutrition 
Facts Label requirements. I believe that FDA is most effective when 
stakeholder input is fully considered in developing regulatory 
requirements.
                     Finished Drug Product Testing
    It is vital that consumers feel confident in the products that bear 
the FDA seal of approval. Earlier this year there was a recall across 
the U.S., Canada, Taiwan, Pakistan, and several European countries of 
the heartburn drug Zantac and its generic due to concerns that it 
contained a probable carcinogen and posed a potential health risk for 
patients. The problem was identified by a pharmacy in Connecticut--
Valisure--because they conduct chemical testing of every batch of drugs 
before they dispense them to patients. To my knowledge, this is not 
commonly done in the U.S., either by the FDA or by other pharmacies.

    Question 8.

    What can the FDA do to reassure the public about the safety and 
integrity of the U.S. drug supply chain? While the agency has a limited 
ability to inspect all of these facilities, do you think the FDA should 
consider conducting more widespread chemical testing of finished 
products? Has the FDA considered opportunities to partner with private 
industry to help conduct this type of testing to ensure the safety of 
our Nation's supply chain?

    Answer 8. I am not currently a part of the administration and 
cannot speak to the specifics of the agency's capacity or actions that 
have come under consideration to address any shortcoming. If I am 
confirmed, I commit to working closely with FDA staff to understand 
this issue and will carefully consider any proposals that will protect 
the Nation's drug supply. I am committed to FDA remaining the gold 
standard for ensuring the safety.

                             senator warren
                        I. Antibiotic Resistance
    Antibiotic drugs are critical tools for treating serious bacterial 
infections, but they are becoming less and less effective as bacteria 
develop a resistance to the antibiotics that are currently available. 
Today, resistance has been seen in almost all antibiotics ever 
developed. The World Health Organization (WHO) has described 
antimicrobial resistance (AMR) as ``one of the biggest threats to 
global health, food security, and development today,'' and the threat 
is no less significant right here in the U.S. According to the Centers 
for Disease Control and Prevention (CDC), nearly 3 million people in 
the U.S. develop antibiotic-resistant infections every year, resulting 
in over 35,000 deaths.

    Unfortunately, discovery of new antibiotics is failing to keep pace 
with the emergence of new ``superbugs.'' Almost every antibiotic in use 
today is based on a scientific discovery made more than 30 years ago. 
Currently, there are only 42 antibiotics in clinical development 
worldwide. While that number may seem sufficient, only 11 of those have 
the potential to address the most dangerous superbugs as identified by 
the WHO, and historical data indicates that only 1 in 5 infectious 
disease drugs entering phase 1 trials typically receive FDA approval. 
Developing new antibiotics is essential in the effort to combat AMR, 
yet a number of unique scientific and economic challenges hamper drug 
development efforts. Furthermore, there is strong and growing evidence 
that antibiotic overuse in food animals can lead to antibiotic 
resistance in humans. The 2014 National Strategy for Combatting 
Antibiotic-Resistant Bacteria brought together the Secretaries of 
Health and Human Services, Agriculture, and Defense to declare that, 
``the misuse and over-use of antibiotics in health care and food 
production continue to hasten the development of bacterial drug 
resistance, leading to the loss of efficacy of existing antibiotics.''

    Question 1.

    Do you agree that supporting the development of new antibiotics is 
an important part of FDA efforts to combat antimicrobial resistance? If 
confirmed, what steps would you take to encourage the development of 
new antibiotics?
    Answer 1. Yes, supporting the development of new antibiotics is a 
critical part of combating antimicrobial resistance. If confirmed, I 
would rely on FDA career experts to support the LPAD pathway and 
examine whether the program requires anything additional to stimulate 
the innovation of new antibiotics.

    Question 2.

    If confirmed, will you commit to continue the implementation of the 
priorities and goals outlined in the FDA's 2019 Strategic Approach for 
Combatting AMR?

    Answer 2. Yes, if confirmed, I would commit to implementing the 
2019 Strategic Approach for Combatting AMR.

    Question 3.

    If confirmed, what will you do to improve physician education on 
the safe prescribing of antibiotics?

    Answer 3. My first step, if confirmed, would be to engage with the 
career staff in both Center for Drug Evaluation and Review (CDER) and 
Center for Veterinary Medicine (CVM) to learn about their ongoing work. 
I believe the work the Agency has done on prescribing guidelines to 
help combat the opioid crisis is a model we could use to engage 
physicians and create a strategy for improving physician education. I 
personally commit to being a forceful educator and advocate for safe 
prescribing of antibiotics by physicians.

    Question 4.

    As part of the FDA's Strategic Approach for Combatting AMR, the FDA 
released a five-year plan to support antimicrobial stewardship in 
veterinary settings. A key component of the five-year plan is the 
establishment of defined durations of use for animal drugs. Currently, 
roughly 1 in 3 medically-important antibiotics can be provided to 
animals for ``very long or undefined durations of use''--increasing the 
likelihood of AMR. In June 2018, I introduced the Strengthening 
Antibiotic Oversight Act, a bill that would require the FDA to review 
the durations of use of medically-important antibiotics labeled for use 
in animals and withdraw approvals for antibiotics with unjustified 
duration limits. In April 2019, the FDA released a funding opportunity 
to help jumpstart the process of defining duration limits.

    4a. If confirmed, will you commit to continue the implementation of 
the FDA's five-year plan to support antimicrobial stewardship in 
veterinary settings?

    Answer 4a. Yes, I look forward to supporting the implementation of 
the FDA's five-year plan to support antimicrobial stewardship in 
veterinary settings.

    4b. If confirmed, will you commit to finalizing defined durations 
of use for medically-important antibiotics in a timely manner?

    Answer 4b. Yes, if confirmed, I will work to finalizing defined 
durations for use for medically-important antibiotics in a timely 
manner.

    Question 5.

    If confirmed, how will you evaluate the effectiveness of guidance 
designed to limit animal antibiotic overuse, including Guidance for 
Industry #209 and #213, and the Veterinary Feed Directive?

    Answer 5. I will partner with the experts at CVM to establish 
meaningful metrics on the effectiveness of the guidance. One helpful 
metric the Agency currently collects to examine antibiotic utilization 
is the volume of sales data for antibiotics, but I would look forward 
to learning about other tools the agency could use to establish metrics 
and tools for measurement.

    Question 6.

    If confirmed, how will you direct the FDA to work with the 
Departments of Agriculture and Defense, among other executive agencies, 
to combat AMR?

    Answer 6. No one country, organization, or company will be able to 
address AMR and I would rely on strong domestic partnerships with USDA 
and the Department of Defense, in addition to other executive agencies 
to combat AMR. If confirmed, I would first learn more about the Agency 
existing partnerships and discuss how we can build off of them.
                       II. Blood Donation Policy
    Ensuring a safe and adequate blood supply is a critical aspect of 
our public health system. The FDA develops blood donation policy for 
the Nation's blood banks--a task that is even more important as we 
respond to emerging diseases that threaten the safety of our blood 
supply. Evidence indicates that moving to a risk-based referral policy 
could increase the U.S. blood supply by up to 4 percent, helping to 
address the Nation's blood shortage. In June 2016, the FDA started 
collecting public input on scientifically sound solutions to risk-based 
screening, and the information collection period closed in November 
2016. In 2019, the FDA solicited contractors to conduct an ``HIV Risk 
Questionnaire (HRQ) Study'' to assess the ``predictive value of a panel 
of questions for recent infection with'' HIV. Building on these steps 
will require leadership from the next FDA Commissioner.

    Question 1.

    As FDA Commissioner, how would you support the FDA's efforts to 
move to a risk-based referral policy for all blood donors?

    Question 2.

    Do you commit to respect the advice of the FDA's Blood Products 
Advisory Committee Meeting in their scientific findings and 
recommendations with regard to the safety and public health risks of 
blood donation?

    Question 3.

    Will you commit to developing a risk-based, on-site questionnaire 
to be used at blood donation clinics? What is the current status of the 
FDA's HRQ Study?

    Question 4.

    What specific steps will you take to engage with impacted groups, 
which may be newly eligible for blood donation, to encourage blood 
donation in line with new policies?

    Answers 1-4. I know how important it is to make sure there is a 
safe and ample donated blood supply. It is absolutely critical and 
life-saving to the American people. If confirmed, I will continue the 
work of the FDA to implement policies that ensure that we have access 
to a safe and adequate blood supply. I will also commit to continuing 
to work with FDA staff to review the donor policies to ensure they are 
up to date, and reflect current science and data.

    The work of the Blood Products Advisory Committee (BPAC) is so 
critical, as it reviews and evaluates available data concerning the 
safety, effectiveness, and appropriate use of blood, products derived 
from blood and serum or biotechnology which are intended for use in the 
diagnosis, prevention, or treatment of human diseases, and, as 
required, any other product for which the Food and Drug Administration 
has regulatory responsibility, and advises the Commissioner of Food and 
Drugs of its findings. I commit to using the data provided by this 
Committee to driving the decision making surrounding blood product 
polices.

    Ensuring the safety and adequacy of our Nation's donated blood 
supply is critically important to public health. If confirmed, I will 
work with FDA staff to closely develop, implement, and monitor the 
impact of policies to promote blood safety. I will also commit to 
continuing to work with FDA staff to review its donor deferral policies 
to ensure they reflect the most up-to-date scientific knowledge.
                 III. Clinical Trial Data Transparency
    Increased sharing of clinical trial data could strengthen academic 
research, improve the practice of medicine, and protect the integrity 
of the clinical trials system. Noting the potential benefits of 
increased transparency, leading medical journals have begun to require 
authors to disclose their plans to share de-identified data from their 
studies as a condition for publication. Furthermore, a new scorecard 
tool that rates companies on their ethics and transparency practices 
has spurred some pharmaceutical companies to improve their reporting 
practices. Unfortunately, some efforts to improve data sharing have 
been hampered by incomplete compliance with Federal requirements. The 
Food and Drug Administration Amendments Act (FDAAA) of 2007 required 
trial results to be registered and reported on ClinicalTrials.gov, with 
penalties up to $10,000 per day for non-compliance, but despite uneven 
compliance, the FDA has never levied a monetary penalty or withheld 
research funding for researchers who failed to meet the registration 
requirements. In September 2016, the FDA removed a major barrier to 
enforcement of the FDAA penalties by issuing a final rule detailing the 
requirements for submitting clinical trial results to 
Clinicaltrials.gov, and in September 2018, it published draft guidance 
on the circumstances and process by which the agency would seek civil 
money penalties against researchers who fail to submit results or 
submit false or misleading information.

    Question 1.

    What do you believe the impact of greater transparency of clinical 
trial data and results would be on clinical trial efficiency, the cost 
of drug development, drug safety, and biomedical innovation?

    Question 2.

    If confirmed, what specific steps will you take to increase sharing 
of clinical trial data?

    Question 3.

    Currently, the FDA allows applicants to release the complete 
response letters they receive in response to their applications, but 
does not require the letters to be made public.

        a. What would be the impact of making complete response letters 
        publicly available on clinical trial efficiency, the cost of 
        drug development, drug safety, and biomedical innovation?

        b. If confirmed as Commissioner, will you commit to making 
        complete response letters publicly available?

        c. If confirmed, what specific steps will you take to make 
        complete response letters publicly available?

    Question 4.

    If confirmed, how will you ensure compliance with the disclosure 
policy implemented by FDAAA and the September 2018 guidance? Will you 
enforce the law using civil monetary penalties or by other means?

    Answer 1-4. Thank you for your questions regarding transparency of 
clinical trial data. As a clinical trialist, I understand the 
importance of transparency and the sharing of information to spur new 
research. Transparency is critical to advancement of science and 
medicine. FDA has announced a pilot program to evaluate whether 
disclosing certain information included within a clinical study report 
improves public access to drug approval information. The FDA also 
announced it will add the ClinicalTrials.gov identifier numbers to FDA 
materials for future FDA drug approvals so that members of the patient, 
academic, and scientific communities can learn more about the drug's 
development. If confirmed, I will work with Agency staff to determine 
what can be done to build upon the recent progress by the agency to 
enhance transparency of clinical trial information. If fortunate to be 
confirmed as Commissioner, my decision-making will be guided by 
science, data and the law.
                               IV. Drugs
                              Drug Pricing
    Millions of Americans are struggling with the high cost of 
prescription drugs. Nearly one in four Americans taking prescription 
drugs ``report difficulties affording their medications,'' and 
according to a recent poll conducted by the Kaiser Family Foundation, 
at least three in ten adults reported skipping drug doses, delaying 
filling prescriptions, or taking less of a drug than prescribed to save 
money. As the agency responsible for evaluating the safety and efficacy 
of brand-name, generic, and biosimilar drugs, the FDA has a role to 
play in government-wide efforts to lower the costs of drugs for 
American families.

    Question 1.

    In your view, what role should the FDA play in efforts to lower 
prescription drug prices?

    Question 2.

    If confirmed, what steps will you take to help lower the cost of 
drugs for American consumers?

    Question 3.

    If confirmed, how will you work with other agencies within HHS and 
the executive branch as a whole to coordinate and develop policies 
designed to reduce prescription drug costs?

    Response to 1-3. Thank you for these questions. High prescription 
drug prices and affordability are a significant problem and addressing 
this issue through a variety of means has been a priority of Congress, 
the administration and the Department. I agree that strong action is 
needed to address this issue. It's also important to ensure that 
whatever solutions we consider, do not have the unintended consequences 
of stifling innovation and the development of new medical products for 
the American people. There are indirect ways that FDA can assist in 
lowering prescription drug prices such as facilitating innovation and 
competition. As you know, FDA has a Drug Competition Action Plan and I 
look forward to working with Congress and career staff on this plan. I 
am particularly supportive of introducing more competition to help 
reduce drug prices including generic approvals, working to improve the 
biosimilar pathway, and ensuring that there is transparency and a clear 
regulatory pathway, not game-playing in the generic and biosimilar 
spaces. I look forward to working with you on measures to reduce high 
prescription drug prices. I will make this a priority and do all that I 
can as FDA commissioner to ensure access of medical products for all 
Americans.
                             Drug Shortages
    In recent months, a number of high-profile drug shortages have 
dominated the news, including shortages of immune globulin and 
vincristine. According to the American Society of Health-System 
Pharmacists, there have been more than 100 drug shortages per year 
since 2007. In 2018, the number of drug shortages reached 186, the 
second highest since the peak of 267 drug shortages in 2011. In 
addition to harming patients, shortages cause severe financial burdens 
for hospitals. A recent survey of 700 hospital pharmacy managers found 
that all of them experienced a drug shortage in the previous year--
forcing 81 percent of the pharmacy managers to hoard medications and 66 
percent to ration medication. Every year, drug shortages cost hospitals 
$216 million in labor costs and an additional $200 million to 
substitute drugs in shortages. In October 2019, the FDA released a 
report, ``Drug Shortages: Root Causes and Potential Solutions.'' The 
report identified three ``root causes'' of drug shortages, including 
(1) a ``lack of incentives to produce less profitable drugs'' (a 
problem that is particularly acute in the antibiotics market); (2) the 
market's failure to adequately ``reward manufacturers for mature 
quality management systems''; and (3) ``logistical and regulatory 
challenges'' that ``make it difficult for the market to recover after a 
disruption.'' The report identified three potential solutions to 
prevent drug shortages and highlighted existing FDA efforts to combat 
shortages.

    Question 1.

    If confirmed, will you commit to making the prevention of drug 
shortages a top priority at the FDA?

    Answer 1. I commit that, if confirmed, I will prioritize the 
prevention and alleviation of drug shortages. I will bring the 
perspective of a physician who has had to make changes to my patients' 
treatments because of drug shortages.

    Question 2.

    If confirmed, what specific steps will you take to combat drug 
shortages in the brand-name and generic drug marketplaces, 
respectively? What additional steps will you take to address the unique 
challenges facing manufacturers of antibiotics?

    Answer 2. I found FDA's recent report on the root cause of drug 
shortages to be very informative. This is not a new issue nor is it one 
that will be solved with a single action. But I am optimistic that with 
the commitment I have seen from Congress, we can make progress.

    Question 3.

    If confirmed, how will you direct the FDA to work with Federal 
agencies, Congress, manufacturers, and other stakeholders to implement 
the recommendations included within the 2019 report?

    Answer 3. If confirmed, I will work to take the next steps 
recognizing that the solutions may require FDA to work with a number of 
stakeholders including Congress. I commit to prioritizing this work. 
The first action I would take is it to consult with the staff at FDA, 
and I believe I will bring a new perspective.

    Question 4.

    In July 2018, then-Commissioner Gottlieb stated that the FDA would 
``be looking at whether it makes sense to develop a critical drugs 
list, or a list of essential drugs where it would be especially 
important, from a clinical perspective, to ensure an uninterrupted drug 
supply.''

        4a. What is the current status of this ``critical drugs list''?

    Answer 4a. Although I cannot speak to the status of FDA's critical 
drug list, I see real promise in this initiative. I will bring an 
important perspective as an oncologist who has seen the real-life 
effects of drug shortages.

        4b. If confirmed, will you commit to finalizing this ``critical 
        drugs list'' to help combat drug shortages?

    Answer 4b. If confirmed, I will commit to looking into the status 
of critical drugs to promote the public health.
                Drug Supply Chain and National Security
    Last week, the U.S. China Economic and Security Review Commission 
released a report highlighting ``China's dominance as a global [active 
pharmaceutical ingredient] producer and the United States' growing 
reliance on Chinese pharmaceutical products.'' Active pharmaceutical 
ingredients (APIs) are the raw chemical components of drugs that 
``furnish pharmacological activity or other direct effect in the 
diagnosis, cure, mitigation, treatment or prevention of disease.'' APIs 
are necessary to manufacture pharmaceutical products such as generic 
drugs and vaccinations. Despite the critical role of APIs in drug 
production, the U.S. ``only makes about 20 percent of the APIs used in 
domestic pharmaceutical production.'' Instead, the U.S. relies heavily 
on China for the import of these materials.

    Experts warn that the Nation's ``growing reliance on Chinese 
pharmaceutical products puts U.S. consumers--including active service 
members and veterans--at risk.'' However, the FDA reportedly has little 
formal means for quality surveillance or oversight of Chinese 
manufacturers and drug plants.

    Question 1.

    Do you agree that the United States' reliance on Chinese 
pharmaceutical products places American consumers at risk? If so, what 
role do you believe the FDA should play in mitigating this risk?

    Question 2.

    If confirmed, what steps will you take to improve the FDA's ability 
to monitor the quality of imported pharmaceutical products, 
particularly those products produced in China? What steps will you take 
to ensure that the United States' supply line of these pharmaceutical 
products is secure and safe from disruption?

    Question 3.

    If confirmed, how will you direct the FDA to work with the 
Department of Defense and other executive agencies to address national 
security and public health risks posed by the Nation's reliance on 
Chinese pharmaceutical products?

    Question 4.

    In July 2018, then-Commissioner Gottlieb stated that the FDA would 
``be looking at whether it makes sense to develop a critical drugs 
list, or a list of essential drugs where it would be especially 
important, from a clinical perspective, to ensure an uninterrupted drug 
supply.'' Though this statement was made in the context of reducing 
drug shortages, a ``critical drugs list'' could also be helpful as the 
Federal Government analyzes the Nation's reliance on Chinese 
pharmaceutical products. If confirmed, what steps would you take to 
ensure that this list can be used to both prevent drug shortages and 
address national security and public health risks posed by the Nation's 
reliance on Chinese pharmaceutical products?

    Answer 1-4. Thank you for your question. FDA's role is to ensure 
the safety of the drug supply. The U.S. has the safest drug supply in 
the world and if confirmed, I am committed to maintaining the safety of 
drugs and biologics used by the American people. According to recent 
testimony from FDA, as of August 2019, only 28 percent of the 
manufacturing facilities making APIs to supply the U.S. market were in 
our country. By contrast, the remaining 72 percent of the API 
manufacturers supplying the U.S. market were overseas, and 13 percent 
are in China. I believe advanced manufacturing could help to bring this 
manufacturing back to the U.S. If confirmed, I look forward to working 
with the staff at the FDA, along with partnering with Congress, ASPR, 
BARDA, the Department of Defense and others to address this issue and 
ensure that the U.S. drug supply remains safe.
                               V. Ethics
    With public trust in government at an all-time low, it is essential 
for public officials to hold themselves to the highest ethical 
standards. This is especially true for the FDA, given that the 
pharmaceutical industry spent record amounts on lobbying last year: the 
Pharmaceutical Research & Manufacturers of America spent $27.5 million, 
and the industry as a whole spent more than $194 million as of October 
2018.

