[Senate Hearing 115-341]
[From the U.S. Government Publishing Office]




                                                        S. Hrg. 115-341
 
 NOMINATION OF SCOTT GOTTLIEB, 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 FIFTEENTH CONGRESS

                             FIRST SESSION

                                   ON

     EXAMINING THE NOMINATION OF SCOTT GOTTLIEB, M.D., TO SERVE AS 
                     COMMISSIONER OF FOOD AND DRUGS

                               __________

                             APRIL 5, 2017

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and Pensions
 
 
 
 
 
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                     U.S. GOVERNMENT PUBLISHING OFFICE
                   
 25-027 PDF                  WASHINGTON : 2018            
      


          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                     AL FRANKEN, Minnesota
SUSAN M. COLLINS, Maine                 MICHAEL F. BENNET, Colorado
BILL CASSIDY, M.D., Louisiana           SHELDON WHITEHOUSE, Rhode Island
TODD YOUNG, Indiana                     TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah                    CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas                     ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska                  TIM KAINE, Virginia
TIM SCOTT, South Carolina               MAGGIE HASSAN, New Hampshire

                                     
                       
                                       

               David P. Cleary, Republican Staff Director

         Lindsey Ward Seidman, Republican Deputy Staff Director

                  Evan Schatz, Minority Staff Director

              John Righter, Minority Deputy Staff Director

                                  (ii)

  

                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                        WEDNESDAY, APRIL 5, 2017

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Murray, Hon. Patty, a U.S. Senator from the State of Washington, 
  opening statement..............................................     3
Murphy, Hon. Christopher, a U.S. Senator from the State of 
  Connecticut....................................................     6
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming..    15
Sanders, Hon. Bernard, a U.S. Senator from the State of Vermont..    17
Young, Hon. Todd, a U.S. Senator from the State of Indiana.......    19
Kaine, Hon. Tim, a U.S. Senator from the State of Virginia.......    20
Scott, Hon. Tim, a U.S. Senator from the State of South Carolina.    22
Warren, Hon. Elizabeth, a U.S. Senator from the State of 
  Massachusetts..................................................    24
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina.......................................................    26
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of 
  Pennsylvania...................................................    28
Paul, Hon. Rand, a U.S. Senator from the State of Kentucky.......    30
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah......    33
Bennet, Hon. Michael F., a U.S. Senator from the State of 
  Colorado.......................................................    35
Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana...    36
Franken, Hon. Al, a U.S. Senator from the State of Minnesota.....    38
Roberts, Hon. Pat, a U.S. Senator from the State of Kansas.......    40
Baldwin, Hon. Tammy, a U.S. Senator from the State of Wisconsin..    41
Murkowski, Hon. Lisa, a U.S. Senator from the State of Alaska....    43
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode 
  Island.........................................................    45
Hassan, Hon. Margaret Wood, a U.S. Senator from the State of New 
  Hampshire......................................................    47

                                Witness

Gottlieb, Scott, M.D., Nominee to Serve as Commissioner of Food 
  and Drugs,.....................................................     7
    Prepared statement...........................................    10

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
    Letters of Support...........................................    54
    Response by Scott Gottlieb to questions of:
        Senator Alexander........................................    59
        Senator Murray...........................................    60
        Senator Enzi.............................................    83
        Senator Sanders..........................................    84
        Senator Burr.............................................    86
        Senator Casey............................................    87
        Senator Isakson..........................................    90
        Senator Franken..........................................    92
        Senator Paul.............................................    94
        Senator Bennet...........................................    96

                                 (III)
        Senator Collins..........................................    97
        Senator Whitehouse.......................................   100
        Senator Cassidy..........................................   105
        Senator Baldwin..........................................   106
        Senator Hatch............................................   107
        Senator Murkowski........................................   109
        Senator Murphy...........................................   110
        Senator Roberts..........................................   113
        Senator Warren...........................................   114
        Senator Kaine............................................   125
        Senator Hassan...........................................   127



  


 NOMINATION OF SCOTT GOTTLIEB, M.D., TO SERVE AS COMMISSIONER OF FOOD 
                               AND DRUGS

                              ----------                              


                        WEDNESDAY, APRIL 5, 2017

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:02 a.m. in 
room SD-430, Dirksen Senate Office Building, Hon. Lamar 
Alexander, chairman of the committee, presiding.
    Present: Senators Alexander, Enzi, Burr, Paul, Cassidy, 
Young, Hatch, Roberts, Murkowski, Scott, Murray, Sanders, 
Casey, Franken, Bennet, Whitehouse, Baldwin, Murphy, Warren, 
Kaine, and Hassan.

                 Opening Statement of Senator Alexander

    The Chairman. The Senate Committee on Health, Education, 
Labor, and Pensions will please come to order.
    This morning, we are holding a hearing on the nomination of 
Dr. Scott Gottlieb to be the next Commissioner of Food and 
Drugs.
    Senator Murray and I will each have an opening statement 
then we will introduce Dr. Gottlieb. After his testimony, 
Senators will each have two rounds of 5-minute questions, if 
they wish to.
    Last year, the most important legislation that Congress 
enacted was the 21st Century Cures law. Those are not my words; 
they are Majority Leader McConnell's words.
    The reason it was such an important bill is that it will 
drive forward research and the extraordinary medical miracles 
that are in the works and that have the potential to affect 
every American family.
    Dr. Francis Collins, at the National Institutes of Health, 
has talked about some of the discoveries that he predicts are 
possible in the next decade: Non-addictive painkillers; hearts 
rebuilt from our own stem cells; a universal flu vaccine; an 
HIV/AIDS vaccine; an artificial pancreas for diabetes patients 
who have spent decades injecting themselves with insulin.
    The key to making these miracles a reality is not just 
investment in research, but a regulatory process that is 
efficient and effective enough to bring safe discoveries to 
patients in a timely way.
    The Food and Drug Administration has always been important, 
but there has never been a more important time to capitalize on 
the significant funding Congress has given to medical research, 
and to realize the promise of 21st Century Cures.
    Dr. Gottlieb, congratulations to you on your nomination. 
Welcome to you and to your family members who are here. I hope 
you will introduce them at the appropriate time. We have 
enjoyed having the opportunity to visit with you in my office.
    If confirmed to lead the Food and Drug Administration as 
its commissioner, you will be in charge of steering the agency 
responsible for assuring the safety and effectiveness of our 
Nation's medical products and protecting our country's food 
supply. My hope is you will help move the agency forward so 
that America's patients benefit from the remarkable discoveries 
our Nation's researchers are working on.
    The FDA affects nearly every single American. It regulates 
a quarter of all consumer spending in the United States, over 
$4 trillion annually.
    It is responsible for prescription drugs for humans and 
animals, medical devices, biologics, dietary supplements, 
cosmetics, over the counter medications, food, and tobacco 
products. It is a vital mission, and we all want to make sure 
the right person is leading it.
    The President has nominated you to do that job, and like 
every full-time nominee, you have been through an exhaustive 
process to make sure you do not have conflicts of interest or 
other problems in your background.
    The President announced your nomination on March 10, after 
an extensive vetting process by the White House and the FBI. 
Your official nomination was received on March 27 by the 
Senate. Eight days ago on March 28, this committee received a 
letter from the Office of Government Ethics, which carefully 
reviewed your financial information and found that, with 
several recusals which you have committed to do, you are, ``In 
compliance with applicable laws and regulations governing 
conflicts of interest.''
    In accordance with our committee rules, you have submitted 
your committee paperwork to Senators on March 31, 5 days before 
this hearing. You have offered to meet with every Senator on 
this committee. You have met with every Democratic Senator and 
all but two Republican Senators.
    That brings us to today. You come here with impressive 
qualifications.
    You were a practicing physician and a hospitalist for many 
years receiving your medical degree at Mount Sinai and your 
residency at the Mount Sinai Hospital.
    We will hear more from Senator Murphy about your other 
credentials, so there is no need for me to repeat them at this 
time, including those in the Health and Human Services, and 
your time as a Resident Fellow at the American Enterprise 
Institute.
    You are a prolific writer and speaker, and no stranger to 
testifying to Congress. You have testified here 18 times on a 
variety of issues. You are also a cancer survivor. You know 
firsthand how medical treatments affect patients and their 
families.
    I am eager to hear your views today on both the User Fee 
reauthorizations and 21st Century Cures. Your first order of 
business will be to work with us on the reauthorization of the 
User Fee Agreements. We have had over 15 bipartisan briefings 
on the User Fees going back to late 2015.
    Senator Murray and I have held two bipartisan hearings on 
the reauthorization, our second one yesterday. I support 
quickly moving the reauthorization recommendations sent to us 
in January, and I am committed to working with the 
Administration, and all members of this committee, to authorize 
the User Fees before August 1.
    In addition to drugs and medical devices, you are 
responsible for protecting our Nation's food supply and working 
to reduce the number of people who get sick from foodborne 
illness. Technology is improving and changing the way we 
improve food safety. It holds the potential to reduce foodborne 
illnesses and deaths.
    FDA is a large and diverse organization that faces 
management challenges. When I asked Dr. Califf, your 
predecessor, his top priority while we were working on 21st 
Century Cures, he said it was to give the FDA the authority to 
hire and to pay people to do what the agency needs to do. We 
included that authority in 21st Century Cures.
    I am concerned, as are other members of this committee, 
about the Administration's hiring freeze, and how it will 
affect the FDA, and how you plan to deal with that, if 
confirmed.
    Thank you for being here. I look forward to hearing your 
testimony on these important issues.
    Senator Murray.

                  Opening Statement of Senator Murray

    Senator Murray. Thank you very much, Chairman Alexander.
    Dr. Gottlieb, I want to welcome you and your family. Thank 
you for being here and for your willingness to serve.
    I do want to start by expressing my disappointment about 
the limited time we have had to review Dr. Gottlieb's committee 
paperwork.
    We have the full paperwork on Friday, meaning we have had 
just a handful of days to fully understand the extent of Dr. 
Gottlieb's unprecedented financial entanglements with the 
industries he would regulate as FDA Commissioner, find and 
review the more than 800 publications Dr. Gottlieb has listed, 
and delve into the wealth of companies and products that raise 
concerns about potential conflicts of interest.
    Chairman Alexander, as you know, I have repeatedly 
stressed--privately and publicly--the importance of a thorough 
and complete vetting process for each of President Trump's 
nominees. Fully vetting the Administration's nominees should 
not be a priority for Democrats alone. Both parties deserve to 
make fully informed decisions about the potential leaders of 
these critical departments and agencies that we oversee.
    Unfortunately, the inexplicable rush to advance this 
nomination falls far short of that basic standard. I will 
continue to push for a thorough review of Dr. Gottlieb's 
nomination. Dr. Gottlieb, I hope you will give clear and 
thorough responses to any followup questions after today as 
well.
    I do appreciate that you responded to my letter requesting 
additional information on your clients. I hope you are 
committed to leading an agency that responds to and works with 
Congress.
    I have to say I have been disheartened by the unprecedented 
lack of responsiveness by this Administration. Throughout 
several nomination processes, Democrats have requested 
documents and additional information to assist in our vetting.
    Disappointingly, Secretary Price failed to respond to a 
single one of the questions this committee asked him following 
his confirmation hearing. We have yet to receive a response to 
even one of the inquiries we have sent since his confirmation.
    Across the Administration, this seems to be the new normal. 
No responsiveness. No transparency. No accountability. It is 
really frightening and frustrating. It cannot go on. I hope, 
given the importance of the work of this agency, that if 
confirmed, you will not follow that trend.
    Our constituents rely on the work of the FDA every single 
day. They trust the food they buy from the grocery store is 
safe. That when they go to the emergency room, the drugs and 
medical devices used in their care have been held to the 
highest standards of approval, and that the FDA's decisions are 
based upon science--not politics or ideology--the gold 
standard.
    As you well know, Dr. Gottlieb, I have a long history of 
holding very firm on that particular point. To me, it is 
critical the FDA have strong, independent leadership, 
especially now in light of President Trump's apparent disregard 
for public health.
    Dr. Gottlieb, in the limited time we have had to review 
your professional history and background, I have grown 
increasingly concerned about whether you can withstand 
political pressure pushing you to ignore science by upholding 
the gold standard, and if you can lead the FDA in an unbiased 
way, given your unprecedented industry ties. I will ask you to 
address those concerns here today.
    I am very interested in how you would ensure independent, 
science-based decisionmaking at the FDA if you are confirmed.
    During your time at the FDA under the Bush administration, 
then-Senator Clinton and I fought long and hard to ensure that 
emergency contraception, known as Plan B, would be sold over 
the counter to all age groups, consistent with expert 
recommendations.
    The Administration then ignored the science and made a 
decision based on purely ideological grounds, a choice that a 
GAO report later called unprecedented.
    Dr. Gottlieb, you defended the Administration's ideological 
position on behind the counter options for Plan B, allowing 
politics to interfere directly with women's access to the 
health services they need.
    Given the Trump administration's clear willingness to skirt 
ethics' rules and pressure Federal employees to jam their 
policies through, not to mention their commitment to 
undermining women's access to birth control and other health 
services, I find that aspect of your professional history 
especially troubling.
    As I mentioned, I am also very concerned about your 
unprecedented financial entanglements, especially given this 
Administration's record on this issue from President Trump on 
down.
    One example of my concerns is in 2012, you were quoted in 
the ``Washington Post'' stating,

          ``If consumers can track their blood sugar levels 
        using pen and paper, why should the Government have to 
        clear an application that does the same thing more 
        reliably?''

    You are an investor in Glytec, a medical technology company 
that developed software that allows patients and doctors to 
manage and adjust insulin therapy using smart phones and 
devices, and received an FDA approval for that software in 
2012. Not surprisingly, you have also served on Glytec's board 
since 2013.
    Another example, FDA and Congress have both been engaged in 
an ongoing debate about the regulation of medical tests. In a 
column related to embattled lab company Theranos, you argued 
the regulation of these tests is best left outside of FDA's 
jurisdiction, all the while serving on the board of two medical 
lab companies that would be directly impacted by your preferred 
regulatory scheme.
    Dr. Gottlieb, it does trouble me greatly that you appear to 
be investing in and advising a company, and then using your 
public platform to promote policies that actually benefit that 
company in the future.
    Meanwhile, reports continue to surface about Secretary 
Price's questionable actions on behalf of companies in which he 
invested. In fact, this committee should know that just last 
Friday, a ProPublica story indicated Secretary Price had 
lobbied the Department of Health and Human Services on behalf 
of companies on the very same day his broker invested in them 
on his behalf.
    When the Trump administration released its financial 
disclosures just a few days ago, we learned of more financial 
entanglements in the health sector.
    President Trump's top economic advisor, Gary Cohn, has 
millions of dollars in financial investments in a number of 
medical technology, drug, and tobacco companies.
    President Trump's pick to lead the Justice Department's 
Anti-Trust Division--which decides whether to approve the 
proposed $54 billion Anthem-Cigna merger--received hundreds of 
thousands of dollars as a lobbyist on behalf of Anthem.
    You can see there is a concerning pattern here, and we do 
not need more of it. I know that, if confirmed, you have agreed 
to recuse yourself for 1 year from decisions involving some 
companies in which you have invested. I do struggle to see how 
this will make sure your views and decisions will not be shaped 
by your investments. I will ask for your response on that 
today.
    Our HELP committee research shows that companies that you 
invested in have more than 60 drugs that could come before the 
FDA for approval, and companies you worked for have interests 
in over 120 drugs that are currently being tested, and that is 
unprecedented.
    Finally, Dr. Gottlieb, the vast majority of your 
professional work is focused on drugs and medical devices, and 
I have some concerns with your published positions on a number 
of important issues.
    On marketing and communications by drug companies for off-
label or unapproved uses of their products, you were quoted in 
2006 saying,

          ``Efforts to limit prescription and scientific 
        exchange to indications only specified on a label could 
        slow the most important advances in 21st century 
        medicine.''

    I would argue that over the last 11 years we have seen 
incredible advances in medicine, while also ensuring that only 
truthful and non-misleading information is given to doctors and 
patients.
    I am concerned about what you describe as regulatory 
overreach by FDA, including your opposition to the regulation 
of medical applications, and your rejection of Risk Evaluation 
and Mitigation Strategies, or REMS, meant to protect patients: 
FDA's central mission.
    I am also eager to hear how you will implement recent 
legislation passed by this committee, including 21st Century 
Cures and the Drug Quality and Security Act, passed to regulate 
compounding pharmacies and build a modern supply chain.
    Your plans to encourage a more robust market for generics 
and biosimilars to help reduce the astronomically high cost of 
prescription drugs.
    The FDA also does far more than drugs and devices. I hope 
in this hearing you will directly address priorities like 
keeping tobacco out of the hands of children, ensuring a safe 
and nutritious food supply, and other efforts to protect public 
health. These are all core responsibilities at the FDA, and I 
would be very concerned if you simply aligned with President 
Trump's extreme vision and take orders from his Administration. 
I will ask about those today.
    Again, I really appreciate you and your family who are 
doing really well behind you right now, joining us today. I 
look forward to hearing from you about whether and how you will 
provide strong, independent, and science-based leadership that 
families in my State and across the country expect from this 
agency.
    Thank you very much.
    The Chairman. Thank you, Senator Murray.
    We will now welcome the nominee Dr. Scott Gottlieb. We 
welcome your wife and your daughters, your parents, your 
sisters-in-law, as well as your other guests whom you should 
feel free to introduce.
    Dr. Gottlieb will be introduced by a member of this 
committee, Senator Murphy. I will turn it over to him and then 
to Dr. Gottlieb for his opening statement.

                      Statement of Senator Murphy

    Senator Murphy. Thank you very much, Chairman Alexander, 
for the opportunity to introduce Dr. Scott Gottlieb to this 
committee.
    I am indeed eager to hear from him today. I have disclosed 
to Dr. Gottlieb that I have not made up my mind as to his 
nomination as will be clear. We have some serious policy 
disagreements between us, but I am very eager to take the 
opportunity to welcome an important Connecticut resident to the 
HELP committee.
    While Dr. Gottlieb was born in New Jersey, he does have 
long ties to my State of Connecticut. He has lived in Westport 
since 2010. Dr. Gottlieb is joined today by his family 
including his wife Allison and their three daughters; I will 
let Dr. Gottlieb do the formal introductions.
    I would note that Dr. Gottlieb's twin daughters' first 
grade class in Westport will be watching part of today's 
hearing to learn about our work in Washington. As the father of 
an 8-year-old and a 5-year-old, I know that first graders 
really want nothing more than to hear about the FDA and watch 
the HELP committee in action.
    Senator Murphy. I am really glad that they are here with us 
today.
    Dr. Gottlieb and Allison are active members in their town 
and their surrounding community, especially through their 
synagogue Temple Israel. Dr. Gottlieb serves on the board of 
directors at the temple and Allison helps run a local homeless 
shelter in Westport and volunteers in the Bridgeport school 
system.
    Dr. Gottlieb's connection to our State started when he 
attended Wesleyan University in Middletown. He was the editor 
of the school newspaper there and a student member of the board 
of trustees.
    After graduating from Wesleyan with a bachelor's degree in 
economics, he went on to receive his medical degree from Mount 
Sinai School of Medicine in New York. After completing his 
residency at Mount Sinai Medical Center, Dr. Gottlieb then 
practiced medicine for 6 years at Stanford Hospital, again in 
Connecticut.
    If confirmed, Dr. Gottlieb will be returning to the FDA for 
the third time. He first served as senior advisor to 
Commissioner Mark McClellan for medical technology and then as 
director of the medical policy development. During this time, 
he would travel back to Connecticut to work at Stanford 
Hospital on the weekends.
    Dr. Gottlieb also brings a unique perspective to this 
committee because he has both been a practitioner and a 
patient. He is a survivor of Hodgkin's lymphoma and has served 
as a policy board member with the Leukemia and Lymphoma Society 
from 2012 to 2014.
    Since leaving the FDA, Dr. Gottlieb has primarily worked as 
a consultant and advisor to a number of companies including as 
a venture partner at New Enterprise Associates. NEA is one of 
the largest venture capital firms in the country. It has 
investments in many firms in the broader healthcare space. He 
also has his own consulting firm. He has been a managing 
director of T.R. Winston, a merchant corporate investment 
banking firm which has a focus in healthcare.
    He has come before various committees in Congress over the 
years to offer his opinions as a resident fellow at the 
American Enterprise Institute. She is no stranger to the U.S. 
Congress. We are proud of him in Connecticut and his commitment 
to Stanford Hospital and his community in Westport, and I look 
forward to his testimony, and I welcome him to the committee 
today.
    The Chairman. Thank you, Senator Murphy.
    Dr. Gottlieb, we now invite you to give your opening 
remarks. Your written statement will be entered into the record 
in its entirety.

  STATEMENT OF SCOTT GOTTLIEB, M.D., WESTPORT, CT, NOMINEE TO 
            SERVE AS COMMISSIONER OF FOOD AND DRUGS

    Dr. Gottlieb. I would like to just take a moment to 
introduce my family.
    My wife Allison is here with my three daughters, Alex, Em, 
and Dillon. Do you want to say hi?
    My mother and father are here. My mother is a school 
teacher in New Jersey. My father is a physician and a veteran 
of the Vietnam War. He was stationed in Cam Ranh Bay and 
wounded in that theater.
    Chairman Alexander, Ranking Member Murray, members of the 
committee, thank you for the invitation to testify this 
morning. I am honored to appear before you today as the 
President's nominee to be the next Commissioner of Food and 
Drugs.
    I come before you today humbled by the realization that the 
lives and futures of families like mine are affected by the 
decisions made by the FDA.
    Should you choose to confirm me, I will make it my mission 
to fight for those families every single day, and ensure that 
the FDA puts their interests first in everything we do.
    I have seen the importance of FDA's work as both a doctor 
and a patient.
    I graduated from Wesleyan University in Middletown, CT and 
went on to graduate from the Mount Sinai School of Medicine, 
where I also completed a residency in Internal Medicine.
    I have had the honor to serve in senior roles at both CMS 
and FDA.
    I have practiced medicine as a hospitalist physician, 
taking care of hospitalized patients. I have tried to ease 
suffering and illness as a physician, and I have had both 
visited upon me. I am a cancer survivor. I was treated for 
cancer during my last tour at FDA, so I know the importance of 
what American medicine does and what the FDA does for every one 
of us.
    For the last 10 years, I have been a policy analyst and an 
entrepreneur starting and building businesses. I have advised 
and invested in early stage medical technology and healthcare 
services companies with the hope that some of these innovations 
could improve the medical technology that we use and the 
systems through which we deliver care.
    Some of these endeavors were successful. Some were not. For 
many others, it is still too early to tell. That is the 
unpredictable nature of innovation in this dynamic sector. It 
is a dynamism that I have come to know well from working on the 
regulatory, policy, clinical, and business aspects of these 
enterprises.
    I am proud of the projects I have worked on, and what I 
have learned in the process. The things I have done--my 
accomplishments, my failures, and everything in between--have 
shaped who I am today. Collectively, they have helped inform my 
values and my perspectives. But among other things, they have 
taught me the need for an absolutely objective regulatory 
watchdog over this field.
    If confirmed, I will lead the FDA as an impartial and 
passionate advocate for the public health. I know what is at 
stake here.
    People's lives are literally on the line when it comes to 
the decisions that the FDA makes in its oversight and its 
enforcement of Congress' laws. The American people deserve to 
trust that the agency is led in an impartial manner, guided 
only by the science that informs its work and an abiding faith 
to the public health. That is the mandate by which I would lead 
this agency, if I were fortunate enough to win your approval.
    I will respect the intent of Congress. I will make sure the 
laws you passed are implemented in a timely fashion and in the 
way you intended. Every decision I make will be guided by the 
advice of career experts. I will be guided by the scientific 
rigor that the public deserves and the rigor that the hard 
challenges before this agency demands. It is to take on these 
challenges that I seek this role.
    We are at an inflection point in biomedical science. New 
technologies give us a fundamental chance to cure many 
intractable diseases. We have more opportunities to improve our 
diets and our health with the foods we eat.
    In areas where there is an inherent, obvious, and seemingly 
unavoidable risk related to certain consumer products--whether 
it is combustible tobacco or dangerously addictive opioid 
drugs--we have the opportunity to help consumers move to less 
risky alternatives.
    This owes to the foresight of Congress in envisioning paths 
to reduced harm as an animating principle in FDA regulation. I 
want to build on these opportunities and achievements.
    I want to use the authorities Congress recently included in 
the 21st Century Cures Act to develop a template to lean 
forward in these areas. We need to make sure we are getting the 
most bang for our regulatory buck. That means being cognizant 
of the risks and being sure that we are not adding to consumer 
costs without improving consumer safety.
    We must constantly ask ourselves are we doing everything we 
possibly can? Does the FDA have the policies and processes in 
place to play its part in tackling the important public health 
issues of our day?
    We should be reminded always that we save lives by allowing 
good things to happen, but we also save lives when we keep bad 
things from happening. FDA's enforcement tools are a bedrock of 
its mission. We should reject the false dichotomy that it all 
boils down to a choice between speed and safety.
    If the FDA is leaning forward in these areas of new 
technology--if it is investing in good tools for doing its own 
work, and better science for evaluating regulatory questions, 
in other words, if we are doing our jobs and leveraging the 
authorities you have given us in new congressional mandate--we 
could have better efficiency and better safety, and also remain 
faithful to FDA's gold standard for regulatory conduct.
    I have seen FDA's positive impact in my prior roles at the 
agency. I am seeking this new role because I am drawn to FDA's 
unique spirit of public health protection that inspires its 
work and its workforce.
    I am drawn to the opportunities we have to leverage FDA's 
platform and its new authorities and resources to enable 
advances in medicine and science to safely reach consumers.
    I am drawn by the challenges the agency confronts as it 
tries to address and enable Americans to make the most of this 
unique moment in science.
    I hope to earn your confidence and support in delivering on 
these opportunities.
    Thank you again for the opportunity to appear before you 
this morning and I look forward to answering your questions.
    [The prepared statement of Dr. Gottlieb follows:]
               Prepared Statement of Scott Gottlieb, M.D.
    Chairman Alexander, Ranking Member Murray, members of the 
committee: Thank you for the invitation to testify this morning.
    I am honored to appear before you today as the President's nominee 
to be the next Commissioner of Food and Drugs.
    I come before you today humbled by the realization that the lives 
and futures of families like mine are affected by the decisions made by 
FDA.
    Should you choose to confirm me, I will make it my mission to fight 
for those families every single day, and ensure that FDA puts their 
interest first in everything we do.
    I have seen the importance of FDA's work as both a doctor and a 
patient.
    I graduated from Wesleyan University, in Middletown, CT and went on 
to graduate from the Mount Sinai School of Medicine, where I also 
completed a residency in Internal Medicine.
    I have had the honor to serve in senior roles at both CMS and FDA.
    I practiced medicine as a hospitalist physician, taking care of 
hospitalized patients.
    I have tried to ease suffering and illness as a physician, and I 
have had both visited upon me--I am a cancer survivor, I was treated 
for cancer during my last tour at FDA, so I know the importance of what 
American medicine does--and what the FDA does--for every one of us.
    For the last 10 years, I have been a policy analyst and an 
entrepreneur, starting and building businesses.
    I have advised and invested on very early stage medical technology 
and healthcare services companies with the hope that some of these 
innovations could improve the medical technology that we use, and the 
systems through which we deliver care.
    Some of these endeavors were successful. Some were not. For many 
others, it is still too early to tell.
    That is the unpredictable nature of innovation in this dynamic 
sector.
    It is a dynamism that I have come to know well from working on the 
regulatory, policy, clinical, and business aspects of these 
enterprises.
    I am proud of the projects I have worked on, and what I have 
learned in the process. The things I have done--my accomplishments, my 
failures, and everything in between--have shaped who I am today.
    Collectively, they have helped inform my values and my 
perspectives.
    Among other things, they have taught me the need for an absolutely 
objective regulatory watchdog over this field.
    If confirmed, I will lead the FDA as an impartial and passionate 
advocate for public health.
    I know what is at stake here. People's lives are literally on the 
line when it comes to the decisions FDA makes, its oversight, and its 
enforcement of Congress' laws.
    The American people deserve to trust that the agency is led in an 
impartial manner--guided only by the science that informs its work--and 
an abiding faith to the public health.
    That is the mandate by which I would lead this agency, if I were 
fortunate enough to win your approval.
    I will respect the intent of Congress.
    I will make sure the laws you passed are implemented in a timely 
fashion and in the way you intended.
    Every decision I make will be guided by the advice of career 
experts.
    I will be guided by the scientific rigor that the public deserves, 
and the rigor that the hard challenges before this agency demand.
    It is to take on these challenges that I seek this role. We are at 
an inflection point in biomedical science.
    New technologies give us a fundamental chance to cure many 
intractable diseases.
    We have more opportunities to improve our diets and our health with 
the foods we eat.
    In areas where there is an inherent, obvious, and seemingly 
unavoidable risk related to certain consumer products--whether its 
combustible tobacco or dangerously addictive opioid drugs--we have the 
opportunity to help consumers move to less risky alternatives.
    This owes to the foresight of Congress, in envisioning paths to 
reduced harm as an animating principle in FDA regulation.
    I want to build on these opportunities and achievements.
    I want to use the authorities Congress recently included in the 
21st Century Cures Act to develop a template to lean forward in these 
areas.
    We need to make sure we are getting the most bang for our 
regulatory buck. That means being cognizant of risks and being sure 
that we are not adding to consumer costs without improving consumer 
safety.
    We must constantly ask ourselves, are we doing everything we 
possibly can? Does FDA have the policies and processes in place to play 
its part in tackling the important public issues of our day?
    We should be reminded always, that we save lives by allowing good 
things to happen, but we also save lives when we keep bad things from 
happening. FDA's enforcement tools are a bedrock of its mission.
    We should reject a false dichotomy that it all boils down to a 
choice between speed and safety.
    If FDA is leaning forward in areas of new technology, if it is 
investing in good tools for doing its own work, and better science for 
evaluating regulatory questions--in other words, if we are doing our 
jobs and leveraging the authorities you have given us in new 
congressional mandate--we can have better efficiency, and better 
safety, and also remain faithful to FDA's gold standard for regulatory 
conduct.
    I have seen FDA's positive impact in my prior roles at the agency.
    I am seeking this new role because I am drawn to FDA's unique 
spirit of public health protection that inspires its work and its 
workforce.
    I am drawn to the opportunities we have to leverage FDA's 
platform--and its new authorities and resources--to enable advances in 
medicine and science to safely reach consumers.
    I am drawn by the challenges the agency confronts as it tries to 
enable Americans to make the most of this unique moment in science.
    I hope to earn your confidence and support in delivering on these 
opportunities.
    Thank you again for the opportunity to appear before you this 
morning. I would be happy to answer any questions.