    My Anti-Corruption and Public Integrity Act would require common-
sense measures to avoid conflicts of interest for officials in 
positions of public trust to assure Americans that their government is 
working for them, and not for deep-pocketed lobbyists. I ask that if 
you are confirmed, you voluntarily comply with the conflict of interest 
and revolving door provisions of the Act to give the public confidence 
that your decisions at the FDA are in the best interest of patients and 
consumers, rather than lobbyists and corporations.

    Question 1.

    If confirmed, from what issues, if any, do you plan to recuse 
yourself due to your own or your family members' financial conflicts of 
interest?

    Question 2.

    If confirmed, will you commit to recusing yourself from all issues 
that could provide a financial benefit to your previous employer, M.D. 
Anderson Cancer Center?

    Question 3.

    If confirmed, will you commit to divesting from all individual 
stocks outside of widely held investment vehicles (such as mutual or 
index funds)?

    Question 4.

    If confirmed, will you commit to refraining from lobbying 
activities after your tenure ends?

    Question 5.

    If confirmed, will you commit to refraining from employment with 
any company that lobbied the FDA for at least one year?

    Answer 1-5. If confirmed, I will abide by all of the commitments 
set forth in my ethics agreement and will comply with all applicable 
laws and regulations. I will also be bound by the requirements and 
restrictions set forth in this administration's Ethics Pledge (EO 
13770). If confirmed, I will meet with the career ethics officials at 
the Department of Health and Human Services during the first week of my 
service to ensure compliance with all of these ethics standards. 
Throughout my public service I will consult with appropriate ethics 
officials for guidance on these matters, including with respect to any 
recusal obligations not already set forth in my ethics agreement. I 
will also follow the Office of Government Ethics recommendations 
regarding my personal financial portfolio. I am committed to leading 
the FDA driven by science, data and the law, and will uphold the gold 
standard of the FDA that provides Americans peace of mind in the 
reliability of the FDA.
                           VI. FDA Workforce
    FDA's work is supported by highly skilled, professional employees 
who uphold the agency's mission and protect public health in the United 
States.

    Question 1.

    If confirmed, will you work cooperatively with employees and 
employees' representatives, including unions?

    Question 2.

    If confirmed, will you meet with national leadership of employees' 
union representatives soon after you begin your duties?

    Answers 1-2. The FDA's gold standard comes directly from the great 
men and women who make up the dedicated outstanding career workforce. 
If confirmed, I plan to make workforce issues a top focus and will 
immediately get to know the wonderful staff, and their representatives, 
to better understand the opportunities, challenges and needs that 
affect their work and mission. I will work with all appropriate 
stakeholders to ensure that FDA has the best and brightest to 
accomplish its mission.
                   VII. Over-the-Counter Hearing Aids
    Approximately 48 million Americans experience age-related hearing 
loss, including over half of adults in their seventies. However, only 
an estimated 14 percent of Americans with hearing loss use hearings 
aids, primarily because they cannot afford to buy them. Medicare and 
most private insurance plans do not cover hearing aids, and out-of-
pocket costs for a single hearing aid averaged $2,400 in 2015--far out 
of reach for many Americans. Furthermore, in 1977, the FDA issued 
regulations preventing individuals from purchasing hearing aids unless 
they had obtained a medical evaluation (or signed a waiver of that 
evaluation). These regulations meant that Americans could not purchase 
hearing aids over-the-counter.

    To expand Americans' access to hearing aid technology, I introduced 
the Over-the-Counter (OTC) Hearing Aid Act with Senators Grassley, 
Hassan, and Isakson in March 2017. In August 2017, the bill was signed 
into law. The OTC Hearing Aid Act makes certain types of hearing aids 
available over-the-counter. It requires the FDA to issue regulations 
establishing safety and efficacy requirements for OTC hearing aids and 
to update and finalize its draft guidance, ``Regulatory Requirements 
for Hearing Aid Devices and Personal Sound Amplification Products.'' 
The FDA must issue proposed regulations no later than August 2020 and 
must finalize its guidance when final regulations are issued.

    Question 1.

    If confirmed, will you commit to issuing the proposed regulations 
required under the OTC Hearing Aid Act in a timely manner and in 
compliance with statutory deadlines?

    Answer 1. I commit to following the laws of Congress.

    Question 2.

    If confirmed, will you commit to finalizing the draft guidance on 
personal sound amplification products in a timely manner and in 
compliance with statutory deadlines?

    Answer 2. I am not privy to current decision making of the FDA. If 
confirmed, I look forward to looking into this matter and reporting 
back to you.

    Question 3.

    If confirmed, what additional actions will you take to expand 
access to affordable hearing aid technologies?

    Answer 3. I'd like to know more about this and am open to having 
conversations that science and data would provide to provide Americans 
with the safest and most effective medical products.
                         VIII. Medical Devices
                  Pre-Cert for Software Pilot Program
    The FDA has established a ``Software Pre-Cert Pilot Program'' to 
test the feasibility of altering the traditional device approval 
pathway for certain software as medical devices (SaMD). Senator Murray, 
Senator Smith, and I have repeatedly communicated with the FDA about 
the Pre-Cert Pilot, and we continue to have concerns about the 
program's impact on public safety and its compliance with existing 
statute. Specifically, these concerns relate to: (1) the agency's 
ability to ensure public safety under a ``precertification'' regime, 
particularly through its proposed ``Excellence Appraisals''; (2) the 
appropriateness of the De Novo pathway as a statutory basis for the 
pilot; and (3) the agency's use of real world performance to assess the 
safety and efficacy of SaMD devices approved through the pilot. Most 
recently, in October 2019, we sent a letter to the FDA requesting 
information about the program.

    Question 1.

    If confirmed, will you commit to re-examining the Software Pre-Cert 
Pilot Program to assess its compliance with existing statutory 
authorities?

    Answer 1. If confirmed, I commit to working closely with staff at 
the FDA, and the Department of Health and Human Services, and all other 
appropriate parties to ensure that all programs at FDA are in 
compliance with existing law. I strongly believe in FDA's ability to 
advance tools that give patients more information about their own 
health, and I will support FDA's efforts to do so within its existing 
statutory authority.

    Question 2.

    Please provide detailed answers to the questions included in the 
October 2019 letter referenced above, which include:

        a. Since responding to us in June 2019, has the FDA gained 
        additional clarity on the type of data or evidence that would 
        be appropriate--and inappropriate--to demonstrate excellence 
        during an Excellence Appraisal? If so, please describe the type 
        of data or evidence that the agency is considering. If not, 
        please provide a description of the steps the agency will take 
        to identify this type of data or evidence.

        b. Since responding to us in June 2019, has the FDA gained 
        additional clarity on how it will ``appropriately limit'' the 
        flexibility granted to entities seeking to demonstrate 
        excellence via an Excellence Appraisal?

        c. As part of its retrospective testing, the ``Pre-Cert team 
        developed a mock Excellence Appraisal summary'' for pilot 
        participants that had previously received FDA approval for a 
        SaMD regulatory submission. The team developed these summaries 
        ``based on the pilot participant site visits and public 
        comments.''

                i. Please provide a copy of each ``mock Excellence 
                Appraisal summary'' developed as part of this 
                retrospective testing, including a copy of all ``public 
                comments'' used to develop these summaries.

                ii. What data or evidence did the Pre-Cert team review 
                during pilot participant site visits, and how did this 
                data or evidence contribute to the reviewers' ability 
                to determine whether the pilot participant complied 
                with the Excellence Principles? Does the agency believe 
                it has the authority to collect and review all of the 
                data and evidence it examined during the site visits 
                and anticipates examining in future site visits?

                iii. In developing these summaries, how much 
                flexibility--if any--did the agency grant pilot 
                participants in demonstrating compliance with the 
                Excellence Principles? How did granting this 
                flexibility to participants impact the data or evidence 
                examined during the Pre-Cert team's site visits? Was 
                the data or evidence standardized across all sites, or 
                did it vary from site to site?

                iv. The FDA concluded that its retrospective tests 
                demonstrated the ``feasibility'' of the Excellence 
                Appraisal (along with the Streamlined Review) ``to be 
                sufficient to conduct a premarket review of SaMD.''

                v. How did the FDA determine that the Excellence 
                Appraisal was ``sufficient''?

                vi. What would ``failure'' of the Excellence Appraisal 
                have looked like during this retrospective testing?

        d. The FDA is currently engaged in ``prospective testing'' of 
        the precertification model. This testing involves 
        simultaneously reviewing SaMD submissions using both the 
        traditional and Pre-Cert approval pathways. In July 2019, the 
        FDA announced that, based on its tests, ``the elements 
        identified in the [Working] model can be demonstrated and 
        provide a comprehensive view of an organization's 
        capabilities.''

                i. Please provide a summary of all Excellence 
                Appraisals performed under the FDA's prospective 
                testing to date. For each Excellence Appraisal, please 
                provide a list of the data and evidence used--including 
                KPIs--to demonstrate adherence to each element and 
                principle listed in the Working Model.

                ii. In the Excellence Appraisals it has performed so 
                far, what type of data or evidence has the FDA relied 
                on to ``demonstrate'' the elements identified in the 
                Working Model?

                iii. Has this type of data or evidence been consistent 
                across all of the Excellence Appraisals? If not, what 
                flexibility has the FDA allowed in the type of data or 
                evidence used to demonstrate the elements?

        e. In July 2019, the FDA announced that it ``has learned'' 
        based on testing ``that some of the elements [of the Excellence 
        Appraisal] may need to be separated or removed.''

                i. Which elements of the Excellence Appraisal is the 
                FDA considering ``separating'' from the appraisal? Why? 
                How will the FDA separately assess companies' 
                compliance with those elements?

                ii. Which elements of the Excellence Appraisal is the 
                FDA considering ``removing'' from the appraisal? Why?

        f. In its Working Model, the FDA states that it ``does not 
        intend to make individual organizations' KPI reports or results 
        available publicly, to the extent consistent with the Freedom 
        of Information Act.'' In its July 2019 update, it also 
        described Excellence Appraisals as ``confidential.''

                i. On what basis would the FDA withhold Excellence 
                Appraisals--and the KPIs used to develop them--in whole 
                or in part from public disclosure under the Freedom of 
                Information Act?

                ii. What information, if any, does the FDA anticipate 
                providing the public about Excellence Appraisals should 
                the Pre-Cert Pilot Program extend beyond the pilot 
                stage?

        g. The FDA has proposed utilizing third parties to conduct 
        precertification assessments in cases where it ``can identify 
        existing entities with the capacity and expertise to conduct a 
        Pre-Cert appraisal''--though it will not be doing so ``in the 
        first phase of implementing the Software Pre-Cert Program.'' In 
        its June 2019 response, the FDA notes that the ``FD&C Act 
        currently authorizes a third-party review program for 510(k) 
        submissions and for accrediting third part[ies] to perform 
        inspections of eligible device manufacturers so the concept is 
        not entirely new.'' It also states that the agency ``will 
        consider whether the future use of third parties would be 
        consistent with our existing statutory authorities.'' Has the 
        FDA determined whether allowing third-party entities to conduct 
        precertification assessments during the Pre-Cert Pilot Program 
        would ``be consistent with existing statutory authorities''?

        h. Given the FDA's assertion that the De Novo pathway was 
        established ``to ensure the most appropriate classification of 
        a device consistent with the protection of the public health 
        and the statutory scheme for device regulation,'' does the 
        agency believe that Congress intended for the pathway to be 
        used to establish pilot programs that fundamentally alter the 
        FDA's existing method of device review and approval? If so, 
        please explain why.

                i. Since the De Novo pathway was established in 1997, 
                how many times has the FDA used it as the statutory 
                basis to establish a pilot program? Please provide a 
                summary and the outcomes of all pilot programs 
                identified.

        j. The December 2018 proposed rule lists a series of content 
        requirements for a De Novo request (proposed 21 CFR 860.234). 
        For each requirement listed in the proposed rule, please 
        indicate whether a manufacturer participating in the Pre-Cert 
        Pilot Program would be required to provide information 
        fulfilling the requirement during an Excellence Appraisal or 
        during a subsequent De Novo submission. Please also indicate 
        whether a manufacturer participating in the Pre-Cert Pilot 
        Program would be required to provide information not included 
        in the content requirements for a De Novo request as outlined 
        in the December 2018 proposed rule.

        k. In its Working Model, the FDA has proposed two levels of 
        precertification ``based on an organization's excellence'': 
        ``Level 1 Pre-Cert'' would ``allow organizations to develop and 
        market certain lower risk software without review while 
        requiring a streamlined review for other types of software,'' 
        and ``Level 2 Pre-Cert'' would ``allow organizations to develop 
        and market certain lower and moderate risk software without 
        review while requiring a streamlined review for other types of 
        software.'' Please indicate how the content requirements for De 
        Novo requests outlined in section 513(f) of the FD&C Act and 
        the December 2018 proposed rule would be met by Level 1 Pre-
        Cert and Level 2 Pre-Cert organizations that develop and market 
        software without review.

        l. The Pre-Cert Pilot Program proposes utilizing the De Novo 
        pathway in ways that are not identified in the December 2018 
        proposed rule--most notably, through the receipt of required 
        information periodically rather than all at once. How would the 
        standards and processes described in the proposed rule, if 
        implemented as written, affect the agency's ability to utilize 
        the De Novo pathway for the Pre-Cert Pilot Program, given that 
        they do not mimic the Excellence Appraisal and Streamlined 
        Review used in the pilot?

        m. The FDA proposed its De Novo Classification rule in December 
        2018--over one year after the agency first proposed the Pre-
        Cert Pilot Program in August 2017. However, the proposed rule 
        does not mention the Pre-Cert Pilot Program, which proposes to 
        utilize the De Novo pathway in novel ways. Why did the FDA not 
        mention the Pre-Cert Pilot Program, and its novel use of the 
        pathway, in its December 2018 proposed rule?

        n. During the pilot, and if the Pre-Cert Program extends beyond 
        a pilot, how does the FDA plan to ensure that the RWPA it 
        receives from organizations are accurate, timely, and based on 
        all available information?

        o. In its 2019 response, the FDA stated that it was ``still 
        working to identify all the right information and data elements 
        to be shared before'' it addressed the ``mechanisms'' by which 
        the FDA and companies would exchange data. Since June 2019, has 
        the FDA identified the right information and data elements?

        p. In its Working Model, the FDA states that post-market RWPA 
        may form the basis of a change in claims and labeling. Please 
        provide greater detail on the evidence that would be required 
        to support such changes.

        q. Why is the FDA not requiring Pre-Cert pilot participants to 
        share data with the National Evaluation System for health 
        Technology (NEST)?

        r. Will the FDA retain the right to request and obtain all raw 
        data collected by participants as part of the Pre-Cert Pilot 
        Program?

    Answer 2. Although I am not currently a part of the administration 
and cannot speak to the specifics of the agency's current thinking, 
what FDA considered in establishing the program, or what FDA has 
learned since establishing this program, I can commit to working 
closely with Congress in a transparent and accountable manner on this 
program. I agree that patient safety and sound science must be a top 
priority as FDA considers medical software products.
                      Progressive Approval Pathway
    Following the enactment of the Minor Use and Minor Species Animal 
Health Act in 2004, the FDA established a ``conditional approval'' 
pathway to accelerate the development of animal drugs in commercially 
limited markets. Under the conditional approval pathway, manufacturers 
developing drugs for certain animal species have been able to bypass 
traditional FDA approval processes and market qualifying drugs without 
fully demonstrating their effectiveness. To receive conditional 
approval, manufacturers must only demonstrate that a drug has ``a 
`reasonable expectation of effectiveness' ''--a lesser standard than 
the ``substantial evidence of effectiveness''; upon receiving 
conditional approval, manufacturers have been able to market their 
drugs for up to five one-year terms as they continue to gather the data 
necessary to meet the ``substantial evidence'' standard.

    In August 2018, the Animal Drug User Fee Act further expanded the 
conditional approval pathway by creating a 10-year pilot expansion 
program that allows certain other animal drugs to qualify. At the time, 
I joined Senator Murray in strongly objecting to any expansion of the 
conditional approval pathway to human medical products--and the HELP 
Committee received assurances from then-Commissioner Scott Gottlieb 
that the FDA would not extend the pathway to human drugs or devices. In 
a July 2018 letter, Commissioner Gottlieb wrote that the ``FDA does not 
believe this pathway would be suitable for human medical products.''

    Despite Commissioner Gottlieb's assurances, however, the FDA's 
Fiscal Year 2020 budget justification referenced an FDA proposal called 
``progressive approval for devices'' which, as written, seemed hardly 
distinguishable from the ``conditional approval'' pathway. In June 
2019, Senator Murray and I sent a letter to the FDA requesting 
information about the program. After receiving a response in August 
2019, we sent a follow-up letter requesting additional information in 
November 2019.

    Question 1.

    Do you agree that assuring patient safety and device effectiveness 
must be the primary goal of any device approval system managed by the 
FDA?

    Answer 1. FDA must continue to operate under its mission to protect 
and promote patient health, and I believe that it can only do so by 
making safety and efficacy the top priority in product review and 
approval programs.

    Question 2.

    Do you believe that developing a ``progressive approval'' pathway 
for medical devices contributes to or detracts from the FDA's goal of 
assuring patient safety and device effectiveness?

    Answer 2. I look forward to learning more about this policy and the 
FDA's current thinking on this issue. If confirmed I will work with FDA 
staff to assess the progressive approval pathway in order to conclude 
how it will impact the FDA's mission.

    Question 3.

    If confirmed, will you commit to re-examining the ``progressive 
approval'' proposal included within the FDA's fiscal year 2020 budget 
justification to determine whether it adequately safeguards patients?

    Answer 3. If confirmed, I commit to examining all policies that 
come before me with a focus on patient safety and public health 
protection.

    Question 4.

    Please provide detailed answers to the questions included in the 
November 2019 letter referenced above, which include:

        a. The FDA envisions progressive approval as a pathway that 
        would ``expedite[] access to devices intended to treat or 
        diagnose a life-threatening or irreversibly debilitating 
        disease or condition and address an unmet medical need.''

                i. For the purposes of the progressive approval 
                pathway, how would the FDA define ``unmet medical 
                need''?

                ii. In its August 21st response, the FDA repeatedly 
                uses the example of children as an example of a 
                population underserved by existing medical device 
                pathways. Does the FDA envision limiting the 
                progressive approval pathway to certain populations, 
                such as children? If so, please provide an overview of 
                the populations the FDA is considering.

                iii. Does the FDA envision limiting the progressive 
                approval pathway to disease populations with a certain 
                number of patients, similar to the Humanitarian Device 
                Exemption pathway? If so, please provide an overview of 
                the numbers the agency is considering.

                iv. What additional limits, if any, is the FDA 
                considering on the populations and devices eligible for 
                the progressive approval pathway?

        b. In its August 21st response, the FDA pointed to the limited 
        success of the Humanitarian Device Exemption (HDE) pathway in 
        spurring device innovation to justify the need for a 
        progressive approval pathway. The agency notes that the HDE 
        pathway, as ``the only existing regulatory marketing pathway 
        intended to support medical device innovation for small 
        populations like pediatric patients,'' does ``not adequately 
        meet the needs of children.'' It continues to state that, 
        ``despite multiple actions by Congress . . .[to] optimize the 
        potential of the HDE program to help small patient populations 
        . . . there has been no significant change in the number of 
        Humanitarian Use Device (HUD) or HDE applications submitted or 
        approved.'' In contrast, the agency states, ``progressive 
        approval would foster safe innovation in medical devices to 
        meet many unmet needs.''

                i. What are the primary economic challenges facing 
                device makers interested in producing devices for 
                small, underserved populations, such as pediatric 
                patients? For each economic challenge identified, 
                please describe which aspects of the progressive 
                approval pathway (as envisioned by the FDA) would 
                mitigate the challenge and increase the number of 
                devices available to these populations.

                ii. What specific aspects of the HDE pathway have made 
                it unsuccessful at increasing the number of devices 
                available to these populations? Could modifications to 
                the HDE pathway address the problems in product 
                development that the FDA has identified as 
                necessitating the conditional approval pathway? If so, 
                what are these modifications? If not, why not?

                iii. What additional policies, if any, should Congress 
                consider in an effort to expand the types of devices 
                available to these populations?

        c. In its initial description of the progressive approval 
        pathway, the FDA stated that devices approved via the pathway 
        would ``be eligible for provisional approval . . . and could 
        remain on the market after an established time period only 
        after a demonstration of reasonable assurance of safety and 
        effectiveness.'' In its August 21st response, the agency 
        narrowed down the established time period to ``up to three 
        years.'' How did the FDA decide upon the three-year provisional 
        approval period?

        d. According to the FDA's initial description of the 
        progressive approval pathway, in cases where a device sponsor 
        could not ``demonstrate reasonable assurance of safety and 
        effectiveness,'' the device's ``initial approval would 
        automatically sunset and the device could no longer be legally 
        marketed.''

                i. What challenges, including those presented by 
                patients, physicians, sponsors, investors, and other 
                device industry stakeholders, does the agency 
                anticipate could arise in cases where the agency seeks 
                to remove provisionally approved devices from the 
                market?

                ii. How could uncertainty concerning the possible 
                removal from the market of a device that has received 
                provisional approval under the progressive approval 
                pathway limit the pathway's ability to mitigate the 
                economic forces inhibiting device development described 
                in Question 2?

        e. In its August 21st response, the FDA states that the 
        progressive approval ``proposal would provide accountability to 
        ensure that devices demonstrate a reasonable assurance of 
        safety and effectiveness to remain on the market.'' The FDA 
        also indicated that a device sponsor using the progressive 
        approval pathway ``would be required to collect additional 
        information through a registry, electronic health records 
        (EHRs), or another source of real-world data on more patients 
        and for a longer duration than the time period for obtaining 
        the initial, provisional approval, and then demonstrate a 
        reasonable assurance of safety and effectiveness.''

                i. Please provide a complete summary of the oversight 
                that the FDA envisions conducting on progressive 
                approval pathway participants to ensure that safety and 
                effectiveness standards are met. What resources would 
                be necessary to make this post-market surveillance 
                effective?

                ii. Independent audits of the FDA's expedited approval 
                pathways by the HHS Office of Inspector General and the 
                U.S. Government Accountability Office have revealed 
                challenges associated with implementing post-marketing 
                requirements and indicate the need for better oversight 
                measures. How would the FDA ensure that post-market 
                studies of provisionally approved devices are completed 
                in a timely manner?

                iii. A recently published analysis of the Manufacturer 
                and User Facility Device Experience (MAUDE) database 
                has underscored the challenges of post-market data 
                collection, including the underreporting of adverse 
                events. The analysis also found a significant degree of 
                miscategorization of deaths as reports of injury and 
                malfunction. If safety determinations will be made at 
                least in part through post-market data collection and 
                analysis, what will the FDA do to ensure that the 
                information provided by sponsors is accurate--
                especially when there is a significant incentive for 
                them to underreport and misclassify adverse events?

                iv. Is it the agency's view that real-world evidence 
                would be sufficient to demonstrate ``a reasonable 
                assurance of safety and effectiveness''? If so, what 
                precedent, if any, is there for relying exclusively, or 
                almost exclusively, on real-world evidence to support 
                the initial approval or clearance of a device?

                v. The FDA notes in its response that the labeling for 
                a provisionally approved device ``would have to make 
                clear that the medical device [meets] only the safety 
                and performance standard, rather than the reasonable 
                assurance of safety and effectiveness standard, to 
                allow patients and health care professionals to make 
                informed decisions.'' What, if any, additional patient 
                protections does the FDA envision being necessary for 
                devices possessing only provisional approval?

                vi. In the agency's view, are EHRs sufficiently 
                widespread (and interoperable) that the FDA can rely on 
                them for data collection for the purposes of the 
                progressive approval pathway? If not, what could 
                Congress and HHS do to increase the reliability of EHRs 
                as a data collection tool?

                vii. In the agency's view, are device registries 
                sufficiently widespread and well-developed such that 
                the agency can rely on them for data collection for the 
                purposes of the progressive approval pathway? If not, 
                what could Congress and HHS do to increase the 
                reliability of registries as a data collection tool?

        f. What additional data sources are the FDA considering using 
        to collect data for the progressive approval pathway?

        g. In its August 21st response, the FDA notes that the agency 
        ``is in an ideal position to continue leveraging [real-world 
        evidence], in part, due to its work to develop the National 
        Evaluation System for health Technology (NEST).''

                i. Does the FDA plan to require sponsors seeking 
                progressive approval to share data with NEST? If not, 
                why not?

                ii. In the agency's view, is NEST sufficiently well-
                developed such that the agency could rely on it for 
                data collection for the purposes of the progressive 
                approval pathway? If not, what could Congress and HHS 
                do to increase the reliability of NEST as a data 
                collection tool?

    Answer 4. Although I am not currently a part of the administration 
and cannot speak to the specifics of the agency's thinking or views, if 
I am confirmed, I commit to working closely with FDA staff to 
understand this issue and to ensure that any actions taken by the 
agency are grounded in sound science and the best available data. It 
will be my top priority to uphold the FDA's mission and adhere to its 
gold standard for safety and efficacy. I will also commit to getting 
you detailed answers to these questions promptly.
                Third-Party Servicing of Medical Devices
    Some medical devices, such as patient examination gloves, are 
disposable or designed to be used only once. Other devices, however, 
are used repeatedly and on multiple patients. Original equipment 
manufacturers (OEMS) and third party entities often refurbish, repair, 
recondition, rebuild, remarket, or remanufacture these devices to 
ensure that they continue to operate safely and effectively after 
entering the market.

    Entities that perform maintenance activities face different 
regulatory requirements depending on the type of maintenance being 
performed. Activities that ``significantly change'' the performance, 
safety specifications, or intended use of a finished device are 
considered ``remanufacturing.'' Remanufacturers, which can include OEMs 
and third party entities, must comply with numerous FDA requirements to 
ensure the safety of remanufactured devices. Activities that do not 
``significantly change'' the performance, safety specifications, or 
intended use of a device--but instead provide ``preventive or routine 
maintenance . . . for the purpose of returning [a finished device] to 
the safety and performance specifications established by the OEM and to 
meet its original intended use''--are considered ``servicing.'' Third-
party servicers are not subject to the same safety and reporting 
requirements as remanufacturers. In May 2018, in response to Section 
710 of the FDA Reauthorization Act of 2017 (Public Law No. 115-42), the 
FDA issued a report on the continued quality, safety, and effectiveness 
of medical devices with respect to servicing. The report noted 
significant stakeholder confusion over the difference between 
``servicing'' and ``remanufacturing.'' In response, the FDA announced 
that it would publish guidance clarifying the difference between 
``servicing'' and remanufacturing'' to ``allow more consistent 
interpretation and clarification.''

    The FDA original announced that it would issue draft guidance by 
the end of Fiscal Year 2019; however, draft guidance is now on the 
agency's list to release in Fiscal Year 2020. In October 2019, Senator 
Cassidy and I sent a letter to the agency requesting information about 
the guidance.

    Question 1.

    If confirmed, will you commit to publishing draft guidance on 
distinguishing between medical device servicing and remanufacturing in 
a timely manner and no later than the end of Fiscal Year 2020?

    Answer 1. If confirmed, I will commit to engaging with FDA's 
professional staff the information available that is related to this 
issue. I will prioritize taking steps to provide clarity to the public 
on the difference between servicing and remanufacturing in a timely 
manner. I look forward to working with FDA's staff, Congress, and 
stakeholders to ensure that the agency has in place the right policies 
and processes to ensure the safety and effectiveness of medical 
devices.

    Question 2.

    Please provide detailed answers to the questions included in the 
October 2019 letter referenced above, which are:

        a. In its May 2018 report, the FDA stated that ``[a] majority 
        of comments, complaints, and adverse event reports alleging 
        that inadequate ``servicing'' caused or contributed to clinical 
        adverse events and deaths actually pertain to 
        ``remanufacturing'' and not ``servicing.''

                i. If so many entities believed to be involved in 
                ``servicing'' are actually ``remanufacturing'' devices, 
                and FDA has said ``the precise number of entities that 
                perform servicing of medical devices in the U.S. is not 
                known,'' how does FDA intend to identify the universe 
                of actors to whom its upcoming guidance will apply?

                ii. How does the FDA intend to educate those entities 
                who are unknowingly involved in remanufacturing 
                activities about their obligations when the upcoming 
                guidance is released?

        b. The FDA has estimated approximately 16,000 to 20,000 
        entities are engaged in servicing activities. How will the FDA 
        promote compliance with the guidance by those entities who 
        consider themselves as only servicers but who may in fact also 
        be involved in remanufacturing?

        c. What surveillance mechanisms are available to the FDA to 
        detect servicers who are also performing remanufacturing?

        d. What actions does the FDA currently take if it identifies 
        unregistered entities engaged in remanufacturing? What, if any, 
        new options for action are under consideration?

    Answer 2. Although I am not currently a part of the administration 
and cannot speak to the specifics of the agency's intentions, current 
thinking, or activities, I can commit to working closely with Congress 
in a transparent and accountable manner on this program.
                  Unique Device Identification System
    In 2007, Congress instructed the FDA to establish a ``unique device 
identification system for medical devices'' to better track medical 
device outcomes and adverse events. In response, the agency developed a 
system requiring device labels and packages to include Unique Device 
Identifiers (UDIs). UDIs include both a device identifier (DI), a 
``fixed portion of a UDI'' that identifies the ``specific version or 
model of a device,'' and a production identifier (PI), a ``variable 
portion of a UDI'' that identifies information about a device's 
expiration date, serial number, and lot or batch number.

    For years, Members of Congress have advocated for the inclusion of 
UDI information in electronic health records and insurance claims 
forms. Insurance claims forms capture longitudinal data on patient 
outcomes across healthcare providers and are a critical component of 
the FDA's efforts to establish the National Evaluation System for 
health Technology (NEST). However, claims forms--including the Medicare 
claim form--do not currently have a field to record UDIs. This lack of 
ability to track device outcomes is costly for taxpayers. A 2017 
investigation by the Office of the Inspector General at the Department 
of Health and Human Services found that recalls or premature failures 
of just seven faulty cardiac devices resulted in $1.5 billion in 
Medicare payments to providers and $140 million in out-of-pocket costs 
to beneficiaries. Moreover, the report was not able to examine the 
total cost of all device failures because of the lack of information 
about specific devices in claims data. The examiners were able to 
assess the impact of the seven devices included in the report only 
through a ``complex and labor-intensive'' audit. Ultimately, The OIG 
recommended that the Center for Medicare and Medicaid Services (CMS) 
collaborate with the Accredited Standards Committee X12 (X12), which 
sets standards for electronic claims, to include medical devices' 
unique device identifier (UDI) on health insurance claim forms. Last 
month, X12 released draft recommendations to incorporate the device 
identifier portion of the UDI of high-risk implantable medical devices 
in claims forms.

    The FDA has historically supported the inclusion of UDI information 
on claims forms. In a July 2016 joint letter to X12, the FDA and CMS 
identified several benefits to collecting device identifiers on medical 
claims forms. The agency agreed to develop a list of specific, high-
risk implantable devices for which reporting on claims will be 
recommended and in 2018 released a Medical Device Safety Action Plan 
highlighting the benefits of UDI information to post-market 
surveillance. Furthermore, in a November 2018 letter, then-Commissioner 
Gottlieb stated that the FDA ``supports the incorporation of the full 
Unique Device Identifier (UDI) into claims forms and believes, at a 
minimum, the DI portion of the UDI should be included.''

    Question 1.

    Do you agree that including device identifier information in 
medical claims could support the evaluation of medical devices after 
approval?

    Question 2.

    If confirmed, will you continue to support the process of adding 
device identifiers to claims as a critical tool to better understand 
the performance of these products after approval?

    Question 3.

    How will you direct FDA to work with CMS to ensure that device 
identifiers can be effectively used to monitor threats to Medicare 
program integrity and patient health?

    Answers to 1-3. I believe FDA should take every step possible to 
enhance the agency's ability to capture comprehensive and accurate 
post-market data on all medical products, including devices. If 
confirmed I will work with FDA staff as well as CMS to understand their 
work to date on the incorporation of full unique device identifiers 
into claims forms, and I will make it a priority to ensure there is a 
process in place to achieve the best outcome for patients.

                              IX. Opioids
                            Opioid Epidemic
    For decades, the United States has found itself in the midst of the 
opioid epidemic--a public health crisis that takes dozens of lives and 
impacts countless families each day. Massachusetts has been greatly 
impacted by this epidemic, leading local and state officials to work 
closely with first responders, health care providers, and community 
advocates to develop a comprehensive approach to help those suffering 
from substance use disorder access treatment and recovery services. The 
Massachusetts Department of Public Health (DPH) estimates that there 
were 1,974 opioid overdose deaths in Massachusetts in 2019--a 4 percent 
reduction from 2018. Despite this decrease, it is critical that we 
continue to provide support to states like Massachusetts through the 
work of relevant Federal agencies, and with congressional action to 
provide adequate resources to tackle this crisis.

    Question 1.

    If confirmed, what FDA authorities will you use to help address the 
opioid crisis?

    Answer 1. Thank you for your question. The opioid crisis is one of 
the largest and most complex public health tragedies that our Nation 
has faced. This is a top priority for the administration, the 
Department and Congress. It will be a top priority for me if I am 
fortunate enough to be confirmed. My own personal experience with this 
issue is as a cancer doctor. I have known patients who have survived 
cancer only to become addicted to opioids. For many years, our medical 
education was that addiction did not occur in cancer patients and we 
were encouraged to use opioids liberally. This turns out not to be the 
case and unfortunately, there have been tragic consequences. There has 
been a significant change based upon doctor education efforts in the 
prescribing habits for opioids. An evidence-based holistic approach to 
treating pain with non-opioid medications, behavioral therapies, and 
when appropriate, opioids is now being used effectively in many medical 
settings to effectively treat pain. We have new ways of prescribing 
pain medications that create a balance between relief of suffering and 
preventing addiction. There is outstanding research being performed on 
addiction and the causes of pain. I am optimistic that even better 
approaches will be developed in the future. That being said, we are 
still dealing with a devastating and urgent crisis with opioids. FDA 
was given important authorities by Congress in the SUPPORT act to 
assist in the prevention of misuse of opioids. Actions by FDA such as 
changes to packaging, labeling, the REMS program and efforts to stop 
the illegal importation of opioids are all important steps forward. I 
promise, if confirmed as FDA Commissioner, to make combating the opioid 
crisis a top priority of the agency and I look forward to continuing 
and enhancing those efforts, if I am fortunate enough to be confirmed. 
I understand that FDA is also evaluating other activities that could be 
helpful including setting standards for new opioid approvals, 
additional doctor education, and revising regulatory procedures for 
mandatory recall authority of opioids that have a substantial risk for 
adverse health consequences or death. I am supportive of efforts by the 
agency to help innovators of non-opioid alternatives for pain control 
and abuse-deterrent formulations because we cannot forget the 
importance of safely helping Americans with pain syndromes. I am also 
supportive of efforts to advance the development and use of safe and 
effective medication-assisted therapy or MAT in a holistic therapy 
setting. I have cared for numerous patients with serious and 
debilitating pain, and understand that we must strike a balance between 
maintaining patients' access to effective opioid drugs and non-opioid 
alternatives, while reducing misuse and abuse of opioid drugs.

    Question 2.

    If confirmed, how will you work with other Federal agencies, such 
as the Substance Abuse and Mental Health Services Administration 
(SAMHSA) and the Drug Enforcement Administration (DEA), to develop an 
administration-wide approach to the opioid crisis that is evidence-
based?

    Answer 2. If confirmed, I look forward to working across the 
Department and the administration to address the opioid crisis. The 
Department of Health and Human Services currently has a five point 
strategy for addressing the opioid crisis. HHS' five point strategy 
aims to: (1) Improve access to prevention, treatment, and recovery 
support services to prevent the health, social, and economic 
consequences associated with opioid addiction and to help individuals 
to achieve long-term recovery; (2) Target the availability and 
distribution of overdose-reversing medications (3) Strengthen public 
health data collection and reporting (4) Support cutting-edge research 
that advances our understanding of pain and addiction, and (5) Advance 
the practice of pain management. I believe the FDA should contribute to 
this overarching strategy by utilizing the authorities provided by 
Congress, including through the SUPPORT Act. Additionally, the FDA and 
DEA should continue to work together to combat the sale of illicit 
opioids online.

    Question 3.

    If confirmed, what will you do to accelerate FDA review of 
alternative therapies to chronic pain, while still ensuring that those 
who require such medications receive it?

    Answer 3. Thank you for your question. The opioid crisis is one of 
the largest and most complex public health tragedies that our Nation 
has faced. This is a top priority for the administration, the 
Department and Congress. It will be a top priority for me if I am 
fortunate enough to be confirmed. My own personal experience with this 
issue is as a cancer doctor. I have known patients who have survived 
cancer only to become addicted to opioids. For many years, our medical 
education was that addiction did not occur in cancer patients and we 
were encouraged to use opioids liberally. This turns out not to be the 
case and unfortunately, there have been tragic consequences. There has 
been a significant change based upon doctor education efforts in the 
prescribing habits for opioids. An evidence-based holistic approach to 
treating pain with non-opioid medications, behavioral therapies, and 
when appropriate, opioids is now being used effectively in many medical 
settings to effectively treat pain. We have new ways of prescribing 
pain medications that create a balance between relief of suffering and 
preventing addiction. There is outstanding research being performed on 
addiction and the causes of pain. I am optimistic that even better 
approaches will be developed in the future.

    Question 4.

    Earlier this year, the FDA announced a public education campaign, 
``Remove the Risk,'' aimed at encouraging individuals to safely dispose 
of unused prescription medications in their home. This announcement 
noted that ``in 2017, retail pharmacies dispensed more than 191 million 
opioid prescriptions to almost 60 million patients as many as 90 
percent of these patients reported not finishing what was prescribed to 
them.'' If confirmed, what will you do to enhance these ongoing FDA 
efforts to encourage Americans to safely dispose of unused medications?

    Answer 4. The opioid crisis is one of the largest and most complex 
public health tragedies that our Nation has faced. This is a top 
priority for the administration, the Department and Congress. I have 
seen the significant benefits of physician education on the topic of 
opioid prescribing. If confirmed, I am committed to continuing FDA's 
successful efforts, including educational efforts, to address the 
opioid crisis in addition to working with agency staff to determine 
additional opportunities for FDA to address the opioid crisis, 
including through encouraging the safe disposal of unused medications.
                       Over-the-Counter Naloxone
    Over 130 Americans die each day as a result of an opioid overdose. 
Naloxone is an easy-to-use, life-saving drug that reverses the toxic 
effectives of an opioid overdose. Currently, naloxone is only available 
via prescription, yet doctors and public health administrators across 
the country have called for the provision of an over-the-counter (OTC) 
naloxone product to help combat the rising number of opioid-related 
deaths. In January 2019, the FDA issued a series of documents to 
``encourage drug companies to enter the OTC market,'' including two 
model ``consumer-friendly'' Drug Facts labels (DFLs), which are 
required--along with studies showing ``that consumers can understand 
how to use the product without the supervision of a health care 
professional''--before a product can be marketed over the counter.

    Question 1.

    Do you agree that increased access to naloxone, including making it 
available over the counter, could meaningfully prevent and reduce 
deaths associated with the opioid crisis?

    Question 2.

    If confirmed, will you continue existing FDA efforts to expand 
access to OTC naloxone?

    Question 3.

    What additional steps could the FDA take to expand access to all 
types of naloxone, including OTC naloxone?

    Question 4.

    What efforts does the FDA have underway to encourage physicians to 
co-prescribe naloxone with opioid medication? What additional steps can 
the FDA take to safely facilitate increased rates of co-prescribing of 
naloxone with opioid medication?

    Question 5.

    How can the FDA encourage manufacturers to continue expanding 
access to all types of naloxone, including OTC naloxone and generic 
naloxone products?