    The Chairman. Thank you, Dr. Gottlieb.
    We will now begin two rounds of 5-minute questions for 
Senators who wish to ask those.
    Dr. Gottlieb, you have written a lot and said a lot. If one 
were looking for your articles, where would one find them?
    Dr. Gottlieb. I sent you most of the URL's, I believe.
    The Chairman. Are they on the Web?
    Dr. Gottlieb. They are. Most of them are on the Web except 
for the ones that are very old. I have put together, we have 
put together, a binder of all of them. I would be happy to make 
it available to the committee.
    The Chairman. Thank you.
    As far as the opportunity to review, Dr. Gottlieb, I would 
go back through what I said in my statement. He has visited 
with every Senator who wanted to visit with him on the 
committee. He has complied with all the requirements of the 
Office of Government Ethics who have agreed that with the 
recusals he has agreed to do, he will not have a conflict of 
interest.
    All of his papers are in, in a timely way according to the 
rules of our committee. We will have a chance to question him 
today through two rounds of questions, if members would like to 
do that. It will be at least 2 weeks before we have a chance to 
have a markup. Members will have a chance to thoroughly 
consider him and his record before casting a vote as to whether 
to report him to the full Senate.
    As to his work with companies that have to do with drugs 
and food, that is not so unusual for someone who is going to be 
head of the FDA. In my view, it helps to have somebody who 
knows something about the subject.
    An example would be Dr. Califf, his predecessor, who 
supports Dr. Gottlieb's nomination. Dr. Califf from Duke 
University was previously employed by over 20 drug and device 
companies between 2010 and 2014, before he became Commissioner 
of the FDA. That did not disqualify him from serving. I 
supported him. He was approved by the Senate 89 to 4.
    I am glad to know that you have a background and experience 
in the issues before you.
    As far as Dr. Califf goes, let me say a question to you 
that I asked him. When we were working on 21st Century Cures, I 
asked him his No. 1 priority for the Food and Drug 
Administration. He said it was to be able to hire and pay 
personnel at the FDA so they could deal with these lifesaving 
drugs and devices that are coming the way of the FDA. The 
Administration has placed a hiring freeze that seems to be 
interfering with that.
    Should you be confirmed, what would you do about that?
    Dr. Gottlieb. Senator, thanks for the question.
    I understand how important a strong workforce is to FDA and 
helping FDA maintain its gold standard. I think FDA is unique 
among Federal agencies in that it does not pass through most of 
its money. Most of the money that Congress allocates to the FDA 
gets spent at the FDA on the work.
    It is incumbent upon us to have a world class workforce 
that we are providing the proper tools to and the proper 
training to, to maintain that very high standard.
    I have, through my career and my time at FDA, been 
committed to making sure we have a very strong workforce at 
FDA. I have spoken out about that. I will continue to make my 
views known on that issue.
    The Chairman. I hope that you will because this was not a 
minor issue with us. It was his top priority and it was a top 
priority of ours, both Democrats and Republicans. We want 21st 
Century Cures to be a reality and that is an important part of 
it.
    Dr. Collins, the head of the National Institutes of Health, 
has predicted a number of medical miracles over the next 10 
years. One of the most important would be the possibility of 
the discovery of non-addictive pain medicines, which would make 
the opioid epidemic much less of a problem by providing a 
substitute. The President has indicated a similar priority. 
Many of us have on both sides of the aisle.
    What could you do as Commissioner of the FDA working with 
Dr. Collins, the President, and others in the Administration, 
and with us to be forward leaning on accelerating and finding a 
discovery of non-addictive pain medicines, which might be more 
than anything else to relieve the opioid epidemic?
    Dr. Gottlieb. Thank you, Senator.
    The opioid epidemic in this country is having staggering 
human consequences. I think that this is the biggest crisis 
facing the agency, and is going to require dramatic action on 
the part of whoever steps into the agency, and I hope the 
Senate confirms me to take on this challenge.
    It is going to require an all-of-the-above approach. There 
are some things we are going to have to do to really push the 
boundaries of the policy framework in this area, and that does 
include re-evaluating the framework for how we can develop 
alternatives to opioid drugs.
    It also includes looking at device alternatives to opioid 
drugs and looking at devices in the context of drugs. I would 
also add to that looking at medically assisted therapy to help 
people live a life of sobriety after they have become addicted.
    There is going to be a need--
    The Chairman. Thank you.
    Dr. Gottlieb. Thank you.
    The Chairman. My time is running out. It is out.
    I will submit for the record a question about a persistent 
issue with the FDA not properly clearing medical device 
shipments, and I hope you will look into it.
    Dr. Gottlieb. Absolutely.
    The Chairman. Thank you.
    Senator Murray.
    Senator Murray. Dr. Gottlieb, you do wear an extraordinary 
number of hats. You are a partner in an investment bank, a 
venture partner in a large venture capital firm, a CEO or co-
CEO of two health companies, and an individual investor in more 
than 20 health companies. You have sat on various types of 
boards for 16 companies including two of the world's largest 
pharmaceutical companies. You also publish regularly, make 
speeches, consult for a number of large drug companies, and 
practice medicine.
    My question for you is about one of those hats, your role 
as a venture partner for New Enterprise Associates, the largest 
venture capital firm in the world. You revealed in your ethics 
agreement that you hold a direct financial interest in six 
client companies including a laboratory and pathology test 
company, two health insurance companies, a medical equipment 
and supply company, a rapidly growing company that buys 
radiology practices, and the third largest dialysis firm in the 
country. You have also received hundreds of thousands of 
dollars from New Enterprise Associates as a consulting 
retainer.
    If confirmed, you are committed to making the required 
steps to divest and recuse yourself from a select number of 
companies. Those were really just the tip of the iceberg.
    Until recently, you were also a consultant and an investor 
in two large firms operated by NEA. Those funds respectively 
have investments in an additional 75 health-related companies 
who have dozens of new drugs that could potentially come before 
FDA for approval.
    Those companies include Cerecor, which is a 
biopharmaceutical company with eight drugs in its pipeline; 
Galera, a biotechnology company with cancer drugs in 
preclinical and clinical trials; CRSPR, a company developing 
novel therapeutics based on the new gene editing technology; 
and Intact Vascular, it is a medical device company focusing on 
treating vascular disease.
    Your involvement in so many companies likely to have 
business before the FDA--including key decisions by the agency 
on the safety and effectiveness of the company's drugs, 
devices, and products--is unprecedented.
    Will you recuse yourself for the 2 years laid out in the 
Trump Ethics Pledge from all companies in which NEA is an 
investor?
    Dr. Gottlieb. Thank you, Senator. Thank you for the 
question.
    I recognize the importance to maintain my impartiality in 
this role and make sure I am taking the proper steps. I have 
taken the proper steps through the OGE process and I look 
forward to working with the ethics officials at HHS and FDA to 
have continued discussions about what additional steps I should 
take to make sure I am fully compliant with the law if I am 
confirmed into this role.
    As you noted, all of the investments I have made in NEA are 
healthcare services companies and a lot of my work at NEA was 
related to healthcare services, not to their life sciences 
portfolio.
    Senator Murray. I am aware that you have met all your 
minimum legal obligations, but that does not mean you are 
recused from involvement in decisions that affect all of those 
companies.
    What I am concerned about is how your involvement with so 
many companies shapes your priorities. Tell me how you answer 
that.
    Dr. Gottlieb. Senator, I am going to work hard to make sure 
I preserve my integrity in this role and the integrity of the 
FDA. I get it. I understand how important the impartiality of 
this agency is so that people can continue to have trust in the 
decisions that FDA makes.
    I am going to make sure that I have a process in place, if 
I am confirmed into this role, in my front office for helping 
me to manage whatever recusals I do have to put into place, and 
I will consult with ethics officials. This is exceedingly 
important to me. I want to earn and keep the public's trust.
    Senator Murray. OK. The FDA is considered the gold standard 
for approval around the world because the FDA reviews raw data 
to determine if a new drug is both safe and effective, and that 
scientific and nonpolitical process is critical to the trust of 
patients and families across this country.
    Do you commit to upholding that standard?
    Dr. Gottlieb. Yes, I do, Senator.
    Senator Murray. That is good to hear, but the Trump 
administration you will be working under has been clear about 
their disregard for our country's leadership in this respect.
    Trump claims the FDA approval process is slow and 
burdensome. Secretary Price has said, ``One of my passions is 
to get Government out of the way of innovation.''
    Do you commit to making decisions on safety and efficacy of 
new products based on the standards in the current law and the 
science, and not bow to political pressure from the 
Administration?
    Dr. Gottlieb. Senator, thank you for the question.
    I am going to be guided by the science, I am going to be 
guided by the expertise of the career staff, and I am going to 
be guided by impartiality and what is good for patients as a 
physician.
    Senator Murray. OK. I have an additional question on that, 
but to be clear here, you are willing to stand up to the 
Administration if they put political pressure on you?
    Dr. Gottlieb. Senator, thanks for the question.
    For those who have worked with me, I have not been shy 
about offering my unvarnished advice. We mentioned 866 articles 
I have written where I offered very clear thoughts, and I am 
going to continue to offer people my very clear thoughts on 
whatever issues I am asked to apply it on, including my bosses.
    Senator Murray. Thank you very much.
    The Chairman. Thank you, Senator Murray.
    Senator Enzi.

                       Statement of Senator Enzi

    Senator Enzi. Thank you, Mr. Chairman.
    Thank you Dr. Gottlieb for being willing to take this on 
and obviously to leave all those things behind that were very 
profitable. Working in Government is not that profitable and 
your expertise is greatly needed.
    One of the most common themes that we talk about in medical 
innovation is precision medicine and advances in science that 
put formerly inconceivable cures within reach. The FDA has the 
authority and, in some cases, does work with manufacturers to 
do adaptive trial designs that meet the needs of a particular 
disease population more appropriately.
    I also hear about frustrations--that it can be difficult to 
work out with the FDA an approach to clinical trial design for 
small or more complicated populations.
    When I hear this, I think about the difficulty that 
manufacturers with their innovative products can face in the 
drug approval process. They have to fight it out with the FDA, 
and that can be a delicate balance for these companies, and can 
mean significant delays in moving forward through the approval 
process. You have written extensively about this sort of thing.
    Can you tell me what you view as the biggest challenge to 
addressing this problem?
    Dr. Gottlieb. Senator, thanks for the question.
    We have a real opportunity to try to improve the efficiency 
of the development process and give us better tools for 
ensuring the safety and effectiveness of drugs at reduced costs 
with more efficiency. What was done in the Cures Act gives us a 
great template for doing that.
    If I am confirmed into this role, I am going to look 
forward to trying to make efficient implementation of the Cures 
Act.
    I do not want some future Commissioner to be sitting at 
this table 10 years from now discussing that they have not 
fully implemented Cures the way--when I was at FDA--we were 
still implementing provisions of FDAMA 10 years after it had 
passed.
    I am going to be focused on doing that, and you provided 
those provisions in that bill.
    Senator Enzi. Thank you.
    Congress did enact the Food and Drug Administration Safety 
and Innovation Act in 2012 in which it reinforced its support 
for the use of accelerated approval to speed up access to novel 
treatments.
    The FDA has been very clear that drugs approved this way do 
not have a different set of requirements to meet or a lesser 
standard. These are drugs reviewed for the same safety and 
effectiveness requirements as any drug that receives FDA 
approval.
    However, there is some sense outside of the FDA that 
accelerated approval does mean a lesser standard. This is 
concerning as it can impact patients and their access to these 
drugs.
    Will you commit to working to clarify that accelerated 
approval of drugs are not investigational? What do you see as 
any specific actions that the FDA can take to dispel the notion 
that these products are investigational in nature, and to 
clarify that these drugs are fully approved?
    Dr. Gottlieb. Thank you for the question, Senator.
    There is one standard for safety and effectiveness, and no 
commissioner can change that standard. It has been enshrined in 
law many times. I will continue to affirm that there is a 
single standard for safety and effectiveness.
    The FDA does have the ability to make certain 
accommodations owing to congressional statute in the kinds of 
requirements it can pose to demonstrate that standard; but the 
standard is a single standard.
    Senator Enzi. Thank you.
    Changing gears again. For years, we have talked in this 
committee about biosimilars. Since the launch of the Biosimilar 
User Fee Agreement in 2012, there have been four approvals. 
However, only two made it onto the market. By 2021, there will 
be more than 70 biological agents coming off of the patent 
protection and there could be a significant amount of activity 
in the biosimilar space.
    What kind of progress do you hope to see in the review of 
biosimilars? Knowing that the FDA has been slow in implementing 
the biosimilar pathway, what do you see as improvements that 
can be made?
    Dr. Gottlieb. Thank you for the question, Senator.
    Many of us have been disappointed by the economic savings 
we have seen from biosimilars so far. I do think that there is 
a lot of opportunity for these to have a meaningful impact on 
consumers and spending going forward.
    I was at FDA when we first started to contemplate a pathway 
for biosimilars and started to do it through the 505(b)(2) 
process.
    If I have the opportunity to be confirmed into this role, I 
am going to want to make sure that we are implementing guidance 
in a timely fashion to try to create the kinds of opportunities 
for competition. Issues like can biosimilars be used 
interchangeably in the market, could have a meaningful impact 
on the potential to get economic savings.
    Congress recently directed the agency to put out that 
guidance. I want to make sure that we are putting out those 
documents in a timely fashion in evaluating these questions.
    Senator Enzi. Thank you for the conciseness of your 
answers.
    I have a couple of other questions that I will just submit.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Enzi.
    Senator Sanders.

                      Statement of Senator Sanders

    Senator Sanders. Thank you, Mr. Chairman.
    Welcome, Dr. Gottlieb. I enjoyed our conversation in the 
office, and welcome to your family, and all the first graders 
in Connecticut.
    Dr. Gottlieb. Thank you.
    Senator Sanders. Let me begin, Mr. Chairman, by expressing 
my amazement, I think, shared by millions of Americans that we 
have a President who ran for President, and perhaps won the 
election, by saying that he was a ``champeen'' of the working 
class of America.
    He said that he would not cut Social Security, and 
Medicare, and Medicaid. You know what? He appointed his key 
advisors, people like Representative Mulvaney and 
Representative Price, who spent their entire careers trying to 
do exactly that.
    He said that he would, ``Drain the Swamp.'' He now has more 
billionaires in his administration than any President in 
American history.
    He said he would provide, ``Health insurance for 
everybody,'' but he just supported an embarrassing, disastrous 
healthcare proposal that would have thrown 24 million people 
off of health insurance.
    He said he was, ``Going to stop Wall Street from getting 
away with murder,'' but he has drained half of Goldman Sachs 
into his administration.
    In other words, he ran for President saying one thing, and 
he ended up doing something exactly the opposite, which brings 
us to Dr. Gottlieb.
    Candidate Trump and, in fact, President Trump after he was 
elected, made some very important and, in my view, correct 
statements about the outrageously high prices that we pay for 
prescription drugs in this country.
    I must say, Mr. Chairman, that if you go out to the 
American people and you ask them the most important issue that 
concerns them in healthcare, do you know what it will be? It is 
the fact that we pay, by far, the highest prices in the world 
for prescription drugs, an issue which has not yet been even 
mentioned in this hearing.
    The fact that almost one out of five adults in this 
country, who get a prescription from their doctor, cannot 
afford to fill that prescription.
    The fact that in my State, and I expect in Tennessee, you 
have senior citizens who are cutting their medicine in half.
    We have heard from oncologists and other doctors that 
people are dying. Their patients are dying because they cannot 
afford the outrageously high prices of prescription drugs.
    You know what? Trump talked about that and he was right. As 
Senator Murray indicated, he nominates somebody who has 
received millions of dollars from the pharmaceutical industry. 
According to the ``New York Times,'' he has received more than 
$150,000 in compensation from Vertex Pharmaceuticals, a company 
that is charging more than $250,000 a year for drugs to treat 
cystic fibrosis.
    Even more interestingly, Trump runs for office and he says,

          ``Look. There are, among other things, two ways that 
        we can deal with the high cost of prescription drugs. 
        We should be able to re-import lower cost prescription 
        drugs from Canada and other countries. We should be 
        able to negotiate prices with Medicare.''

    Yet, Dr. Gottlieb writes an Op Ed for ``Forbes,'' in which 
he directly contradicts what Trump has to say about re-
importation. That was the thrust of his Op Ed.
    I ask Dr. Gottlieb, why would President Trump appoint 
somebody to the very important position of head of the FDA 
whose views run diametrically opposite to what he said during 
the campaign?
    Do you support, as Trump does, the re-importation of low 
cost medicine from Canada and from other countries, allowing 
Americans to save significant sums of money on the medicine 
they need?
    Dr. Gottlieb. Thank you, Senator, for the question.
    I obviously cannot speak to why the President of the United 
States nominated me for this role. I can tell you, as we 
discussed in your office, I have a lot of ideas that I want to 
work on right away for how I think we can get more product 
competition onto the market.
    You and I talked about the fact that many complex drugs 
have monopolies effectively in perpetuity because of--
    Senator Sanders. I apologize for having interrupted you. I 
have very little time left.
    A quote from your article in ``Forbes,''

          ``The problem is that drug importation does not 
        address any of these core challenges. In fact, the 
        imported drugs may end up being quite expensive.''

    That is fine. That is your opinion.
    It happens not to be the opinion of the guy you will be 
working with, and I just find it amazing that Trump says 
something during the campaign, and then appoints people who 
have radically different ideas.
    What is your view on the need for Medicare to negotiate 
prescription drug prices with the pharmaceutical industry?
    Dr. Gottlieb. Senator, it is true. I have written a lot of 
things on a lot of different subjects, including issues around 
Medicare.
    I am coming before you for the position at the FDA and I am 
going to get asked my position on a lot of different subjects 
that fall outside of FDA's purview. I would do the agency, that 
I hope to lead, no favors by wading into other territory.
    Senator Sanders. Dr. Gottlieb, as you are more than aware 
of, part of the FDA's mission is to make medicines--this is the 
FDA mission not Bernie Sanders' idea--``More effective, safer, 
and more affordable.''
    That is within the jurisdiction of the FDA.
    Dr. Gottlieb. that is my goal, Senator.
    Senator Sanders. Your goal is, from what I am hearing, you 
oppose the ideas that President Trump said he was going to do 
to the American, for the American people.
    Sounds a little bit strange to me, Mr. Chairman.
    The Chairman. Thank you, Senator Sanders.
    Senator Young.

                       Statement of Senator Young

    Senator Young. Dr. Gottlieb, thanks so much for being here 
today.
    First to my colleagues who are concerned about the price of 
prescription drugs, there are a number of ways we can tackle 
that issue. I look forward to engaging with them for, perhaps, 
some alternative paths to get where I know others want to go 
that I think could be palatable in a bipartisan way. With that 
said, we will discuss that offline, as opposed to negotiating 
publicly here.
    On the issue of safety and efficacy, which has already been 
addressed in a fulsome way, you have responded to some of the 
questions. Thank you.
    I just want to give you the opportunity to discuss the 
existing standards. You have indicated you support the existing 
standards, Doctor, with respect to the drug approval process.
    Do those standards, however, provide enough flexibility for 
rare and common diseases, chronic and acute diseases, and the 
varying levels of knowledge we have about different diseases?
    Dr. Gottlieb. Thank you for the question, Senator.
    There are parts of the agency that have leaned forward to 
try to use some of the new authorities that Congress has given 
to the FDA to contemplate how to incorporate better scientific 
principles into the evaluation of products, particularly 
targeted to unmet medical needs.
    I would commend, in particular, the Oncology Division and 
what they have done, as an outside observer, to try to lean 
forward in new areas, to find new metrics for the approval of 
products that incorporate new science.
    I think there are other parts of the agency that have not 
focused as much on the adoption of some of these new 
opportunities. And I would hope in leading the agency, if I am 
confirmed into this role, to bring more consistency to how 
different parts of the FDA look at the authorities that 
Congress has given to the agency to achieve the kinds of things 
you talk about.
    Senator Young. As a follow up, some of FDA's review 
divisions perform incredibly well, as I understand it. The 
Oncology Division being perhaps the most notable positive 
example. They collaborate with patients, manufacturers, and 
other stakeholders to proactively facilitate innovation. 
However, I understand not all review divisions are as forward 
leaning or as flexible as others.
    As FDA Commissioner, specifically, how will you work to 
raise the performance or consistency of all review divisions 
regardless of the therapeutic areas they focus on?
    Dr. Gottlieb. Thank you for the question, Senator.
    One of the things that I tried to do last time I was at the 
agency was to compel the agency to look at how it was 
performing. By doing that, we sometimes were able to help 
people who were working in the divisions reveal these things 
for themselves, and that was a healthy exercise.
    I would hope to do the same thing, if I am confirmed into 
the role, again to allow review staff and leadership in the 
Centers the opportunity to evaluate how different parts of 
their Centers are working, and to find those places where we 
might be able to adopt some best practices and broaden them.
    Senator Young. Sounds as though it is a bottom-up approach, 
which strikes me as good management.
    Dr. Gottlieb. Everything is a bottom-up approach at the 
FDA. The ideas really need to come from the career staff in the 
Centers.
    What leadership can do is help facilitate the opportunities 
to recognize places where there could be underperforming parts 
of the agency.
    Senator Young. Doctor, you have spoken of biosimilars and 
some changes that might be made to improve the approval process 
and expedite the ability of bringing them to market.
    What about in the area of generics? Are there certain 
regulations or guidances you think are particularly burdensome, 
or obsolete that should be withdrawn, or significantly revised? 
In generics, you could touch on medical devices or pharma as 
well, if you like.
    Dr. Gottlieb. Thank you for the question, Senator.
    One of the issues I have looked at recently is the issue of 
so-called high-value generics or complex generics where the FDA 
struggles to put certain drugs through the ANDA process because 
it is difficult to demonstrate substantial equivalents using 
just the traditional tools, which is bioequivalence and 
bioavailability studies.
    Congress did not envision with Hatch-Waxman that certain 
drugs would have monopolies in perpetuity long after their 
intellectual property has expired but for the inability of the 
FDA to have a scientific process that can prove 
interchangeability for those drugs.
    This is an area where we can make a lot of progress. We 
might need to come back to Congress, to talk to Congress about 
what additional steps we need to take. There are things the FDA 
could contemplate administratively.
    This is an area I want to work on. There is literally 
billions of dollars worth of drugs each year that are sold as 
branded drugs at high prices, but should be subject to generic 
competition.
    Senator Young. Very encouraged that you intend to be 
forward leaning in this area of delivering to this committee, 
and perhaps others, some solutions that we might work with you 
on, and I would like to play an active role in that effort. 
Thank you.
    Dr. Gottlieb. Thank you, Senator.
    The Chairman. Thank you, Senator Young.
    Senator Kaine.

                       Statement of Senator Kaine

    Senator Kaine. Thank you, Mr. Chair.
    Thank you, Dr. Gottlieb for your testimony. I want to talk 
to you about opioids, which you addressed in your opening 
comment.
    Two million Americans today have a substance abuse disorder 
with prescription pain relievers and in the most recent year, 
more than 20,000 died of overdoses on prescription drugs, 
prescription opioids.
    Another 600,000 Americans have a substance abuse disorder 
because of addiction to heroin. Four-fifths of new heroin users 
began by using prescription opioids. An additional 12,000 
Americans died last year from heroin overdoses.
    In 2012, the last year for which we have very good 
statistics, 259 million opioid prescriptions were written in 
this country--prescriptions with multiple doses of prescription 
opioids.
    There are many at fault for this scourge. There was bogus 
research that was published and perpetrated suggesting that 
these drugs do not have addictive qualities, which they do.
    There was unscrupulous advertising, a drug developed that 
provided pain relief in emergency situations. There was a 
realization that there was not a big enough patient base, and 
so there was a decision to market it more broadly to people 
suffering from chronic pain conditions.
    There are dishonest providers who have been caught, pill 
mills and there might be doctors, there might be allied health 
professionals or pharmacies that were being caught.
    There has been inadequate training about pain management, 
often in medical schools and other places. Without any malice, 
the absence of appropriate training about how to manage pain 
has contributed to this.
    The FDA has played a role in it too. The FDA approved 
Zohydro, despite the fact that the advisory committee at the 
FDA recommended that that not be the case.
    The FDA approved use of Oxycontin by adolescents, despite 
the fact that the advisory committee expressed grave 
reservations about that.
    You and I chatted a little bit about this yesterday. I 
would like to hear you talk about in your leadership of the 
FDA, should you be confirmed, what would be your strategy for 
taking on this challenge that the FDA has been somewhat 
complicit in, even if unwittingly, in the past?
    Dr. Gottlieb. Thank you for the question, Senator.
    I enjoyed our discussion yesterday.
    This is a staggering human tragedy that, as I said at the 
outset, is going to require dramatic action on the part of the 
agency. It is going to an all-of-the-above approach. There are 
a number of things we can do.
    I feel I have a bipartisan mandate through my discussions 
with this committee to try to push the agency to look harder at 
what the right framework would be.
    To give you some examples, FDA does take on as part of its 
review process the mandate for looking at the potential for 
abuse and diversion as a component of the approval process. I 
think we need to ask hard questions whether or not the agency 
has the adequate authorities, resources, and policy framework 
for doing that, to make sure it is being done appropriately.
    We need to look at opioid drugs in the context of medical 
devices that could provide alternatives. The safety and benefit 
of a systemic opioid drug might look a lot different when it is 
juxtaposed against a device alternative that is delivering 
localized therapy. That we might need to look at a different 
framework.
    Congress has given the FDA some authority to look at drugs 
and devices in conjunction. We have done that with the Oncology 
Division.
    We have to look harder about how to create generic 
standards for the drugs that have abuse deterrents, so that we 
feel more confident clearing the market of the older drugs that 
do not have abuse deterrent features. We need good guidelines 
for how we are going to genericize those drugs so that we are 
not just forcing people onto high-cost drugs when we take the 
older, generic drugs off the market.
    We need to do all these things and we need to look at 
alternatives to opioids, and do we have the right framework in 
place, and the guidance in place to accelerate the development 
of non-opioid alternatives for the treatment of pain. We are 
going to need to push harder on all these things.
    It might be the case that when we look at these questions 
in a hard way, I might have to come back to Congress, if I am 
fortunate enough to be confirmed into this role, and have 
another conversation with all of you about how to make these 
things happen.
    Senator Kaine. Dr. Gottlieb, if I could just follow up on 
that.
    As I think about the FDA, I am not an expert, but as I 
think about it, I think of the work of this agency as largely 
around applications and then the testing to determine--when 
whether it is a device or a drug--is it available, and ready, 
and proven efficacious, and safe for use by the public. An 
application, we are going to look at this particular 
application to see when it is ready for prime time.
    What I would hope that the FDA would be able to do is look 
more broadly at the issue of pain management. Do we have the 
right set of tools and strategies, devices and pharmaceuticals 
that can effectively manage pain in a way that is safe? To the 
extent that we do not, I would hope the FDA could look in a 
proactive way about, what do we not have? What do we still 
need?
    If you need to come back to us and tell Congress that the 
FDA's mission is to fine tune narrowly just around the approval 
process rather than being proactive to deal with an issue that 
is as massive as the management of pain, I hope you will come 
back to us and tell us that because I would think we would need 
to. You would probably find some bipartisan support for 
altering and expanding the mission of the FDA so that we could 
take a proactive approach to this public health scourge.
    Dr. Gottlieb. Senator, this will be my highest immediate 
priority and I am committed to do that.
    Senator Kaine. Thank you, Mr. Chair.
    The Chairman. Thank you, Senator Kaine.
    Senator Scott.