    Answers to 1-5. Thank you for your questions. I agree that naloxone 
is a critical and life-saving drug that can prevent and reduce overdose 
deaths. In January, in order to spur the development of OTC naloxone, 
FDA designed, tested and validated the key labeling requirements 
necessary to approve an OTC version of naloxone. I applaud the FDA's 
actions to make it easier for manufacturers to development an OTC 
naloxone amidst this urgent public health crisis, and if confirmed, I 
would seek actions that FDA can appropriately take to remove any 
additional barriers to approving an OTC naloxone. I am also supportive 
of HHS' recommendation in December 2018 to prescribe or co-prescribe 
naloxone to patients at high risk for an opioid overdose. If confirmed, 
I would also work with other agencies within HHS to support increase 
education and access for this life saving drug.
                         X. Reproductive Health
    The United States is facing a maternal mortality and morbidity 
crisis. Women in the United States die as a result of pregnancy and 
childbirth at a higher rate than in any other developed country, and in 
the past twenty years, our Nation's maternal mortality rate has 
doubled--making it the only industrialized nation with an increasing 
maternal mortality rate.

    Unfortunately, information about how to treat conditions in 
pregnancy is profoundly limited and very few drugs are approved for use 
during pregnancy. In large part, this is due to the fact that women, 
and especially pregnant and lactating individuals, have historically 
faced systemic barriers to participating in clinical trials.

    Question 1.

    What do you believe the impact of greater inclusion of pregnant and 
lactating women in clinical trial data and results would be on drug 
safety and biomedical innovation?

    Question 2.

    If confirmed, what efforts will you undertake to improve the 
inclusion of women and pregnant individuals in clinical trials?

    Question 3.

    What specific plans do you have to implement the goals, priorities, 
and recommendations of the Federal Task Force on Research Specific to 
Pregnant Women and Lactating Women?

    Question 4.

    How can FDA support the development of new therapeutic products for 
conditions specific to pregnant and lactating women?

    Question 5.

    Do you support efforts to strengthen the FDA's authority to require 
clinically relevant data on pregnant women and lactating women to 
inform drug dosing and safety decisions?

    Question 6.

    As FDA Commissioner, how would you strengthen the FDA's Pregnancy 
Exposure Registries Initiative?

    Answers to 1-6 . Thank you for these questions. It is important to 
have more information about the safety, efficacy and dosing of drugs 
during pregnancy. As you know, the Federal Task Force on Research 
Specific to Pregnant Woman and Lactating Women issued their report to 
the Secretary of HHS and Congress in September 2018. I look forward to 
working with staff at the FDA on implementing these recommendations 
where appropriate.
                      XI. Vaping and E-Cigarettes
    Rates of youth tobacco use have skyrocketed in recent years, 
largely due to the popularity of e-cigarettes. According to the most 
recent National Youth Tobacco Survey, nearly 30 percent of high school 
students and over 10 percent of middle school students use e-
cigarettes. Of students who use e-cigarettes, seventy-two percent of 
high school students and 60 percent of middle school students used e-
cigarettes with kid-friendly flavors like fruit and mint. It is widely 
known that nicotine is extremely addictive and can harm brain 
development.

    Rising rates of e-cigarette use have also given rise to a series of 
vaping-related illnesses that have caused more than 2,000 people to 
fall ill and have led to at least 42 deaths. Experts currently believe 
that these illnesses are linked to the inclusion of vitamin E acetate 
additives in THC vape products.

    Question 1.

    Do you agree that rising rates of youth e-cigarette use reflect a 
public health emergency that the FDA should take robust steps to 
combat?

    Answer 1. I'm a lung cancer doctor, and I have seen the ravages of 
tobacco-related cancers. I also know youngsters who were very close to 
me who use e-cigarette products. I'm aware of the National Youth 
Tobacco Survey data. And I think this is an important, urgent crisis in 
this country. I do not want to see another generation of Americans 
become addicted to tobacco and nicotine. And I believe that we need to 
take aggressive action to stop that.

    Question 2.

    Do you agree that flavored e-cigarettes, such as fruit and mint, 
contribute to youth use of e-cigarettes?

    Answer 2. I've seen the data suggesting that flavors are a 
significant effect for children using e-cigarettes and I am alarmed by 
those data. I think it's a serious issue.

    Question 3.

    In September 2019, the administration announced that it would 
``outline a plan . . . for removing flavored e-cigarettes and nicotine 
pods from the market,'' including mint and menthol. Earlier this month, 
however, the administration reversed course. Reportedly facing 
``pressure from his political advisers and lobbyists,'' the President 
``has resisted moving forward with any action on vaping.'' This failure 
to act is unacceptable. If confirmed, will you push to implement the 
robust ban on e-cigarette flavors announced in September?

    Answer 3. I understand that the final compliance policy is under 
consideration by the administration. I look forward to their decision. 
I'm not privy to that decision making process. But I very much agree 
and support that aggressive action needs to be taken to protect our 
children.

    Question 4.

    If confirmed, what additional steps will you take to combat youth 
e-cigarette use? What steps will you take to make it more challenging 
for youth to access e-cigarettes?

    Answer 4. I am alarmed by the situation and what we're facing right 
now. If confirmed, I look forward to working with partners across the 
academic, medical and youth outreach communities to gather ideas and 
deliver on results. I think this is an important, urgent crisis in this 
country. I do not want to see another generation of Americans become 
addicted to tobacco and nicotine. And I believe that we need to take 
aggressive action to stop that.

    Question 5.

    If confirmed, what steps will you take to address the targeting of 
youth by e-cigarette manufacturers through their products and 
advertising?

    Answer 5. In July, the FDA announced the first targeted ad campaign 
to educate kids about the dangers of e-cigarette use. I was happy to 
see the Agency take this important step. Ad campaigns such as this were 
successful in combatting youth use of combustible cigarettes and I am 
optimistic we can deploy lessons learned from the combustible tobacco 
campaigns to this effort as well as look for new opportunities to reach 
our kids. I personally commit to being a forceful educator leading 
voice regarding this issue.

    Question 6.

    There are currently no nicotine cessation therapies approved for 
youth use. If confirmed, how will you direct the FDA to work with other 
Federal agencies and Congress to expand youth access to nicotine 
cessation therapies?

    Answer 6. Tobacco cessation and nicotine addiction are serious 
problems. I see that because many of my patients want to stop. 
Fortunately, there is important and impactful research, much of which 
has been funded by Congress at NIH that's allowed us to look at this 
intersection between nicotine addiction, tobacco use and what we may be 
able to do in the future. I am very supportive of taking measures and 
expediting those measures to try to find out what novel products we can 
use to help with the tobacco cessation problem that we have. I think 
this is an important, urgent crisis in this country. I do not want to 
see another generation of Americans become addicted to tobacco and 
nicotine. And I believe that we need to take aggressive action to stop 
that.

    Question 7.

    If confirmed, what steps will you take to combat the outbreak of 
vaping-related illnesses? What is the status of current CDC and FDA 
investigations into the cause of the vaping-related illnesses?

    Answer 7. If confirmed, I look forward to immediately getting up to 
speed on this issue. What I now know if from press reports--that CDC 
and FDA are working closely with States to investigate each reported 
illness and death. And that they have found some common causes, but 
more work remains. I will continue the good work of the Agency to work 
collaboratively with CDC and make the public aware of key findings and 
precautionary warnings as expeditiously as possible. I personally 
commit to being a forceful educator leading voice regarding this issue.
                             senator kaine
    Question 1.

    You spoke in my office about the importance of compliance and 
enforcement in addressing the youth e-cigarette epidemic. FDA has 
sought to curb youth access to tobacco products with warning letters, 
compliance checks, and no-tobacco sale orders--but the youth e-
cigarette crisis continues to worsen. Enforcement and compliance can 
only be as effective as the laws and regulations on the books. What 
strategies should the FDA pursue to address the youth e-cigarette 
epidemic beyond standard compliance and enforcement activities?

    Answer 1. If confirmed, I look forward to learning from many 
internal and external stakeholders about all the options and working 
with Congress to tackle this problem together. I think this is an 
important, urgent crisis in this country. I do not want to see another 
generation of Americans become addicted to tobacco and nicotine. And I 
believe that we need to take strong action to stop that.

    Question 2.

    Should Congress pass my bipartisan legislation to raise the tobacco 
age to 21, do you commit to updating the relevant regulations governing 
the minimum age of purchase of tobacco products within 180 days?

    Answer 2. As part of the executive leadership at MD Anderson, I was 
a strong supporter of the T21 legislation that recently passed the 
Texas Legislature and along with strong Agency enforcement believe that 
these are two great starts to addressing the youth e-cigarette crisis.

    Question 3.

    I am concerned that we don't know much about the quality or safety 
of CBD-containing products, even as consumers are using them. What is 
the status of FDA's work to develop a regulatory approach for CBD-
containing products and what is the timeline for rollout of that 
approach? How can we protect consumers while the regulatory framework 
is in development?

    Answer 3. Thank you for your question. As you know, CBD is widely 
available throughout the United States. It can be purchased in many 
places across the country. There are open questions and knowledge gaps 
about these products such as: `What is the appropriate dosage and for 
which health claim?' What are the potential interactions with other 
drugs? What are the health effects of long term usage particularly 
among youth. On the other hand, we need to recognize that there are 
potential therapeutic benefits from CBD. In fact, FDA approved a CBD-
containing product for the treatment of a serious childhood seizure 
disorder. There are signals that CBD might be useful for other 
conditions. However, I am concerned about the unsubstantiated claims 
that CBD can be useful for conditions like cancer and Alzheimer's 
disease. It is important to ensure that any claims made to treat a 
disease are supported by the appropriate safety and efficacy data. I 
look forward to reviewing the data on the safety of CBD with career 
staff and to work with the Agency and all appropriate Federal partners 
to determine if there is a clear and transparent pathway for consumer 
products (e.g. food additives and dietary supplements).

    Question 4.

    If confirmed, how will you direct FDA to combat drug shortages on 
both domestic and global supply chain levels? What steps should FDA 
take to reduce reliance on foreign manufacturing of important drugs?

    Answer 4. Thank you for your question. FDA's role is to ensure the 
safety of the drug supply. The U.S. has the safest drug supply in the 
world and if confirmed, I am committed to maintaining the safety of 
drugs and biologics used by the American people. According to recent 
testimony from FDA, as of August 2019, only 28 percent of the 
manufacturing facilities making APIs to supply the U.S. market were in 
our country. By contrast, the remaining 72 percent of the API 
manufacturers supplying the U.S. market were overseas, and 13 percent 
are in China. I believe advanced manufacturing could help to bring this 
manufacturing back to the U.S. If confirmed, I look forward to working 
with the staff at the FDA, along with partnering with Congress, ASPR, 
BARDA, the Department of Defense and others to address this issue and 
ensure that the U.S. drug supply remains safe.

    I believe FDA's recent report on drug shortages is a significant 
step forward in addressing this problem. I will make preventing and 
alleviating drug shortages one of the highest priorities of the Agency 
should I be confirmed as Commissioner.

    Question 5.

    The Task Force Specific to Research in Pregnant Women and Lactating 
Women (PRGLAC) is working to learn more about women's health during 
pregnancy and close the knowledge gap on research in pregnant women. If 
confirmed, will you commit to ensuring proper implementation, including 
potential new guidance and inclusion of pregnant women and lactating 
women in clinical trials where appropriate?

    Answer 5. If confirmed, I look forward to implementing these 
recommendations where appropriate.
                             senator hassan
    Question 1.

    I strongly agree with your comments this morning on the importance 
of Americans trusting FDA as the gold standard for protecting public 
health.

    For millions of parents with children who are nicotine dependent 
because of e-cigarettes, that trust took a hit this week when they 
watched the president cave to special interests and reverse his 
commitment to address the youth e-cigarette epidemic.

    Whether it's Purdue Pharma influencing the approval and marketing 
of OxyContin, or DC lobbyists dictating FDA's response to the youth e-
cigarette epidemic, the public may lose faith in FDA when they see 
decisions being driven by corporate special interests instead of facts 
and science.

    How will you ensure that every decision made under your leadership 
is based on facts and science, and what will you do if one of your 
decisions is overruled by political consultants or corporate lobbyists?

    Answer 1. As I stated in the hearing, throughout my career, whether 
it was at the patient's bedside or as a medical executive, I've made 
decisions based upon data and science, congruent with the law. Nothing 
is more important for a patient than for them to trust that you are 
making a decision that's in their best interest and no one else's 
interest. And I commit to you that science, data and the law will guide 
decisions that I would make if I'm fortunate enough to be confirmed by 
the Senate as Commissioner of Food in Drugs. I pledge to represent 
faithfully the decisions made by the Agency which, as stated above, 
will be based upon data, science and the law.

    Question 2.

    Reports that the administration caved to corporate special 
interests in reversing the e-cigarette flavor ban are incredibly 
disturbing.

    If confirmed, you will oversee the FDA Premarket Tobacco 
Application process for e-cigarettes. Parents, teachers, public health 
advocates, and Members of this Committee will be counting on you to 
protect the integrity of that process.

    As Commissioner, will you publicly disclose all meetings between 
FDA and Juul that take place before and during the Premarket Tobacco 
Application process, including who attended and what was discussed?

    Answer 2. FDA has a very transparent process for accepting and 
disclosing meetings. I look forward to continuing that tradition.

    Question 2b.

    Will you provide this Committee with any data you receive from 
companies like Juul that relate to youth e-cigarette use, including 
data on flavors and diversion?

    Answer 2b. I will disclose all data requested of the Committee, 
consistent with legal and ethics requirements.

    Question 3.

    The FDA encouraged development of `abuse-deterrent' opioids by 
approving products on an accelerated approval pathway.

    We know that these abuse-deterrent opioids are no less addictive 
than other products on the market, and can be abused.

    FDA requires that drug manufacturers submit post-market data, but 
often fails to hold them accountable for meeting submission deadlines.

    This problem is not limited to opioids. Manufacturers of high-cost 
drugs often fail to comply with post-market reporting requirements, and 
in some cases we learn years later that the drug was ineffective.

    If confirmed, what actions will you take to ensure that drug 
manufacturers meet their post-market reporting deadlines?

    How will you ensure that FDA takes swift action based on post-
market data, including revoking approval of drugs where appropriate, if 
post-market data shows a drug is unsafe or clinically ineffective?

    Answer 3. The data provided in post-market reporting is critical to 
ensuring the enduring safety, efficacy and overall patient benefit the 
gold standard of the FDA delivers. I commit to using science and data 
to drive decision-making, which includes leveraging these data to take 
swift action on products if they are no longer living up to their 
promise.

    Question 4.

    Since 2001, FDA has been asked by stakeholders to consider removing 
chronic pain from the label of opioid products.

    What is your position on labeling opioids such as OxyContin as 
appropriate for patients managing chronic pain?

    Question 5.

    Officials from the Centers for Disease Control and Prevention, 
Department of Defense, and Department of Veterans Affairs have stated 
that the risks of opioid therapy for chronic conditions such as 
headaches, fibromyalgia, and chronic back pain likely outweigh the 
benefits.

    Do you agree? Can you explain your position on how best to move 
forward with labeling, marketing and prescribing guidelines for opioids 
to ensure patient safety?

    Question 6.

    The Centers for Disease Control and Prevention, Department of 
Defense, and Department of Veterans Affairs have warned against 
prescribing opioids at doses that exceed 90mg morphine equivalents per 
day.

    Answers 4-6. Thank you for this question. I believe science and 
data should inform FDA's actions. My own personal experience with this 
issue is as a cancer doctor. I have known patients who have survived 
cancer only to become addicted to opioids. For many years, our medical 
education was that addiction did not occur in cancer patients and we 
were encouraged to use opioids liberally. This turns out not to be the 
case and unfortunately, there have been tragic consequences. There has 
been a significant change based upon doctor education efforts in the 
prescribing habits for opioids. I refer my patients to a supportive 
care team that provide evidence-based pain care. If confirmed, I look 
forward to reviewing the science and data on opioid labeling. While 
patient care must be provided on an individualized basis, I agree that 
providers should be cautious in prescribing opioids, especially in high 
doses. The prescribing guidelines from the Centers for Disease Control 
and Prevention have transformed opioid prescribing in recent years, but 
much remains to be done.
                             senator smith
                      Questions About Youth Vaping
    On November 13, 2019, the Senate HELP Committee heard from the FDA 
about its efforts to address the issue of youth vaping. Mr. Zeller, the 
Director of the FDA's Center for Tobacco Products, told us that FDA is 
investing in a bathroom-based poster campaign to stop this epidemic.

          What are the data and evidence driving the decision 
        to invest in posters instead of taking steps to ban kid-
        friendly flavors?

    In July, the FDA announced the first targeted ad campaign to 
educate kids about the dangers of e-cigarette use. I was glad to see 
the agency take this important step. Ad campaigns such as this were 
successful in combatting youth use of combustible cigarettes and I am 
optimistic we can deploy lessons learned from the combustible tobacco 
campaigns to this effort as well as look for new opportunities to reach 
our kids.

          If confirmed as FDA Commissioner, will you use data 
        and evidence to lead the FDA's efforts to stem the youth vaping 
        epidemic?

    Answer. If confirmed, I commit to using science, data and the law 
to guide my decisions at FDA.

          Will you invest in comprehensive youth cessation 
        tools for kids who are already addicted to vaping?

    Answer. Yes.
                      Questions About Drug Pricing
    The first bill I introduced in the Senate is legislation to prevent 
the ability of generic manufacturers to park their 180-day market 
exclusivity and delay their entry to the market. My solution would 
prevent manufacturers from gaming the system, while still streamlining 
generic drug approvals. You heard about this issue from my colleague, 
Senator Scott, during your nomination hearing. There are multiple 
competing proposals in Congress on how to best address this issue.

          If you are confirmed as FDA Commissioner, do you 
        commit to working with my office to listen to our concerns, 
        listen to the concerns of stakeholders, and address this gaming 
        issue?

    Answer. Senator, I can commit to working with your office and the 
offices of other Senators. It is crucial that pathways for drug 
approval work efficiently and safely.
                     Questions About Drug Shortages
    The FDA recently issued a report on drug shortages, its root 
causes, and potential solutions. My colleague, Senator Collins, and I 
recently introduced legislation to mitigate drug shortages.

          If confirmed as FDA Commissioner, do you commit to 
        working with Congress on developing comprehensive solutions to 
        address drug shortages?

    One step FDA can take to prevent and alleviate drug shortages is to 
work with industry to promote advanced manufacturing which is more 
efficient and nimble in addressing drug shortages. I also believe this 
is an initiative which could stimulate domestic manufacturing.

    The FDA recently testified at a House hearing on the drug supply 
chain and its contribution to drug shortages. They highlighted that 
there are loopholes in the current process. International manufacturers 
of active pharmaceutical ingredients can bypass requirements to 
register their products with the FDA. That brings potentially dangerous 
ingredients into the domestic supply chain.

          What additional authorities does FDA need to make 
        sure the drug supply is safe and effective?

          If confirmed as FDA Commissioner, do you commit to 
        working with Congress on these additional authorities that FDA 
        needs?

    Answer. Yes, I commit that I would prioritize initiatives for the 
prevention and alleviation of drug shortages if confirmed. I believe 
FDA's recent report on drug shortages was a very important step 
providing a base of information to inform the necessary next steps.
              Questions About Livestock and Food Industry
    Like my colleagues Senator Braun and Senator Casey on the HELP 
Committee, I also sit on the Senate Agriculture Committee. Minnesota is 
a big livestock and dairy state. We are number 8 in livestock farming, 
number one in turkey farming, number two in hog farming, and number 
four in dairy production. Minnesota also has a significant pet food 
industry. The FDA is vital to ensuring safe food systems in this 
country. Since your nomination to serve as FDA Commissioner, one thing 
that I have heard from the agriculture industry is that they don't know 
much about you. This is a fair assessment, as your career has been in 
cancer research.

    Do you have a plan in place to learn about the food side of the 
FDA?

    Answer. You are right that there are areas of FDA regulation in 
which I have had less experience. I understand that FDA regulates 
around 20 percent of the U.S. economy--a large number. As a physician, 
I am very well versed in medical products oversight but I am not as 
familiar with FDA's programs related to food. That does not change my 
commitment to these programs, particularly because the US has the 
safest and most secure food supply chain in the world. I commit that, 
if confirmed, I will engage the professional staff at FDA across the 
Agency.

    Have you met with Secretary Perdue yet to discuss how the USDA and 
FDA work together?

    Answer. I have not met with Secretary Perdue but commit to 
establishing a strong, collaborative relationship with USDA.

    Will you meet with livestock and dairy farmers and tour food 
production facilities to prepare you for the role of FDA Commissioner?

    Answer. Yes, I commit that, if confirmed I will engage with 
livestock and dairy farmers who play such an important role in our 
Nation's food supply.
                      Questions About CBD and HEMP
    The 2018 Farm Bill legalized the farming and production of hemp. 
This has been a big priority for farmers across the country. However, 
there are still a lot of questions on how to actually legally farm 
hemp. The hemp provision in the Farm Bill coincides with the recent 
explosion of CBD products, like lotions, soaps, and supplements, in the 
market. Many hemp farmers are using their crops for CBD products. The 
USDA released their regulations on hemp in October, but we are still 
waiting for the FDA to issue rules and regulations on CBD products. I 
want you to be aware of the importance of this decision to hemp farmers 
across the country. There is a lot of confusion here, and FDA needs to 
take a leading role in addressing this uncertainty.

          If confirmed as FDA Commissioner, what will be your 
        plan and timeline to regulate the use of CBD in foods, and how 
        will you work with the USDA to implement this plan?

          How will you use science and data to ensure the 
        safety of CBD consumer products?

    Answer. Thank you for your question. As you know, CBD is widely 
available throughout the United States. It can be purchased in many 
places across the country. There are open questions and knowledge gaps 
about these products such as: `What is the appropriate dosage and for 
which health claim?' What are the potential interactions with other 
drugs? What are the health effects of long term usage particularly 
among youth. On the other hand, we need to recognize that there are 
potential therapeutic benefits from CBD. In fact, FDA approved a CBD-
containing product for the treatment of a serious childhood seizure 
disorder. There are signals that CBD might be useful for other 
conditions. However, I am concerned about the unsubstantiated claims 
that CBD can be useful for conditions like cancer and Alzheimer's 
disease. It is important to ensure that any claims made to treat a 
disease are supported by the appropriate safety and efficacy data. I 
look forward to prioritizing this issue and reviewing the data on the 
safety of CBD with career staff and to work with the Agency and all 
appropriate Federal partners to determine if there is a clear and 
transparent pathway for consumer products (e.g. food additives and 
dietary supplements). I am committed to using science, data, and the 
law to guide all of my decisions at the FDA and working with Congress 
and the administration to make the absolute best decisions for the 
American people.
                     Questions About Animal Biotech
    I have heard from farmers about an ongoing outbreak of African 
swine fever that is disrupting livestock and feed markets. There are no 
treatments for African swine fever on the market. While genetic tools 
might address this outbreak, I have heard from stakeholders that there 
are regulatory roadblocks that could delay their approval.

          If confirmed as FDA Commissioner, do you commit to 
        working with Congress and stakeholders to ensure timely 
        approval of genetic tools involving animal DNA?

    Answer. Yes, I commit that, if confirmed, as Commissioner, I will 
ensure FDA works with Congress and stakeholders to ensure timely 
approval of genetic tools involving animal DNA. We must protect our 
food supply from foreign pathogens both for the safety of consumers and 
for the benefit of American producers.
 Questions About Implementation of Food Safety Modernization Act (FSMA)
    The Food Safety Modernization Act (FSMA) was enacted on a 
bipartisan basis in 2011, and FDA is still implementing its provisions.

          If confirmed as FDA Commissioner, what is your plan 
        and timeline to implement FSMA?

          How would you follow data and evidence to implement 
        FSMA and ensure we are maintaining a safe food supply?

    Answer. I commit that, if confirmed, I will make the implementation 
of FSMA and protection of the American food supply a priority. Although 
I cannot speak to a specific timeline as I am not current at FDA, I 
share your concern that we must address foodborne outbreaks both for 
the sake of the public health but also to maintain confidence in food 
produced in the United States.
                             senator jones
    Question 1.

    Dr. Hahn, I appreciate your willingness to serve the country as the 
FDA commissioner. As I discussed during the hearing, I believe the 
youth vaping crisis and the outbreak of vaping-related lung illnesses 
is one of the most pressing items currently before Congress and the 
FDA. We have seen the media reports about the White House deciding to 
reverse course on a vaping flavor ban that had been announced in 
September. Given your history as a lung cancer physician and head of 
one of the Nation's preeminent cancer centers I welcome your opinion on 
what the FDA and Congress should do to halt the youth vaping epidemic. 
Do you think flavors are marketed to youth? Is a ban or pause on new 
flavors an appropriate way to prevent more youth from using addictive 
vaping products?

    Answer 1. I've seen the data suggesting that flavors are a 
significant effect for children using e-cigarettes and I am alarmed by 
those data. I think it's a serious issue. Further, I understand that 
the final compliance policy is under consideration by the 
administration. I look forward to their decision. I'm not privy to that 
decision making process. But I very much agree and support that 
aggressive action needs to be taken to protect our children.
                              Biosimilars
    Question 1.

    Dr. Hahn, I know that FDA tries to educate physicians and consumers 
about the safety and efficacy of biosimilars. Section 206 of the Lower 
Health Care Costs Act that passed this Committee in June requires FDA 
to establish a website to provide education materials for patients and 
doctors about the interchangeability of biosimilar and biologic 
products. How can we better educate the public on biosimilars? What 
role should FDA play in this education process?

    Answer 1. Thank you for your question. Biologics are increasingly 
important in American medicine to treat serious illnesses and represent 
about a third of the new therapies approved by FDA. I am concerned 
about the relatively slow pace of biosimilar use in the market and I 
agree that action is needed. I agree that provider education is 
important to increasing the uptake of biosimilars. I look forward to 
working with FDA staff, if confirmed, to increase education and build 
on current methods of outreach at FDA.
                         Antibiotic Resistance
    Question 1.

    Last week the Centers for Disease Control and Prevention found that 
2.8 million people are infected and more than 35,000 people die every 
year from the bugs in the U.S. This CDC report placed five drug-
resistant superbugs on the ``urgent threat'' list, meaning that our go 
to antibiotics may no longer work for these infections.

    I know that the FDA is working to address antibiotic resistance 
through working groups, and antimicrobial stewardship in veterinary 
settings. If confirmed, what will you do to lead the FDA in combatting 
a growing antibiotic resistance? What more should be done?

    Answer 1. If confirmed, I would support continued implementation of 
the 2019 Strategic Approach for Combatting AMR and learn about the 
progress and challenges of plan. This would be one area I could use my 
personal experience as a practicing physician and running a large 
organization to apply lessons I have learned about stewardship and the 
challenges of AMR in the cancer setting.
                             senator rosen
    Question 1.

    Dr. Hahn, sexual harassment unfortunately continues to be a problem 
among American workplaces. I am greatly concerned by the 2018 report 
from the National Academies of Sciences, Engineering, and Medicine, 
which found that sexual harassment was even worse among STEM fields, 
compared to non-STEM fields. As a former computer programmer and 
systems analyst, I know how hard it is for women to succeed in male-
dominated fields--much less adding harassment on top of that.

    Dr. Hahn, what steps would you take to both prevent and address 
harassment within the FDA? And how would you hold recipients of FDA 
grants accountable with regards to those facing claims of sexual 
harassment? I'm very interested in what you think is currently working, 
and what you would change regarding policies in this area. Keeping in 
mind, the National Academies report stated ``There is no evidence that 
current policies, procedures, and approaches have resulted in a 
significant reduction in sexual harassment.''

    Answer 1. Thank you for your question. I believe that sexual 
harassment, and sexual harassment within the workplace are 
unacceptable. In my time on the Executive Leadership Team at MD 
Anderson, we made addressing sexual harassment in the workplace a top 
priority. If confirmed, it would be one of my highest priorities to 
make sure FDA has the top talent and expertise needed in order to 
appropriately ensure the safety and efficacy of medical products. In 
order to attract and retain staff, employees must be confident that 
sexual harassment will not be tolerated. If confirmed, I will review 
the Federal Government's policies and FDA policies related to this 
issue to determine where they may be strengthened.
                           Precision Medicine
    Question 1.

    Dr. Hahn, as research advances to make medical treatment for 
patients more personalized, FDA's role in ensuring expedited review is 
critical--especially for patients with rare subtypes and genetic 
mutations, who do not respond to regular treatment options. How would 
you approach how FDA evaluates investigational therapies for patients 
with rare mutations in relation to standards of care? How do you think 
the FDA could improve existing programs to help bring new targeted 
therapies to patients more quickly?

    Answer 1. Thank you for your question. As an oncologist, I am very 
interested in the advancement of precision medicine. Precision medicine 
has transformed cancer care in recent years, and it holds the potential 
to help us find new treatments and cures for a variety of diseases. If 
confirmed, I would work with the National Institutes of Health to 
leverage the data collected by their precision medicine program--All of 
Us--to advance drug development. I pledge to work across agencies to 
encourage development of innovative therapies to the precision medicine 
and rare diseases space.
                        Donor Human Milk Safety
    Question 1.

    Dr. Hahn, it is my understanding that even as donor milk products, 
such as those used to prevent necrotizing enterocolitis in premature 
infants, are playing an important role in infant health, there is still 
a lack of standardized safety protocols and manufacturing requirements 
due to varying classifications. This creates a potential risk for 
contaminants, such as drugs, bacteria, or viruses, to enter the donor 
milk supply. What steps would you take at FDA to update and streamline 
donor milk screening protocols for collection and processing?

    Answer 1. If confirmed, I look forward to working with the career 
staff at the FDA to determine how FDA can update and streamline donor 
milk screening protocols for collection and processing. Access to safe, 
effective contraception is essential to public health and women's 
health. Continued research is necessary to develop improved options for 
all people who choose to use hormonal drug products for both pregnancy 
prevention and non-contraceptive purposes. Clinical trials on new and 
emerging hormonal contraceptives should reflect the unique health needs 
of the wide range of individuals that use these products.
                       Generic Drugs/Drug Prices
    Question 1.

    Dr. Hahn, one of the issues I hear about most from constituents is 
how concerned they are about the cost of prescription drugs. This is a 
serious issue, to the point of patients skipping needed medication--
like rationing insulin. What else could FDA do to speed the process for 
bringing generic drugs to market? What recommendations do you have to 
Congress for what other tools FDA needs to help address drug costs?

    Answer 1. High prescription drug prices and affordability are a 
significant problem and addressing this issue through a variety of 
means has been a priority of Congress, the administration and the 
Department. I agree that strong action is needed to address this issue. 
It's also important to ensure that whatever solutions we consider, do 
not have the unintended consequences of stifling innovation and the 
development of new medical products for the American people. There are 
indirect ways that FDA can assist in lowering prescription drug prices 
such as facilitating innovation and competition. As you know, FDA has a 
Drug Competition Action Plan and I look forward to working with 
Congress and career staff on this plan. I am particularly supportive of 
introducing more competition to help reduce drug prices including 
generic approvals, working to improve the biosimilar pathway, and 
ensuring that there is transparency and a clear regulatory pathway, not 
game-playing in the generic and biosimilar spaces. I look forward to 
working with you on measures to reduce high prescription drug prices. I 
will make this a priority and do all that I can as FDA commissioner to 
ensure access of medical products for all Americans.
                           Marijuana Research
    Question 1.

    Dr. Hahn, I wanted to follow-up on one of the questions I asked 
during your hearing. We discussed the successful research that led to 
cannabidiol being used to treat seizures in children with a severe form 
of epilepsy. Finding new treatments that have fewer side effects, or 
are more effective, is so important--yet researchers, including at the 
University of Nevada Las Vegas, are stymied in their scientific efforts 
because of the challenges of gaining access to marijuana to legally 
study, including developing different strains. This is true even in 
states like Nevada where marijuana is legal. I've heard from UNLV that 
it can take 1-2 years just to get approval for the schedule 1 license 
required to do this research.

        1a. Given the great need for alternatives to opioids for pain 
        management, and a whole host of other conditions, why shouldn't 
        we be making it easier for our medical community and scientific 
        researchers to study this plant to see what positive medicinal 
        value might be there?

        1b. I understand this is also an issue involving DEA, but I'd 
        like to know what are you specifically willing to commit to 
        doing as FDA Commissioner to improve access for medical 
        researchers so they can study how various compounds in 
        marijuana plants could be used to treat a variety of illnesses 
        and conditions? And on what timeline?

        1c. Do you have specific recommendations for how DEA and FDA 
        could work together more effectively in this area?

    Answers to 1a-c. Thank you for this question. Conducting clinical 
research using marijuana and other controlled substances involves 
interactions with several Federal agencies, including obtaining the 
marijuana for research from the National Institute on Drug Abuse (NIDA) 
within the National Institutes of Health or another Drug Enforcement 
Administration (DEA)-registered source; review of an investigational 
new drug (IND) application and the research protocol by the Food and 
Drug Administration (FDA) and an investigator registration and site 
licensure by the DEA. I agree that it is important to eliminate 
unnecessary barriers to research that could lead to breakthroughs or 
new treatments for the American people. If confirmed, I look forward to 
working with you, Congress, the administration, and relevant Federal 
agencies to reduce unnecessary barriers to this research. While DEA is 
the Federal agency that regulates controlled substances, if confirmed, 
as Commissioner of Food and Drugs, I would support reducing unnecessary 
barriers that prevent researchers from studying compounds that could 
have a benefit for Americans.
                             CBD Regulation
    Question 1.

    Dr. Hahn, another area I'd like to touch on is the regulation of 
CBD products, which contain cannabidiol--and very low THC--so these are 
not what we traditionally think about as the kind of marijuana products 
that people use for recreational purposes. We're talking about skin 
creams, oils, and supplements. FDA currently has the authority to 
regulate these products and ensure their safety for consumers, but it 
has yet to establish a regulatory pathway for marketing products that 
contain CBD. This has caused great uncertainty among both consumers and 
companies making these products, including in Nevada, where both CBD 
and other marijuana products are legal.

        1a. Dr. Hahn, what are your thoughts on FDA's responsibility to 
        create a regulatory pathway for CBD products?

        1b. What timeline will you commit to for an update to this 
        Committee on FDA's progress, and what timeline do you expect 
        for FDA rulemaking?

    Answers to 1a-b. Thank you for your question. As you know, CBD is 
widely available throughout the United States. It can be purchased in 
many places across the country. There are open questions and knowledge 
gaps about these products such as: `What is the appropriate dosage and 
for which health claim?' What are the potential interactions with other 
drugs? What are the health effects of long term usage particularly 
among youth. On the other hand, we need to recognize that there are 
potential therapeutic benefits from CBD. In fact, FDA approved a CBD-
containing product for the treatment of a serious childhood seizure 
disorder. There are signals that CBD might be useful for other 
conditions. However, I am concerned about the unsubstantiated claims 
that CBD can be useful for conditions like cancer and Alzheimer's 
disease. It is important to ensure that any claims made to treat a 
disease are supported by the appropriate safety and efficacy data. I 
look forward to reviewing the data on the safety of CBD with career 
staff and to work with the Agency and all appropriate Federal partners 
to determine if there is a clear and transparent pathway for consumer 
products (e.g. food additives and dietary supplements). I commit to 
providing timely and meaningful updates to the Committee on this issue.
                Drug Development for Addiction Treatment
    Question 1.

    Dr. Hahn, we heard just last week in this Committee's hearing on 
vaping that there are no FDA-approved treatments for teenagers who are 
addicted to nicotine. It is my understanding that there is also a lack 
of options for anyone, adult or youth, addicted to psychostimulant 
drugs like cocaine and meth.

        a. What steps would you take at FDA to proactively address this 
        problem, beyond simply responding to approval applications that 
        come to FDA?

    Answer 1. Thank you for your question. Like you, I am concerned 
that there are no FDA-approved treatments for teenagers who are 
addicted to nicotine. We must take action to prevent youth from 
becoming addicted to nicotine. Unfortunately, there are already youth 
who are addicted and we need treatments. I believe it is critical for 
the FDA to provide certainty and clarity to manufacturers in order to 
develop applications for cessation products that can be used by youth 
who are addicted to nicotine. I look forward to working with the staff 
at FDA to determine ways that the FDA can advance the development of 
tobacco cessation products. I think this is an important, urgent crisis 
in this country. I do not want to see another generation of Americans 
become addicted to tobacco and nicotine. And I believe that we need to 
take strong action to stop that.

        b. Obviously, prevention is critical, but when it comes down to 
        it, we need to do a better job of ensuring treatment options 
        for addiction to a wide range of substances--for the specific 
        populations that are impacted. Unfortunately, cocaine and meth 
        are a growing problem in Nevada. Dr. Hahn, what lessons from 
        the opioid crisis would you look to for guidance on how to 
        address, and curb, the changing nature of the overdose crisis?

                i. How does effective treatment play into that plan?

    Answers to b-i. Thank you for your question. As you mention, 
prevention of substance use disorders is critical. For opioid use 
disorder, medication assisted therapy is the gold standard of 
treatment. However, currently, there are no FDA approved medical 
products for the treatment of addiction to cocaine or methamphetamines. 
Behavioral therapy is currently the only treatment. I understand that 
the National Institute of Drug Abuse is conducting significant research 
on addiction and treatments and I pledge to work across agencies to 
encourage development of innovative therapies to address all addiction 
illnesses.
                            Cosmetic Safety
    Question 1.

    Dr. Hahn, I'd like to ask you about the need to update FDA's 
oversight of cosmetic products. This includes a wide range of personal 
care products--shampoo, lotion, make-up, shaving cream, hair dye--
products that most Americans use daily. Yet our laws have changed 
little with regard to FDA safety oversight of cosmetics since the Food, 
Drug, and Cosmetic Act was passed in 1938. A lot has changed since 
then, including questions about the safety of certain ingredients, and 
issues of contamination--like the recent cases of asbestos in make-up 
marketed to teens and preteens. I appreciate the work that my 
colleagues have done over the last several years, especially Senators 
Feinstein and Collins with the Personal Care Products Safety Act, which 
I have co-sponsored.

        1a. Dr. Hahn, do you believe that FDA needs updated authority 
        for stronger oversight and capacity to review the safety of 
        ingredients in personal care products that Americans use on a 
        regular basis, especially ingredients that the medical 
        community has raised serious concerns about--like endocrine-
        disrupting parabens and phthalates, or chemicals like 
        formaldehyde? How would you plan to work with this Committee to 
        address this issue?

    Answer to 1a. I commend FDA staff for their work to ensure that 
adulterated cosmetics products are promptly detected and removed from 
the market--asbestos has no place in cosmetics. If confirmed, science, 
data, and the law will guide every decision I make and every effort the 
agency undertakes. I commit to working closely with you and your 
colleagues as you work on legislation to modify the FDCA.

        1b. Can you please speak about current limitations within FDA's 
        capacity to screen imported cosmetic products for serious 
        contaminants, like asbestos, lead, and mercury? What steps 
        should FDA and Congress take to improve consumer safety for our 
        constituents?

    Answer to 1b. Although I am not currently a part of the 
administration and cannot speak to the specifics of the agency's 
capacity, if I am confirmed, I commit to working closely with FDA staff 
to understand and address any such limitations.
                             senator murray
                                Tobacco
                       Flavors Compliance Policy
    During your confirmation hearing, I was disappointed by your 
answers to questions from multiple Senators on your commitment to 
combatting youth tobacco use. The lack of a commitment from you 
followed the testimony of Mitch Zeller, Director of FDA's Center for 
Tobacco Products, one week earlier. Mr. Zeller refused to provide the 
Committee, under repeated questioning, with an update on the status of 
the policy announced by the administration in September to remove all 
non-tobacco flavored e-cigarettes from the market until reviewed by the 
FDA. Rather than answer us, Mr. Zeller suggested that I and other 
Members direct our questions to the White House. At the same hearing, 
Dr. Anne Schuchat, principal deputy director of the CDC, told the 
Committee, ``We know flavors are particularly attractive to youth,'' 
and said that, if a flavored e-cigarette were permitted to remain on 
the market, ``we believe kids will likely use whatever flavor is 
left.''

    Question 1.

    If confirmed, are you committed to finalizing the flavors 
compliance policy the administration announced on September 11?