                       Statement of Senator Scott

    Senator Scott. Thank you, Mr. Chairman.
    Dr. Gottlieb, thanks for being here this morning.
    You bring a healthy balance, or equilibrium, to this 
opportunity. You are a doctor. You have also been a patient. 
Not just a patient, but a cancer survivor. You appreciate the 
necessity of new drugs, and sound quality, and safe drugs.
    You have worked for the FDA on a couple of occasions, but 
you have also worked with industry for a long time. You also 
have the support of Dr. Hamburg and Dr. Califf, the 
Commissioners of the FDA. So I like the equilibrium that we see 
here.
    One of the comments that you made during your opening 
statement, or at least the comments that I read in your opening 
statement, was that you see a false dichotomy that it boils 
down to either speed or safety. I would appreciate you 
expounding on that because there has been much conversation 
around the pricing. Price, oftentimes, is a component of how 
long it takes to get to market.
    There is a successful venture from Clemson University, in 
my home State of South Carolina, of tissue bioprinting. I would 
imagine that, given the current investment in capital and time 
to get a drug to market, we should encourage every tool 
possible that helps us get there faster and safer.
    I would love to hear your comments on tools like 
bioprinting, as well as your comments about the dichotomy that 
may be a false paradigm.
    Dr. Gottlieb. Thank you for the question, Senator.
    It is the case that drugs do get priced to some measure of 
the cost of capital to create those drugs. The longer the 
timeline--the more costs, and the more uncertainty of that 
process--the higher the cost of capital to fund an endeavor to 
try to find a new innovation.
    Anything we can do to try to make that process more 
predictable, to create bright lines, to use better tools to 
evaluate safety and effectiveness that could bring down the 
cost--while not doing anything to sacrifice our ability to 
ferret out the safety of a product--are things we should be 
looking at.
    I come back to the Cures Act because I think that there is 
a lot of opportunity for that to be a template for policymaking 
in this regard, not just what Congress directed the agency to 
do with respect to adaptive clinical trial designs. Also what 
Congress directed the agency to do with respect to modeling and 
simulation as a tool to helping better evaluate safety and 
effectiveness.
    All of these things can make the process more efficient and 
perhaps less costly while still allowing us to fully evaluate 
safety and effectiveness.
    This is one place, if we are doing our jobs right, we can 
have our cake and eat it too.
    Senator Scott. That is awesome. Thank you.
    Another question for you, I spend a lot of time every 
Valentine's Day, I enjoy going to the Medical University of 
South Carolina and visiting the pediatric unit, specifically 
the oncology center because you have an opportunity to see 
children who are going through incredible situations, 
challenging times, but they are optimistic; they are positive.
    The care that they receive at the Medical University of 
South Carolina is outstanding care. But there are times when 
doctors do not have all the tools necessary. As you are well 
aware, cancer affects children and adults differently and often 
the type of cancer that develops in a child is very different 
than what might develop in an adult.
    Given this, and the fact that pediatric cancer is so rare, 
what can the FDA do to continue to enable innovation in this 
space?
    Dr. Gottlieb. Thank you for the question, Senator.
    Congress has given the agency certain authorities to try to 
encourage the development of clinical data in the pediatric 
setting. As you noted, there are still obstacles to getting 
drugs studied in these ways.
    This is something I would be committed to trying to work 
with you and others on to see if there are additional steps we 
could be taking to try to create incentives for the development 
of information around the use of products in the pediatric 
population, and also finding ways to conduct more feasible 
clinical trials in these settings. Sometimes it is hard to run 
the same kinds of perspective, large, randomized trials in very 
small populations where children are involved, and I think we 
need to look at different clinical trial constructs as well.
    I, again, come back to the issue of adaptive designs and 
alternative clinical trial designs as being something that 
could be particularly applicable in this area. I would be 
committed to working on this if I am confirmed.
    Senator Scott. Last question and probably, perhaps, a quick 
answer because we have little time left.
    A lot of the smaller biotech companies are working on 
cutting edge research and development. They may have one drug 
in the pipeline and none on the market. Working with small 
staffs and, frankly, private capital.
    What are some of the ways that the FDA can support these 
smaller companies and help more drugs come to market at the 
lowest cost?
    Dr. Gottlieb. Thank you, Senator.
    As it was noted at the outset, I have helped create some of 
those smaller companies.
    Senator Scott. I did note that.
    Dr. Gottlieb. I have seen this experience from both sides.
    The most important thing when you are trying to raise 
capital to develop a new innovation is understanding exactly 
what your costs are going to be. Obviously, there is an 
inherent unpredictability to the scientific process, and you 
can never fully anticipate that.
    Understanding what the benchmarks are, and what the 
clinical requirements are going to be, is very important. It 
becomes important for the FDA to have very clear guidance, 
especially in areas of unmet medical needs so that people who 
are trying to find capital for these endeavors know what their 
costs are going to be.
    The Chairman. Thank you, Senator Scott.
    Senator Warren.

                      Statement of Senator Warren

    Senator Warren. Thank you, Mr. Chairman.
    In the 1950s, a German company began selling a drug called 
Thalidomide all over Europe, a sleep aid that was also marketed 
for nausea during pregnancy. Pregnant women, who took 
Thalidomide, starting having babies with severe birth defects 
most notably deformed flipper-like arms and legs.
    More than 10,000 children were born with severe 
disabilities caused by Thalidomide, but fewer than 100 of those 
were born in the United States and that is because an FDA 
reviewer kept the drug off the market over concerns about the 
shoddy data to support the drug's safety.
    Following that episode, public outrage led Congress to 
strengthen the FDA so that drug company profits would never be 
put ahead of the safety of our children.
    I was surprised, Dr. Gottlieb, to read in a 2012 article 
that you asserted that the Thalidomide episode had a harmful 
effect on the FDA. You said the incident,

          ``Fostered an idealization of FDA reviewers as 
        `championing' an issue of safety against the prevailing 
        orthodoxies especially when it meant taking on 
        corporate interests.''

    You were critical.
    Dr. Gottlieb, do you think the FDA puts too high a priority 
on championing safety and protecting unborn babies and other 
consumers?
    Dr. Gottlieb. Absolutely not, Senator.
    The thrust of that article was about a much different 
point, but I absolutely believe the FDA needs to be answering 
these questions in full. In fact, the modern FDA does a very 
good job ferreting out risks of teratogenicity preclinically, 
actually because of the modern tools that we use in the drug 
development process.
    Senator Warren. I am not quite sure that I am following 
because you talk about,

          ``In so heavily prioritizing the protection of 
        consumers, the FDA has `subordinated and neglected' its 
        obligation to `guide new medical innovations to 
        market.' ''
    In other words, it sounds like to me you are saying in this 
piece that you think that the FDA places too much emphasis on 
consumer protection.
    Dr. Gottlieb. Senator, I remember the piece well and the 
thrust of the piece was focused on my concern that the agency 
was losing confidence in physicians and felt that it needed to 
step into the regulation and the practice of medicine to try to 
supplant its judgement for the judgement of doctors in certain 
situations. Moreover, I was concerned that the agency did not 
have the enforcement tools to follow up on what it was doing.
    One thing I learned when I was at FDA was you have had to 
be careful about imposing a requirement that you are not 
capable of enforcing, and that was the thrust of the article as 
I remember it.
    Senator Warren. I have to say that is not how I read the 
article, and I worry about your language, in that you 
criticized FDA reviewers saying that they, ``Believe it is 
appropriate to prioritize safety over speed.''
    I know there are always judgments to be made, but 
belittling reviewers who are concerned about safety makes me 
very uneasy. I want to get innovative products to market as 
fast as possible, and I support more resources for the FDA to 
be able to do that. I support better science for the FDA. I 
have written bills to do both of those.
    Your view of the FDA's response to the Thalidomide problem 
is deeply disturbing and it raises, for me, real questions 
about your commitment to the FDA's basic safety mission.
    As my colleagues have pointed out, you have spent your life 
entrenched in the companies that would benefit from looser 
regulations. I think it raises the very real question of 
whether someone who seems to oppose the FDA's basic safety 
mission should be running the agency. I just have real concerns 
here.
    I also have concerns about off-label marketing. I see that 
I am running out of time and it is a long series of questions.
    In deference to the Chair, I will do those as questions for 
the record.
    I just want to say the position of the head of the FDA is 
one in which all of America and, indeed, all of the world 
places its trust.
    For me, that means it is profoundly important that you be 
committed to safety and that you be committed to the role of 
the FDA; not the drug companies, not others outside who stand 
to profit, but to the FDA itself to watch out for that safety.
    Dr. Gottlieb. I agree, Senator.
    Senator Warren. Thank you, Mr. Chairman. Thank you.
    The Chairman. Thank you, Senator Warren, for respecting the 
time. There will be an opportunity for another round of 
questions if you wish.
    Senator Burr.

                       Statement of Senator Burr

    Senator Burr. Thank you, Mr. Chairman.
    Dr. Gottlieb, to your parents, congratulations; you did a 
great job. I hope you are proud of him. All the criticism is 
about his successes.
    To your wife and to your children, thank you for the 
sacrifice that you are making. It is a job I have always 
wondered as people get nominated why they do it, and especially 
somebody with as many irons in the fire as Dr. Gottlieb has.
    Let me ask you, Dr. Gottlieb, do you think the FDA follows 
the 1997 FDAMA statutes today?
    Dr. Gottlieb. It follows important elements of the FDAMA 
statutes in part because of the foresight of this committee in 
recodifying some of those and reinvigorating them for the 
Breakthrough Therapies.
    Senator Burr. We went through a period of time where the 
FDA did not even follow the statute of law. Right?
    Dr. Gottlieb. I have been on the record of being critical 
of that. Yes.
    Senator Burr. As the author of it, that was discouraging to 
me. Yet, I hear you having to be held to a standard of 
following the letter of a statute. Yet, you are inheriting an 
agency that had not done that.
    Let me ask you. In 2017, should there still be double-blind 
studies where the doctor does not even know whether the patient 
is getting a placebo or not?
    Dr. Gottlieb. Senator, thank you for the question.
    I believe that there are opportunities to modernize how we 
do clinical trials in ways that are not going to sacrifice on 
the gold standard of safety and effectiveness, but perhaps 
could think of clinical trial constructs that do not require 
the tight randomization that current clinical trials do. 
Congress believes this as well because it has directed the 
agency to look at alternative clinical trial design as the 
component of the review process.
    To your point about FDAMA, I believe that getting 
sufficient implementation of Cures and following Congress' 
intent in that regard is going to be an essential part of what 
I hope to do if I am confirmed into this role.
    Senator Burr. In fact, Congress in 2012 passed Breakthrough 
Therapy legislation on drugs. We followed it up in the Cures 
Act with a Breakthrough Therapy Pathway for devices. That was 
an acknowledgement by Congress that there was a risk aversion 
within the culture of the FDA.
    If confirmed, what are you going to do to change the 
culture of the FDA; not the standard, the culture?
    Dr. Gottlieb. Thank you for the question, Senator.
    I want to find ways to look at what is working well within 
the agency, if I am confirmed into this position, and try to 
bring those best practices to the parts of FDA that might not 
be adopting the tools, especially the tools that Congress has 
instructed FDA to start to incorporate.
    We have seen, for example, I think to your point, uneven 
adoption of the principles embedded in the Breakthrough Therapy 
Pathway, and I think there are ways to try to inspire more 
consistency and more broad adoption of that ethos.
    That would be something I hope to work on. That is 
something we were able to do when I was at FDA the last time in 
part by challenging the agency to examine its own processes to 
see how it was performing against these kinds of benchmarks and 
against the prerogatives of Congress.
    I would hope to bring back those same tools, those same 
techniques, to try to do that again with respect to these new 
sets of authorities that Congress has given the FDA.
    Senator Burr. When Andrew von Eschenbach was the 
commissioner of the FDA, Dr. von Eschenbach recognized at the 
time that the success of the FDA was in his ability to have the 
talent that he needed in the future to be able to address 
technology changes that they were going to be presented with 
from the standpoint of reviewers.
    If you are confirmed as the next FDA Commissioner, how will 
you ensure that the FDA is ready to regulate cutting edge 
products coming before the agency today and in the future? I 
might add, that Dr. von Eschenbach set up a whole mechanism to 
identify future employees, recruit future employees, train 
future employees that was dismantled after Dr. von Eschenbach 
left as commissioner.
    What are your plans?
    Dr. Gottlieb. Thank you for the question, Senator.
    This is one of the most critical issues facing the agency 
right now. I think it is critical, in part, because the 
complexity of the science coming before the agency is going to 
require the FDA to have more and more specialized talent.
    It is also critical insofar as we have a workforce at the 
FDA that is aging to the point where you are going to have, a 
spate of retirements. When you look at the demographics of the 
agency, you are going to lose a lot of very senior 
professionals over a short period of time. Replacing that kind 
of expertise and institutional knowledge is going to be a real 
significant challenge.
    This is something, if I am confirmed into this role, that 
is going to be something I need to work very hard on and a 
significant challenge to the job.
    I do believe what Congress has done in Cures--in giving the 
agency certain hiring authorities and certain abilities to go 
out and target people with specialized knowledge--does provide 
the basis for trying to address this challenge. Getting that 
implemented as Congress intended is something I hope to do 
working with my administration, if I am confirmed into this 
role.
    Senator Burr. I thank you for that commitment.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Burr.
    If I may editorialize, that is a commitment that almost all 
of us share.
    Senator Casey.

                       Statement of Senator Casey

    Senator Casey. Thank you, Mr. Chairman.
    Doctor, good to be with you. Thank you for coming to visit 
our office to talk about some issues. I will raise some other 
issues with you now that we did not have a chance to review in 
my office.
    The first is the Over-the-Counter Monograph System, which I 
think many would argue is ineffective and in need of 
improvement. I have been working with Senator Isakson on 
legislation to reform the Over-the-Counter Monograph process, 
to modernize it. In particular, to modernize drug regulations, 
and ensure that both safety and efficacy information is 
communicated to consumers in a timely fashion.
    I would ask you first about that system, your view of it. 
Second, ask you if you would commit to work with us in this 
process to create a better, safer, and more efficient 
regulatory structure for over the counter drugs.
    Dr. Gottlieb. Thank you for the question, Senator.
    Anytime a problem persists from when I was there 10 years 
ago to today is an indication that it requires immediate 
action.
    I am familiar with what Congress is working on. I have the 
sense from what I read outside of the agency--I do not have the 
benefit of being inside the agency--that there is support in 
the agency for Congress' ideas. I also believe, I think like 
you, that this is a system that is in need of modernization.
    This is something I would be very committed to work with 
you on, if I had the opportunity to be confirmed into this 
role.
    Senator Casey. I wanted to ask you as well about a rather 
recent development.
    A January 2017 white paper from the FDA analyzed 22 cases 
of drugs, vaccines and devices where promising Phase 2 results 
were not supported by subsequent trials in Phase 3. Alarmingly, 
seven of these products had safety problems that were not 
detected until Phase 3 trials were completed.
    Based upon that report, and the concerns that emanate from 
that, I would ask you about the Phase 3 process in particular. 
You have been critical of FDA's reliance on data from Phase 3 
clinical trials for drug approvals.
    Do you continue to hold that view?
    Dr. Gottlieb. Thank you for the question, Senator.
    I am not sure insofar as I am critical of Phase 3 trials. I 
have articulated a point of view that with more modern clinical 
trial designs, you could compress the Phase 2 and Phase 3 
clinical trials into one, big adaptive design. That is a view 
that the FDA has had and FDA officials in terms of trying to 
design modern clinical trial constructs.
    That a proper clinical program is an essential feature of 
ensuring the safety and effectiveness of products, and I am 
familiar with the study you talk about. Having proper post-
market enforcement tools is an essential part of the overall 
paradigm of regulatory approval.
    Senator Casey. Do you believe in allowing market forces to 
be the judge of efficacy in Phase 3? Do you believe that?
    Dr. Gottlieb. I believe in the gold standard for safety and 
effectiveness, and I believe Congress has delineated a single 
standard for demonstrating that, Senator. That is something 
that needs to be demonstrated through a regulatory process 
guided by science and the public health.
    Senator Casey. Do you support, or I should say, do you 
continue to support the requirement that all new drug 
applications must include Phase 3 trial data for a drug to be 
approved for marketing?
    Dr. Gottlieb. Congress has directed the FDA to allow 
certain drugs in certain situations to be approved on the basis 
of Phase 2 data under the Breakthroughs Pathway under some of 
the provisions in FDAMA. Congress has given FDA the tools to 
make certain accommodations in areas of unmet medical need.
    I support following the directive of Congress in making 
sure your laws are faithfully implemented.
    Senator Casey. I wanted to ask you as well something we 
raised initially yesterday with regard to preparedness for all 
kinds of threats to public health. We have had so many lately 
that we are reminded all the time of the emerging--not just the 
threats we have seen--but emerging diseases and bioterrorism 
concerns.
    Senator Burr and I have worked for years on medical 
countermeasures, policy, and legislation. The development of 
these new countermeasures to combat these threats is, of 
course, a huge priority for everyone here. The FDA plays an 
important role in that, but here we are now facing a hiring 
freeze and potentially facing adverse budget impacts.
    I would hope, and I will ask you the question, it is a 
simple yes or no question. Would you advocate within the 
Administration against the views of the Administration 
apparently? Would you advocate in the Congress for 
appropriations needed to meet FDA's mission as a public health 
agency including FDA's obligation with respect to medical 
countermeasure development?
    Dr. Gottlieb. I am going to be committed, Senator, to 
advocating for a strong FDA.
    Senator Casey. I would hope that means that you would 
advocate against proposals with regard to a hiring freeze or 
the budget.
    Would you or not?
    Dr. Gottlieb. I am going to be committed to advocating for 
proper resources at the FDA and a strong user fee program, 
making sure that the mandates that you have given FDA are 
properly resourced, so we could fulfill our mission.
    Senator Casey. That was not the answer I was waiting for, 
but I know my time is over.
    The Chairman. Thank you, Senator Casey.
    Senator Paul.

                       Statement of Senator Paul

    Senator Paul. Dr. Gottlieb, congratulations on your 
nomination.
    It is my considered and biased opinion that we have plenty 
of lawyers in Government, so I am always happy to see a fellow 
medical doctor being appointed to something.
    It is important just to reiterate maybe and tell us your 
approach in general and motives. Would you ever let drug 
profits--drug company profits or medical device company 
profits--would you ever let that obscure your duty to safety 
and efficacy?
    Dr. Gottlieb. Absolutely not, Senator.
    Senator Paul. That is important, because that goes to 
character. To me it is sort of your honor is on the line when 
you say that. We can argue back and forth, but you only can 
tell us that, and I think that is your stated opinion, and I 
accept that.
    While your primary duty is safety and efficacy, there are 
sort of market forces that ultimately determine prices of 
drugs, availability of drugs, whether there are monopolies or 
not. The FDA gets in the middle of that.
    My hope is that we can get to a point where generics are, 
obviously knowing that safety and efficacy is our primary duty, 
but that we can maybe get them approved quicker so we can have 
more competition. That we cannot have markets where we only 
have one generic, that we are doing things to allow more 
competition, understanding that competition will bring prices 
down.
    I guess what I would like to hear from you is just in 
general your approach to how we balance that, patented drugs 
versus generics. What are the things you think we can do better 
in the generic market?
    The one you and I have talked about, the EpiPen, where the 
generic, applied for approval like in 2009, and still does not 
have approval. The FDA will say, ``Oh, we are doing a lot 
better and we are only doing them in a year and a half now. We 
used to do them in 25 years,'' or whatever.
    It still has to be even better, and I hope you will see 
that as something that we can work on, and that you will give 
us feedback on how you are going to make that better. I would 
just appreciate your general comments.
    Dr. Gottlieb. Thanks for the question, Senator.
    This is something I would hope to work on early if I am 
fortunate enough to be confirmed into this role.
    That when it comes to generics, there are really two 
problems. The first is just the ordinary generic approval 
process where we have seen situations where certain drug 
markets have fallen to one or two drugs, prices have been 
raised, and the market is not self-correcting because trying to 
get in an application and get it approved could take up to 4 
years.
    You have people who have been able to take advantage of 
regulatory arbitrage by buying a product that might not face 
generic competition, even though it is a generic drug, jack up 
the price, and it takes a long time for other people to come 
into the market even though the high price should be attracting 
competition.
    That is a solvable problem and something I would hope to 
work on.
    The other problem, which is more complex, are the generic 
drugs that we have talked about here today where the agency 
does not have good standards for demonstrating substantial 
equivalence because the drug is a complex formulation.
    Simply looking at the blood levels of the drug, which is a 
standard by which we approve generics under Hatch-Waxman, is 
not sufficient for demonstrating substantial equivalence.
    This might be a drug that acts topically where measuring 
the blood levels does not approximate the effect. It might be a 
drug that acts inside the lungs, like a metered dose inhaler. 
It might be a drug that acts inside the gut, a pill you swallow 
that acts inside the gut.
    In all these cases, you cannot simply look at blood levels 
as a proxy for how the drug is going to have its therapeutic 
effect.
    In those cases, we need to develop better scientific 
principles for doing that. There is opportunity to do that 
within the framework of Hatch-Waxman. I would want to challenge 
the agency to do that. But this might be an area where we need 
to come back to Congress and have a broader discussion around 
what that should look like.
    This is a situation where you have drugs that Congress 
intended for them to be subject to vigorous competition, but we 
did not envision it when we passed Hatch-Waxman because the 
drugs themselves have had 10 more complex.
    Senator Paul. Thank you.
    The Chairman. Thank you, Senator Paul.
    Senator Murphy.
    Senator Murphy. Thank you very much, Mr. Chairman.
    Dr. Gottlieb, I think you are hearing from this side a 
level of discomfort with your nomination, certainly connected 
to your private sector history. It is also fairly unprecedented 
to have a nominee before this committee for this position that 
has such an extensive political history as well.
    It is very well known you were one of the most outspoken 
opponents of the Affordable Care Act. There is virtually no 
piece of that legislation that you did not have a strong 
opinion on that was very strongly worded. You have been a 
political advisor to Republican candidates running for 
President.
    The worry about impartiality is certainly connected to the 
private sector experience, but it is also to your very deep 
political involvement as well.
    I may want to ask a question about where today politics and 
science are intersecting, in a way that make a lot of us on 
this committee uncomfortable, and that is on the issue of 
vaccines.
    I am encouraged that you have commented and published on 
multiple occasions in support of vaccinations based on 
scientific data.
    However, you are going to be working for a President who 
has been a frequent critic of vaccinations. He has also 
suggested that he might convene a political commission that 
will look into the connection between vaccines and autism, for 
instance.
    Let me just ask you these two questions. No. 1, is there 
any medical evidence that you know of to support the idea that 
vaccines cause autism or that vaccines administered in the 
current recommended vaccination schedule cause autism?
    If this political commission is convened, if there is an 
attack on vaccinations from this Administration, will you 
commit to publicly opposing that effort?
    Dr. Gottlieb. Thank you for the question, Senator.
    As a physician, I share the concerns that parents have 
about putting any product in an otherwise healthy child. I 
understand that this issue elicits a lot of emotion.
    That this has been one of the most exhaustively studied 
questions in scientific history.
    You had the 540,000 patient Danish study. You have had 
exhaustive studies by the IOM and other esteemed bodies. I 
think we need to come to the point where we can accept no for 
an answer around this question, and come to a conclusion that 
there is no causal link between vaccination and autism.
    At some point, we have to accept no for the answer after we 
have invested, and Congress has invested, enormous resources in 
studying this question.
    I have a history of not being shy. I think to your original 
premise of your question, when you talked about some of my 
writings, not being shy about speaking truth to power, and 
making my views known sometimes in an unvarnished way on the 
editorial pages of America's newspapers.
    I will bring the same operating platform to this position. 
I will give people my direct advice, my unvarnished opinion, my 
science-based judgement, and the science-based judgement of the 
people of the agency I hope to lead. I will make that known in 
the proper venues.
    Senator Murphy. The worry is that there will be industry-
supported reforms that will find a voice inside the agency 
because of your connection to the industry.
    Let me talk about a piece that you wrote, I believe, in the 
``New England Journal of Medicine'' that discussed your 
``National Affairs'' article in 2012, where you proposed a 
major shift in the FDA drug approval process where you 
suggested that there should be a politically accountable board 
that ultimately makes decisions on drugs, which is a 
revolutionary change from the way that we do things now.
    It seems like it would be a big gift to the drug industry 
being able to use their political donations in order to 
ultimately put a group of ``friendlies'' on a process or a 
commission that decides approval rather than having that 
process sheltered from the political process.
    Can you talk a little bit more about that proposal and 
explain to this committee why that ultimately would not lead to 
the politicization of drug approvals if you put that process 
into the political realm outside of the protected area of the 
FDA?
    Dr. Gottlieb. I appreciate the question and a chance to 
clarify what the article said.
    In that article, if I remember correctly--and it has been a 
while, I have written a lot of things on a lot of different 
topics as you noted--I lamented the fact that the advisory 
committee process itself, in my view, was already becoming 
politicized.
    My point was, and it was sort of a rhetorical point, 
perhaps we should be more transparent about what is happening 
and just allow Congress to appoint the members to the boards or 
the GAO as we do with other advisory committees in Congress. 
Because it might be a more transparent and deliberate way to 
achieve what seems to have been the effort underway, which was 
to influence the appointment of members to its board.
    It was in some respects a rhetorical exercise, but in some 
respects an acknowledgement of what I thought was a trend that 
was underway with respect to the appointment of those members.
    Senator Murphy. I hope that you will see that it is your 
role to depoliticize that process to the extent that you think 
it is politicized rather than to elevate the politicized 
process.
    Dr. Gottlieb. I agree with you, Senator.
    Senator Murphy. Thank you. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murphy.
    Senator Hatch.