    Answer 1. I understand that the final compliance policy is under 
consideration by the administration. I look forward to their decision. 
I'm not privy to that decision making process. But I very much agree 
and support that aggressive action needs to be taken to protect our 
children. I think this is an important, urgent crisis in this country. 
I do not want to see another generation of Americans become addicted to 
tobacco and nicotine. And I believe that we need to take strong action 
to stop that.

    Question 2.

    If confirmed, are you committed to responding to questions about 
FDA matters instead of referring us to the White House?

    Answer 2. I will respond to questions asked of the Committee, 
consistent with legal an ethics requirements.

    Question 3.

    Do you agree with Dr. Schuchat that flavors make e-cigarettes more 
attractive to youth and that, if all flavors are not removed from the 
market, youth will shift to the flavors that remain on the market?

    Answer 3. I've seen the data suggesting that flavors are a 
significant effect for children using e-cigarettes and I am alarmed by 
those data. I think this is an important, urgent crisis in this 
country. I do not want to see another generation of Americans become 
addicted to tobacco and nicotine. And I believe that we need to take 
strong action to stop that.

    Question 4.

    As Commissioner, would you ensure the decisions FDA makes are based 
on the best available science?

    Answer 4. If confirmed, I commit to using science, data and the law 
to guide my decisions at FDA.
                           Youth Tobacco Use
    Question 5.

    All flavored tobacco products pose a threat to children. Are you 
committed to clearing the market of all flavored tobacco products, 
including menthol cigarettes and flavored cigars?

    Answer 5. I'm a lung cancer doctor, and I have seen the ravages of 
tobacco-related cancers. I also know youngsters who were very close to 
me who use e-cigarette products. I'm aware of the National Youth 
Tobacco Survey data. And I think this is an important, urgent crisis in 
this country. I do not want to see another generation of Americans 
become addicted to tobacco and nicotine. And I believe that we need to 
take aggressive action to stop that.

    Question 6.

    What other steps do you intend to take to combat youth tobacco use?

    Answer 6. If confirmed, I look forward to learning from many 
internal and external stakeholders about all the options and working 
with Congress to tackle this problem together. I am open to evaluating 
strategies that would aggressively address this epidemic. I think this 
is an important, urgent crisis in this country. I do not want to see 
another generation of Americans become addicted to tobacco and 
nicotine. And I believe that we need to take strong action to stop 
that.

    Question 7.

    As youth tobacco use skyrockets, the need for effective youth 
cessation options has become especially acute. What steps would you 
take to improve the availability of FDA-approved youth cessation 
products?

    Answer 7. Tobacco cessation and nicotine addiction and are serious 
problems. I see that because many of my patients want to stop smoking 
cigarettes. Fortunately, there's great research, much of which has been 
funded by Congress at NIH that's allowed us to look at this 
intersection between nicotine addiction, tobacco use and what we may be 
able to do in the future. I am very supportive of taking measures and 
expediting those measures to try to find out what novel products we can 
use to help with the tobacco cessation problem that we have. I think 
this is an important, urgent crisis in this country. I do not want to 
see another generation of Americans become addicted to tobacco and 
nicotine. And I believe that we need to take strong action to stop 
that.
                        Vaping-Linked Illnesses
    As of November 13, more than 2,000 people have been sickened by 
vaping-linked lung illnesses.

    Question 8.

    What steps do you intend to take to combat the outbreak of vaping-
linked illnesses and prevent similar outbreaks in the future?

    Answer 8. If confirmed, I look forward to immediately getting up to 
speed on this issue. What I now know if from press reports--that CDC 
and FDA are working closely with States to investigate each reported 
illness and death. And that they have found some common causes, but 
more work remains. I will continue the good work of Acting FDA 
Commissioner Ned Sharpless to work collaboratively with CDC and make 
the public aware of key findings and precautionary warnings as 
expeditiously as possible. I think this is an important, urgent crisis 
in this country. I do not want to see another generation of Americans 
become addicted to tobacco and nicotine. And I believe that we need to 
take strong action to stop that.
                           Nicotine Reduction
    The Trump administration now also appears to be breaking its 2017 
promise to reduce the level of nicotine in cigarettes to minimally or 
non-addictive levels.

    Question 9.

    Is FDA continuing its work toward reducing nicotine levels in 
cigarettes?

    Answer 9. I am not privy to the internal decision making of the 
FDA. I pledge to look into this matter should I be confirmed.

    Question 10.

    Are you committed to moving forward with the administration's 
proposal to reduce nicotine in cigarettes?

    Answer 10. I commit to using science, data and the law to guide my 
decisionmaking. If evidence suggests this is a viable option to 
discourage the use of tobacco products, I will pursue it.
                         Antibiotic Resistance
    The Centers for Disease Control (CDC) estimates that more than 2.8 
million antibiotic-resistant infections occur in the U.S. each year, 
resulting in over 35,000 deaths annually. The World Health 
Organization's global assessment of antibiotic resistance concluded 
that antibiotic resistance is a ``major threat to human health.'' There 
are well-established connections between antibiotic use in food 
production and rising antibiotic resistance in common human pathogens. 
Already, the CDC estimates that antibiotic resistant foodborne 
pathogens cause 430,000 illnesses each year in the United States.

    Question 11.

    Please provide your assessment of this situation and the actions 
that FDA intends to take to prevent animal antibiotics from being used 
for unlimited or excessive durations?
    Answer 11. All growth promotion indications have been removed from 
labeling indications, which reduced the amount of antibiotics used in 
animals. I would consult with careers at the Agency on additional steps 
FDA could take. I think this is an area that deserves attention and 
close monitoring of sales data and additional studies. The Agency 
issued grants in 2016 to study this issue and, if confirmed, I would 
look forward to learning about the findings from these studies and the 
potential recommendations. I will partner with Congress, the 
administration and other stakeholders moving forward on this important 
issue.

    Question 12.

    How does FDA intend to ensure that antibiotics currently available 
over-the-counter will not be used in excessive doses and durations that 
are beyond the scope of their ``disease prevention'' indication?

    Answer 12. If confirmed, I would partner with career staff to 
better understand over-the-counter utilization of antibiotics and 
examine any data the Agency is collecting on the issue. This is a very 
important issue. I believe that tracking sales data of these products 
will be informative and could guide evidence-based actions in the 
future.

    Question 13.

    What role do you envision for veterinarians in antimicrobial 
stewardship in food production?

    Answer 13. Veterinarians play a critical role in antimicrobial 
stewardship in food products. I understand that CVM has recognized the 
value of their role and has established an effective partnership with 
the veterinarian community to combat AMR. I look forward to partnering 
with appropriate stakeholders including the veterinarian community to 
address this important issue.

    Question 14.

    If confirmed, do you commit to requiring veterinarian involvement 
any time an antibiotic is used in an animal?

    Answer 14. I think veterinarian involvement is critical when 
antibiotics are prescribed to animals.

    Question 15.

    What is the current status of FDA and USDA joint efforts to collect 
data on antibiotic use in food animal production?

    Answer 15. Since I am not currently at the FDA, I do not know the 
current status of these efforts. However, if confirmed, I commit to 
looking into this issue.

    Question 16.

    What investments should Congress prioritize to improve data 
collection and antibiotic use reporting and to further improve 
understanding of changes in antibiotic resistance patterns?

    Answer 16. If confirmed, I would consult with experts at the Agency 
to discuss this issue. From my own medical experience, I believe that 
tracking infections, prescriptions, and product sales will provide 
valuable tools to track utilization and potentially partner with health 
care systems to better understand prescribing practices. This could 
guide evidence-based actions in the future.

    Question 17.

    Please provide an assessment of FDA's progress in implementing 
Guidance for Industry 209 and 213 and the Veterinary Feed Directive 
final rule. Please preview any expected milestones for the coming year.

    Answer 17. There are many well-documented challenges to conducting 
clinical trials for antibiotics; for example, finding and enrolling 
patients with rare drug resistant infections. The 21st Century Cures 
Act of 2016 granted FDA authority to establish a new regulatory 
pathway, Limited Population Pathway for Antibacterial and Antifungal 
Drugs (LPAD), to overcome challenges specific to development of new 
antibiotic therapies.

    Question 18.

    Please give your assessment of the current state of the LPAD 
pathway implementation.

    Answer 18. To date, two drugs have been approved in the LPAD 
pathway since it was authorized in 21st Century Cures in 2016. The lack 
of products in the antibiotic development pipeline has been a 
significant issue for many years and in my opinion, it is too early to 
assess the true impact of the LPAD pathway. My understanding is that 
our career staff works hard to appropriately engage with sponsors to 
use the appropriate regulatory tools to support development and review. 
Because drug development generally takes 10 years it will take some 
more time to understand the full effect of the program.

    Question 19.

    Please describe actions FDA can take to further facilitate 
development of new antibiotics.

    Answer 19. I believe the Agency has taken many steps to facilitate 
development of new antibiotics including utilizing the LPAD pathway, 
leveraging the flexibility of clinical trials and developing 
breakpoints. Diagnostics can play a critical role in stewardship and 
utilization so physicians could identify the appropriate drug and 
dosage to treat the infection. I believe that post-market surveillance 
and real-world evidence can play a critical role to better 
understanding these infections, the treatments and stewardship. If 
confirmed, I would be eager to engage with experts at the Agency to 
learn more about this critical work.
                           Cannabidiol (CBD)
    At this time, it is unlawful to market food or dietary supplements 
containing cannabidiol (CBD) in interstate commerce. Under current law, 
for CBD to be lawfully marketed in a food or dietary supplement, FDA 
would have to issue a regulation allowing for the marketing of CBD in 
those products. FDA has said that it is exploring an approach to 
regulating CBD that takes into account the safety and quality of CBD-
containing products. In addition, FDA has also noted the importance of 
preserving incentives for research and drug development. FDA has 
estimated that rulemaking on CBD would take three to five years.

    I want to preserve FDA's role in regulating cannabis products 
marketed as drugs and in foods, dietary supplements, and cosmetics, as 
well as preserve the incentive to develop new pharmaceutical 
treatments. I am concerned that the FDA timeframe is too long, given 
the agency's concerns. It is important that FDA move as quickly as 
possible, without sacrificing consumer safety and the public health.

    Question 20.

    Will you make FDA regulation and oversight of CBD-containing 
products--including food, dietary supplements, drugs, and cosmetics--a 
top priority?

    Answer 20. Yes, if confirmed, I will make this a top priority. As 
you know, CBD is widely available throughout the United States. It can 
be purchased in many places across the country. There are open 
questions and knowledge gaps about these products such as: `What is the 
appropriate dosage and for which health claim?' What are the potential 
interactions with other drugs? What are the health effects of long term 
usage particularly among youth. On the other hand, we need to recognize 
that there are potential therapeutic benefits from CBD. In fact, FDA 
approved a CBD-containing product for the treatment of a serious 
childhood seizure disorder. There are signals that CBD might be useful 
for other conditions. However, I am concerned about the unsubstantiated 
claims that CBD can be useful for conditions like cancer and 
Alzheimer's disease. It is important to ensure that any claims made to 
treat a disease are supported by the appropriate safety and efficacy 
data. I look forward to reviewing the data on the safety of CBD with 
career staff and to work with the Agency and all appropriate Federal 
partners to determine if there is a clear and transparent pathway for 
consumer products (e.g. food additives and dietary supplements). I am 
committed to using science, data, and the law to guide all of my 
decisions at the FDA and working with Congress and the administration 
to make the absolute best decisions for the American people.

    Question 21.

    Will you aggressively enforce current law against CBD products that 
are marketed with false or misleading claims?

    Answer 21. I am concerned about the unsubstantiated claims that CBD 
can be useful for conditions like cancer and Alzheimer's disease. It is 
important to ensure that any claims made to treat a disease are 
supported by the appropriate safety and efficacy data and that 
enforcement actions reflect this principle. I take very seriously the 
role of the FDA in protecting public health and ensuring consumers have 
accurate information to make the best decisions possible.

    Question 22.

    How will you preserve and enhance incentives for research and 
development of drugs that contain CBD and other cannabinoids?

    Answer 22. I look forward to learning more about the barriers to 
research and development of drugs that contain CBD and other 
cannabinoids. I will also work with the Drug Enforcement Agency, the 
National Institute on Drug Abuse, the USDA and other relevant Federal 
agencies to determine if there are unnecessary barriers that can be 
streamlined.
                              Compounding
    In 2013, Congress enacted the Drug Quality and Security Act (DQSA), 
to establish a clear regulatory regime for compounded products, after a 
contaminated compounded injectable caused a meningitis outbreak that 
sickened over 800 people and killed 64 people in 2012. Since passage of 
the DQSA, FDA has devoted significant agency resources to implementing 
and enforcing its compounding-related authorities.

    Question 23.

    Do you commit, if confirmed, to continuing FDA's work to ensure 
continued access to quality compounded drugs for patients who need them 
and strengthen regulatory oversight to protect patients from unsafe, 
ineffective, and poor quality products?

    Answer 23. Yes. This is an issue of importance particularly with 
respect in situations where there is a shortage of a prescription drug 
or a patient cannot use an FDA-approved product; in other words to meet 
a specific medical need. If confirmed, I am committed to implementing 
DQSA, as intended by Congress, to both protect patient safety, and 
allow the safe and appropriate practice of pharmacy compounding to 
occur in the way that Congress intended.
                               Cosmetics
    In December 2018, a Reuters investigation showed a long history of 
asbestos contamination in talc used for baby powders. This year, FDA 
has released findings from testing several products, which revealed 
asbestos contamination in a number of cosmetic products marketed to 
children and teenagers. Most recently, in October, FDA alerted 
consumers that Johnson & Johnson had voluntarily recalled one lot of 
Johnson's Baby Powder after a sample tested positive for asbestos. I am 
alarmed by the continued reports of asbestos contamination in cosmetic 
products, especially those marketed to children and teenagers. FDA must 
do everything it can to respond to these issues and ensure our products 
are safe for use.

    Question 24.

    Do you believe FDA needs to do more to ensure cosmetic products on 
the market are safe?

    Answer 24. I agree that FDA must do everything possible to ensure 
that consumer products under the agency's jurisdiction are free from 
adulterants like asbestos. If confirmed I will work with FDA staff to 
get quickly up to speed on this issue, and will work to address any 
shortcomings. I commend the agency on its work to detect these 
adulterated products and get them off the market.

    Question 25.

    What resources will you commit to continuing FDA's investigations 
of contamination in talc products--and to monitoring, testing, and 
enforcement of applicable laws and regulations governing cosmetic 
products?

    Answer 25. If confirmed, I will ensure that the cosmetics program 
prioritizes products that have demonstrated a higher level of risk to 
consumers. I will also commit to working with Congress and stakeholders 
to better understand ways that the program can be more effective in 
achieving its mission.

    Question 26.

    What authorities and resources does FDA need to ensure the safety 
and quality of cosmetic products?

    Answer 26. Although I am not currently a part of the administration 
and cannot speak to the specifics of the agency's capacity, if I am 
confirmed, I commit to working closely with FDA staff to understand and 
address any such limitations.

    Question 27.

    Do you believe consumers have an adequate understanding of FDA's 
limited legal authority over cosmetics and the extent to which FDA 
monitors cosmetic products on the market?

    Answer 27. I look forward to learning the consumer's viewpoint of 
FDA's role in cosmetics. If confirmed I will prioritize transparent and 
effective communication with the American people.
                             Device Safety
    In 2015, I asked my Committee staff to investigate a series of 
dangerous infections at Virginia Mason hospital in Seattle linked to 
contaminated duodenoscopes. I issued a staff report in 2016 that linked 
this type of medical device to at least 25 different outbreaks of 
antibiotic-resistant infections that sickened at least 250 patients 
worldwide. These devices remain difficult to clean and can contribute 
to the spread of infections. My staff's report recommended that FDA 
expand post-market surveillance of medical devices to protect patients 
from infection. FDA has made some progress by committing new resources 
to develop and implement an active surveillance system using the 
National Evaluation System for health Technology (NEST), but we need to 
do more.

    Question 28.

    Will you make it a top priority to enhance monitoring of marketed 
medical devices, including fully leveraging the functions of NEST?

    Question 29.

    Will you insist on greater certainty about the risks associated 
with the use of devices before they are marketed?

    Answers to 28-29. If confirmed, I will carefully consider all tools 
for their ability to enhance accurate monitoring of the safety and 
effectiveness of marketed devices. I think it is important for FDA to 
take a proactive, not passive approach to upholding the gold standard 
for all medical products before and after they enter the market.
                          Dietary Supplements
    The dietary supplement market has grown exponentially over the past 
twenty years. Today, three out of every four consumers take a dietary 
supplement on a regular basis. Earlier this year, former Commissioner 
Gottlieb highlighted the widespread use of dietary supplements and 
announced a new plan to modernize dietary supplement regulation and 
product oversight to ensure product safety and quality. As part of this 
plan, Gottlieb acknowledged that a ``mandatory listing requirement 
could provide significant benefits by improving transparency in the 
marketplace and promoting risk-based regulation'' and ``could also help 
facilitate efficient enforcement of the law and establish new 
mechanisms to identify bad actors who put the public at risk and 
undermine consumer confidence in the entire industry.'' According to 
the Pew Charitable Trusts, a product listing requirement would ``enable 
FDA to direct its resources and expertise toward supplements with 
greater potential to harm consumers'' and ``enhance FDA's ability to 
respond effectively to emerging safety concerns.''

    Question 30.

    Do you believe FDA needs to do more to oversee marketing of dietary 
supplements?

    Question 31.

    Will you continue to advance FDA's efforts to strengthen the 
regulation and oversight of dietary supplements?

    Question 32.

    Do you support a product listing requirement for dietary 
supplements?

    Question 33.

    What other authorities and resources does FDA need to help protect 
consumers, without imposing unnecessary burdens on companies that 
market safe, high-quality products?

    Answers to 30-33. So many Americans trust in the FDA to ensure the 
products they use are safe and effective. I have been pleased to see 
the new efforts surrounding the enhanced oversight of dietary 
supplement products, including the creation of the Office of Dietary 
Supplement Programs (ODSP), and the very recent announcement that the 
Botanical Safety Consortium (BSC) has been convened. I commit to 
continuing this work to modernize and enhance oversight of dietary 
supplements.
                           Drug Supply Chain
    The U.S. drug supply chain is one of the safest in the world, but 
it has become more complex, in part because of increased globalization. 
Today, the majority of the active ingredients in drug products sold in 
the United States are manufactured in India and China. With this shift 
has come troublesome news about safety. A 2016 GAO report found that 
FDA lacks inspectional history for one-third of the foreign drug 
establishments in its catalog. This year, FDA announced millions of 
people had been exposed to possible carcinogens found in widely used, 
FDA-approved blood pressure and heartburn medications, like Zantac, 
manufactured in part by facilities in China and India. These reports 
raise concerns about the FDA's foreign drug inspection program, and the 
agency's ability to detect contaminants before drugs reach patients, 
wherever they are manufactured.

    Question 34.

    What actions will you take to ensure the drug supply is safe for 
patients in the United States?

    Answer 34. Thank you for your question. FDA's role is to ensure the 
safety of the drug supply. The U.S. has the safest drug supply in the 
world and if confirmed, I am committed to maintaining the safety of 
drugs and biologics used by the American people. According to recent 
testimony from FDA, as of August 2019, only 28 percent of the 
manufacturing facilities making APIs to supply the U.S. market were in 
our country. By contrast, the remaining 72 percent of the API 
manufacturers supplying the U.S. market were overseas, and 13 percent 
are in China. I believe advanced manufacturing could help to bring this 
manufacturing back to the U.S. If confirmed, I look forward to working 
with the staff at the FDA, along with partnering with Congress, ASPR, 
BARDA, the Department of Defense and others to address this issue and 
ensure that the U.S. drug supply remains safe.

    Question 35.