                       Statement of Senator Hatch

    Senator Hatch. Thank you, Mr. Chairman.
    I just want to compliment you for the experiences you have 
had in this life. You have had a wealth of experience. Yes? A 
lot of it in business, and a lot of it in industry, but on the 
other hand, there is nothing that should discourage you from 
being head of the FDA because you have had extensive industry 
experience as well.
    I am going to personally compliment you because I am 
wondering, why are doing this? Why go through all this pain? 
You do not have to give a long answer.
    Dr. Gottlieb. Senator, I could think of no better time to 
serve the public health in this capacity than right now.
    Given the opportunities we have with science and technology 
to find fundamental cures for many diseases because of the new 
scientific platforms that we are seeing. The authorities that 
Congress has recently passed, I think will give the agency a 
fundamentally different way or the opportunity to enact a 
fundamentally different way of looking at these new 
technologies.
    We have within our grasp the ability to cure pediatric 
inherited diseases. We have within our grasp the ability to 
cure many cancers with immunotherapy and other applications, 
regenerative medicine, cell therapy, gene therapy. These are 
enormous scientific opportunities, and I think the FDA stands 
at a tremendous opportunity to try to make these come to the 
market.
    Senator Hatch. I want to commend you for your attitude 
because there should be no question about your being selected 
here. In all honesty, you bring a tremendous amount of 
experience and ability to the agency. You know where business 
is right and where business is wrong too.
    I am absolutely convinced that you will stop some of the 
things that are wrong in the agency and outside of the agency. 
I have great confidence in you.
    Take Hatch-Waxman, can we improve Hatch-Waxman?
    Dr. Gottlieb. There are opportunities to make sure that 
Hatch-Waxman is having its intended effect on the market, 
Senator.
    Sitting here today without the benefit being briefed by the 
staff at FDA and better understanding these issues--because 
issues always look different from the inside than they do 
outside--I think that there are opportunities to make sure the 
law is having its intended impact.
    If that requires us to look at certain aspects of the 
statute, I would certainly come back to Congress and have that 
discussion.
    Senator Hatch. I would like you to do that because as the 
author of Hatch-Waxman, I want it to be perfect for the agency 
and for our country, and not just what I thought at the time 
was perfect. I appreciate your answer on that particular 
subject.
    We are very fortunate to have you willing to do that with 
the vast experience that you have. Having worked with the FDA 
for, really, years, and years, and years, this is a pleasant 
experience as far as I am concerned.
    Let me just ask you this. The independent Office of 
Government Ethics, in consultation with the Department of 
Health and Human Services' Ethics Division, approved your 
public financial disclosure form and your ethics agreement.
    Is that correct?
    Dr. Gottlieb. They did, Senator.
    Senator Hatch. They went into that thoroughly?
    Dr. Gottlieb. They did, Senator.
    Senator Hatch. OK. Based on information the OGE--the Office 
of Government Ethics--concluded, Dr. Gottlieb is in compliance 
with applicable laws and the regulations governing conflicts of 
interest. According to your ethics agreement, upon 
confirmation, you will resign from 13 positions.
    Is that correct?
    Dr. Gottlieb. I have not counted, Senator, but it sounds 
about right.
    Senator Hatch. Within 3 months of confirmation, you will 
divest yourself from 30 financial interests?
    Dr. Gottlieb. That could be right, Senator. That sounds 
about right. Yes.
    Senator Hatch. How stupid can you be?
    The reason I am asking that rhetorical question is because 
I do not think people appreciate what it means for somebody 
like you, with the tremendous expertise that you have, to walk 
out of the private sector into this Government job, with all 
the sacrifices that are going to be required and the huge 
commitments that are required.
    I do not think they appreciate what you are doing here. 
They should.
    I want to personally thank you for your willingness to 
serve this country in this position, with your vast background, 
and with your reputation as an honest, decent, very scientific 
person.
    There should not even be any question about your ability to 
do this job and to do it well. I personally want to 
congratulate you for being willing to do it and to tell you how 
much I appreciate it.
    Dr. Gottlieb. Thank you, Senator.
    The Chairman. Thank you, Senator Hatch.
    Senator Bennet.

                      Statement of Senator Bennet

    Senator Bennet. Thank you, Mr. Chairman.
    Dr. Gottlieb, congratulations on your nomination and 
welcome to the committee.
    I wanted to go back to the opioid and heroin epidemic that 
is happening in this country. I have, like my colleagues on 
this panel, spent a lot of time having town hall meetings 
throughout my State. I have noticed over time that families are 
ripped apart and communities are having profound difficulties 
coping with this problem, which, by the way, we do not have an 
answer for right now in terms of addiction treatment especially 
in rural areas of this country. I am going to park that 
observation and ask you the question.
    How did we get here in your view? Not just from the FDA 
point of view, because the problem of very addictive opioid 
prescription drugs being approved without a sense of how 
addictive they were, if you look at the history, and then cheap 
heroin coming in behind those drugs that have perpetuated the 
addictions that we face.
    I wonder if you could give us a perspective, not just as 
the potential Commissioner of the FDA, but also as a physician 
in thinking about the way these drugs have been prescribed and 
used to manage pain.
    What do we need to learn from this experience? So that we 
not just do not make the same mistakes, but we can dig 
ourselves out of this horrible epidemic across our country.
    Dr. Gottlieb. Thank you for the question, Senator.
    I have stated here a number of times, I think this is a 
public health emergency on the order of Ebola and Zika. We need 
to treat it that way. We need to treat this as a public health 
crisis that is going to require dramatic action.
    For a long period of time, we did not fully recognize the 
scope of this evolving problem and our actions to try to 
address it might have been too incremental in nature. I do not 
say this to try to pass judgement on people who have preceded 
me at the FDA. I was at the FDA for part of that time as well.
    I do not think we fully recognized the scope of the 
emerging problem, the true addictive nature of these products. 
Clinical medicine and physicians, and I am a physician who has 
prescribed these drugs, are partly responsible for that.
    To your point, this is now a problem that is big enough 
that whereas at one time it might have been within the scope of 
FDA to address this problem in a more robust way--I do not want 
to say solve the problem--but address it in a more fulsome way. 
It has now grown so large that it has grown outside of FDA's 
ability to address by itself.
    This is a public health challenge that we are going to need 
to address through the full gamut of our public health 
resources. That does not mean that the FDA does not have an 
important role to play, but I will say from the standpoint of 
FDA, I think in order to address it now, the types of actions 
we are going to need to take are going to be far more dramatic, 
perhaps, than the types of actions we would have needed to take 
if we had done more 10 years ago to get ahead of this.
    Again to your point, we now have the problem that people 
move to the lowest cost alternatives. It is no longer just 
opioids. Having become addicted on opioid, people are moving to 
heroin.
    Senator Bennet. I am delighted to hear you say that and the 
Chairman's very first question was about opioids today. You now 
probably have a sense of the priority this is for this 
committee.
    I agree that this is beyond the purview of just the FDA. We 
are going to have to find a way to get agencies to collaborate 
to deal with these issues, and you calling it an Ebola-like 
crisis, is very helpful to the cause.
    I want to shift gears just for the remainder of my time. Am 
I out of time, Mr. Chairman?
    The Chairman. No.
    Senator Bennet. For the remainder of my time just to talk a 
little bit about the Breakthrough Therapy legislation Richard 
Burr and I worked on.
    That is, as I said the other day in the committee, we have 
seen great breakthroughs as a result of that in oncology, not 
so much in neurology.
    I wonder if you have some views of why that has been? 
Whether in the progress that you are seeing or predicting, 
whether neurological diseases will be part of that as well?
    Dr. Gottlieb. Thank you for the question, Senator.
    We have seen some parts of the agency work exceedingly well 
with respect to implementing the spirit and the practicality of 
the Breakthrough Pathway.
    We have seen uneven application of it, but I think that 
that is resolving inside the FDA. You are starting to see more 
uniform application of both the spirit and the letter of the 
law in that regard.
    I would hope if I am confirmed into this role to find ways 
to try to install a broader embrace of this Pathway. It is an 
exceedingly important Pathway. It has provided the opportunity 
for patients who have unmet needs to get therapy that might not 
have been available as efficiently without this in place. It 
has had a real positive impact.
    As a physician, I can say I think this has had a real 
positive impact on the ability of patients with unmet medical 
needs to get safe and effective therapeutics in a timely 
fashion.
    Senator Bennet. Thank you for that.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Bennet.
    Senator Cassidy.

                      Statement of Senator Cassidy

    Senator Cassidy. Dr. Gottlieb, enjoyed our conversation.
    Dr. Gottlieb. Thank you.
    Senator Cassidy. One thing I remember is that when I almost 
tempted you to criticize the staff, you said no. You thought 
you must first look at the systems. That oftentimes you can 
improve the performance because you just put in better systems. 
That was obviously the insider's perspective, but also very 
generous. Some who have suggested, that you are not going to be 
supportive, and I just thought you were incredibly supportive.
    That said, there is a GAO report that I am looking at from 
May 2016 in which--just a comment on this briefly because this 
will lead to the next question--in which the GAO was somewhat 
critical of the FDA saying it lacks measurable goals to assess 
its progress in advancing regulatory science. The science 
supporting its effort to assess the products it regulates.
    It goes on further to say there are lots of resources that 
have been given to the FDA, but that indeed they have not 
systematized how they account for the spending.
    Any thoughts on that?
    Dr. Gottlieb. Thank you for the question, Senator.
    I am familiar with the report. I have reviewed it in the 
past. That this is both a challenge and an opportunity trying 
to make sure that we not only have the best workforce possible 
in order to ensure the FDA gold standard. That they have the 
best training, the best tools, and are being forward leaning in 
trying to adopt the best science into the principles that they 
use to govern the review process.
    This is something--when I was at the FDA with Dr. 
McClellan, we initiated a critical path initiative to try to 
democratize an effort to try to improve the quality of the 
tools that were being used. Not just by reviewers, the tools on 
their desk, but also the tools that they were enabling sponsors 
to use as part of the requirements by which they judged drugs.
    This would be a high priority of mine if I was fortunate 
enough to be confirmed into this role to continue to push on 
these opportunities.
    Ultimately, this is how we are going to make the review 
process more efficient without sacrificing on the gold 
standard. I think it is ultimately how we are going to make the 
development process less costly, while still meeting FDA's high 
bar.
    Senator Cassidy. You said it is a false dichotomy, science 
versus safety or speed versus safety. This would be one way you 
could achieve both.
    Dr. Gottlieb. This is the way you can achieve both. 
Absolutely.
    Senator Cassidy. Let me ask you something else. I am going 
to hit a tangent and then come back.
    One of my favorite historical figures is William 
Wilberforce, many reasons why, but among them is that he 
realized there were a lot of problems with drunkenness related 
to gin. The way he mitigated that was he had pushed the sale of 
beer. The idea is you would get so bloated, you have to 
urinate, et cetera, etc., that you could only drink so much 
beer as opposed to drinking a lot of gin. It was really 
successful.
    About that because tobacco is a scourge in terms of health, 
but I sometimes think maybe the way to address tobacco is by 
tobacco mitigation. If you look at the Center for Tobacco 
Products, it seems as if there is less than openness about 
looking for products that would be an alternative to a 
cigarette, although still a nicotine delivery system, that 
would have less of the untoward effects associated with 
cigarettes.
    It does seem like the Center for Tobacco Products does not 
really use the traditional notice and rulemaking process. You 
know more about this than I, but it seems to not follow a 
process that would allow some of these mitigating products to 
be released.
    Any thoughts on that?
    Dr. Gottlieb. Thank you for the question, Senator.
    If I am confirmed into this position, I am committed to the 
goals of the TCA and making the TCA work.
    Congress had great foresight in envisioning the opportunity 
for reduced harm products to transition smokers off of 
combustible tobacco onto reduced harm products that posed less 
of a risk as an animating principle as part of a comprehensive 
regulatory scheme for nicotine containing products. I am 
committed to trying to make that component of the TCA work 
along with all of the other components of the TCA.
    These are ultimately questions that can be adjudicated in a 
proper regulatory context. An e-cigarette, for example, or a 
vaping product might be a good smoking cessation tool and an e-
cigarette flavored like chocolate chip cookie dough might not 
be.
    That in the proper regulatory context, we have the tools, 
thanks to Congress, to adjudicate these questions.
    I do think that, to your point, I think there is an 
opportunity to make this framework much more comprehensive and 
much more viable.
    Senator Cassidy. I have 16 other questions, but I have 15 
seconds, so I will yield back and thank you.
    The Chairman. Thank you, Senator Cassidy. We will have a 
second round if you want one.
    Senator Franken.

                      Statement of Senator Franken

    Senator Franken. Thank you. I am struck by the gin for beer 
because I would just like to throw it open to anybody here. 
That does not actually work.
    Senator Cassidy. It worked in England. That was actually 
seen as a milestone. I do not want to use your time, but it is 
used as a milestone in the cessation of alcoholism.
    Senator Franken. I am skeptical.
    Sorry, it just threw me.
    Let us talk a little bit about, first, conflicts of 
interest. You are taking yourself out of this for a year and 
you have recused yourself from decisions that would impact 20 
or so healthcare companies that you have been involved in for a 
period of a year.
    President Trump pledged that all his appointees would 
recuse themselves for 2 years. Why do you not just do that?
    Dr. Gottlieb. Senator, I appreciate the question.
    That was the discussion that I had with the Office of 
Government Ethics and what they required me to do. I am going 
to have a separate discussion, if I am fortunate enough to be 
confirmed into this role, with the ethics officials at FDA and 
HHS. They might very well impose additional requirements, and I 
will follow whatever advice and counsel I get from those 
officials.
    Senator Franken. OK. I would prefer it, too.
    You mentioned on opioids, you said we need an all-of-the-
above strategy, but I did not hear you mention some of the 
obvious all-of-the-above. One is treatment. Treatment now in 
ACA is an essential health benefit, but there was an attempt to 
take that away in the House bill.
    I just want to know how you feel about taking that 
essential health benefit away?
    Dr. Gottlieb. I thank you for the question, Senator.
    I did mention MAT, Medically Assisted Therapy, and I think 
within the context of my responsibilities at FDA, if I were to 
be confirmed--
    Senator Franken. What did you say?
    Dr. Gottlieb. I said within the context of my 
responsibilities--if I was going to be confirmed into this 
role--would be, in the context of this problem, to look at what 
the principles are for evaluating Medically Assisted Therapy, 
MAT.
    Senator Franken. OK.
    Dr. Gottlieb. Medically Assisted Therapy as a component of 
treatment.
    Senator Franken. I thought you said medications.
    Dr. Gottlieb. Yes it is medication, but--
    Senator Franken. OK. That is what you mean.
    Dr. Gottlieb. Right. Medication for people who are 
addicted, yes.
    Senator Franken. That is different than in-house treatment. 
I am sorry. That is different than rehab.
    Dr. Gottlieb. You are talking about a service. I am talking 
about the medication that is used in the context of a service.
    My responsibility as FDA Commissioner would be to approve--
    Senator Franken. I am talking about the essential health 
benefits in the ACA. That was my question.
    Dr. Gottlieb. Right. I appreciate the question.
    Senator Franken. You can answer the question without it 
having to be directly related to your duties at FDA, please.
    Dr. Gottlieb. Senator, I appreciate the question. If I am 
confirmed into this job, I am going to have a lot of people 
asking me to opine on issues that fall outside of the scope of 
FDA. I think I would do--
    Senator Franken. OK. Never mind. I am just saying that 
residential treatment for opioid addiction is a really good 
thing. That is what I wanted to say, and if you are talking 
about all-of-the-above, if you are talking about all of the 
above that is really important to people.
    If you are talking about a crisis that is the scope of 
Ebola, and you do not keep residential treatment as part of the 
essential benefits package of insurance, I do not think you are 
taking it as seriously as you would an Ebola-level crisis.
    I want to talk about something more maybe in your purview 
which is Naloxone, which you have not mentioned either. If you 
are taking an all-of-the-above approach, I think you would talk 
about Naloxone.
    I spent a minute on beer, Mr. Chairman, so I want 30 
seconds.
    A two pack dose of the auto-injector for Naloxone rose from 
$690 in 2014 to $4,500 today. This goes to the prices of drugs, 
which everyone in Minnesota talks about when I go around the 
State.
    You did not mention Naloxone which saves a tremendous 
number of lives. It is part of the all-of-the-above, believe 
me.
    What are you going to do to keep down the cost of drugs?
    Dr. Gottlieb. Thank you, Senator, for the question.
    I talked about the importance of MAT generally, which all 
of these things fall under. I share your concerns.
    With respect to Naloxone, that falls into the scope of 
complex drugs that I have talked about today. It is a drug-
device combination that is hard to ANDA those processes. It is 
hard to put alternatives through the generic drug approval 
process.
    I do think that there are ways that the FDA can 
administratively, perhaps, and it might require a statute, 
allow a pathway to make it easier to put generic alternatives 
to some of these drugs through the generic drug approval 
process so we can create more competition.
    Some of these issues relate to instructions for us under 
the current guidelines. The instructions for use for drug-
device combinations needs to be precise or the same for the 
branded drug and the copy drug in order to go through the ANDA 
process. There might be opportunities to relook at that 
framework.
    This is something I have spoken about a number of times 
here today that I am committed to working on with you.
    Senator Franken. OK. I hope you address that.
    Thank you, Mr. Chairman, for indulging.
    The Chairman. Thank you, Senator Franken.
    Senator Roberts.

                      Statement of Senator Roberts

    Senator Roberts. Doctor, congratulations on your nomination 
and thank you for being here today.
    I want to associate myself with the very pertinent remarks 
by Senator Hatch regarding your decision for public service. 
Your background, as a physician and prior service at the FDA 
make you an excellent choice to lead the agency.
    We talked in my office, or to be more accurate, I talked 
and you listened. I am confident in your commitment to public 
health and in putting patients first in decisionmaking. I am 
going to vote for you and I am not going to ask you a yes or no 
question.
    I am chairman of the Agriculture Committee, as well as a 
member of this committee. I am particularly interested in your 
thoughts on the FDA's role in ensuring food safety.
    Under the previous administration, it is my opinion, that 
we saw increased activity and regulation actions on nutrition 
policies such as issuing voluntary guidance. Yet, at the same 
time, requesting additional money to comply with statutory 
requirements under the Food Safety Modernization Act, the 
acronym for that, by the way, is FSMA, which I find somewhat 
unique.
    I have concerns that the agency has not prioritized the 
FDA's mission to protect our Nation's food supply and instead 
focused on nutrition policies.
    How will you focus on core FDA duties such as implementing 
the law that Congress passed rather than agenda-driven 
nutrition policy guidance as we saw with sodium and added 
sugars?
    Dr. Gottlieb. Thanks for the question, Senator.
    This is an agency that has a statute that has been amended 
over 100 times since 1938 and has a vast scope of 
responsibilities. We do need to focus on core mission and make 
sure we are achieving what Congress intended in terms of 
protecting and promoting the public health.
    FSMA was a significant advance in terms of giving the 
agency authorities it needed and the resources it needed to 
ensure the food supply is safe. My mandate is going to be to 
make sure FSMA is implemented in a proper way and that we are 
striking the right balance with respect to that implementation.
    Senator Roberts. Last year in the Agriculture Committee, we 
worked the whole year and we are finally successful in passing 
the Biotech Labeling bill of which the Department will be 
working to implement in the next couple of years.
    At the same time, FDA has been working to update the 
Nutrition Facts Panel, which is set to go into effect next 
summer.
    There is a great deal of concern that the FDA has not 
provided the guidance necessary for compliance. This includes 
guidance for dietary fibers, which we discussed previously when 
you were in my office.
    In addition, hundreds of millions of dollars could be lost 
due to lack of coordination between the Department of 
Agriculture and the Food and Drug Administration on these label 
change timelines.
    Will you please work to ensure proper guidance is available 
and consider postponing the current deadline for the Nutrition 
Facts Panel to help reduce regulatory burdens?
    Dr. Gottlieb. Senator, this is something I would certainly 
be delighted to work with you on if I was confirmed into this 
role.
    I am philosophically in favor of trying to make sure that 
we do these things efficiently. Not only because it imposes 
undue costs on the manufacturers if they are constantly 
updating their labels, but we also have to keep in mind it does 
create confusion for consumers if the labels are constantly 
changing.
    You want to try to consolidate the label changes when you 
are making changes as a matter of public health so the 
information is conveyed accurately and efficiently to the 
consumers.
    This is something that I do care about, and I would look 
forward to working on it if I am confirmed.
    Senator Roberts. I appreciate that.
    Mr. Chairman, I have further questions. I will submit them 
for the record.
    Thank you very much.
    The Chairman. Thank you, Senator Roberts.
    Senator Baldwin.

                      Statement of Senator Baldwin

    Senator Baldwin. Thank you, Mr. Chairman.
    Welcome to the committee.
    Dr. Gottlieb. Thank you.
    Senator Baldwin. I had to step out to attend another 
committee meeting and missed some of the questioning, but 
hopefully I will not be covering all the same ground.
    I want to start by saying that I share some of my 
colleagues' concerns about both the optics and the potential 
for conflict of extensive financial ties and relationships with 
companies that you would directly regulate at the FDA.
    In addition to your financial holdings in multiple medical 
companies and board memberships, you have also long served as 
an advisor to and invested in New Enterprise Associates, a 
venture capital firm.
    During our meeting, and I appreciate you taking the time to 
visit with me, you noted that the FDA should focus on a more 
holistic approach to chronic pain to address, in particular, 
the opioid epidemic that we talked at some length about.
    One of the things you talked about was looking to medical 
devices as therapy options, but it turns out that New 
Enterprise Associates has invested in one such company, Nevro 
Corporation, which markets devices for chronic pain.
    I would like to ask you beyond what is already in your 
ethics agreement, what assurances can you give us that those 
significant business and financial relationships will in no way 
influence or bias your work directly regulating these companies 
at FDA, should you be confirmed?
    Dr. Gottlieb. I appreciate the question and I appreciate 
the opportunity to answer it, Senator.
    Just by way of background, and I am proud of my 
relationship with NEA. It has been one of the premiere venture 
capital firms in the country starting a lot of innovative 
ventures.
    Over the time period that I was there, they invested about 
$14 billion in 500 different companies. Per my ethics 
agreement, I disclosed that I had investments in five of those, 
all healthcare services companies.
    I was not actively involved on the medical device 
portfolio. A lot of my time was spent on the healthcare 
services portfolio, and that is not to say that it was 
exclusively spent on the healthcare services portfolio, but a 
lot of my time was spent working on healthcare services 
companies. That is just sort of a general understanding of my 
role at FDA [sic].
    I recognize the importance of bringing impartiality to this 
position. I recognize that someone could look at my background 
and have these questions. I appreciate the opportunity to 
answer them.
    I am going to be cognizant of trying to make sure I 
preserve the integrity of my role and do nothing in exercising 
my obligations, if I am confirmed into this role that would 
besmirch the agency and reduce people's confidence in the 
agency's mission.
    This is exceedingly important to me. I get it. I know why 
people care. The FDA's decisions are literally matters of life 
and death and I do not want to do anything in my conduct to 
reduce people's confidence in the agency's mission.
    Senator Baldwin. Thank you.
    You have also stated that the FDA should approve drugs 
faster and that too much regulation is the main barrier to 
lower prices, and these are certainly positions supported by 
the drug industry.
    To me it is about much more than just speeding more drugs 
to market. The FDA should address this through robust oversight 
of industry tactics especially when they are meant to game the 
system; simply to boost their bottom line. For example, by 
seeking to add or prolong market exclusivity periods or 
creating misleading direct-to-consumer advertisements.
    Will you commit to working with Congress to advance 
policies, which may be unpopular with drug companies, but yet 
give the FDA more authority to crackdown on abuses that lead to 
higher prices?
    Dr. Gottlieb. Thank you for the question, Senator.
    I agree with your concerns here. I think the FDA is 
constantly getting drawn into commercial disputes, which puts 
the agency in a very difficult position because it is a public 
health agency. It is not the FTC.
    It is hard for the FDA to simultaneously design policies 
intended to protect and promote the public health, and design 
policies intended to try to prevent companies from trying to 
use the regulatory process for commercial advantage.
    This is a problem that I am uniquely suited to try to look 
at and solve because of my background. Because I understand how 
companies have tried to game the process in the past. It is not 
illegal to try to use the regulatory process to gain commercial 
advantage.
    We should try to design policies that prevent those abuses 
because we do not want to be playing whack-a-mole with 
companies and going after them one by one.
    What I want is a framework in place that prevents those 
kinds of things from happening so people cannot use the 
regulatory process as a commercial arbitrage to gain unfair 
advantages. I could think of other places where I think that 
goes on.
    These are things I want to look at and frankly, I think 
these are things I am uniquely positioned to look at, 
hopefully, because of my background. That is where my work does 
inform some of these issues.
    Senator Baldwin. Thank you.
    The Chairman. Thank you, Senator Baldwin.
    Senator Murkowski.

                     Statement of Senator Murkowski

    Senator Murkowski. Thank you, Mr. Chairman.
    Dr. Gottlieb, welcome. I look forward to our visit this 
week.
    I want, as a kind of follow-on to what Senator Baldwin has 
raised in your response here, but I want to speak about it in 
the context of a specific example, and that relates to 
genetically engineered salmon.
    As you know, there were millions of Americans that wrote to 
the FDA opposing the approval of genetically engineered salmon. 
A whole number of grocery stores have announced that they will 
not sell it.
    Despite all of this immense opposition, in November 2015, 
the FDA approved AquaBounty Technologies' application for this 
new animal drug process. It was approved through that process 
despite the application being for Genetically Engineered 
AquAdvantage salmon for human consumption. It was the first 
G.E. animal approved for human consumption through this 
process.
    The FDA did not have any mandatory labeling requirement. 
Instead it said, well, it can be labeled voluntarily. We refer 
to this G.E. salmon as ``frankenfish,'' nobody is going to 
voluntarily label it as such.
    The valid question and concern is whether or not this fish 
should even be called a salmon, and there is great fear that 
lies with these mutated fish that have not gone through a 
proper EIS.
    The question to you this morning is whether or not you 
believe that genetically engineered fish and other animals for 
human consumption should be approved through the animal drug 
process?
    I am looking for your commitment to work with me to ensure 
that we have a better process, and hopefully a better solution, 
to what many of us, particularly in Alaska, are quite concerned 
about as a big problem.
    Dr. Gottlieb. Senator, I am familiar with the issue.
    I was not at the FDA when these issues were adjudicated as 
part of the approval process. The FDA has recently issued 
guidance on this matter that does not address all the issues 
that you have raised here.
    You have my commitment, if I am confirmed into this role, 
to work with you on it after I have had the opportunity to 
study the issue more closely once I am at the agency, if I am 
confirmed.
    Senator Murkowski. Good. Well another, keeping in that vein 
of seafood or fish, let me continue with an issue that is very, 
very concerning to us. This stems from FDA published advice on 
January 19 of this year, and it was advice for pregnant and 
nursing women on seafood consumption. This advice that came out 
purports to update the prior version of the same advice that 
was published back in 2004.
    When you look back at that scientific authority that speaks 
to regular seafood consumption by pregnant and nursing women, 
and the benefits that it provides, it is important information.
    The FDA's peer-reviewed study on maternal seafood 
consumption for fetal brain development, this is the Net 
Effects report, concludes that regular seafood consumption by 
pregnant and nursing mothers adds 2.63 IQ points to a child's 
growing brain. You have the additions for the cardiovascular 
and general health benefits of eating fish by the mothers 
themselves.
    What we then see is we have this guidance that comes out, 
or this advice that comes out, on January 19 that is based not 
on the Net Effects report. Instead on EPA's mercury reference 
dose, which is a toxicological standard that ignores the 
benefits of seafood and measures risks in isolation.
    What we have seen from this is that this advice is 
confusing. It does not give clear guidance to pregnant or 
nursing women. It widens the gap between the seafood advice and 
the dietary guidelines for Americans. It gives the EPA a more 
prominent role in developing a better nutrition policy.
    We have a great deal of concern about this particularly 
with regards to the latest information relating to halibut and 
sable fish.
    I would like your commitment to me that, if confirmed, you 
will revisit this seafood advice and consider modifications to 
what was issued in January of this year.
    Dr. Gottlieb. Senator, you have my commitment to making 
sure that the FDA guidance is fully science-based and providing 
proper information to consumers.
    I am familiar with the issue, but again, have not had the 
benefit of studying it and being fully briefed on it. You have 
my commitment that I will take a look at it and work with you 
on it.
    Senator Murkowski. It is something that we will have an 
opportunity to discuss further, but I will tell you this is one 
of those issues that I am really running out of patience on.
    We need to make sure that full consideration is given to 
the FDA science that was the basis for updating the advice in 
the first place, instead of this EPA mercury data that has 
nothing to do with ocean-caught fish. I want to work with you 
on that as well.
    Mr. Chairman, my time has expired.
    I thank you and I look forward to further conversation.
    The Chairman. Thank you, Senator Murkowski.
    Senator Whitehouse.

                    Statement of Senator Whitehouse

    Senator Whitehouse. Thank you, Mr. Chairman.
    Thank you, Dr. Gottlieb, for being here. A-plus to your 
girls for the super-good behavior they have had. It is probably 
an exceedingly boring morning for them.
    Senator Whitehouse. Back to the question of New Enterprise, 
I have been told that there are 82 companies that New 
Enterprise has investments in that might have products, or do 
have products that are before the FDA.
    Because of the nature of your relationship with New 
Enterprise, you were paid directly by New Enterprise. You were 
cut out from having a direct, financial relationship with those 
companies, which would have triggered more recusal 
requirements.
    I am not an investment person, but I do believe that very 
often people have pretty close working relationships on the 
investment banking side with the companies that they are 
invested in and are often de facto managers.
    When those--assume I am right about it being 82 companies--
when those 82 companies crop up with applications at the FDA, 
assuming that you are confirmed, who will take a look at that 
to make sure that the relationship is not one that you should 
recuse from?
    Dr. Gottlieb. Thank you for the question, Senator.
    Senator Whitehouse. By the way, this is not your fault. 
This is a question that has to do with the way the Government 
demands things of you. Your compliance is fine with what you 
have been asked to do.
    A little bit like Miss DeVos, not having to answer 
questions about her dark money operation or Administrator 
Pruitt not having to answer questions about his dark money 
operation. We have these places where our disclosure rules have 
not caught up with, what you might call, the new technology.
    I do not want to blame you for this, but I do think to what 
you said very clearly before about not impugning the integrity 
of the FDA. How would you manage that, or how would the FDA 
manage that for these exact companies?
    Dr. Gottlieb. Right. Thank you, Senator.
    I do not fully know what the phrase ``dark money'' refers 
to, but we have been very transparent with the NEA portfolio 
including putting the entire portfolio of my Form 278. The 
companies are all listed there with brief descriptions.
    Just to table set with respect to my relationship to New 
Enterprise Associates, and since it has come up a couple of 
times today.
    I was effectively a consultant to NEA and paid as a 
consultant to NEA, and advised them on a selected number of 
companies in their portfolio. Those companies are not entirely, 
but largely, reflected by the list of companies I recused from 
because a lot of my time was spent on the healthcare services 
portfolio at NEA, not on the life sciences and medical deice 
portfolio.
    That is not to say that I did not occasionally get drawn 
into meetings related to other portfolio companies, but it is a 
circumscribed set of companies that I might have touched in 
that relationship.
    This is another issue where I am looking forward, if I have 
the opportunity to be confirmed into this position, to talking 
to the ethics officials at the FDA and HHA about how to manage 
any potential conflicts that could arise with my relationship 
to New Enterprise Associates.
    You and I spoke in your office about the importance of 
personal integrity in this position, and I took that to heart. 
That means a lot to me. I am going to make sure that I follow 
the rules and do what I am told to with respect to this 
relationship.
    Senator Whitehouse. We have talked a little bit in this 
hearing about pricing of pharmaceuticals and talked a lot about 
opioids. I associate myself with the questions and concerns of 
FDA's role in the opioid epidemic.
    I do not think that we have talked much about antibiotics. 
I worry a bit that you described a ``brave new world'' in which 
new discoveries were going to lead to a whole new era of health 
and prosperity. At the same time, we are looking at potentially 
an end to a great era of health and prosperity brought on by 
antibiotics that were effective against most of the dangerous 
bugs that come after us.
    The more those bugs adapt to our antibiotics, if we do not 
keep up, I understand that the Centers for Disease Control 
estimates that 2 million people develop antibiotic resistant 
infections in the United States every year, and it kills 23,000 
of them. Antibiotic resistance is described by the World Health 
Organization as, ``One of the biggest threats to global 
health.''
    In all of these areas, we have concerns that really impact 
the public health that do not relate narrowly to the product 
being safe when used as prescribed. Right? The opioids were 
going to be likely safe when used as prescribed. It was being 
overprescribed that was the problem. The antibiotics, 
obviously, you have that problem of resistance developing. And 
with respect to price, if you cannot afford it, you have a real 
problem. There is an access issue that affects the public 
health.
    To what extent do you think the FDA should be venturing 
outside of that narrow question and into the broader questions 
of public health around those three points? Sorry, a long 
question.
    Dr. Gottlieb. As a hospital-based physician who has lost 
patients to resistant infections in the ICU, I recognize the 
gravity of the problem that you describe.
    That the agency has taken steps in recent years largely 
owing to congressional statute to try to address the problem in 
different ways, both on the development side with the 
provisions embedded in Cures, as well as what they have done on 
the animal feed side with respect to the use of anti-infectives 
in animal feed.
    What you describe is the broader stewardship question and 
whether or not it is within the scope of FDA's current 
authority to address that more societal question as a component 
of the review process.
    My short answer is: I do not know. My instinct is to think 
that this is something Congress needs to contemplate, and I 
would certainly be happy to work with you on this question.
    Senator Whitehouse. Fair enough.
    The Chairman. Thank you, Senator Whitehouse.
    Senator Hassan.

                      Statement of Senator Hassan

    Senator Hassan. Thank you, Mr. Chair.
    I will add my compliments to your girls. Senators have a 
hard time sitting still through these hearings, so you are 
doing really, really well. Thank you.
    Dr. Gottlieb, I appreciated the visit we had in my office 
as well. I just do want to go on the record echoing the 
concerns that many of my colleagues have raised about the issue 
of conflict of interest.
    To Senator Whitehouse's point, you are following the rules. 
That is good. You have extensive ties to the drug and biotech 
industry. If confirmed, you are going to be tasked with 
regulating the same companies.
    You take the issue of personal integrity very seriously. I 
appreciate that. I will just say that part of this issue is 
about self-awareness, and perspective, and who you identify 
with. If you are confirmed, I hope you will take that to heart 
as well.
    I wanted to spend a little bit more time on the issue of 
opioids. We spoke about it in my office and New Hampshire is 
one of the States which has just been devastated. We had about 
500 deaths in New Hampshire in the last year; 70 percent of 
those deaths involved the drug Fentanyl, which is becoming even 
more of an issue around the country.
    At a hearing that the FDA was at before this committee a 
few weeks ago, I asked about what are known as abuse-deterrent 
formulations, and you referred to them a little while ago in 
one of your exchanges.
    The opioids in the abuse deterrent formulations are just as 
addictive as they are in other products without the so-called 
abuse deterrent properties. Experts have done surveys that show 
that 46 percent of primary care providers think that these 
abuse deterrent products are less addictive than other opioids.
    That statistic is very high, but it does not surprise me 
because I can see how the term ``abuse deterrent'' could be 
confusing or misleading in this regard. What we are learning is 
that the opioid at issue may be packaged in a way that makes it 
hard to use in a traditional way for somebody suffering with 
addiction, but they just find a different way to use it.
    Do you think the FDA has a role to play here in ensuring 
that there is a common understanding among providers that 
products called ``abuse deterrents'' are just as addictive as 
other opioids and are not abuse proof? Because they can still 
be abused easily by, for example, just swallowing them.
    Dr. Gottlieb. Right. I echo your sentiments in many 
regards, Senator. I appreciate the question.
    The primary impediment to these abuse deterrent 
formulations becoming abused is that they are expensive right 
now. Once they go generic and become cheap, they are just as 
easily abused if you just take more of them.
    Senator Hassan. Right.
    Dr. Gottlieb. What we are talking about are drugs that are 
harder to divert or tamper with in ways that might make them 
more attractive abusable items.
    The underlying issue that you surface as to whether or not 
we have the right nomenclature to describe these drugs--and 
whether or not the nomenclature that we are using in how we 
describe these drugs is conveying the right message, not only 
to patients but in particular to providers--is a reasonable 
question.
    Within the scope of what I want to do to try to push the 
agency around looking at a different framework for how we 
address this problem, I would include that question.
    You and I talked about it. I saw the press release that 
went out from one of the groups, and when I read it, it struck 
me as a reasonable question to be asking. I want to ask that 
question.
    Senator Hassan. Thank you.
    One of the other tools that we know we can use to combat 
this public health crisis, and one of the ones that you have 
that the FDA has at its disposal, is the Risk Evaluation and 
Mitigation Strategies, otherwise known as REMS, which the 
agency uses to try to stem the risks associated with certain 
medications. As you know, that includes things like prescriber 
training.
    You have been public in the past about your opposition to 
REMS saying that they put burdens on providers. Because we are 
in the middle of a public health crisis, as you have 
acknowledged with this addiction epidemic, and because I know 
that many providers in my State welcome guidance from the FDA 
or anybody else who has the expertise about how to curb this 
public health crisis.
    Do you think physicians should be able to look to the FDA 
for guidance about how to prescribe drugs like opioids?
    Dr. Gottlieb. I do, Senator.
    The article you reference--which was a ``Health Affairs'' 
article, I think in 2007, 10 years ago--spoke to a different 
issue, which was the use of REMS to start to address drugs 
where there was a known risk. The FDA wanted to attenuate the 
off-label prescribing of the drugs across the range of purposes 
for which a physician might want to use a drug under his 
discretion; very different than this issue.
    I actually affirmed in that article--I largely affirmed the 
historical context in which the REMS had been used, which 
included the use of trying to prevent diversion and abuse of 
opioid drugs. That had been the historical use of REMS and, in 
fact, the early genesis of REMS under a different name--it was 
not called REMS back then--was created under Subpart H for the 
purpose, largely, of trying to address the opioid problem back 
at FDA.
    I do fully support the use of that tool in this context. In 
fact, I support the use of the tool across a lot of contexts. 
In many respects, the agency has gone on to use the program in 
ways that are far more judicious than what I was initially 
worried about when I wrote that article.
    Senator Hassan. Thank you.
    I see I am over time.
    I will submit for the record a question about some women's 
health issues because I am concerned about your involvement in 
what I thought, and many have thought, was a politically 
motivated delay of the emergency contraceptive Plan B when you 
were at the FDA. I will submit that in writing.
    Thank you.
    The Chairman. Thank you, Senator Hassan.
    Senator Murray.
    Senator Murray. I will actually follow up on that because I 
am concerned about political pressure at the agency, and I 
personally am outraged by this Administration's continued 
efforts to undermine and rollback women's rights and access to 
healthcare.
    This is not the first time I have had to fight a President 
and his administration to protect healthcare for women.
    In fact, I fought back the last time you were actually at 
the FDA, and the Bush administration ignored overwhelming 
scientific consensus and recommendations of two advisory 
committees and FDA career staff by deciding not to sell Plan B 
emergency birth control over the counter.
    I want to know if you will stand up for women and fight 
against any political attempts by President Trump and Vice 
President Pence to politicize decisions about women's health.
    Let me ask you specifically. Do you think the Bush 
administration made the wrong decision to deny women access to 
Plan B over the counter?
    Dr. Gottlieb. Senator, I am fully supportive of efforts to 
promote women's health.
    Insofar as there are concerns, I am not in my capacity, if 
I am confirmed into this role, going to re-litigate settled 
science and settled approval decisions in the absence of some 
compelling safety information that drives the agency to do that 
and a very clear recommendation from the career staff.
    Senator Murray. Do you think they were wrong in denying 
Plan B?
    Dr. Gottlieb. Senator, I was not involved in adjudicating 
that decision. That decision was made at the time based on the 
science that was available and the judgement of the people who 
were involved in doing that.
    I do not want to supercede the judgement of people 
retrospectively who made a decision at a certain point in time 
who were looking at certain data and certain issues, when I was 
not party to that evaluation.
    Senator Murray. You will be under immense pressure from 
this President and Secretary Price who continue to put politics 
ahead of women.
    Can you commit to me today that you will not allow them to 
use the FDA to further a political agenda against women's 
health?
    Dr. Gottlieb. In this regard, Senator, I appreciate the 
question.
    I am not going to relitigate settled approval decisions.
    Senator Murray. I am not talking about the past. I am 
talking about the future.
    We have watched the agenda of this Administration, and I am 
very fearful that they will put political pressure on you to 
make decisions not based on science and not based on evidence-
based treatment, and ask you to make decisions. What will you 
do?
    Dr. Gottlieb. As a physician and someone who cares about 
women's health issues, I am going to be guided by the science, 
and the public health, and the judgement of the career staff in 
how the FDA makes decisions under my leadership.
    Senator Murray. OK. This is very important because I asked 
Secretary Price during his confirmation hearing before this 
committee for his commitment that all 18 FDA-approved methods 
of contraception would continue to be covered, and he refused 
to make that commitment.
    Your commitment to make sure that any decision is science-
based, evidence-based is really important on this issue to me.
    Dr. Gottlieb. Thank you.
    Senator Murray. I also want to ask you about tobacco, which 
we touched briefly on before. When we met, you said you would 
prioritize continued implementation of the Tobacco Control Act.
    I have to tell you, I am concerned about your commitment to 
do everything you can to protect health under this really 
important landmark law in looking at your record in terms of 
this. Because while the Tobacco Control Act prohibited fruit 
and candy-flavored cigarettes, flavored e-cigarettes, and 
cigars have flooded the market in recent years. E-cigarettes 
are now available in thousands of flavors. You mentioned one a 
moment ago about Cookies and Cream. There is Pop Rocks.
    This should come as no surprise to you. I know that you had 
a financial stake and then served on the board of directors of 
the interestingly named KURE, a company that sells liquid for 
e-cigarettes in huge numbers of flavors including Gummy Bear, 
and bases its business model on attracting Millennials. You 
also had a financial stake in a separate company that markets 
those products, KURE's products.
    Children's use of these flavored tobacco products is a 
serious public health concern. Research supported, actually, by 
the FDA itself says 81 percent of children who have ever used 
tobacco products started with a flavored product. You cite 
flavors as the major reason for their current use of non-
cigarette tobacco products.
    If you are confirmed, do you commit to wholeheartedly 
addressing the clear, public health risk posed by flavored e-
cigarettes and cigars by resisting industry pressure to weaken 
the so-called ``deeming rule'' which brought e-cigarettes and 
cigars under FDA's authority?
    Dr. Gottlieb. Senator, I appreciate the question.
    I am committed to proper implementation of the TCA. As a 
physician and a cancer survivor, I am not going to countenance 
a rise in adolescent smoking rates in this country under my 
watch. I am going to make sure that we appropriately implement 
the law and fulfill Congress' intent in this regard.
    These are empirical questions, in my view, that you are 
raising about when a reduced harm product can be a useful tool 
for transitioning people off of combustible cigarettes onto a 
reduced harm product, and when they might be a gateway towards 
adolescent smoking to the point, you are making.
    In a properly constructed, properly overseen regulatory 
process, we should have the capacity under the authority the 
Congress gave to the agency to make these determinations. I am 
committed to trying to make that work.
    Senator Murray. What about banning flavored tobacco 
products and marketing practices that actually target our 
children?
    Dr. Gottlieb. Again, certainly marketing practices that 
target children, as I understand, are already illegal under the 
scope of the law.
    The issues of the flavoring and all these other issues that 
deal with the specific qualities of the vaping products are 
those kinds of empiric questions that I think career staff 
should be adjudicating in the Center.
    I want to provide the proper support to make these 
judgments. Make sure that we are finding a way to fulfill 
Congress' intent here, that there should be reduced harm 
products available to consumers to transition them off of 
combustible cigarettes.
    I do not want to supercede my judgement sitting here today 
without having the expertise of the career staff and certainly 
the ability to talk to them for what might or might not be a 
proper product. Other than to say that I recognize that a 
vaping product or an e-cigarette manufactured and flavored in a 
certain way might be inappropriate in one context, appropriate 
in another.
    Senator Murray. Gummy Bears? Cookies and Cream?
    Dr. Gottlieb. That I used the example of Cookies and Cream 
in my own comment, so I recognize that there is a line here 
somewhere, and I do not know where that line gets drawn. I 
think that that line needs to get drawn by people who are 
expert in evaluating that science, and I want to support them.
    Senator Murray. My time has run out. I have gone over. I 
appreciate that, Mr. Chairman.
    I do have a number of other questions and I appreciate your 
willingness to be here to answer them that I will submit for 
the record. I know a number of my committee members on this 
side do as well.
    Your thorough and straightforward responses will be much 
appreciated.
    Dr. Gottlieb. Absolutely.
    The Chairman. Thank you, Senator Murray.
    Thanks, Dr. Gottlieb, for your testimony this morning and 
let me join several of the Senators who commented on your 
children.
    As a father and a grandfather, I do not think I have seen 
5- and 7-year-olds sit so still for so long in a long period of 
time better than some I know pretty well.
    We compliment you and your family on that.
    Listening to the comments today, most of the criticism of 
you, to the extent that there has been any, has been because of 
your work with industries, and companies, and agencies that 
have something to do with the job you are about to do.
    We put public servants like you in an odd position. We ask 
someone to come in and run the Agriculture Department, and then 
we criticize them if they were a farmer.
    We expect someone to come in and take jobs in the Pentagon 
and deal with very complex issues of war and peace, and assume 
most of the time it would help if they knew something about 
military strategy before they come.
    The Secretary of Education, Miss DeVos, was heavily 
criticized because she had not worked for a public school or 
one of the public education agencies that she would be in 
charge of regulating as the Secretary.
    I remember when Secretary Tillerson was nominated, some 
even on my side of the aisle raised great questions because he 
knew Vladimir Putin so well.
    My own view is I like to have a Secretary of State who 
knows Vladimir Putin very, very well. I do not want someone in 
his pocket, but I want someone who does not spend 4 years 
getting to know him, trying to evaluate him, understanding his 
strengths and weaknesses, and what he might do right, and what 
he might do wrong.
    I agree with those Senators who said we are fortunate that 
you do have this broad experience. You are asked to be 
responsible for product areas as diverse as prescription drugs 
for humans, prescription drugs for animals, medical devices, 
biologics, dietary supplements, cosmetics, over the counter 
medication, food, and tobacco products.
    You are asked to implement a law we call 21st Century Cures 
that we worked on for more than 2 years and it is filled with 
nuance, and opportunity, conflicts, and differences of opinion.
    I like the idea of having someone in your position who is 
experienced, who recognizes those nuances, who sees the 
conflicts, who knows what a company may be able to do to create 
a new drug and how a company may be trying to game the system.
    Who might understand more rapidly than someone who does not 
have your background, how to look at a market that does not 
have competition and speed up competition so that it is, as you 
mentioned, less than 4 years and brings the price down so more 
families can afford the drug.
    I welcome your experiences and your background. I am glad 
that you are willing to serve.
    I would note that we had a very good experience with Dr. 
Califf, who had a distinguished career at Duke, who worked with 
20 drug and device companies before he came. I think that made 
him a much better Commissioner of the Food and Drug 
Administration. He did what you have done. He signed an 
agreement with the Office of Government Ethics and he recused 
himself from any activity that he had that presented a conflict 
of interest.
    On March 28, we received a letter from the Office of 
Government Ethics, which carefully reviewed your financial 
transactions, found that with several recusals--which you have 
committed to do--you are in ``Compliance with the applicable 
laws and regulations governing conflicts of interest.''
    You have said here that while you are in your position, you 
will continue to consult, as all agency heads must do, with the 
appropriate ethics personnel. If there are other recusals or 
decisions that you need to make, you will make those decisions 
at that time.
    Am I correct about that?
    Dr. Gottlieb. Yes, Sir.
    The Chairman. All these questions are appropriate about 
your past background, but in my view, I am delighted you have 
that background. I welcome your coming.
    This is a committee that, in the Senate, it does not take a 
genius to notice that we are in a little bit of a disagreeable 
patch right now in the U.S. Senate on some issues and that this 
is a committee with a broad diversity of opinions.
    We usually find an opportunity to work together on some big 
issues that benefit the American people.
    You heard one mentioned several times today and that was to 
see whether you and other parts of the Government could be 
forward leaning on opioids and particularly the idea of non-
addictive pain medicines, which Dr. Collins has talked about.
    You have heard us emphasize the importance of the new 
hiring authority that you have and our hope that you will work 
with the Administration with our support to quickly move to 
fill those spots in the agency, so that you will be able to 
consider and approve rapidly those applications that deserve to 
be approved.
    Senator Murray and I are committed to working together on 
the User Fees, which provide a lot of the funding, and it is 
important that we do that in a timely way.
    Senator Bennet asked you about the Breakthrough Pathways 
that he and Senator Burr authored. The new legislation has 
Breakthrough Device Pathways. It allows regenerative medicine 
to be a part of the existing, accelerated pathway.
    We hope that you will take advantage of all of those ideas 
and those authorities.
     Thank you for your testimony today.
    I ask consent to put into the record seven letters of 
support representing 29 groups including physician, 
pharmaceutical, and patient advocacy groups.
    [The information referred to may be found in Additional 
Material.]
    The Chairman. If Senators wish to ask additional questions 
of our nominee, questions for the record are due by the close 
of business Friday, April 7.
    For all other matters, the hearing record will remain open 
for 10 days. Members may submit additional information for the 
record within that time.
    Thank you for being here today.
    The committee will stand adjourned.
    [Additional Material follows.]

                          ADDITIONAL MATERIAL

                           Letters of Support
                    Alliance of Specialty Medicine,
                                            March 31, 2017.

Hon. Lamar Alexander, Chair,
Senate HELP Committee,
U.S. Senate,
Washington, DC 20510.

Hon. Patty Murray, Ranking Member,
Senate HELP Committee,
U.S. Senate,
Washington, DC 20510.

    Dear Chairman Alexander and Ranking Member Murray: The undersigned 
members of the Alliance of Specialty Medicine write to express our 
support for the recent appointment of Scott Gottlieb, M.D. to 
Commissioner of the Food and Drug Administration (FDA).
    As a practicing physician and hospitalist for many years, Dr. 
Gottlieb has a deep understanding of the effect healthcare policy can 
have on patients as well as physicians. We believe he will bring a 
wealth of knowledge to the position and be an important advocate for 
the health care community.
    He has also served in government in various capacities, including 
as senior adviser for medical technology, director of medical policy 
development, and deputy commissioner for medical and scientific affairs 
at the FDA. Given that wealth of policy experience, we believe he will 
provide a steady hand at the FDA to ensure that our patients receive 
products that are both safe and effective. In addition, his broad-based 
policy experience will hopefully help to guide a more collaborative 
effort between the FDA and other entities, especially the Centers for 
Medicare and Medicaid Services (CMS).
    Like Dr. Gottlieb, our organization is dedicated to fostering 
patient access to the highest quality care. We look forward to working 
with him to improve health care policy for specialty physicians and 
their many patients.

            Sincerely,

American Academy of Facial Plastic & Reconstructive Surgery; American 
    Association of Neurological Surgeons; American Society of Cataract 
    and Refractive Surgery; American Society of Echocardiography; 
    American Society of Plastic Surgeons; Coalition of State 
    Rheumatology Organizations; Congress of Neurological Surgeons.

        Association for Accessible Medicines (AAM),
                                      Washington, DC 20001,
                                                     April 4, 2017.

Hon. Lamar Alexander, Chair,
U.S. Senate,
455 Dirksen Senate Office Building,
Washington, DC 20510.

Hon. Patty Murray, Ranking Member,
U.S. Senate,
154 Russell Senate Office Building,
Washington, DC 20510.

    Dear Chairman Alexander and Ranking Member Murray: On behalf of the 
Association for Accessible Medicines (AAM), formerly the Generic 
Pharmaceutical Association (GPhA), I am writing in support of the 
nomination of Dr. Scott Gottlieb, M.D. to serve as the next 
Commissioner of Food and Drugs. AAM represents the manufacturers and 
distributors of finished generic pharmaceuticals and biosimilars, 
manufacturers and distributors of bulk pharmaceutical chemicals, and 
suppliers of other goods and services to the generic industry. I urge 
the committee to conduct its business promptly and approve the 
President's nominee without delay.
    Dr. Gottlieb is one of the most formidable thought leaders in the 
medical field and makes an excellent choice to lead the agency 
responsible for ensuring the health of the millions of patients FDA 
serves. I believe his firm grasp on the science and his understanding 
of the pharmaceutical market, and specifically the generic and emerging 
biosimilar markets, is unmatched. Dr. Gottlieb has advocated for 
effectively addressing the backlog of generic drug applications pending 
at FDA and ensuring that safe, effective and quality products are 
approved at their earliest possible date. This not only has the benefit 
of increasing competition to lower costs of drugs and biologics for 
millions of Americans, the Federal Government and other payors, but 
also improves public health by expanding access to quality treatments.
    We stand ready to work with Congress, the President, Dr. Gottlieb 
and his entire team to ensure that generic medicines continue to keep 
lifesaving treatments within reach of all Americans. We strongly urge 
the Senate to move forward with his confirmation in order to begin 
addressing the important task of lowering prescription drug costs for 
Americans.

            Sincerely,

                               Chester ``Chip'' Davis, Jr.,
                                               President and C.E.O.

           Every Life Foundation for Rare Diseases,
                                         Novato, CA, 94949,
                                                     April 3, 2017.

Hon. Lamar Alexander, Chair,
455 Dirksen Senate Office Building,
Washington, DC 20510.

Hon. Patty Murray, Ranking Member,
154 Russell Senate Office Building,
Washington, DC 20510.

    Dear Chairman Alexander and Ranking Member Murray: On behalf of the 
EveryLife Foundation for Rare Diseases, we write today to strongly 
endorse Dr. Scott Gottlieb for the next Commissioner of the Food and 
Drug Administration (FDA) and urge his speedy confirmation. The FDA is 
critical for advancing treatments for patients affected by rare 
diseases and we believe Dr. Gottlieb has the necessary skills, 
experience, and knowledge to lead the Agency.
    In particular, Dr. Gottlieb's prior experience at FDA means that he 
has the institutional knowledge that will allow him to begin working 
immediately on enhancing the agency. He has spoken out about the 
workforce issues that continue to impact the FDA, as well as the need 
for flexibility in review of rare disease therapies and the importance 
of improving specialization and expertise among FDA reviewers. 
Improving specialization will help ensure potential rare disease 
therapies receive a thorough review by the agency staff and will 
improve health outcomes for rare disease patients.
    Dr. Gottlieb has highlighted the importance of biomarkers in the 
use of development of novel treatments for rare diseases, which we view 
as a vital tool for helping to improve the efficiency and speed of drug 
development, while maintaining FDA's core and critical standards for 
safety and efficacy. If we are to successfully close the innovation gap 
that currently exists for the 95 percent of rare diseases without an 
FDA-approved treatment, new models and approaches are needed to help 
the 30 million Americans affected by a rare disease.
    Dr. Gottlieb has a strong track record as a supporter of biomedical 
research and innovation for rare diseases and understands how to 
improve and enhance drug review at the FDA. We believe he is well-
suited to be the next Commissioner.
    The EveryLife Foundation for Rare Diseases is a 501(c)(3) nonprofit 
dedicated to accelerating biotech innovation for rare disease 
treatments through science-driven public policy. We can do more with 
the science we already have and bring life-saving treatments to 
millions of people suffering from rare diseases.

            Sincerely,

                                          Max G. Bronstein,
                           Chief Advocacy & Science Policy Officer.

                                              Julia Jenkin,
                                                Executive Director.

                     HealthCare Leadership Council,
                                             April 3, 2017.

Hon. Lamar Alexander, Chairman,
U.S. Senate,
Health, Education, Labor, and Pensions Committee,
Washington, DC 20510.

Hon. Patty Murray, Ranking Member,
U.S. Senate,
Health, Education, Labor, and Pensions Committee,
Washington, DC 20510.

    Dear Chairman Alexander and Ranking Member Murray: The Healthcare 
Leadership Council (HLC), comprised of leaders from all sectors of 
American healthcare, enthusiastically endorses the nomination of Scott 
Gottlieb, M.D., to serve as Commissioner of the Food and Drug 
Administration (FDA) and encourages your committee and the full Senate 
to support his confirmation.
    Dr. Gottlieb's qualifications to lead the FDA are extensive and 
indisputable. In his previous roles at the FDA, the Centers for 
Medicare and Medicaid Services (CMS), and the Department of Health and 
Human Services, he has been centrally involved in some of the most 
important healthcare policy advances in recent years, including the 
implementation of the Medicare Prescription Drug, Improvement and 
Modernization Act, the generic drug user fee program, and expanding CMS 
coverage parameters to provide beneficiaries greater access to new 
medical innovations.
    Additionally, he has acted as a health policy thought leader, 
helping to shape the Nation's discussion on key issues through his work 
at the American Enterprise Institute, the American Medical 
Association's ``Pulse'' journal, and op-ed pieces in many major 
publications. In his writings, Dr. Gottlieb has consistently 
demonstrated his vision for accelerated medical innovation in this 
country and greater patient access to the drugs and devices that extend 
and improve lives.
    We need strong, active leadership at the FDA. In the ongoing effort 
to address concerns over healthcare pricing, enabling more robust 
competition in the biopharmaceutical marketplace is one of the most 
effective actions government can take. This can occur by expediting the 
processes through which generic drugs are approved for patient use. We 
believe this should be one of Dr. Gottlieb's highest priorities, should 
he be confirmed to lead the agency. As well, it is essential that the 
FDA take decisive administrative and regulatory actions in implementing 
the 21st Century Cures Act, enacted by Congress last year, and remove 
barriers that slow the movement of new, beneficial medical technologies 
to patients and healthcare providers.
    In coming years, the FDA will be instrumental in supporting 
profound advances in healthcare and victories against cancer, heart 
disease, diabetes and other severe illnesses. We believe Scott Gottlieb 
is the right person to lead the agency at this critical time and, 
again, we urge his confirmation.