    On October 30, Dr. Janet Woodcock, Director of the Center for Drug 
Evaluation and Research (CDER) testified before the House Committee on 
Energy and Commerce's Subcommittee on Health that data available to 
CDER related to the manufacture of active pharmaceutical ingredients 
(APIs) have several limitations, including which API supplier a 
finished dosage form manufacturer is using at any given time. What 
authorities and resources does FDA need to improve the accuracy and 
completeness of information about API used in drugs marketed in the 
United States?
    Answer 35. If confirmed, I look forward to working with Dr. 
Woodcock and others at the FDA to determine what additional authorities 
FDA may need to address this issue.
                               FDA Hiring
    FDA officials and staff have long raised concerns about barriers to 
hiring and retaining the staff and expertise needed to keep pace with 
modern science and research. In 2016, the 21st Century Cures Act 
included provisions intended to improve hiring of premier talent at the 
FDA. Soon after, MDUFA IV authorized funding for CDRH to hire several 
new premarket reviewers. A 2017 FDA report found that FDA's hiring 
process would benefit from a comprehensive redesign and modernization 
effort and, in 2018, FDA launched a new public campaign to recruit and 
retain new employees. However, FDA continues to face hiring challenges 
and many positions remain unfilled at the Agency.

    Question 36.

    What steps will you take, if confirmed, to ensure FDA is fully 
staffed and able to meet its performance expectations?

    Question 37.

    Are there additional authorities that Congress could provide to FDA 
to assist with hiring and retaining staff, especially in key 
underrepresented disciplines (for example, providing additional pay 
authorities or greater flexibility to directly hire staff)?

    Answers to 36-37. If confirmed, one of my top priorities on day one 
will be to ensure that all of the new authorities that were given to 
FDA through the 21st Century Cures Act are in fact being fully 
implemented. Nothing is more important than getting the right expertise 
in the agency to help keep our food safe, swiftly and safely bring 
cures to the American people, and fulfill the mission of the agency. We 
must be positioned to recruit and retain the best and brightest talent 
at the agency, and I look forward to working with Congress to making 
sure the FDA is fully staffed with the right people for years to come.
                              Food safety
    Congress passed the Food Safety and Modernization Act (FSMA) in 
2011, helping to protect public health and strengthen consumer 
confidence in our food supply. However, eight years later, the Agency 
still has not implemented parts of FSMA, and food-borne outbreaks 
remain a problem. For example, over the past two years, there have been 
four outbreaks of E. coli in romaine lettuce, resulting in 210 
illnesses and 5 deaths. Just last week, FDA announced an investigation 
into incidents of illnesses caused by E. coli in packages of Caesar 
salad that contain romaine lettuce.

    Question 38.

    Your experience has been in the medical field, but FDA oversees the 
safety of 80 percent of the food supply. What actions will you take to 
ensure FDA fully implements FSMA and takes concrete steps to prevent 
food-borne outbreaks, including an effective food traceability system?

    Answer 38. You are right that there are areas of FDA regulation in 
which I have had less experience. I understand that FDA regulates 
around 20 percent of the U.S. economy--a large number. As a physician, 
I am very well versed in medical products oversight but I am not as 
familiar with FDA's programs related to food. That does not change my 
commitment to these programs, particularly because the US has the 
safest and most secure food supply chain in the world. I commit that, 
if confirmed, I will engage the professional staff at FDA across the 
Agency.
                              Drug Pricing
    As you know, patients and families around the country are concerned 
about the high cost of prescription drugs. FDA does not regulate drug 
prices, but it does have a role in increasing access to lower cost 
generics and biosimilars.

    Question 39.

    Please provide specific proposals of how you would target increased 
patient access to generics and biosimilars without sacrificing product 
safety, efficacy, or quality.

    Answer 39. High prescription drug prices and affordability are a 
significant problem and addressing this issue through a variety of 
means has been a priority of Congress, the administration and the 
Department. I agree that strong action is needed. It's also important 
to ensure that whatever solutions we consider, do not have the 
unintended consequences of stifling innovation and the development of 
new medical products for the American people. There are indirect ways 
that FDA can assist in lowering prescription drug prices such as 
facilitating innovation and competition. As you know, FDA has a Drug 
Competition Action Plan and I look forward to working with Congress and 
career staff on this plan. I am particularly supportive of introducing 
more competition to help reduce drug prices including generic 
approvals, working to modernize and make more efficient the biosimilar 
pathway, and ensuring that there is transparency and a clear regulatory 
pathway, not game-playing in the generic and biosimilar spaces. I look 
forward to working with you on measures to reduce high prescription 
drug prices. I will make this a priority and do all that I can as FDA 
commissioner to ensure access of medical products for all Americans.
                               Nutrition
    In March 2018, Former Commissioner Scott Gottlieb announced FDA's 
Nutrition Innovation Strategy. The strategy addresses a number of key 
agency actions to improve nutrition, including two-year short-term 
voluntary sodium-reduction targets for industry, and educational 
campaigns for menu labeling and the updated Nutrition Facts Label.

    Question 40.

    What are your priorities for improving nutrition?

    Answer 40. FDA plays an important role in promoting the nutrition 
of the country. If confirmed as Commissioner, I will use the best 
science to guide the appropriate steps related to sodium levels.

    Question 41.

    What are your specific plans to continue the progress on the 
Nutrition Innovation Strategy?

    Answer 41. I support FDA's efforts to promote the nutrition of the 
country, perhaps in ways that have not been considered previously. In 
all the decisions we make, we must follow the best and most current 
science and engage in stakeholders who can provide the necessary 
information to inform the best course of action.

    Question 42.

    What is your timetable for finalizing two-year sodium voluntary 
targets?

    Answer 42. I cannot speak to a timeline as I am not currently part 
of FDA. But I commit that, if confirmed, I will work expeditiously on 
the next steps.

    Question 43.

    What resources and activities do you plan to commit to educating 
consumers about menu labeling and the updated Nutrition Facts label?

    Answer 43. I cannot speak to a specific level of funding but I will 
commit, if confirmed, to prioritizing FDA's efforts around menu 
labeling and continuing to keep the Nutrition Facts Label requirements 
up to date.
                                Opioids
    As an oncologist, you have mentioned the importance of holistic 
treatment while working on the front lines in pain management for 
patients who need it, while also balancing concerns of addiction. 
Substance use disorder (SUD) remains a deadly problem, and efforts are 
necessary across all areas of prevention, treatment and recovery. 
Research shows that medication assisted treatment (MAT) can be an 
effective part of treatment for opioid use disorder (OUD) and help 
sustain recovery. However, despite rising rates of opioid addiction in 
our country, millions of people still lack access to quality, evidence-
based treatment for OUD, even with existing FDA-approved medications 
for OUD treatment, including buprenorphine, methadone, and naltrexone. 
Further, for people with other forms of SUD, options for MAT are even 
more elusive.

    Question 44.

    If confirmed, as Commissioner, how will you facilitate treatment 
options and the development of therapies to address SUD, including OUD, 
as a chronic disease?

    Question 45.

    How will you support development of options for MAT and address the 
challenges that remain in patient access and provider utilization of 
MAT as a key FDA priority in its response to the SUD epidemic?

    Question 46.

    This week, Public Citizen sent a letter to FDA requesting ``a 
formal compliance investigation into an apparent clinical investigation 
conducted by California-based BioCorRx, Inc., and the Louisiana 
Department of Public Safety and Corrections that involved testing the 
effectiveness of sustained-release naltrexone implants--a formulation 
of naltrexone never approved by the FDA--for management of opioid and 
alcohol use disorders in prison inmates. The agency also should 
investigate whether BioCorRx has conducted or is currently conducting 
any similar clinical investigations.'' If confirmed, do you commit to 
immediately initiate an FDA investigation into this matter, including 
whether BioCorRx and the Louisiana Department of Public Safety and 
Corrections violated any applicable laws and regulations related to the 
protection of human subjects?

    Answers to 44-46. The opioid crisis is one of the largest and most 
complex public health tragedies that our Nation has faced. This is a 
top priority for the administration, the Department and Congress. It 
will be a top priority for me if I am fortunate enough to be confirmed. 
FDA was given important authorities by Congress in the SUPPORT act to 
assist in the prevention of misuse of opioids. Actions by FDA such as 
changes to packaging, labeling, the REMS program and efforts to stop 
the illegal importation of opioids are all important steps forward. I 
promise, if confirmed as FDA Commissioner, to make combating the opioid 
crisis a top priority of the agency and I look forward to continuing 
and enhancing those efforts, if I am fortunate enough to be confirmed. 
I am supportive of efforts to advance the development and use of safe 
and effective medication-assisted therapy or MAT. If fortunate enough 
to be confirmed, I will look into the specific issue that you refer to 
in question 46.
                           Pediatric Devices
    From 2008 to 2017, an average of only 24 percent of the total 
premarket approval (PMA) and humanitarian device exemption (HDE) 
application approvals in each fiscal year had an indication for a 
pediatric population or subpopulation, and the majority of those 
pediatric indications were designated for children 12 years and older. 
The disparity in medical device innovation for adults and for children 
has led to unmet needs and difficulty in finding appropriate treatments 
for pediatric patients. Devices for adult indications may not be 
suitable for pediatric use because children are, among other things, 
often smaller and more active than adults. To address the lack of FDA-
approved pediatric devices, FDA has pursued efforts such as funding 
consortia to provide seed funding and technical advice to sponsors of 
pediatric medical devices.

    Question 47.

    If confirmed, as Commissioner, how will you lead new and existing 
efforts to support the development and availability of safe and 
effective pediatric devices?

    Answer 47. I agree that there is a strong need to increase access 
to medical devices in the pediatric population, and recognize the 
unique needs of this population. If confirmed I commit to working with 
staff at FDA, stakeholders, and Congress to understand any challenges 
or barriers to bringing pediatric devices to market, and to advance 
policies and procedures that will spur progress in this space.
                               Shortages
    The number of new drug shortages has increased after declining from 
a peak of 251 in 2011. There were 39 drug shortages in 2017 and 54 
drugs shortages in 2018. Recent drug shortages include critical drugs 
such as hydromorphone, vincristine sulfate, immune globulin, and 
EpiPens. I applaud last month's release of FDA's Drug Shortage Task 
Force report, ``Drug Shortages: Root Causes and Potential Solutions,'' 
which attempts to identify many of the root cause of shortages and 
offer policy solutions.

    Question 48.

    FDA's Task Force on Drug Shortages supports the concept of a rating 
system to incentivize manufacturer investment in quality management 
maturity for their facilities. What authorities and resources does FDA 
need to implement this type of rating system?

    Answer 48. I think the rating system you mention is an idea worthy 
of consideration. Before I can opine on the specific authorities and 
resources FDA would need, I would have to consult with the staff at FDA 
but I will commit to looking into this idea if confirmed.

    Question 49.

    On October 30, Dr. Janet Woodcock, Director of the Center for Drug 
Evaluation and Research (CDER) testified before the House Committee on 
Energy and Commerce's Subcommittee on Health that advanced 
manufacturing technologies can ``improve drug quality, address 
shortages of medicines, and speed time-to-market'' of medical products. 
If confirmed, how will you work with drug manufacturers to foster the 
adoption of advanced manufacturing technologies?

    Answer 49. I agree with Dr. Woodcock that advanced manufacturing 
could go a long way toward addressing drug quality and drug shortages. 
FDA should work together with regulated industry to speed up the 
adoption of this technology and there are a few specific actions I 
think they can take. For example, they can work closely with industry 
to tailor regulatory requirements so they are not over burdensome.

           FDA's Authority and Science-Based Decision-Making
    FDA's gold standard and commitment to science over ideology are 
essential to continued public trust in FDA approved products.

    Question 50.

    If confirmed, do you commit to opposing efforts, legislative or 
otherwise, to limit FDA's authority to make decisions about the 
approval of safe and effective medication based on the best available 
evidence?

    Question 51.

    Do you believe FDA's ability to make scientific judgments about 
drug products and devices should be the same across all medical 
products?

    Answers to 50-51. Senator, I agree wholeheartedly that FDA 
represents the gold standard for protecting the public health and that 
these decisions must be based upon the best available evidence. It is 
trusted by all Americans and admired around the world for its mission 
of ensuring the safety, security, effectiveness of medical products and 
ensuring the safety of our Nation's food supply. The professionals that 
FDA have remarkable expertise and a deep commitment to the agency's 
mission. I believe strongly in the importance of science, data and the 
law that have guided and continue to guide FDA in their decision making 
across all medical and food products.
                          New Drug Development
    Access to safe, effective contraception is essential to public 
health and women's health. Continued research is necessary to develop 
improved options for all people who choose to use hormonal drug 
products for both pregnancy prevention and non-contraceptive purposes. 
Clinical trials on new and emerging hormonal contraceptives should 
reflect the unique health needs of the wide range of individuals that 
use these products.

    On July 12, FDA released draft guidance for industry that included 
recommendations for manufacturers to expand clinical trials for 
hormonal drug products to include people over the age of 35 or with a 
Body Mass Index over 30. Inclusive research will ensure new hormonal 
drug products better meet the needs of all patients who can become 
pregnant.

    Question 52.

    Do you agree it is critical to continue research on hormonal 
contraception to develop new and improved options and ensure safe, 
effective methods are available to meet individual needs and 
preferences?

    Question 53.

    If confirmed, how will you ensure that clinical research during the 
course of developing new hormonal drug products accurately reflects the 
needs of the wide range of people who can become pregnant?

    Answers to 52-53. Thank you for these questions. As you mention, 
the FDA recently issued a new draft guidance, ``Establishing 
Effectiveness and Safety for Hormonal Drug Products Intended to Prevent 
Pregnancy.'' I believe it is important for the FDA to provide clarity 
to industry to advance the introduction of safe and efficacious drugs 
for consumers, including hormonal contraception.
          Banning Electric Shock for People with Disabilities
    The Judge Rotenberg Educational Center (JRC) in Massachusetts is a 
specialized day and residential school for people with disabilities 
ages five though adulthood. The JRC, despite its mission of promoting 
``very effective education and treatment,'' uses electric shock to 
punish students. The practice has no evidence as therapy and has been 
found to be inhumane and harmful. In 2016, the FDA proposed to ban the 
device the JRC uses to shock people with disabilities. Unfortunately, 
the rule has not been finalized despite widespread public support to 
ban the practice.

    Question 54.

    If confirmed, will you commit to finalizing this critical rule and 
banning the electric shock of people with disabilities?

    Answer 54. I am committed to working with your office on this issue 
and working to protect American patients.

    I look forward to working with FDA's professional staff to study 
this issue and understand the most efficient path forward that protects 
patients.

    Question 55.

    If so, please provide your proposed timeline for finalizing the 
rule, and if you believe the rule is on track with the FDA's fall 
agenda to be finalized by the end of 2019.

    Answer 55. I am committed to working with your office on this 
issue. I cannot speak to a proposed timeline, as I am not part of the 
administration yet.
                            senator collins

    Question 1.

    An estimated 5.8 million Americans--including 29,000 Mainers--are 
currently living with Alzheimer's. Alzheimer's also costs the U.S. $290 
billion a year, including $195 billion in costs to Medicare and 
Medicaid, making it our Nation's most expensive disease. If we continue 
along this trajectory, Alzheimer's is projected to affect nearly 14 
million Americans and surpass $1 trillion in costs by 2050. Yet there 
is still no therapy. The FDA just announced a modernization of its 
Center for Drug Evaluation in order to ensure more timely access to the 
latest science and the most efficient review pathway for cutting edge 
treatments, which could provide a glimmer of hope for potential 
Alzheimer's therapies that are in the works. If confirmed, what ideas 
will you bring to advance treatments for the millions of families 
facing Alzheimer's disease? Do you believe it is important for the FDA 
to collaborate with the NIH, the CDC or other partners in contributing 
to the broader research and development effort on Alzheimer's disease?

    Answer 1. Alzheimer's Disease is a devastating condition with wide-
ranging effects on individuals and families across the Nation. I 
believe FDA must continue to look for ways to support drug development 
and streamline the approval process for all products, and especially 
those with the potential to address critical unmet needs such as 
Alzheimer's Disease. For example, FDA should continue to work to 
modernize the clinical trial process to improve efficiency and reduce 
the costs and uncertainty present in drug development. I also think it 
is important that FDA work with other government agencies such as NIH 
and CDC to ensure that we employ a unified approach. NIH plays a 
critical role in funding the basic research necessary to understand the 
underlying mechanisms of disease and is an important partner in 
translating that knowledge into treatments for patients.

    Question 2.

    The average consumer uses 10 personal care products every day, yet 
the laws governing the cosmetics and personal care products industry 
haven't been updated since 1938. There is growing support in Congress 
for modernizing cosmetic safety laws and providing greater transparency 
for consumers and regulatory certainty for manufacturers. Can you 
commit to working with us and other Senators to modernize FDA's 
authority to regulate cosmetic products to better serve public health?

    Answer 2. I commit that, if confirmed, I will work with staff at 
FDA, industry, consumers, and members of the scientific community to 
understand what needs to be done to take a proactive stance to 
monitoring the safety of the cosmetics market for consumers. I will 
also work to better understand the risks to public health presented by 
cosmetics products. It is important that consumers be able to trust 
that the cosmetics they buy are not contaminated by harmful substances 
or manufactured under substandard conditions.

    Question 3.

    Last year, former Commissioner Gottlieb stated, ``we're committed 
to exploring ways to help FDA scientists and product developers reduce 
reliance [on animal testing] and that ``we have already taken 
significant steps to reaffirm and strengthen our commitment to 
replacing, reducing, and/or refining animal studies and support the 
development and use of alternative methods.'' Will the FDA commit to 
working with animal welfare experts and the personal care products 
industry to further phaseout animal testing broadly, with specific 
attention to animal experiments for cosmetics? What is FDA currently 
doing to advance recognition and acceptance of alternatives to animal 
test methods?

    Answer 3. I agree that we should minimize the use of animals in 
research especially in the area of cosmetics. If confirmed, I will 
support efforts to develop alternative testing methods that do not 
require animals. I also recognize that there are a number of 
stakeholders, including industry, that need to work together on this 
issue and I will ensure that FDA works collaboratively to make progress 
in lessening the burden of research on animals.

    Question 4.

    Electronic Labeling of Prescribing Information. During the 
appropriations process, I often raise FDA's proposed rule on Electronic 
Prescribing Information and its implication for rural pharmacists. This 
would have an adverse effect on patient safety, particularly for 
Americans who live in areas with limited internet access, and have 
serious implications for patients and pharmacists during a power outage 
or in the wake of a natural disaster. Given that 96 percent of the 
public comments were in opposition to the proposal, are you willing to 
evaluate carefully the concerns and consider withdrawing this ill-
conceived proposal?

    Answer 4. I recognize that FDA regulation should not unnecessarily 
burden rural pharmacists, who play a front-line role in the health of 
their communities. If confirmed, I will ensure that their interests are 
taken into account as well as other stakeholders in deciding the path 
forward for rules related to electronic prescribing information.

    Question 5.

    Fishless Fish. I want to ask you about a truth in labeling issue 
that hits home for the seafood industry in my state. Recently, a 
variety of ``fishless fish'' products made from algae, plants, and 
legumes have appeared in the U.S. marketplace. Producers of these foods 
market them to consumers as salmon, lobster, shrimp, or tuna, yet none 
of these products contain any actual fish or seafood. These products 
appear to violate FDA regulations and labeling requirements. Under 
Sections 343(b) and (c) of the Federal Food, Drug, and Cosmetic Act, a 
product offered for sale under the name of another food or as an 
imitation of another food is considered misbranded when the label does 
not expressly state that the product is ``imitation''. Consumers should 
be able to enjoy new and innovative food products, but Congress has 
provided FDA with the authority and responsibility to ensure those 
products are not mislabeled or misleading. If confirmed, will you 
ensure that the FDA uses its authority to remove these inaccurate 
labels from the marketplace and enforce its existing Seafood List with 
respect to these products?

    Answer 5. I agree that consumers should be able to trust that the 
food they buy is accurately labeled. And manufacturers and farmers 
should have a level playing field where they are not facing unfair 
competition. If confirmed as Commissioner, I will support FDA's use of 
its authority provided by Congress to ensure products labeled as 
seafood are, in fact, seafood.
                             senator scott
    Question 1.

    Given FDA's numerous responsibilities and authorities, will you 
commit to engaging with my office and with relevant stakeholders to 
explore and, ideally, to address each of the following issues and 
opportunities for the agency?

    Answer 1. I commit to you that, if confirmed, I will work with your 
office and other interested stakeholders on each of these important 
issues. I offer the following initial thoughts.

        a. PDUFA VI and the 21st Century Cures Act outlined a number of 
        new initiatives aimed at facilitating efficient patient access 
        to life-changing new therapeutic options. I urge you to build 
        upon your predecessor's work in continuing to push forward with 
        these initiatives, including patient-focused drug development, 
        real-world evidence, and innovative clinical trial designs.