            Sincerely,

                                            Mary R. Grealy,
                                                         President.

               Sarcoma Foundation of America (SFA),
                                        Damascus, MD 20872,
                                                    March 31, 2017.

Hon. Lamar Alexander, Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
466 Dirksen Senate Office Building,
Washington, DC 20510.

Hon. Patty Murray, Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
154 Russell Senate Office Building,
Washington, DC 20510.

    Dear Senators Alexander and Murray: The Sarcoma Foundation of 
America (SFA), the leading national patient advocacy organization 
representing the needs of sarcoma patients and their families, would 
like to express our enthusiastic support for the nomination of Scott 
Gottlieb, M.D., as Commissioner of the Food and Drug Administration 
(FDA).
    The SFA, a 501(c)(3) nonprofit charitable organization, advocates 
for increased research to find new and better therapies with which to 
treat patients with sarcoma. Sarcoma is a rare cancer of the connective 
tissue (bone, muscle, nerve, blood vessel, tendon, fat) with about 
16,000 new cases and 6,000 deaths each year in the United States. At 
any one time, more than 50,000 patients and their families are 
struggling with Sarcoma. It is rather prevalent in children, accounting 
for about 20 percent of all childhood cancers.
    The sarcoma community understands the importance of having strong 
leadership at the FDA. As a doctor and a cancer survivor, Dr. Gottlieb 
has proven through his distinguished career that he has the experience 
and knowledge to ensure that the agency successfully complete its 
important work, particularly in its efforts in drug review.
    Dr. Gottlieb has an exemplary track record of supporting and 
spearheading efforts to ensure that safe and effective treatments are 
moved through the review process in an expedient manner. During his 
tenure as the Deputy Commissioner for Medical and Scientific Affairs at 
the FDA, Dr. Gottlieb championed the need for the FDA to be efficient 
and patient-focused in its job of evaluating new therapies. This prior 
experience at the FDA and his efforts to increase efficiency through 
the Critical Path Initiative demonstrate his ability to improve the FDA 
through thoughtful, science-driven reforms. For these efforts, the SFA 
honored Dr. Gottlieb in 2007 with our Visionary in Medicine Award.
    As you complete your work to confirm the net Commissioner of the 
FDA, we ask that you take into consideration the needs of the sarcoma 
community and confirm Dr. Scott Gottlieb. The Sarcoma Foundation of 
America looks forward to working with Dr. Gottlieb upon his 
confirmation on the important issues that directly impact the lives of 
sarcoma patients.

            Sincerely,

                             Bert E. Thomas IV, Ph.D., MBA,
                                           Chief Executive Officer.

                Society of Hospital Medicine (SHM),
                                    Philadelphia, PA 19130,
                                                    March 17, 2017.

Hon. Lamar Alexander, Chairman,
Committee on Health, Education, Labor, and Pensions,
428 Senate Dirksen Office Building,
Washington, DC 20510.

Hon. Patty Murray, Ranking Member,
Committee on Health, Education, Labor, and Pensions,
428 Senate Dirksen Office Building,
Washington, DC 20510.

    Dear Chairman Alexander and Ranking Member Murray: On behalf of 
more than 50,000 practicing hospitalist physicians nationwide, the 
Society of Hospital Medicine (SHM) strongly supports the nomination of 
Scott Gottlieb, M.D., as Commissioner of the Food and Drug 
Administration (FDA).
    Practitioners of hospital medicine include physicians 
(``hospitalists'') and non-physician providers who engage in clinical 
care, teaching, research, or leadership in the field of general 
hospital medicine. In addition to their core expertise managing the 
clinical problems of acutely ill, hospitalized patients, hospital 
medicine practitioners work to enhance the performance of hospitals and 
healthcare systems.
    As a hospitalist and active member of SHM, Dr. Gottlieb has served 
on SHM's Public Policy Committee since 2011. In this period, Dr. 
Gottlieb has been an invaluable asset to SHM in understanding and 
addressing the most pressing healthcare issues of the day. During his 
time with SHM, Scott has been very involved with our efforts around 
empowering hospitalists and the overall healthcare system to push 
forward in delivering quality, patient-centered care at lower cost. His 
expertise has been helpful to both hospitalists and the patients we 
care for.
    Throughout his service to SHM, Dr. Gottlieb has shown his deep 
understanding of the many public health issues, delivery system 
reforms, and quality of care issues that are important to hospitalists 
and our patients. And he has been an invaluable resource and partner in 
developing solutions to these issues. His public service to the 
government in various healthcare-related roles, including his tenure at 
the Centers for Medicare and Medicaid Services (CMS) as Senior Policy 
Adviser to the Administrator, Senior Adviser for Medical Technology, 
Director of Medical Policy Development, and Deputy Commissioner for 
Medical and Scientific Affairs at the FDA will provide him with the 
deep and diverse experience that the role of FDA Commissioner demands. 
His insight into both the CMS and the FDA make him a rare and 
invaluable asset linking approval of much-needed treatments with access 
to such care.
    As a practicing hospitalist, and in his work with SHM, Dr. Gottlieb 
has shown an unwavering respect for physician autonomy and is a 
champion for the preservation of the patient-physician relationship. He 
is committed to putting the patient first in the delivery of high 
quality care.
    Dr. Gottlieb has a track record of leadership and dedication to 
building a patient-centered, quality-focused and efficient health care 
system. As FDA Commissioner, Dr. Gottlieb will bring a demonstrated 
commitment to public service coupled with the quality-driven, results-
oriented mindset of a hospitalist physician.
    We urge you to vote in favor of his nomination.

            Sincerely,

                                   Brian Harte, M.D., SFHM,
                           President, Society of Hospital Medicine.

                                             April 4, 2017.

Hon. Mitch McConnell, Majority Leader,
U.S. Senate,
SR-317 Russell Senate Office Building,
Washington, DC 20510.

Hon. Charles Schumer, Democratic Leader,
U.S. Senate,
SH-522 Hart Senate Office Building,
Washington, DC 20510-6300.

Hon. Lamar Alexander, Chairman,
Senate HELP Committee,
SD-428 Dirksen Senate Office Building,
Washington, DC 20510-6300.

Hon. Patty Murray, Ranking Member,
Senate HELP Committee,
SD-428 Dirksen Senate Office Building,
Washington, DC 20510-6300.

    Dear Majority Leader McConnell, Democratic Leader Schumer, Chairman 
Alexander, and Ranking Member Murray: The undersigned organizations, 
representing millions of patients, advocates, caregivers, and health 
care providers would like to reaffirm our support for President Trump's 
nomination of Dr. Scott Gottlieb as Commissioner of the Food and Drug 
Administration (FDA). We ask that Senators in the Republican and 
Democratic caucuses, and the Senate HELP committee, vote to confirm Dr. 
Gottlieb.
    The United States is at a pivotal moment in terms of public health. 
The FDA and patients need the leadership and experience that Dr. 
Gottlieb will bring as soon as possible.
    Dr. Scott Gottlieb is well-qualified and has received broad-based 
support. Equally important, as a physician who has treated patients, he 
knows the value of having the best available treatments based on the 
best science. As a survivor himself, he knows what it's like to fight 
cancer and understands the challenges that patients face every day.
    Currently a resident fellow at the American Enterprise Institute 
focusing on the FDA and CMS, Dr. Gottlieb is also a member of the 
Federal Health IT Policy Committee. His previous experience includes 
public service from 2005 to 2007, as FDA deputy commissioner under 
President George W. Bush.
    Dr. Gottlieb has not only the experience that will be critical to 
expand upon the agency's important work, but also firsthand expertise 
as a physician who has treated patients, understanding the breadth of 
work that needs to be achieved on their behalf.
    Dr. Gottlieb's strong scientific base and in-depth knowledge of key 
regulatory processes will be key to his success in this position. Due 
to his knowledge and experience, Dr. Gottlieb 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. Gottlieb 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 
immediately confirm Dr. Scott Gottlieb as FDA commissioner.

            Sincerely,

Alliance for Aging Research; American Association for Cancer Research; 
    Association of American Cancer Institutes (AACI); CancerCare; CEO 
    Roundtable on Cancer; Coalition of Cancer Cooperative Groups; 
    FasterCures, a Center for the Milken Institute; Friedreich's Ataxia 
    Research Alliance (FARA); Friends of Cancer Research; Global 
    Healthy Living Foundation; Grandparents in Action; Lung Cancer 
    Alliance; LUNGevity; Lupus and Allied Diseases Association, Inc.; 
    Men's Health Network; National Coalition for Cancer Research 
    (NCCR); National Health Council; National Infusion Center 
    Association (NICA); National Kidney Foundation; National Patient 
    Advocate Foundation (NPAF); The Nicholas Conor Institute; Prevent 
    Cancer Foundation; Swifty Foundation.
                                 ______
                                 
  Response to Questions of Senator Alexander, Senator Murray, Senator 
 Enzi, Senator Sanders, Senator Burr, Senator Casey, Senator Isakson, 
Senator Franken, Senator Paul, Senator Bennet, Senator Collins, Senator 
 Whitehouse, Senator Cassidy, Senator Baldwin, Senator Hatch, Senator 
  Murkowski, Senator Murphy, Senator Roberts, Senator Warren, Senator 
                       Kaine, and Senator Hassan
                           senator alexander
    Question 1. I have heard that the FDA import clearance process does 
not allow critical medical shipments to be cleared in time to be 
delivered as required. Based on the FDA's data, 75 percent of the 
imports are subject to some type of review at the border, which can 
take hours, days, or even weeks to resolve. This problem will only get 
worse as new data requirements went into effect February 9.
    As more FDA-regulated products are imported, people who expedite 
shipment of those products need to have confidence that the products 
are legitimate and that they will get to patients on time.
    Under your leadership, what will the FDA do to improve?
    Answer 1. As a physician, I am sensitive to the needs of patients 
who are seeking critical medical shipments. I am familiar with this 
clearance process and the new data requirements that go into effect in 
February. But I cannot speak to the specific reasons as to why the 
timelines for the clearance process are unpredictable. If confirmed by 
the U.S. Senate, I will commit to working with you and your staff to 
identify and address the underlying issues related to this process to 
ensure that patients are not waiting for critical medical shipments any 
longer than the necessary time it takes the agency staff to assure the 
authenticity of the medical product and the integrity of supply chain 
through which it is delivered.

    Question 2. I have heard that the Center for Tobacco Products needs 
significant improvement and reconsideration with regard to the agency's 
regulatory path for newly deemed tobacco products, particularly premium 
cigars. Preventing long-term health effects of addiction to tobacco, 
particularly among youth, is an important aspect of FDA's public health 
mission. It is important that the tobacco center recognize the 
significant differences in newly deemed tobacco products, such as 
premium cigars, from traditional products covered under the Tobacco 
Control Act, and that the level of risk may be different depending on 
the product category. If confirmed, how could the FDA reconsider the 
regulation of premium cigars?
    Answer 2. Through the Tobacco Control Act (TCA), Congress gave FDA 
regulatory responsibility over tobacco products. If confirmed, I will 
be committed to implementing the TCA, as intended by Congress, 
including section 911 related to modified risk products, which I 
recognize can provide helpful tools for current tobacco-users to 
transition off combustible tobacco. I will also commit to better 
understanding the decision FDA made with respect to premium cigars, and 
any changes that were made in regard to premium cigars between the 
proposed and the final rule. As I was not at FDA during the agency's 
initial TCA implementation activities, I am not fully acquainted with 
internal processes or specific decisions to-date. If confirmed, I will 
work with the staff to quickly get up-to-speed on this issue, and I 
will review current FDA policies, including the deeming rule, to ensure 
FDA treats products appropriately, implements provisions in a timely 
fashion, and in a manner that is consistent with congressional intent 
under the TCA. I believe responsibly implementing the TCA is an 
integral part of FDA's core mission to protect and promote public 
health.
                             senator murray
    Question 1. The Food and Drug Administration (FDA) assures that 
drugs meet the gold standard of being both safe and effective based on 
a scientific, non-political review of raw data before they are marketed 
to consumers. Do you support upholding this gold standard?
    Answer 1. Maintaining the Gold Standard of safety and efficacy for 
medical products is fundamental to FDA's mission to protect and promote 
public health. If confirmed, I will uphold the Gold Standard by 
ensuring FDA makes regulatory decisions based on sound science, good 
regulatory practices, and the support of a strong staff. FDA should 
thoroughly consider regulatory approaches that could improve the 
efficiency of drug and device discovery, development, and regulation. 
But FDA should only adopt those sound scientific approaches that 
reliably improve on its gold standard for being both safe and 
effective.

    Question 2. The field of regenerative medicine has immense promise 
for patients--from cell and gene therapies to stem cells. I am proud 
that some of this innovative research is taking place in my home State 
of Washington within both cutting edge companies and our leading 
research institutions. As part of 21st Century Cures, Congress 
established the regenerative medicine advanced therapy designation for 
cell-based therapies that have the potential to address unmet medical 
needs. There have been repeated reports of patients being harmed by 
experimental regenerative medicine treatments that are being sold both 
here in America and abroad--for example, last month the New York Times 
reported that a clinic blinded three patients by injecting their eyes 
with stem cells. As Commissioner, what steps will you take to ensure 
FDA takes action against unscrupulous providers and ensures continuing 
innovation, the success of the RMAT designation pathway, and patient 
and provider confidence in this emerging field?
    Answer 2. Regenerative medicine is one of the most innovative and 
promising emerging advancements in our scientific approaches to the 
treatment of human disease. Regenerative medicine appears to hold great 
promise for new therapeutic options for patients and physicians, 
particularly in areas of unmet or underserved medical need. However, as 
with all products FDA regulates, the agency must have the appropriate 
policies and processes in place to assess and ensure the safety and 
efficacy of regenerative medical products before they are approved for 
use by American patients. FDA must also ensure patients and providers 
are appropriately educated about the potential risks and benefits of 
regenerative medicine therapies that fall within the scope of FDA's 
oversight, and that these products meet the agency's standard for 
safety and effectiveness. If confirmed, I will embrace the 
responsibility to facilitate important medical innovation in the 
regenerative medicine space, and will seek timely implementation of the 
new pathway created as part of 21st Century Cures, while maintaining 
the agency's Gold Standard of safety and efficacy.

    Question 3. Antibiotic resistance is growing public health threat. 
CDC estimates that there are at least 2 million drug-resistant 
infections each year in the United States resulting in approximately 
23,000 deaths. All antibiotic use increases the risk of development of 
antibiotic resistance. In order to minimize the growth of antibiotic 
resistance, antibiotics should be prescribed judiciously, but the CDC 
estimates that up to 50 percent of antibiotics in human healthcare 
settings in the United States are inappropriately prescribed.
    What do you feel is the appropriate role for FDA in ensuring 
judicious use of antibiotics?
    21st Century Cures established the Limited Population Approval 
pathway for antibiotics. Are you committed to following the strong 
labeling requirements for these products in the law and educating 
prescribers about appropriate use?
    How will you work to prevent drug shortages of antibiotics, which 
can lead to overprescribing of broad spectrum antibiotics?
    Answer 3. The availability and appropriate prescribing of 
antibiotics are vital to our Nation's public health. Additionally, 
antibiotic resistance is a significant and growing public health 
challenge facing our Nation. Within its statutory authorities, FDA 
should encourage the development of new antibiotics and ensure proper 
labeling to help address the issue of inappropriate prescribing and/or 
use. If confirmed, I would commit to following the law, as it relates 
to the Limited Population Approval pathway for antibiotics. Further, I 
would prioritize effectively preventing and decisively alleviating drug 
shortages, particularly those of antibiotics, many of which are 
parenteral drugs used in hospitalized settings.

    Question 4. I believe that precision medicine relies on effective 
and meaningful lab tests to inform treatments, and that this area of 
innovation should be fostered. However, there are many recent examples 
of lab tests being marketed to physicians and patients that have no 
real clinical meaning, have led to patients being over- or undertreated 
for diseases, or exposed patients to inappropriate therapies or stopped 
them from receiving effective therapies. On October 3, 2014 the FDA 
issued a draft oversight framework for LDTs based on risk to patients, 
rather than whether they were an LDT of IVD. Since that time, Congress 
and stakeholders have been actively engaged in the discussion about how 
best to modernize lab oversight in the era of precision medicine. In 
January of this year, FDA released a white paper that updated the 
agency's position based on stakeholder feedback to the 2014 framework. 
You have argued that the regulation of these tests is best left outside 
of FDA's jurisdiction, and instead, CLIA should be updated to be more 
robust.
    Do you support the framework in the January 2017 white paper?
    What FDA role in oversight of LDTs do you believe is necessary to 
address the Agency's longstanding and well-publicized concerns about 
those tests?
    Do you believe that FDA has the legal authority to regulate lab 
rests?
    How will you work with Congress and CMS to ensure that lab tests 
are both accurate and clinically meaningful?
    Are you committed to supporting a regulatory framework that would 
give patients and their provider's confidence in the quality and 
veracity of their tests, and level the playing field for innovators?
    Answer 4. Defining an appropriate regulatory framework for 
Laboratory Developed Tests (LDTs) is important to FDA's mission to 
protect and promote public health. In order to both protect patient 
safety and encourage innovation and patient access, I believe we must 
strike the right balance between Clinical Laboratory Improvement 
Amendments (CLIA) and FDA regulation and regulatory requirements. If 
confirmed, I would commit to working with Congress and stakeholders to 
develop appropriate LDT regulatory policies that strike the right 
balance between encouraging innovation while making sure that patients 
and providers can be confident in the clinical validity of the results 
that they receive from LDTs.

    Question 5. In your hearing, you were asked whether there should 
still be double-blind trials in 2017. While I agree that the FDA should 
consider all appropriate trial designs to assess the safety and 
efficacy of drugs, I am concerned that your response did not provide 
any examples in which you believed that a double-blind study would be 
appropriate. Are there any diseases or drug classes that you believe 
double-blind studies are the best way to determine efficacy or safety? 
If so please include examples. Or do you believe that there are no 
circumstances that warrant such a trial?
    Answer 5. There are many clinical settings where double-blind, 
placebo controlled trials remain the gold standard for properly 
determining safety and efficacy and define the appropriate standard for 
FDA's approval requirements. While it might not be appropriate for me 
to opine on specific approval standards with respect to specific 
clinical circumstances and drug trials--as these determinations are 
best left to the expert judgment of FDA's career staff--I fully 
recognize that there is a continuum of clinical trial designs and 
evidentiary standards that FDA must require based on the clinical 
setting, the clinical appropriateness, the feasibility, and the 
underlying patient need. These requirements are exercised within the 
scope of the discretion that is afforded to agency staff by statute and 
regulation. This ability of FDA's staff to use judgment in how they 
apply the single gold standard for determining safety and effectiveness 
is a reflection of the careful consideration that FDA's staff must 
strike in order to properly balance access, innovation, and safety. If 
confirmed, I will support a strong FDA, with staff making these kinds 
of judgments through a rigorous, science-based process.

    Question 6. I understand the urgency that patients and their 
families feel when they are desperate for new treatments. I believe 
that we must ensure therapies are available to those who need them 
most. I have concerns about so-called ``right-to-try legislation,'' 
which could hurt those it is designed to help. I believe that access to 
investigational drugs should be done in a way that maintains and 
bolsters the drug development process that brings us lifesaving cures, 
and prevents a two-tiered system where those who can afford to buy an 
investigational treatment can have access and those that cannot have to 
wait. In your confirmation hearing I asked if you were willing to stand 
up to the Administration if they put political pressure on you, and you 
stated that you would give ``unvarnished advice'' and ``clear 
thoughts'' on issues you are asked to opine on. Given the Trump 
administration's support of right to try laws, please give your 
perspective on both the impact on patients, and drug development 
process, if the current Federal legislative proposal was enacted.
    Answer 6. Access to off-label and investigational products for 
patients facing serious and terminal illness is not an abstract issue 
to me. As a cancer survivor who used a commercially available 
combination therapy in an off-label manner, I understand, at a very 
personal level, that patients who are fighting serious or life-
threatening diseases want the flexibility to try new therapeutic 
approaches, including access to investigational medical products, 
particularly when there is no other FDA-approved treatment option. I 
also believe that the clinical trial process is crucial to the 
development of innovative new medical products that can improve or save 
patients' lives. If confirmed, I would commit to ensuring FDA has the 
right policies and processes in place to appropriately balance 
individual patients' needs for access to investigational therapies 
while recognizing the importance of maintaining a rigorous clinical 
trial paradigm for testing investigational products and demonstrating 
safety and efficacy. I would be happy to work with Congress as it 
considers Right-to-Try legislative proposals.

    Question 7. According to a New England Journal of Medicine study 
published earlier this week,\1\ the FDA in recent years has approved 
more products, and approved them more quickly, than the European 
Medicines Agency. In a 2012 article published in National Affairs, you 
stated that the FDA puts up too many barriers to approval, and 
prioritized safety over speed.
---------------------------------------------------------------------------
    \1\ Downing, Nicholas S., et al. ``Correspondence: Regulatory 
Review of New Therapeutic Agents--FDA versus EMA, 2011-2015.'' The New 
England Journal of Medicine, vol. 376, no. 14, 2017, pp. 1386-1837, 
http://www.nejm.org/doi/pdf/10.1056/NEJMc1700103. Accessed 7 Apr. 2017.
---------------------------------------------------------------------------
    Given the implementation of FDASIA and 21st Century Cures, do you 
still hold that view?
    Can you give examples of products approved in recent years, that 
have since demonstrated a clear benefit to patients, and that you 
believe the FDA moved too slowly in approving?
    Answer 7. FDA has made significant progress in recent years to 
ensure that patients in the United States have access to new, 
innovative therapies thanks to new legislative pathways like 
Breakthrough Therapy designation. The adoption of the Breakthrough 
pathway addressed many of the concerns I raised in that 2012 article. I 
believe we should continue to look for ways to improve the efficiency 
of FDA's medical product review program, modernize the scientific 
standards used in drug regulation, and seek more uniform adoption of 
pathways created by Congress like the Breakthrough Designation, and 
build on these opportunities through adoption of the new provisions in 
Congress in 21st Century Cures. We need to do all these things while 
continuing to ensure that new products meet FDA's Gold Standard for 
safety and efficacy.

    Question 8. In my meeting with Tom Price, he stated that he 
believed in the gold standard of safety and efficacy for, but that it 
needed to be made ``evergreen'' so that it's easier for drug developers 
to innovate. Section 505(b) of the Food Drug and Cosmetic Act states 
that for a drug to be approved, a person must file an application which 
includes ``full reports of investigations which have been made to show 
whether or not such drug is safe for use and whether such drug is 
effective in use.'' \2\ Please describe if you think this language is 
``evergreen'' and applicable to today's technology. What specific 
current regulatory authorities and flexibilities does FDA currently 
have that makes the current standard ``evergreen?''
---------------------------------------------------------------------------
    \2\ 21 U.S.C. Sec. 355(b). 2012. LexisNexis Academic. Web. 7 Apr. 
2017.
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    Answer 8. Maintaining the Gold Standard of safety and efficacy for 
medical products is fundamental to FDA's mission to protect and promote 
public health. But owing to opportunities created by evolving modern 
science as well as new policies created by Congress--including 
provisions in 21st Century Cures--there are now more opportunities to 
make sure that FDA is adopting the best science and most efficient and 
modern regulatory tools for demonstrating that standard. This creates 
opportunities to make the development process more efficient, less 
costly, and at times faster, while also improving upon our ability to 
demonstrate safety and efficacy. These basic principles have formed the 
basis of our collective public health goals with respect to drug 
review. I recognize that FDA must reject policies or processes that 
would in any way undermine the safety and efficacy of our Nation's drug 
and medical technology supply because, for example, we were 
inappropriately prioritizing speed over the gold standard for safety 
and efficacy. If we are adopting modern science and investing in a 
strong FDA workforce, we can strive to achieve greater efficiency while 
improving on our gold standard for safety and efficacy. Getting better 
efficiency, and taking a risk-based approach to FDA's work, means FDA 
needs the appropriate policies, resources, and processes to 
consistently utilize 21st century regulatory science. FDA should 
thoroughly consider regulatory approaches that could improve the 
efficiency of drug and device discovery, development, and regulation, 
but only adopt approaches that reliably improve the ability to 
determine the safety and efficacy of medical products that Americans 
use.

    Question 9. While the FDA gold standard of approval helps to ensure 
the safety and efficacy of new products, we know that many new drugs 
and devices have not been studied on adequate numbers of women, people 
of different races and ethnicities, nor all age ranges. By implementing 
provisions of FDASIA, the FDA has taken a number of steps to improve 
the data required to be submitted for a new drug, and is reporting 
through Drug Snapshots the summaries of who was included in trials and 
whether there are safety or efficacy differences among subpopulations. 
The Drug Snapshots released this year from FDA shows many drugs are 
still being tested predominately in white men--even those intended to 
treat conditions that can have a disproportionate impact on women or 
minorities.
    Do you support requiring inclusion of women and minorities in 
clinical trial data submitted to the FDA?
    Are you committed to supporting additional work by the FDA to 
improve the diversity of clinical trials used to support medical 
product approvals?
    How will you ensure that doctors have information they need about 
how a new medication works in these subpopulations?
    Answer 9. I think it is very important that clinical trials capture 
the diversity of the population who will likely use the medical product 
once it is marketed and becomes available. If confirmed, I will work to 
ensure that FDA policies support the conduct of clinical trials that 
represent the clinical diversity of the intended patient population, 
including through the implementation of Section 907 of the Food and 
Drug Administration Safety and Innovation Act (FDASIA).

    Question 10. This year, Congress needs to reauthorize FDA's 
authority to collect user fees from the drug, medical device, 
biosimilar, and generic drug industries. It is the first time that 
Congress has been charged with this task in the first year of a new 
administration--and the Trump administration has proposed to both 
``recalibrate'' user fees and replace FDA budget authority with 
additional fees. In addition the President has issued a ``Hiring 
Freeze'' across the Federal Government.
    Do you support reauthorization of the PDUFA, MDUFA, GDUFA, and 
BsUFA agreements as finalized and submitted to Congress by the Obama 
administration?
    How does the FDA's appropriated budget contribute to the Agency's 
overall health and independence?
    Do you believe that user fees are an effective replacement for 
congressional appropriations?
    How will you ensure the FDA progresses toward its hiring and 
retention goals in the agreements and in the spirit of 21st Century 
Cures? In January, Senator Warren and I sent a letter to FDA Acting 
Commissioner Ostroff inquiring about the impact and implementation of 
the hiring freeze. When can we expect an answer to this correspondence?
    Answer 10. The reauthorization proposals for PDUFA, MDUFA, GDUFA, 
and BsUFA were developed and submitted to Congress prior to the end of 
the previous Administration. I was not involved with the FDA-industry 
technical negotiations on any of these proposals. I was also not 
involved in the development of the President's Blueprint Budget. I 
recognize these user fee programs are critically important to FDA, and 
the patients the agency serves, as they provide significant resources 
to support FDA's regulatory activities related to innovative and 
generic medicines, biosimilars, and medical technologies. In order to 
ensure FDA is adequately resourced to facilitate the discovery, 
development, and regulatory review of safe and effective medical 
products to help American patients, if confirmed, I will work with my 
colleagues in the Administration, Congress, industry, and stakeholders 
to reauthorize these critical user fee programs in a timely manner. I 
will also commit to making sure that congressional correspondence is 
answered in a timely fashion.

    Question 11. Biologic drugs are extremely important to patients, 
but the historic absence of competition has limited access and 
affordability to these important medicines while driving up health care 
costs. One of the best opportunities to help address this is support 
for timely review and approval of biosimilars. The biosimilar drug user 
fee agreement supports the review of these products.
    Do you support the biosimilars pathway?
    How will you work both within FDA and in collaboration with CMS to 
encourage and speed their development and availability to patients?
    How do you plan to help educate physicians and the public about 
biosimilars to increase their uptake in the market?
    Answer 11. Yes, I fully support the biosimilars pathway. This 
pathway is a critical part of the careful balance Congress prescribed 
between access and innovation, and the ability for consumers to get 
more value when it comes to the medical products they use. If 
confirmed, I intend to work closely with FDA staff and CMS to ensure 
the availability of biosimilar products. I recognize the importance of 
educating physicians and the public about the availability of, and 
FDA's confidence in, approved biosimilar products. I look forward to 
working with FDA staff, if confirmed, to increase education and build 
on current methods of outreach at FDA.

    Question 12. In 2013, a fungal meningitis outbreak took the lives 
of 64 people and sickened 751 in more than 20 States, including 
Georgia, Tennessee, North Carolina, Illinois, Rhode Island, Minnesota, 
and Pennsylvania. Congress responded by passing the bipartisan Drug 
Quality and Security Act, which clarified and enhanced FDA's authority 
to regulate drug compounding. Are you committed to protecting patients 
who need compounded drugs through implementation and enforcement of 
this important public health law as written, including the limitations 
under 503A?
    Answer 12. The practice of pharmacy compounding can serve an 
important role, allowing providers to develop individualized 
formulations of certain medicines for specific patients with unique 
needs. However, I know that there are examples of actors operating as 
manufacturers of unapproved new drugs under the guise of a pharmacy 
license, violating the careful framework created by Congress, 
circumventing the FDA oversight that Congress intended for certain 
products, and putting patient safety at significant risk. Congress 
clarified FDA's regulatory authorities related to compounding by 
passing the Drug Quality and Security Act (DQSA). 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.

    Question 13. Generic drugs now comprise the vast majority of the 
pharmaceutical market, and in many cases are the only products 
available for patients after a brand name product is discontinued. 
However, generic drug manufacturers are not able to update their labels 
efficiently with safety information without prior FDA approval and 
without the brand drug's label being updated as well. The FDA has 
recognized that this is a public health problem, and issued a proposed 
rule to allow such updates, known as CBE-0, but the release of the 
final rule has been delayed repeatedly. You have spoken out against 
this rule in multiple publications. Will you support issuing 
regulations allowing generic drug companies to amend their labels in 
order for patients and physicians to have ready access to the most up-
to-date information about their products?
    Answer 13. I believe it is important that generic drug labels be 
kept up-to-date and generic firms engage in appropriate post-market 
safety surveillance. FDA's proposed rule would alter the legal 
responsibilities of generic firms. If confirmed, I will work with FDA 
staff as we consider future regulatory actions to best achieve the 
underlying public health goals.

    Question 14. In 2013 in my home State of Washington, 32 patients 
were sickened with antibiotic resistant infections that were traced 
back to contaminated medical devices known as duodenoscopes. An 
investigation by my staff found that duodenoscopes around the country 
were harboring these bacteria, and that the cleaning protocols issued 
by the manufacturers were not sufficient. Since then, it has come to 
light that other reusable medical scopes have harbored potentially 
harmful bacteria--putting patients at risk. Section 3059 of the 
recently enacted 21st Century Cures Act requires the Secretary to 
publish a list of reusable devices, like medical scopes, that are 
required to have validated cleaning, disinfecting, and sterilization 
information for 510(k) clearance, and publish a guidance to clarify 
when device modifications require the submission notification under 
510(k). But just 2 weeks ago, another outbreak of antibiotic resistant 
infections was traced back to the same devices that the company said 
were fixed after the outbreak in Washington.
    Are you committed to meeting the deadlines in 21st Century Cures 
statue for these publications?
    What additional actions will you take to ensure reprocessed devices 
are safe for patients?
    Answer 14. If confirmed, I will continue to emphasize the 
importance of maximizing patient benefit and reducing safety risks 
related to duodenoscopes and will work to implement the related 
provisions of the 21st Century Cures Act. I am committed to working 
with FDA staff and Congress, where necessary, to ensure that reusable 
devices are safe for patients.

    Question 15. My investigation of contaminated duadenoscopes 
revealed that for medical devices, ``FDA's reliance on self-reporting 
of adverse events by manufacturers and hospitals is unworkable and 
outdated, particularly when contrasted with the active post-market 
surveillance system for drugs.'' \3\ I believe that the FDA needs to do 
more to improve post-market surveillance for medical devices. The FDA 
has recently engaged with external stakeholders to establish the 
National Evaluation System for health Technology, which acts as a hub 
for electronic data sources for medical device outcome and safety 
information. The NEST is also supported by the medical device industry 
in the MDUFA IV agreement, however, only for uses to improve pre-market 
review and approval of devices. Do you support the utilization of NEST 
for post-market surveillance activities? If so, do you commit to 
requesting funds in your budget for these activities?
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    \3\ ``Preventable Tragedies: super bugs and How Ineffective 
Monitoring of Medical Device Safety Fails Patients.''United States 
Senate Committee on Health, Education, Labor, and Pensions, 13 Jan. 
2016, https://www.help.senate.gov/imo/media/doc/Apples.pdf.
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    Answer 15. The reauthorization proposals for PDUFA, MDUFA, GDUFA, 
and BsUFA were developed and submitted to Congress prior to the end of 
the previous Administration. I was not involved with the FDA-industry 
technical negotiations on any of these proposals.
    However, I am generally supportive of data transparency and 
recognize the importance of collecting valid pre- and post-market data 
that can be used to bring new medical devices to market, expand 
indications for approved medical devices, and enhance the agency's 
ability to collect important patient safety information. If confirmed, 
I will commit to working with the FDA professional staff to quickly get 
up to speed on this issue and help the agency evaluate whether NEST 
could be an appropriate tool for post-market surveillance.

    Question 16. In 2016, CMS and FDA wrote a joint letter in support 
of including unique device identifiers (UDI) in medical claims during 
the next update of the electronic form, the process for which is 
ongoing. Both agencies recognize that our health care system takes too 
long to recognize problems with devices and then take appropriate 
actions, harming patients and resulting in billions in preventable 
costs to Medicare. As pointed out by clinical societies (including the 
Society of Thoracic Surgeons, American College of Cardiology, and 
American Academy of Orthopedic Surgeons), health plans, hospitals, 
Democrats, Republicans, and registries such as the American Joint 
Replacement Registry and many others, adding medical device identifiers 
to health insurance claims would generate better data to detect these 
problems sooner.
    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?
    How will you engage with stakeholders, including CMS and the X12 
Committee, to facilitate the adoption of a field for the DI in 
electronic insurance claims following the February recommendation of 
X12 to move forward such a field.
    Answer 16. I am committed to reviewing the work done to date by 
staff at CMS and FDA on this issue. Appropriate policies that could 
enhance our ability to capture valid post-market data should be 
thoughtfully considered. This also includes achieving interoperable 
electronic health records with UDIs--a goal that is fully consistent 
with the health information technology provisions in 21st Century 
Cures. If confirmed, I look forward to working with my colleagues at 
CMS and the X12 Committee to explore all of these policies.

    Question 17. Medical devices, including imaging equipment, can be 
used for many years and can undergo maintenance and repair. This 
medical device servicing, when done by the original equipment 
manufacturer, is subject to FDA regulation. However, if servicing is 
done by a 3d party, it is not subject to FDA oversight. This regulatory 
gray area causes uncertainty for doctors and patients who trust that 
medical devices are held to FDA standards, and for equipment 
manufacturers who are liable for the safe and effective performance of 
the devices. I was pleased that last year, the FDA opened a public 
docket for comments and held a public workshop on medical device 
servicing. What do you believe FDAs role is in ensuring that servicing 
of medical devices by original equipment manufacturers, hospitals, and 
3d parties is held to the same standards?
    Answer 17. An important part of FDA's responsibility to protect and 
promote public health is upholding the Gold Standard of safety and 
efficacy for medical products American patients use. With regard to the 
issue of medical devices that are serviced by 3d parties, if confirmed, 
I will commit to quickly engaging with FDA's staff to get up to speed 
on this issue, including a review of the public comments received by 
the agency. 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 efficacy of medical devices.

    Question 18. While some blood donor deferral criteria are based on 
an individual's risk of a transfusion transmissible infection, others 
are not. Non-risk-based criteria prevent many healthy people from 
donating blood, while still allowing some high risk donors to donate. 
In December 2015, the FDA published final guidance that overturned the 
non-risk-based criteria that banned on blood donations from men who 
have sex with men (MSM). The 2015 guidance replaced the lifetime ban 
with a 1-year deferral, but the 1-year deferral remains an arbitrary 
time-based deferral, not a risk-based deferral. Since the guidance was 
released, the FDA, in collaboration with other HHS agencies, has been 
working to collect the data necessary to implement a true risk-based 
deferral system for all donors, which will lead to a more robust and 
safer blood supply for American patients.
    Do you commit to continuing the studies and data collection 
necessary, including monitoring of behavioral risk factors of viral 
infections through the Transfusion-Transmissible Infections Monitoring 
System (TTIMS), to support the goal of transitioning to a risk-based 
blood donation deferral system for all blood donors?
    Answer 18. 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.

    Question 19. I am fully supportive of the bipartisan Food Safety 
and modernization Act, which has since helped to protect the public's 
health, strengthen consumer confidence in American food products, and 
level America's playing field with foreign competitors. FDA oversees 80 
percent of the food supply and its oversight prevents countless 
incidents of foodborne illness every year. Critical to implementation 
are the major rules that are due to go into effect this year and 
funding for the States, which will take most of the responsibilities 
for on-farm inspections and other day-to-day work under the produce 
rule. Are you committed to requesting the funds in your budget 
necessary to support FDAs implementation of FSMA to ensure that 
consumers remain confident in our food supply?
    Answer 19. The Food Safety Modernization Act (FSMA) provides FDA 
with important tools and authorities to support its responsibility to 
ensure the safety of our Nation's food supply. If confirmed, I will 
work to ensure the agency has the appropriate policies, processes, and 
resources in place to implement FSMA, as intended by Congress. FDA 
should implement FSMA in a way that protects and promotes public health 
by enhancing food safety, while also collaborating with the U.S. 
Department of Agriculture, State officials, and other government 
agencies to conduct regulatory activities in a manner that takes into 
account the unique challenges faced by small farmers and small 
businesses.

    Question 20. According to the CDC, two million Americans develop 
antibiotic-
resistant infections each year, costing 23,0000 lives and $20 billion 
annually. The World Health Organization's global assessment of 
antibiotic resistance concluded that antibiotic resistance ``is now a 
major threat to human health.'' I am particularly concerned by the 
connection between the use of antibiotics in agriculture and increasing 
antibiotic resistance among foodborne pathogen, which CDC estimates 
cause nearly half a million Americans to become sick each year. Public 
health authorities, including CDC and the FDA, and the production 
agriculture sector itself have made important strides to begin to 
address these challenges. I was pleased the FDA finalized Guidance for 
Industry 209 and 213 which established judicious use principles and 
removed production indications for medically important antimicrobials. 
FDA's publication of the Veterinary Feed Directive (VFD) final rule 
provided veterinarians with clear direction for how to authorize the 
use of antibiotics that are important to human health in animal feed 
when they are needed to protect animal health; this will further 
reinforce the critical role of veterinarians in animal-health 
decisionmaking.
    How do you plan to ensure that antibiotics are indicated for 
``disease prevention'' at the same doses and duration as now removed 
production indications--meaning they could still be used non-
judiciously--are being used for legitimate prevention uses?
    How do you plan to collaborate with USDA to collect the on-farm 
data required to truly assess antibiotic use?
    Answer 20. Antibiotic resistance is a significant and growing 
public health challenge facing our Nation. In addition to measures FDA 
should take to address this issue within the context of human use, the 
agency must effectively collaborate with other government agencies and 
public health authorities to develop policies and processes to address 
the issue of antibiotic use in animals intended for human consumption. 
If confirmed, I will ensure FDA remains engaged on this important 
public health issue, making sure that animal drug labeling reflects the 
most up-to-date science, and working closely with the U.S. Department 
of Agriculture, the Centers for Disease Control, the U.S. Department of 
Defense, and other appropriate Federal and State agencies. FDA should 
also consider input from other important stakeholders, such as the 
farmers, the agriculture industry, and veterinarians. FDA's 
implementation of a voluntary plan with industry to phaseout the use of 
certain antibiotics is an important step in the direction of more 
appropriate stewardship and use of antibiotics.

    Question 21. Drug companies are only allowed to market their 
products for the uses approved by the FDA. Proponents of relaxing this 
FDA standard to allow more so called ``off-label communication'' argue 
that such communication is critical for physicians in this age of rapid 
innovation. Opponents of off-label communication believe it will lead 
us back to an era where companies could peddle unproven products and 
reduce the incentive to invest in truly innovative research and 
development. In a Forbes column, you agreed with this point, writing, 
``[t]he most important incentive to developing useful information 
remains the ability for companies to market drugs based on what can be 
proven scientifically.'' \4\ Can I have your commitment that, if 
confirmed, you will ensure that FDA regulation of communications will 
preserve physician and public trust in approved medical products and 
the important incentive of FDA approval?
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    \4\ Gottlieb, Scott. ``Merck's Pain is Medicine's Gain.'' Forbes, 4 
Oct. 2014, https://www.
forbes.com/2004/10/04/cz_sg_1004soapbox.html.
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    Answer 21. Medical product labeling is one of the primary tools FDA 
uses to promote the appropriate use of medicines and technologies and 
communicate risk information. It is important that information on 
product labeling is accurate, clear, and scientifically based; and be 
the result of a sound regulatory process. Further, it is crucial that 
manufacturers continue to develop and submit to the agency clinical 
data demonstrating the safety and efficacy of medical products for new 
indications they seek to include on labeling and in their marketing 
communications with patients, payers, and providers. I also believe 
that patients and physicians make the best decisions when they have 
access to as much truthful, non-misleading, scientifically based 
information as possible. FDA has long recognized that there is public 
health benefits of allowing certain non-promotional communication about 
truthful, non-misleading, clinical information that is not previously 
incorporated into FDA-approved product labeling. If confirmed, I will 
commit to working with FDA's professional staff to get up to speed on 
the agency's latest thinking and actions on these matters, and 
providing clarity to manufacturers, payers, providers, and patients 
about acceptable truthful and non-misleading communications related to 
clinical data not already incorporated in a label.

    Question 22. As a physician, I am sure you are aware that tobacco 
use is still the leading preventable cause of death and disease in the 
United States.\5\ Nonetheless, when Congress was on the verge of 
approving the legislation which allowed FDA to regulate tobacco 
products in 2009, you were quoted as saying that, instead of addressing 
the public health threats posed by tobacco products, this legislation 
would ``gut'' the FDA's resources--and ``distract it from its core 
mission.'' \6\ Nearly 8 years have passed since Congress enacted the 
Family Smoking Prevention and Tobacco Control Act, and the law has not 
gutted FDA's resources or distracted it from its core mission. As FDA 
Commissioner, you would oversee the Center for Tobacco Products, which 
is funded by user fees from the tobacco companies. Have your views on 
FDA oversight of tobacco products changed? What initiatives do you 
envision the Center for Tobacco Products take to reduce the death and 
disease caused by tobacco?
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    \5\ ``Burden of Tobacco Use in the U.S.--Current Cigarette Smoking 
Among U.S. Adults Aged 18 Years and Older.'' Centers for Disease 
Control and Prevention, https://www.cdc.gov/tobacco/campaign/tips/
resources/data/cigarette-smoking-in-united-states.html. Accessed 7 Apr. 
2017.
    \6\ Associated Press. ``Lawmakers Renew Efforts for Government 
Regulation of Cigarettes.'' Fox News, 2 Mar. 2017, http://
www.foxnews.com/politics/2009/03/02/lawmakers-renew-efforts-
government-regulation-cigarettes.html.
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    Answer 22. If confirmed, I will be committed to implementing the 
TCA, as intended by Congress. As I noted during my confirmation hearing 
before the committee, as a physician and cancer survivor, if confirmed, 
I will be fully committed to the TCA's public health goal of reducing 
morbidity associated with tobacco use in this country. I believe 
responsibly implementing the TCA is an integral part of FDA's core 
mission to protect and promote public health.

    Question 23. Last year, FDA issued a final rule under the 
authorities of the Family Smoking Prevention and Tobacco Control Act 
(TCA), which enabled the agency to begin to oversee e-cigarettes and 
other tobacco products. In the years before FDA completed this rule, e-
cigarette manufacturers introduced thousands of nicotine-
delivering devices and liquids to the marketplace, many with fruit and 
candy flavors, without having to meet any independent standards to 
protect consumers' and the public's health. During this absence of FDA 
oversight, youth use of e-cigarettes soared, eclipsing youth use of 
regular cigarettes. E-cigarette proponents argue that they are less 
harmful than regular combustible cigarettes and can help adult 
cigarette smokers to quit. However, many e-cigarette manufacturers do 
not want to develop the data to support these claims. They instead want 
to exempt e-cigarettes that were on the market before the effective 
date of the deeming rule from a scientific review by FDA. Under the 
product review requirement in the TCA, tobacco product manufacturers 
must provide information about their products so that FDA can assess 
the toxicity, addictiveness, and appeal to youth of a new product. This 
independent scientific review will help answer important questions 
about these products, like whether manufacturers--use of flavors is 
increasing youth use of e-cigarettes, whether adults are using e-
cigarettes to quit regular cigarettes or do they continue to use 
regular cigarettes, and what the risks are of using e-cigarettes. It 
will enable FDA to block more harmful or addictive products from the 
market and incentivize manufacturers to develop products that pose less 
risk to public health.
    Do you support the deeming rule, including the product review 
requirement?
    Can I count on you to ensure that this rule is fully implemented 
and not weakened?
    What will you do to help prevent new users from getting hooked on 
nicotine through electronic cigarettes?
    Answer 23. If confirmed, I will be committed to implementing the 
TCA, as intended by Congress, including Section 911 related to modified 
risk products, which I recognize can provide helpful tools for current 
tobacco-users to transition off combustible tobacco. As I was not at 
FDA during the agency's initial TCA implementation activities, I am not 
fully acquainted with internal processes or specific decisions to-date. 
If confirmed, I will work with the professional staff to quickly get 
up-to-speed on this issue, and I will review current FDA policies, 
including the deeming rule, to ensure FDA treats products 
appropriately, implements provisions in a timely fashion, and in a 
manner that is consistent with congressional intent under the TCA. 
Clearly, manufacturers should not be allowed to target minors through 
indefensible marketing options of any tobacco related products, 
including e-cigarettes. I believe responsibly implementing the TCA is 
an integral part of FDA's core mission to protect and promote public 
health.

    Question 24. The FDA was instructed by Congress to look into the 
addition of menthol to cigarettes and its impact on public health. In a 
2011 report, the FDA found that menthol is a problem--it is more likely 
to initiate smokers and keep them hooked.\7\ However, the FDA has not 
promulgated regulations to reflect this threat. What would you do to 
address the threat of menthol cigarettes?
---------------------------------------------------------------------------
    \7\ ``Preliminary Scientific Evaluation of the Possible Public 
Health Effects of Menthol Versus Nonmenthol Cigarettes.'' Food and Drug 
Administration, 23 Aug. 2013, https://www.fda.gov/downloads/
UCM361598.pdf.
---------------------------------------------------------------------------
    Answer 24. I have not reviewed the scientific evidence related to 
the addition of menthol in cigarettes. If confirmed, I will commit to 
engaging with FDA's staff to quickly get up to speed on the regulatory 
history of this issue, and the agency's latest information, thinking, 
and actions. I would welcome the opportunity to work with Congress on 
this issue moving forward.

    Question 25. In 2012, you wrote an op-ed in the New York Post on 
FDA oversight of premium cigars. In that article, you suggest that 
expanding FDA's oversight to premium cigars was ``never envisioned by 
Congress'' and that doing so could divert the agency's attention from 
other important duties. In 2014, FDA issued a proposed rule that sought 
comments on whether FDA should oversee all cigars or exempt premium 
cigars. In 2016, it issued a final rule that--based on its review of 
comments and the scientific evidence--concluded ``there is no 
appropriate public health justification to exclude premium cigars from 
the scope of the final deeming rule.'' \8\ It concluded that all cigars 
pose serious health risks, all cigars are potentially addictive, and 
premium cigars are not exclusively used by adults.
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    \8\ Deeming Tobacco Products To Be Subject to the Federal Food, 
Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and 
Tobacco Control Act; Restrictions on the Sale and Distribution of 
Tobacco Products and Required Warning Statements for Tobacco Products, 
81 Fed. Reg. 90 (May 10, 2016). Federal Register: The Daily Journal of 
the United States. Web. 10 May 2016. https://www.federalregister.gov/
documents/2016/05/10/2016-10685/deeming-
tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-
act-as-amended-by-the.
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    As FDA Commissioner, would you accept the assessment of FDA's 
scientists about the health risks of cigars? Would you continue to 
implement and enforce the deeming rule as it applies to premium cigars?
    I am concerned about the use of these products by children, 
particularly high school boys, who now smoke cigars at a higher rate 
than regular cigarettes. Are you concerned about efforts to exclude 
from FDA regulation a product that is so frequently being used by high 
school boys?
    Answer 25. If confirmed, I will work with FDA's professional staff 
to quickly get up-to-speed on this issue, and I will review current FDA 
policies, including the deeming rule, to ensure FDA treats products 
appropriately, implements provisions in a timely fashion, and in a 
manner that is consistent with congressional intent under the TCA. I 
will also commit to better understanding the decision FDA made with 
respect to premium cigars--and any considerations that were made in 
respect to premium cigars between the proposed and the final rule--and 
would be happy to work with Congress on this issue.

    Question 26. Today, Americans consume sodium mostly through 
processed foods that they purchase from a grocery store or at a 
restaurant.\9\ Researchers estimate that reducing current sodium 
intakes by 1,200 milligrams a day would prevent 60,000 to 120,000 cases 
of coronary heart disease, 32,000 to 60,000 cases of stroke, and 54,000 
to 99,000 heart attacks annually. This reduction would also save an 
estimated $10 billion to $24 billion in health-care costs and 44,000 to 
92,000 lives annually.\10\ Last June, FDA proposed draft voluntary 
guidance to industry to reduce sodium in processed and restaurant foods 
and has received comments from industry, public health groups and 
consumers. Will you commit to the Agency's finalizing this voluntary 
guidance in 2017?
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    \9\ ``Salt--Sodium and Food Sources.'' Centers for Disease Control 
and Prevention, https://
www.cdc.gov/salt/food.htm. Accessed 7 Apr. 2017.
    \10\ Bibbins-Domingo, Kirsten, et al. ``Projected Effect of Dietary 
Salt Reductions on Future Cardiovascular Disease.'' The New England 
Journal of Medicine, vol. 362, no. 7, 2010, pp. 590-99, http://
www.nejm.org/doi/full/10.1056/NEJMoa0907355#t=article. Accessed 7 Apr. 
2017.
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    Answer 26. We need to ensure that everything FDA does is science-
based and try to encourage science-based, voluntary action to reduce 
sodium levels in foods. I know some companies have already taken 
voluntary steps to reduce sodium levels, and I support these public 
health goals. In some cases sodium plays an important food safety role, 
but many companies are already reducing sodium levels, and we want to 
find ways to continue to encourage those actions in a risk-based and 
science-based manner. If confirmed, I will review the comments received 
from stakeholders and the scientific evidence related to salt intake as 
well as consult agency staff before proceeding on this issue. I am 
committed to taking science-based steps, within the scope of FDA's 
authority and mandate, to reduce the burden of heart disease.

    Question 27. On January 19, 2017, FDA and EPA published a guidance 
document concerning seafood consumption by pregnant and nursing women, 
which was a significant departure from the draft advice on the same 
topic. While I have long urged FDA to finalize this advice, I also have 
emphasized that the advice must reflect the latest science and be 
presented to consumers clearly so they can make the best possible 
decisions about the nutritional value of seafood during pregnancy and 
nursing. I am concerned that the final advice appears not to meet that 
standard. If confirmed, will you consider revisions to this document to 
ensure it is in line with the latest science and provides clear advice 
to consumers?
    Answer 27. If confirmed, I will ensure FDA's advice concerning 
seafood consumption by pregnant and nursing women is based on the most 
current and relevant nutritional science and appropriately takes into 
account both the nutritional benefits, and any toxicological risks 
associated with seafood consumption. I will also work to ensure 
effective collaboration between FDA and the U.S. Environmental 
Protection Agency (EPA) on this issue, and a range of other public 
health matters over which both agencies share regulatory authority.

    Question 28. After many delays, the compliance date for menu 
labeling requirements is May 5, 2017. Calorie labeling at chain 
restaurants, supermarkets, convenience stores, and other food service 
establishments allows consumers to make their own choices about what to 
eat and feed their families. This information is more important than 
ever because people are eating out more than ever before; in 2015, food 
sales at restaurants surpassed spending at grocery stores for the first 
time.\11\ Furthermore, more than 70 percent of Americans support menu 
labeling.\12\ Researchers have concluded that menu labeling could 
prevent up to 41,000 cases of childhood obesity and save over $4.6 
billion in healthcare costs over 10 years.\13\ The restaurant industry 
and over 100 nutrition and public health organizations and 
professionals supported the law, which was the result of a bipartisan 
compromise. Many food establishments including Starbucks, McDonald's, 
Panera, Publix Super Markets, Wegmans Food Markets, and many others 
recognize the importance of this public health measure and are already 
labeling or working toward the May 5 compliance date. Unfortunately, 
efforts to weaken the menu labeling law continue. If confirmed, how 
will you ensure that the FDA implements menu labeling beginning May 5, 
2017, as planned, and does not penalize food establishments that have 
followed the law and prepared to meet the compliance date over food 
establishments that have not? How will you ensure that all Americans 
have access to basic nutrition information to allow them to make up 
their own minds about what to eat?
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    \11\ Jamrisko, Michelle. ``Americans' Spending on Dining Out Just 
Overtook Grocery Sales for the First Time Ever.'' Bloomberg Markets, 14 
Apr. 2015, https://www.bloomberg.com/news/articles/2015-04-14/
americans-spending-on-dining-out-just-overtook-grocery-sales-for-the-
first-time-ever.
    \12\ ``Poll Data re: Support Caloric Labeling in Supermarkets, 
Vending Machines, Movie Theaters.''Center for Science in the Public 
Interest, 27 May 2012, https://cspinet.org/sites/default/files/
attachment/restaurant-calorie-content.pdf.
    \13\ Gortmaker, Steven L. ``Three Interventions that Reduce 
Childhood Obesity Are Projected to Save More than they Cost to 
Implement.'' Health Affairs, vol. 34, no. 11, 2015, pp. 1932-39, http:/
/content.healthaffairs.org/content/34/11/
1932.full?ijkey=lnFXpx4AIM506&keytype=ref&
siteid=healthaff. Accessed 7 Apr. 2017.
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    Answer 28. While I am broadly aware of the menu labeling issue, 
this is not a matter on which I am familiar with the specific technical 
details. As a general matter, I support providing clear, accurate, and 
understandable information to American consumers to help inform healthy 
dietary choices. I believe information about caloric content can be a 
useful tool.
    However, I am mindful of the unique challenges that developing and 
communicating such information can pose, particularly on small, 
independent businesses. If confirmed, I will commit to working with 
FDA's professional staff to quickly get up to speed on the regulatory 
history related to menu labeling, as well as FDA's latest thinking and 
actions. I would welcome the opportunity to work with Congress and 
stakeholders to ensure any regulatory requirements would promote public 
health by providing helpful information to consumers, while not placing 
excessive compliance burden on businesses, particularly small, 
independent ones.

    Question 29. In your November 2005 speech to the Grocery 
Manufacturers of America (GMA) as Deputy Commissioner for Medical and 
Scientific Affairs, you made a number of important statements about the 
importance of nutrition in public health:

     ``Clearly, there is a correlation between food, diet and 
disease.''
     ``FDA has also emphasized that our policies need to be 
solidly based on the latest science, and must emphasize protecting and 
helping consumers.''
     ``. . . (A)ll of these efforts represent a significant 
update to the food label based on science that has been developed in 
recent years, and it represents a major opportunity to re-educate 
consumers about the food label, and the impact of diet on their 
health.''
     ``As people shop for food, they should have at their 
fingertips accurate, helpful, and understandable information about the 
most important nutritional implications of the products on the shelves, 
and they should be able to easily fit individual food products into 
overall healthy diets. People should not need a calculator or an 
advanced degree in math or nutrition to calculate the components that 
comprise a healthy meal.''

    Following up on these statements of yours, I have a few questions: 
Will you commit to prioritizing giving industry the guidance they need 
to move forward with updated packages and maintaining a compliance date 
no later than July 2019 for the revised Nutrition Facts label, which 
would be a 1-year delay from the current compliance date? Other 
countries, like the United Kingdom, France, and Chile, have implemented 
front-of-package labeling where a consumer does not ``need a 
calculator'' as you so aptly put it, and major international companies 
with strong market presence in the United States--Mars, Nestle 
Mondelez, Coca-Cola, Unilever, and Pepsi--have already taken major 
strides toward uniform labeling across Europe. As commissioner, would 
you move ahead with a uniform and useful version of front-of-pack 
labels?
    Answer 29. I agree that providing industry sufficient information 
to comply with this rule, as with any rule, is imperative. I also agree 
that FDA should be open to considering and evaluating additional 
approaches, especially those that could promote better consumer 
awareness and understanding of nutritional information about the foods 
they eat.