    Answer a. Both PDUFA VI, enacted as part of the Food and Drug 
Reauthorization Act in 2017, and the 21st Century Cures Act provided 
FDA with significant new authorities to improve the drug development 
and approval process. I believe we can together build on the work 
underway at FDA which can be tracked at the following two sites:

    https://www.fda.gov/industry/prescription-drug-user-fee-amendments/
completed-pdufa-vi-deliverables.

    https://www.fda.gov/regulatory-information/21st-century-cures-act/
21st-century-cures-act-deliverables.

        b. Innovative gene and cell-based therapies have the potential 
        to transform the treatment landscape. In the long run, they 
        will improve quality of life for tens of millions of Americans 
        and dramatically drive down healthy system costs. However, 
        these products also present unique regulatory challenges and 
        face manufacturing and logistical hurdles. I hope to work with 
        you on ensuring that FDA has the tools and flexibilities needed 
        to tackle the agency's recruitment and retention needs on this 
        front, particularly given the hiring competition that the 
        agency has likely confronted from some of the same startup 
        biotechs that it regulates in this sphere. I also hope to work 
        with your agency and with impacted stakeholders on ensuring 
        that these novel treatments can overcome manufacturing and 
        logistical barriers and reach patients.

    Answer b. I agree that gene and cell-based therapies have great 
potential as new and innovative ways to treat disease. I also recognize 
that recruiting a workforce with experience in these rapidly evolving 
fields can be challenging, both because of the competition for the 
necessary skills and experience and because of bureaucratic challenges 
in the hiring process. As the Chief Medical Executive of University of 
Texas MD Anderson Cancer Center, I am familiar with these challenges 
and recognize that recruitment and retention must be a top priority. I 
commit that, if confirmed, I will focus on building and maintaining a 
modern workforce able to address the many issues facing innovators, 
such as those related to manufacturing and logistics.

        c. On the post-market side, gene therapies and over cutting-
        edge treatments present opportunities for innovative payment 
        arrangements, such as value-based arrangements (VBAs), whereby 
        manufacturers pay over time based on patient outcomes. FDA's 
        Communication guidelines have, however, created some 
        uncertainty on this front. While FDA updated its guidelines in 
        2018, additional clarity would be helpful as to what 
        performance metrics and populations can be part of a VBA, 
        particularly if those metrics or patient subpopulations are not 
        specifically included in a drug's label. Because conversations 
        between developers and payors around these arrangements often 
        need to begin before labeling information and/or approval is 
        available, the ability for VBAs to help facilitate adoption of 
        these therapies may be limited. I encourage the agency to take 
        whatever steps necessary to address remaining uncertainties and 
        to further facilitate the communications needed for efficient 
        and timely VBA design, development, and implementation among 
        interested stakeholders.

    Answer c. I recognize the benefits of providing clear guidance to 
manufacturers and other firms on their communications with different 
audiences. The information appropriate for sophisticated payors is 
different from what is appropriate for patients. I commit that, if 
confirmed, I will support the Agency in providing further clarity on 
this issue.

        d. The goals of FDA's unapproved product enforcement activity 
        are to remove unapproved prescription drugs and devices from 
        the marketplace and to ensure that patients have access to 
        medically necessary products that are safe and effective. In 
        order for the agency's enforcement activity to function well, 
        FDA must continue to encourage manufacturers of unapproved 
        products to obtain approval to be legally marketed. Once such 
        approval is obtained, the agency must then prevent the sale of 
        these products by manufacturers who have not received approval. 
        Removing these unapproved products from the market ensures that 
        patients have access to safe and effective drugs, while also 
        encouraging the R&D necessary to bring previously unapproved 
        drugs up to FDA's standards. If the agency does not take steps 
        to prevent the manufacture, marketing, and distribution of 
        unapproved drugs and devices, patients remain at risk of 
        adverse events. I would encourage FDA to consider taking 
        additional steps to protect patients and uphold the integrity 
        of the marketplace by limiting the availability of unapproved 
        products.

    Answer d. As a physician, I prescribe drugs to my patients relying 
on FDA to ensure their safety and effectiveness. Unapproved drugs that 
are still on the market undermine this trust and pose a risk to 
patients. I commit that, if confirmed, I will support the Agency's 
Unapproved Drugs Program which balances the removal of unapproved drugs 
from the market with the need to ensure patient access to medically 
necessary products.

        e. Under FDA's HCT/P framework, companies must self-designate 
        the products that they believe qualify as 361 HCT/Ps. To date, 
        guidance from FDA has left significant room for interpretation, 
        creating regulatory uncertainty and disincentivizing innovation 
        and investment in this area. In the interest of helping to 
        bring important and affordable treatments to patients, there 
        may be a need for additional certainty as to the appropriate 
        regulatory treatment of these products.

    Answer e. Advances in regenerative medicine have real potential to 
help patients. I recognize that industry will only invest in this area 
if FDA establishes clear rules to help foster innovation. I commit 
that, if confirmed, I will work to ensure that FDA provides the needed 
regulatory clarity so industry can bring innovative new human cells, 
tissues, and cellular and tissue-based products to market.

        f. The potential for 21st century innovations such as AI 
        applications to improve diagnostic accuracy and quality may 
        call for revisiting existing regulatory pathways in order to 
        ensure predictability and efficiency.

    Answer f. As with any technology, advances in artificial 
intelligence bring new challenges along with new opportunities. 
Artificial intelligence has the potential to improve our ability to 
detect disease and improve the outcomes for patients. FDA must strike 
the appropriate regulatory balance to allow innovation while ensuring 
that diagnostic tools that use artificial intelligence are sufficiently 
reliable.

        g. On April 5, 2018, the Surgeon General released an advisory 
        statement, emphasizing the importance of expanding access to 
        naloxone. In December 2018, an FDA joint advisory panel 
        recommended the co-prescribing of naloxone with opioids. 
        Shortly thereafter, HHS released naloxone co-prescription 
        guidelines, calling for ``co-prescribing naloxone when a 
        patient is considered to be at high risk of an overdose,'' as 
        ``an essential element of our national effort to reduce 
        overdose deaths'' that ``should be practiced widely.'' In 
        April, CMS released the final 2020 Medicare Advantage and Part 
        D Advance Notice Part II and Draft Call Letter, encouraging 
        insurance plans to implement co-prescribing for beneficiaries 
        at an increased risk for an opioid overdose. In short, the 
        Surgeon General, HHS, CDC, CMS, SAMSHA, the AMA, AAFP, ASAM, a 
        growing number of states, and FDA's advisory committee all 
        support increasing access to naloxone through co-prescription. 
        I hope that you will commit to working with my office and 
        Congress to ensure that FDA increases access to naloxone by 
        considering the addition of labeling language recommending co-
        prescription of naloxone for those at increased risk of opioid 
        overdose.

    Answer g. I commit that, if confirmed, I will review FDA's efforts 
related to the opioid epidemic including the appropriate labeling of 
naloxone. Opioid misuse and abuse is an urgent public health crisis and 
would be one of my very top priorities as Commissioner of Food and 
Drugs. I understand the damage that opioid addiction causes our 
society. I also appreciate the current role opioids play in alleviating 
human suffering. I look forward to the potential opportunity to work 
within HHS on the comprehensive plan to combat this epidemic and 
appreciate your raising this issue.

        h. Earlier this year, I read an article about a woman from 
        Mississippi who has seen promising results to treat her sickle 
        cell disease using a revolutionary treatment from a small 
        biotechnology company. We now know that these treatments can 
        work, but there are some estimates that this class of products 
        might not be on the market for up to a decade, due to FDA's 
        data requirements. Some experts have advised that FDA use 
        biomarkers as the benchmark to approve these types of 
        therapies, assuming that they can be aligned with clinically 
        significant outcomes. I would urge your agency to do everything 
        possible to speed these treatments to market, assuming that 
        they continue to prove safe and effective for patients.

    Answer h. I commit that, if confirmed, I will look for 
opportunities to further speed the development process and review of 
innovative medical products, while upholding FDA's gold standard for 
safety and efficacy. For example, I will review FDA's expedited 
programs, including accelerated approval which allows FDA to approve 
drugs for serious conditions that filled an unmet medical need to be 
approved based on a surrogate endpoint.

        i. As an advocate for the increased personalization of 
        medicine, as evidenced, most recently, by my decision to 
        partner with Senator Sinema to launch a bipartisan Personalized 
        Medicine Caucus, I am deeply interested in the role that 
        diagnostic innovation might play in helping us to detect 
        diseases and other medical conditions earlier, as well as to 
        better identify and thus target and combat their root causes. 
        As some of my colleagues have begun working to modernize the 
        regulatory framework for diagnostic tests of all types, my 
        understanding is that FDA has been a constructive and proactive 
        partner. I look forward to engaging with my colleagues and with 
        the agency in this area.

    Answer i. As a physician who relies on accurate diagnostic tests to 
treat my patients, I thank you for advocating for personalized 
medicine. I agree that innovation in this area will have real benefits 
for the public health of the Nation. I commit that, if confirmed, I 
will ensure FDA continues to partner with you, other members of the 
Personalized Medicine Caucus, and interested stakeholders to adapt 
FDA's framework to modernize the regulation of diagnostic tests.
                            senator isakson
    Question 1.

    Dr. Hahn, FDA first committed to publish separate regulations on 
medical gases in 1978. Congress has passed two statutory mandates that 
require FDA to complete the rulemaking process for medical gases by 
July 2017 and yet small business medical gas manufacturers are still 
waiting.

    If confirmed as Commissioner of FDA, will you ensure that FDA 
complies with its statutory obligations and promulgates its overdue 
separate regulations for medical gases in 2020?

    Answer 1. I am committed to working with your office on this issue 
and working to protect American patients. I look forward to working 
with FDA's professional staff to study this issue and understand the 
most efficient path forward that protects patients.

    Question 2.

    Georgia is one of the top olive-producing states in the country. I 
understand that FDA is or will soon be reviewing a standard of identity 
(SOI) petition that, if approved, would establish quality and purity 
standards for American olive oil. Such standards would provide 
consumers with accurate and reliable information on the products they 
purchase as well as ensure the authenticity of foreign imports. What is 
the status of FDA's review of this petition? Can you offer a timeline 
for when this review will conclude?

    Answer 2. Although I cannot provide a specific timeline for 
reviewing the standard of identity for olive oil as I am not currently 
a part of FDA, I can commit that I will support the Agency in its next 
steps. I think it is important that consumers have access to accurate 
information about the food that they eat and that industry competes on 
a level playing field.
                             senator braun
    Last March, the U.S. Food and Drug Administration (FDA) ordered 
that Aid Access, an international organization based in Austria, cease 
distributing abortion pill Mifeprex (Mifepristone), on demand through 
the mail. Despite regulations by the FDA limiting distribution of these 
pills through a Risk Evaluation and Mitigation Strategy (REMS) 
precluding the importation of these drugs, Aid Access has reportedly 
continued to prescribe these drugs to women in the United States and 
directing them to have these drugs shipped from a company in India. Aid 
Access has ignored the FDA's order and instead countersued them out of 
Idaho to strike down the existing REMS.

    Question 1.

    What enforcement steps could you as FDA commissioner take to 
address these violations of the law? Would you consider issuing an 
import alert--so that international mail facilities could be inspected 
and put on alert? Would you consider partnering with the Department of 
Justice to consider enforcement options such as injunctions or seizure 
of the illegal drugs?

    Answer 1. If confirmed, I will work with Agency staff to determine 
what enforcement steps the FDA has at its disposal. Science, data, and 
the law will guide my decision making at the FDA.

    In 2016, the Obama administration watered down the REMS for 
abortion pills, and since then, abortion groups and a former FDA chief 
have been pushing to make abortion pills available for do-it-yourself 
abortions by mail and without doctor supervision currently still 
required. Given the documented adverse effects of these drugs, allowing 
their availability without doctor supervision will be dangerous and may 
have detrimental, even fatal, consequences to women. Moreover, the 
current reporting may not entirely reflect issues with these drugs. 
Though the drug company that makes Mifeprex DANCO, is mandated to 
report complications to FDA and prescribers must report deaths, it is 
still optional for prescribers to report any other adverse effects to 
DANCO.

    Question 2.

    Would you consider strengthening the current REMS for abortion 
pills to improve protections for patients along the lines of the pre-
2016 REMS--such as by limiting the gestational timeframe back to 49 
days and restoring the requirement to require physician supervision 
(without allowing nonqualified health providers)? How will you better 
ensure complete reporting of adverse events? Would you consider 
requiring adverse events to be reported by prescribers, not only by the 
abortion pill manufacturers?

    Answer 2. As a provider, I am committed to my patient's safety. If 
confirmed, patient safety will be my top priority and I will always be 
guided by science, data, and the law.

    AquaBounty Technologies, which produces AquAdvantage Salmon, has a 
fish farming facility located in my home State of Indiana. Using 
biotechnology and land-based recirculating systems, AquaBounty's salmon 
grows year-round, reaching market weight in half the time of other 
farm-raised Atlantic salmon and thereby requiring less feed and water 
while minimizing waste and stress on our oceans.

    Question 3.

    On what date did AquaBounty file an Investigational New Drug 
Application with FDA?

    Question 4.

    On what date did FDA approve AquAdvantage salmon for human 
consumption?

    Question 5.

    Did FDA find that AquAdvantage salmon was safe to eat?

    Question 6.

    On what date did FDA approve the grow-out of the salmon in a land-
based facility in Albany, Indiana?

    Question 7.

    If you are confirmed as our next FDA Commissioner, would you 
overturn or undermine FDA's previous science-based approvals and 
determinations for AquaBounty's salmon?

    Answers to 3-7. Thank you for your questions on AquaBounty. 
According to public information, AquaBounty Technologies, submitted a 
Supplemental New Animal Drug Application on December 22, 2017, and the 
FDA approved the supplemental NADA on April 26, 2018. If confirmed, 
science, data, and the law would guide all of my decisions.

    Two years ago, Congress passed the FDA Reauthorization Act of 2017 
(FDARA) to adopt uniform standards around not-for-cause inspections and 
to improve the FDA process for inspecting medical device facilities in 
general. The provisions were intended to address inefficiencies and 
inconsistencies in the process, which include the open-ended nature of 
facility inspections, inconsistent communications, a lack of 
punctuality in FDA responses, and differing behavior in U.S. and 
foreign inspections. The legislation was passed in response to 
stakeholder calls for a more transparent, efficient and consistent 
process. I've heard that FDA has had dialog with industry while working 
to implement the provisions, and that some progress has been made but 
more work remains.

    Question 8.

    Please provide an update on FDA's plans to develop and implement 
facility inspection regulations and guidance that take into account 
stakeholder input and congressional intent.

    Answer 8. I do not currently have information on FDA's plan, but if 
confirmed, I commit to providing you and office an update on FDA's 
plans to develop and implement facility inspection regulations and 
guidance that take into account stakeholder input and congressional 
intent.

    Additionally, FDA has been very aggressive in issuing letters with 
safety concerns about particular devices or particular kinds of 
devices--even before they've done a full evaluation of available data 
or talked to the manufacturer. I'm not opposed to FDA communicating 
with patients, doctors, or anyone else regarding safety issues--but 
manufacturers should be included in the process for issuing these 
letters. And there should be a process for correcting the record when 
data show, after the fact, that there isn't an issue after-all.

    Question 9.

    We have heard concerns regarding FDA's implementation of the 
emerging signals program. How will you ensure that manufacturers are 
duly consulted both in the determination of a signal and in 
communicating the signal to the public?

    Question 10.

    Would you agree the agency's emerging signals program must have a 
process for correcting the record in instances where it is later 
determined that the signal is faulty?

    Answers to 9-10. I appreciate you raising your concerns with FDA's 
implementation of the emerging signals program. If confirmed, I will 
work with Agency staff to consider ways to ensure the program is 
working for patients, providers, and manufacturers.

    The FDA issued its final guidance document regarding 
radiopharmaceutical compounding in September 2018. This document 
provides important clarity about definitions of illegal compounding and 
counterfeiting of diagnostic radiopharmaceuticals and FDA staff have 
done a commendable job of raising awareness among stakeholders in the 
nuclear pharmacy community.

    Nonetheless, there is continued evidence that a small, but 
potentially significant subset of nuclear pharmacies continue to 
exploit ambiguities in Federal and state laws and regulations to 
operate defacto drug manufacturing facilities, without complying with 
FDA regulatory protections, which raise serious concerns of illegal 
compounding and counterfeiting.

    For instance, at least one such operation appears to be 
manufacturing thousands of lyophyllized (freeze-dried) kits for the 
preparation of diagnostic radiopharmaceuticals, which constitutes 
compounding copies of FDA-approved and commercially available drugs, in 
anticipation of prescriptions or orders and selling and distributing 
these illegal copycat drugs throughout the United States. These actions 
seem to contradict the final FDA Guidance for Industry Compounding and 
Repackaging of Radiopharmaceuticals by State Licensed Nuclear 
Pharmacies (503A) and by Outsourcing Facilities (503B), both of which 
expressly prohibit compounding copies of FDA-approved and commercially 
available drugs.

    Question 11.

    How is the FDA addressing illegal compounding/counterfeiting of 
diagnostic radiopharmaceuticals at the Federal level, since the release 
of the 2018 guidance document on Compounding and Radiopharmaceuticals?

    Answer 11. Since I am not at the agency, I am not familiar with how 
FDA is addressing illegal compounding/counterfeiting of diagnostic 
radiopharmaceuticals. If confirmed, I will work with FDA staff on this 
important issue.

    Job creators in the food industry need to be able to innovate to 
grow, yet outdated Federal food ``standards of identity'' often stand 
in the way of companies utilizing new technologies. For instance, 
petitions to update the yogurt and cheese standards have been pending 
for 20 years. FDA's Nutrition Innovation Strategy included standards 
modernization as one of its key activities and recently held a public 
meeting on Horizontal Approaches to Food Standards of Identity 
Modernization. However it is unclear what specific actions and under 
what timetable FDA will address changes to its food standards.

    Question 12.

    As Commissioner what actions will you take to be more proactive and 
responsive to modernize dairy standards?

    Answer 12. I am in favor of clear, transparent and understandable 
food labeling for the American people. The American people need this so 
that they can make the appropriate decisions for their health for their 
nutrition. If confirmed, I will ensure that FDA follows the scientific 
evidence to guide actions in this area.

    FDA regulations put a high value on controlled clinical trials to 
provide sufficient evidence of safety and effectiveness to support 
market availability of new drugs. The nature of the controlled trial 
depends on the risks. The value of placebo controlled trials is more 
than questionable in patients with life threatening diseases. Placebo 
controlled trials are not often attempted in therapeutic cancer 
studies. And many cancer drugs are approved based on comparison to 
historical standard of care in situations where no other drugs are 
approved for the specific use or indication.

    Question 13.

    Given this, as Commissioner of FDA, would you insist on placebo 
controlled trials as a condition for FDA approval (conditional or full 
approval) for treatments intended to treat fatal diseases like DMD and 
ALS?

    Answer 13. FDA's role is to ensure the safety and efficacy of 
drugs, and that standard cannot be diminished. However, I believe that 
big data can provide us new opportunities to design clinical trials 
that may not need a control arm when it is not in the best interest of 
patients and when the data collected from these trials allows for the 
best decision making regarding safety and efficacy.

    In DMD and ALS, over half of the treating physicians are easily 
reachable, so news is able to spread quickly about a particular 
treatment and that treatment can be pulled from the market, or its 
effects studied more closely.

    Question 14.

    In your view, with the risks minimized by virtue of a small circle 
of treating physicians and vast advocacy networks, are historical 
controlled trials, post approval studies, and increased FDA post-market 
oversight appropriate to help facilitate conditional or full approval 
of certain treatments intended to treat fatal diseases, like DMD and 
ALS, with no meaningful treatment options available for patients?

    Answer 14. FDA's role is to ensure the safety and efficacy of 
drugs, and that standard cannot be diminished. However, within that 
construct I hope to work with Agency staff to advance the drug approval 
process to make sure patients can have access to life-saving drugs, 
particularly in disease states where there is substantial unmet 
clinical need.
                                 ______
                                 
    [Whereupon, at 12:14 p.m., the hearing was adjourned.]

                                  [all]