    Question 30. Currently, there is little knowledge around the safety 
and efficacy of medications used by pregnant and lactating women, due 
in large part to a lack of inclusion in clinical trials for medications 
and treatments. The 21st Century Cures Act created a Federal task force 
to examine some of the issues involved in doing so but much more 
remains to be done. What steps would you take to increase knowledge 
regarding safe treatments for pregnant and lactating women?
    Answer 30. If confirmed, I would look forward to FDA's 
participation in the Federal task force to examine the inclusion of 
pregnant and lactating women in clinical trials. As always, my 
commitment is to seek advances in treatments that are useful to 
individuals in all stages of life. Understanding the impact of 
treatments on women who are pregnant and lactating is crucially 
important. I commit to working with scientific experts at the various 
agencies and participants of the task force to develop our body of 
knowledge on safe treatments for this population and help to make sure 
FDA policies reflect this science.

    Question 31. We know that you would like to see FDA partner with 
industry to bring innovative products more quickly to market for the 
benefit of patients, who are the ultimate beneficiaries of 
breakthroughs and improved drugs and devices. However, you disapprove 
of ACA provisions intended to make preventive care more widely 
available to patients, especially women. What is the appropriate role 
of government in ensuring that all women can benefit from newly 
approved preventive care like contraception and pre-exposure 
prophylaxis?
    Answer 31. As the nominee to be the next Commissioner of Food and 
Drugs, I do not believe it would be appropriate to comment on questions 
about issues that are outside the jurisdiction of FDA.

    Question 32. Dr. Gottlieb, you are aware of the history of the 
Thalidomide disaster in the 1960s, which was fortunately averted in the 
United States because of our rigorous drug approval standards. Pregnant 
women in other countries were not so fortunate. They were prescribed 
Thalidomide, a treatment for morning sickness that was not thoroughly 
tested, and which resulted in severe birth defects and complications. 
You cited this case in a lengthy article criticizing the ``culture'' of 
the FDA. You grudgingly concede that FDA's rejection of Thalidomide was 
a success story, avoiding the disastrous results women experienced in 
other countries. Yet you conclude that the Thalidomide episode led FDA 
to become overcautious, and too concerned with product safety. Do you 
believe, when it comes to any experimental product for women's 
reproductive health, that today's FDA should prioritize speedy approval 
over thorough study and understanding of long-term effects?
    Answer 32. Maintaining the Gold Standard of safety and efficacy for 
medical products is fundamental to FDA's mission to protect and promote 
public health. There are also unique risks and challenges when it comes 
to studying drugs used in pregnancy, and for this reason, we have not 
seen the sort of innovation and investment in drugs to treat conditions 
of pregnancy as we have achieved in other areas of clinical medicine. 
Because of the unique safety issues related to drugs used during 
pregnancy, we need to make sure we are investing in, and using, the 
best science to fully evaluate the benefits and potential long-term 
effects of any drug used in this setting. Making sure we maintain the 
gold standard for safety and effectiveness in this clinical setting, 
while finding ways to help facilitate investment and innovation in 
medicines used to support pregnant women, should be one of our highest 
public health priorities.

    Question 33. FDA's own guidance states that advisory committees 
should be empaneled when the matter before the agency is one of 
significant public interest. However, through the years, the FDA has 
been inconsistent in convening external advisory committees for opioid 
approval decisions, often bypassing this step all together. The 
Comprehensive Addiction and Recovery Act (CARA), passed in July 2016, 
requires FDA to convene an Advisory Committee for any new drug that is 
an opioid, except if the agency finds that that such referral is not 
necessary for public health and notifies Congress.\14\ But in the FDA's 
``Opioid Action Plan,'' released September 2016, the agency only 
committed to empaneling an external advisory committee for every opioid 
under consideration for approval without abuse-deterrent properties.
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    \14\ Public Law 114-198, Section 106.
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    In 2011, FDA approved a reformulated, abuse deterrent version of 
Opana ER without the benefit of review from an advisory committee. Just 
last month, a post-market review of Opana ER found that the risks of 
Opana ER substantially outweighed the benefits. Given examples like 
this and the goal of CARA, do you believe opioids with claims of abuse-
deterrent properties should also go through an advisory committee, as 
appropriate?
    How will you determine whether a new opioid drug should go to an 
advisory committee?
    Do you commit to ensuring that those who serve on advisory 
committees for the FDA are held to its current high standard of 
impartiality to avoid conflicts of interest?
    Answer 14. I believe FDA should have the benefit of independent 
advice from outside experts and convene Advisory Committees, when 
appropriate. I understand that this advice is often critical to FDA as 
they consider challenging regulatory decisions. I believe that FDA 
should develop a comprehensive and consistent policy with respect to 
the types of opioids that should be reviewed by an Advisory Committee. 
Whether an Advisory Committee is convened should not be made only on a 
product-by-product basis. There should also be clear guidelines used to 
make these determinations. I believe it is important that potential 
Advisory Committee members are screened for conflicts of interest.

    Question 34. In 2015, more than 650,000 opioid prescriptions were 
filled in the United States.\15\ One-in-five individuals experiencing 
non-cancer pain or living with a pain-related diagnosis received an 
opioid prescription from an office-based setting.\16\ And a survey of 
primary care physicians found that 46 percent of doctors mistakenly 
believed that abuse deterrent formulations are less addictive.\17\ 
These statistics indicate that many in the provider community are 
dangerously unaware of the risks of prescribed opioids. An advisory 
committee to the FDA suggested that the agency put in place mandatory 
training for prescribers. Currently, this opioid prescriber education 
is voluntary and fewer than 15 percent of prescribers have availed 
themselves of this training. The FDA has determined that it does not 
have authority to mandate prescriber training, but the agency and 
others inside and outside of the government have called on Congress and 
the DEA to institute a mandatory training/education requirement for 
DEA-controlled substances license, with input on the content of 
training coming from HHS.
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    \15\ ``The Opioid Epidemic: By the Numbers.'' U.S. Department of 
Health and Human Services, https://www.hhs.gov/sites/default/files/
Factsheet-opioids-061516.pdf. Accessed 7 Apr. 2017.
    \16\ ``Opioid Overdose--Prescribing Data.'' Centers for Disease 
Control and Prevention, https://www.cdc.gov/drugoverdose/data/
prescribing.html. Accessed 7 Apr. 2017.
    \17\ Hwang, Catherine S., et al. ``Primary Care Physicians 
Knowledge and Attitudes Regarding Prescription Opioid Abuse and 
Diversion.'' The Clinical Journal of Pain, vol. 32, no. 4, 2016, pp. 
278-84, http://journals.lww.com/clinicalpain/Citation/2016/04000/
Primary_Care_Physi-
cians Knowledge_And_Attitudes.1. aspx. Accessed 7 Apr. 2017.
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    Do you agree that all prescribers should have some minimal 
education and familiarity with the dangers of opioid addiction and 
overdose as well as best practices for prescribing?
    How will the FDA engage with the CDC, the CARA-established task 
force on best practices, and the Trump administration's taskforce on 
opioids to ensure appropriate use of prescription painkillers?
    What steps need to be taken to ensure the FDA can help facilitate 
this type of prescriber education?
    Answer 34. Opioid abuse, misuse, and addiction constitute one of 
the most urgent and immediate public health threats facing our Nation. 
It is also the biggest public health crisis facing the FDA. The human 
and economic toll of this crisis is staggering. If confirmed, this will 
be my highest immediate priority. I will make sure FDA is aggressive, 
forward leaning, and fully engaged in combating this epidemic. I will 
work with FDA's professional staff to ensure FDA has the right policies 
and processes in place to:

     Facilitate the developments of new approaches and 
technologies to reduce the abuse/addictive potential of painkillers 
American patients use;
     Support the development of non-opioid analgesic 
alternatives for physicians and patients;
     Assess whether FDA's current approach to opioid regulatory 
decisions, including labeling, REMS, and physician/patient education 
are appropriate, robust, and fully effective;
     Encourage the development of new pharmacological tools for 
physicians and patients to both prevent opioid misuse and abuse, and 
support treatment and recovery for patients struggling to overcome 
opioid addiction;
     Enhance physician and patient educational materials to 
strengthen public awareness of the risks of opioids, as well as the 
FDA-approved resources available to them, using the full range of FDA's 
risk communication tools to better target this information;
     Taking steps to make sure that providers are appropriately 
educated on identifying, and helping to property intervene with, abuse-
prone patients;
     Re-assess whether FDA has the appropriate framework and 
authorities for evaluating the risk of abuse and diversion as a 
component of its review and approval process for opioids;
     Undertake a comprehensive effort to evaluate the full 
scope of the sources and threats from foreign imported narcotics;
     Evaluate whether FDA should bring more alignment between 
the review and approval of different medical product platforms used in 
the treatment of pain to make sure the agency is adopting the best 
public health standard in assessing these products; and
     Collaborate effectively with other government agencies and 
external stakeholders to develop and execute comprehensive and 
effective strategies to win the battle against opioid abuse, misuse, 
and addiction. This includes steps for FDA to more closely collaborate 
and coordinate with DEA around the two agencies' shared goals.

    Question 35. In 2007, you openly criticized the REMS program in 
writing \18\ and in speeches.\19\ During your confirmation hearing, 
however, you indicated that your original concerns about REMS did not 
manifest because FDA used the REMS process more judiciously than 
initially proposed. Recognizing the overuse and addiction potential of 
all opioid painkillers, in 2012, the FDA approved a post-market shared 
REMS for a subset of highly potent prescription opioid painkillers 
known as extended-release (ER) and long-acting (LA) formulations, of 
which OxyContin is included. In developing the class-wide ER/LA REMS 
established in 2012, FDA convened an advisory committee that 
overwhelmingly indicated that the REMS proposed was not sufficient to 
address the risks associated with use of opioid painkillers.\20\
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    \18\ Gottlieb, Scott. ``Drug Safety Proposals and the Intrusion of 
Federal Regulation Into Patient Freedom and Medical Practice.'' Health 
Affairs, vol. 26, no. 3, 2007, pp. 664-77, http://
content.healthaffairs.org/content/26/3/664. Accessed 7 Apr. 2017.
    \19\ Gottlieb, Scott. ``Remarks by Scott Gottlieb, M.D., Deputy 
Commissioner for Medical and 
Scientific Affairs, Food and Drug Administration.'' American Medical 
Association, 12 June 2006, https://www.fda.gov/NewsEvents/Speeches/
ucm051908.htm.
    \20\ ``Summary Minutes of the Joint Meeting of the Anesthetic and 
Life Support Drugs Advisory Committee (ALSDAC) and the Drug Safety and 
Risk Management Advisory Committee.'' Food and Drug Administration, 
http://www.supportprop.org/wp-content/uploads/2014/12/Minutes_20100722-
23-ALSDAC-DSaRM-M1-Minutes.pdf. Accessed 7 Apr. 2017.
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    Do you believe the REMS process has sufficiently mitigated the 
risks of opioids as originally intended?
    Do you think REMS are a good tool to manage public health risks 
associated with opioids?
    How would you strengthen this process?
    Answer 35. REMS are an important tool for helping to address the 
risk of diversion, misuse and addiction related to opioids. But they 
are only one tool. Clearly FDA needs to be taking many more, and more 
aggressive steps, to address this staggering human catastrophe of 
addiction and abuse. To date, no tool or policy, or combination of 
approaches, has sufficiently mitigated the risk of opioids. If 
confirmed, I will immediately work closely with staff at FDA to see 
what additional steps we can take across the full range of FDA's 
authorities and responsibilities, including through the use of the 
agency's authorities under the REMS provisions, to more aggressively 
address this crisis.

    Question 36. During your confirmation hearing, you referred to the 
opioid crisis as an important public health emergency on the same scale 
as Ebola. For Ebola, in a matter of a few months, the U.S. Government 
increased funding and resources and stood up centers of excellence to 
better understand and combat this epidemic. The FDA responded by doing 
the following:\21\
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    \21\ Hamburg, Margaret A. ``FDA as Part of a Coordinated Global 
Response on Ebola.'' Food and Drug Administration, 28 Oct. 2014, 
https://blogs.fda.gov/fdavoice/index.php/2014/10/fda-as-part-of-a-
coordinated-global-response-on-ebola/.

     Created an Ebola Task Force to help accelerate the 
development of medical products, which included direct engagement with 
industry and academic experts.
     Deployed staff to the heart of the epidemic.
     Collaborated with other agencies and regulators to share 
insight and information.
     Used the agency's Emergency Use Authorization to test 
unapproved products or uses of products to help stymie the spread of 
the disease.
     Monitored fraudulent or misleading claims from companies 
about the efficacy of their products.

    If confirmed, will you advocate for similar initiatives to address 
the opioid epidemic to happen immediately?
    What could the FDA have done differently to help prevent, or at 
least stem, the opioid crisis?
    If confirmed, how will you incorporate these lessons into your 
leadership agenda?
    Answer 36. If confirmed, I will take immediate and aggressive steps 
to try and get ahead of this crisis. In my opinion, one of the many 
lessons learned from our Nation's inability to effectively combat the 
opioid epidemic to-date is that we didn't take aggressive action early 
enough in the throes of this crisis to stem its tide, and to get ahead 
of its evolution from a problem of prescription drugs to one that now 
also involves illicit street drugs. That will be one of among other 
lessons that I take to this task if confirmed--that to adequately 
address the opioid crisis, it will require us to take perhaps even more 
aggressive measures than we might have originally contemplated, since 
we have not been accurate in measuring the full scope of this growing 
crisis, or in effectively calibrating our regulatory steps to confront 
the epidemic. I also believe, among other things, effectively combating 
this crisis is going to require much closer collaboration between 
different Federal and State agencies, and it would be my immediate goal 
to seek even closer partnerships with agencies such as DEA and CMS and 
other Federal and State entities that play an important role in 
confronting aspects of this crisis.

    Question 37. In 1995, the FDA approved the original formulation of 
OxyContin, which FDA considered abuse-deterrent based on premise that 
its extended-release properties would make it less likely to be abused. 
However, we know from OxyContin that abuse-deterrent formulations do 
not make opioids less addictive. Unfortunately, many prescribers appear 
to be unaware of this pivotal implication. In fact, a survey of primary 
care physicians found that nearly half of all primary care doctors 
incorrectly believed that abuse-deterrent formulations are less 
addictive.\22\
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    \22\ Hwang, Catherine S., et al. ``Primary Care Physicians 
Knowledge and Attitudes Regarding Prescription Opioid Abuse and 
Diversion.'' The Clinical Journal of Pain, vol. 32, no. 4, 2016, pp. 
278-84, http://journals.lww.com/clinicalpain/Citation/2016/04000/
Primary_Care_Physi-
cians Knowledge_And_Attitudes.1.aspx. Accessed 7 Apr. 2017.
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    Do you think ``abuse deterrent formulation'' is good terminology 
that the agency should continue to use?
    What steps would the FDA need to take to make a labeling change 
that better characterizes the fact that abuse deterrent does not mean 
addiction proof?
    Answer 37. We need to make sure we are using the appropriate 
terminology to describe these technologies and not creating 
misperceptions with respect to how we label these products. If 
confirmed into this role, I would be committed to working with the 
professional staff at FDA to make sure we are asking the appropriate 
questions about how we describe these features in labeling, and what 
perceptions are conferred to providers by those descriptions.

    Question 38. Last year, the CDC issued guidelines on the use of 
opioid pain medication for chronic pain that reflects the rise in 
opioid addiction and overdoses.\23\ These guidelines recommended, among 
other things, that opioids should be prescribed at the lowest effective 
dose, and that an upper limit of 90 milligrams/day should not be 
exceeded. The CDC has made clear that a dose above 90 milligrams/day is 
dangerously high. Yet opioid formulations come in dosage units that are 
so high, just one pill twice a day can exceed 90 mg of morphine. For 
example, a patient taking Opana ER 40 mg twice a day is taking the 
equivalent of 240 mg of morphine. That is more than 2.5 times the CDC's 
upper dose limit. Yet the patient and prescriber may be unaware that 
this is a dangerously high dose, because it is only one pill taken 
twice a day. If confirmed, how can FDA incorporate some of the CDC 
guidelines on opioid medication into FDA policies related to approvals 
and labeling?
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    \23\ Dowell, Deborah. ``CDC Guideline for Prescribing Opioids for 
Chronic Pain--United States, 2016.'' Morbidity and Mortality Weekly 
Report, vol. 65, no. 1, 2016, pp. 1-49, https://www.cdc.gov/mmwr/
volumes/65/rr/rr6501e1.htm. Accessed 7 Apr. 2017.
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    Answer 38. If confirmed, I would be committed to working with staff 
at FDA to fully evaluate the CDC guidelines as one part of a 
comprehensive effort to try and address this crisis, and to making sure 
we are properly and fully leveraging the expertise at sister agencies 
like CDC and other government partners in addressing these challenges.

    Question 39. You said during your confirmation hearing that the 
opioid epidemic is larger than the FDA, and that we must use an ``all-
of-the-above approach'' to tackling this epidemic. In addition to 
spending several years at the FDA, you were also a senior adviser to 
the Centers for Medicare and Medicaid Services (CMS). CMS also has 
levers to pull to help combat the opioid crisis, including coverage for 
and availability of treatment options for mental health and substance 
use disorders. Given your knowledge of both CMS and FDA, and your 
experience working on behalf of pharmaceutical companies navigating 
these agencies, how would you ensure these agencies work together and 
coordinate on policies to address the opioid epidemic?
    Answer 39. I believe there are many opportunities for agencies to 
more closely collaborate to address this crisis. Indeed, properly 
addressing it is going to require much closer coordination between law 
enforcement and public health agencies at both the local and Federal 
level.
    Among other things, CMS can help FDA better understand patterns of 
use and abuse that can help inform the drug review process, both pre- 
and post-market, as well as assist the FDA in its post-market 
surveillance. If confirmed, it would be one of my immediate goals, in 
an all-of-the-above approach, to seek new ways to collaborate more 
closely with other local and Federal agencies, including CMS, to see 
where we can gain more alignment and leverage in combating this public 
health crisis.

    Question 40. In a 2015 op-ed published in the Wall Street Journal, 
you argued that the ACA permits a ``government takeover of drug 
pricing.'' Specifically, you cite the Centers for Medicare and Medicaid 
Innovation (CMMI) as a mechanism for this government control. Even 
private sector payers and drug manufacturers agree that value-based 
models of drug pricing could help ensure patients have access to 
affordable prescription drugs. What types of drug pricing 
demonstrations do you think would be reasonable for CMMI to test?
    Answer 40. As the nominee to be the next Commissioner of Food and 
Drugs, I do not believe it would be appropriate to comment on questions 
about issues that are outside the jurisdiction of FDA.

    Question 41. In your OGE Form 278, you stated that Venture Partner 
at New Enterprise Associates (NEA) was simply a working title. It is 
unclear what that means and to what extent you were involved in the 
company's broader healthcare portfolio. Collectively, NEA's client 
companies have at least 40 drug products in the product pipeline for 
which they may seek approval from the FDA. In your ethics agreement, 
you committed to recuse yourself from matters involving NEA and two 
client companies--American Pathology Partners and Collective Health--
for 1 year.
    Will you recuse yourself for the 2 years laid out in the Trump 
ethics pledge, from matters involving all of NEA's clients? If not, why 
will you not take this extra step promised by the President who 
nominated you?
    You have committed to recusing yourself for 1 year from the date of 
your resignation for matters involving NEA, American Pathology 
Partners, and Collective Health. Will you recuse yourself for the 2 
years laid out in the Trump ethics pledge for those companies? If not, 
why will you not take this extra step promised by the President who 
nominated you?
    Answer 41. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 42. In your OGE Form 278e, you disclose that you were an 
investor in NEA 14 Limited Partnership (``NEA 14''). You further 
disclose that NEA 14 holds an investment in Cerecor, Inc., a 
biopharmaceutical company with two compounds--CERC-501 and CERC-611--
currently being tested in clinical trials. While I understand that you 
have divested yourself from NEA 14 pursuant to your ethics obligations, 
will you recuse yourself personally and substantially in any particular 
matter in which Cerecor Inc. is a party, including, but not limited to, 
proceedings concerning CERC-501 and CERC-611?
    Answer 42. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 43. In your OGE Form 278e, you disclose that you were an 
investor in NEA 14 Limited Partnership (``NEA 14''). You further 
disclose that NEA 14 holds an investment in Loxo Oncology, Inc., a 
biopharmaceutical company with three compounds--LOXO-101, LOXO-195, and 
LOXO-292--currently being tested in clinical trials or slated to begin 
Phase I trials imminently. While I understand that you have divested 
yourself from NEA 14 pursuant to your ethics obligations, will you 
recuse yourself personally and substantially in any particular matter 
in which Loxo Oncology, Inc. is a party, including, but not limited to, 
proceedings concerning LOXO-101, LOXO-195, LOXO-292?
    Answer 43. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 44. In your OGE Form 278e, you disclose that you were an 
investor in NEA 14 Limited Partnership (``NEA 14''). You further 
disclose that NEA 14 holds an investment in Lumena Pharmaceuticals, 
Inc. a biopharmaceutical company with two compounds--LUM-001 and LUM-
002--currently being tested in clinical trials. While I understand that 
you have divested yourself from NEA 14 pursuant to your ethics 
obligations, will you recuse yourself personally and substantially in 
any particular matter in which Lumena Pharmaceuticals, Inc. is a party, 
including, but not limited to, proceedings concerning LUM-001 and LUM-
002?
    Answer 44. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 45. In your OGE Form 278e, you disclose that you were an 
investor in NEA 14 Limited Partnership (``NEA 14''). You further 
disclose that NEA 14 holds an investment in TRACON Pharmaceuticals, 
Inc., a biopharmaceutical company with three compounds--TRC-105, TRC-
102, and DE-122--currently being tested in clinical trials. While I 
understand that you have divested yourself from NEA 14 pursuant to your 
ethics obligations, will you recuse yourself personally and 
substantially in any particular matter in which TRACON Pharmaceuticals, 
Inc. is a party, including, but not limited to, proceedings concerning 
TRC-105, TRC-102, and DE-122?
    Answer 45. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 46. In your OGE Form 278e, you disclose that you were an 
investor in NEA 15 Limited Partnership (``NEA 15''). You further 
disclose that NEA 15 holds an investment in Ardelyx, Inc., a 
biopharmaceutical company with three compounds--Tenapanor, RDX-8940, 
and RDX-7675--currently being tested in clinical trials. While I 
understand that you have divested yourself from NEA 15 pursuant to your 
ethics obligations, will you recuse yourself personally and 
substantially in any particular matter in which Ardelyx, Inc. is a 
party, including, but not limited to, proceedings concerning Tenapanor, 
RDX-8940, and RDX-7675?
    Answer 46. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 47. In your OGE Form 278e, you disclose that you were an 
investor in NEA 15 Limited Partnership (``NEA 15''). You further 
disclose that NEA 15 holds an investment in Millendo Therapeutics, 
Inc., a biopharmaceutical company with two compounds--ATR-101 and MLE-
4901--currently in clinical trials. While I understand that you have 
divested yourself from NEA 15 pursuant to your ethics obligations, will 
you recuse yourself personally and substantially in any particular 
matter in which Millendo Therapeutics, Inc. is a party, including, but 
not limited to, proceedings concerning ATR-101 and MLE-4901?
    Answer 47. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 48. In your OGE Form 278e, you disclose that you were an 
investor in NEA 15 Limited Partnership (``NEA 15''). You further 
disclose that NEA 15 holds an investment in ObsEva SA, Ltd., a 
biopharmaceutical company with three compounds--OBE-2109, OBE-001, and 
OBE-022--currently in clinical trials. While I understand that you have 
divested yourself from NEA 15 pursuant to your ethics obligations, will 
you recuse yourself personally and substantially in any particular 
matter in which ObsEva SA, Ltd. is a party, including, but not limited 
to, proceedings concerning OBE-2109, OBE-001, and OBE-022?
    Answer 48. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 49. In your OGE Form 278e, you disclose that you were an 
investor in NEA 14 Limited Partnership (``NEA 14'') and NEA 15 Limited 
Partnership (``NEA 15''). You further disclose that NEA 14 and NEA 15 
hold investment in the following biopharmaceutical companies: Amplyx 
Pharmaceuticals, Inc. (NEA 15); Cleave Biosciences, Inc. (NEA 14); 
Clementia Pharmaceuticals Inc. (NEA 15); Envisia Therapeutics Inc. (NEA 
14); Galera Therapeutics, Inc. (NEA 14); Lumos Pharma, Inc. (NEA 14); 
Mersana Therapeutics, Inc. (NEA 14); Mirna Therapeutics, Inc. (NEA 14); 
NightstaRx Ltd. (NEA 15); SetPoint Medical Corp. (NEA 15); Vtesse Inc. 
(NEA 14); and Ziarco Group Ltd. (NEA 14). While I understand that you 
have divested yourself from NEA 14 and NEA 15 pursuant to your ethics 
obligations, will you recuse yourself personally and substantially in 
any particular matter in which any of the companies listed above is a 
party?
    Answer 49. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 50. In your OGE Form 278, you stated that managing 
director of investment banking at T.R. Winston & Company was simply a 
working title.\24\ It is unclear what that means and to what extent you 
oversaw transactions specifically as part of the healthcare banking 
team. Since you started in April 2013, T.R. Winston was involved in 12 
large healthcare transactions involving 9 healthcare companies.\25\ You 
have financial interests in five of those nine companies.\26\ 
Additionally, you have financial interests in two other T.R. Winston 
healthcare client companies that were not involved in transactions 
since the beginning of your tenure. Collectively, T.R. Winston's client 
companies have at least 77 drug products in the products pipeline for 
which they may seek approval from the FDA.
---------------------------------------------------------------------------
    \24\ Executive Branch Personnel Public Disclosure Report (OGE Form 
278e), Scott Gottlieb (U.S. Office of Government Ethics Certification 
Mar. 28, 2017).
    \25\ T.R. Winston & Company, Transactions (online at http://
www.trwinston.com/trans-
actions/) (accessed Apr. 7, 2017).
    \26\ Letter from Scott Gottlieb, M.D., to Elizabeth J. Fischmann, 
Esq., Associate General
Counsel for Ethics/Designated Agency Ethics Official, U.S. Department 
of Health and Human Services (Mar. 28, 2017).
---------------------------------------------------------------------------
    Did you oversee the 12 healthcare transactions as managing director 
of investment banking? If not, what was your involvement in those 
transactions? Will you recuse yourself for the 2 years laid out in the 
Trump ethics pledge, from matters involving all of T.R. Winston's 
clients? If not, why will you not take this extra step promised by the 
President who nominated you?
    You have committed to recusing yourself for 1 year from the date of 
your resignation for matters involving T.R. Winston, Cell BioTherapy, 
Tivorsan Pharmaceuticals, and Kure.
    Will you recuse yourself for the 2 years laid out in the Trump 
ethics pledge for those companies? If not, why will you not take this 
extra step promised by the President who nominated you? Will you recuse 
yourself from involvement in decisions that affect all of T.R. 
Winston's investment banking healthcare clients?
    Answer 50. As a general matter, my role at T.R. Winston was to 
provide clinical and healthcare policy support to the transaction team. 
I did not oversee transactions. 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 am committed to leading the FDA in an impartial manner 
that gives the American public confidence in the integrity of the FDA's 
decisionmaking process.

    Question 51. In your ethics agreement, you noted that you do not 
``hold any financial interest in T.R. Winston & Company;'' however, you 
disclosed that you do hold a financial interest in 13 of T.R. Winston's 
client companies--one of which is Inspyr Therapeutics, Inc. (previously 
known as GenSpera).\27\ You have not committed to recuse yourself from 
matters involving Inspyr. This company is currently developing a 
platform technology to deliver its active ingredient to tumors in a way 
that is less toxic to the body. Inspyr's lead investigational agent, 
mipsagargin (G-202), is a prodrug in human clinical trials for patients 
with hepatocellular carcinoma, glioblastoma, and prostate cancer. 
Inspyr has four different products in ongoing or completed Phase II 
clinical trials.\28\ The decision whether to approve these products may 
occur during your tenure at FDA if you are confirmed.
---------------------------------------------------------------------------
    \27\ Letter from Scott Gottlieb, M.D., to Elizabeth J. Fischmann, 
Esq., Associate General
Counsel for Ethics/Designated Agency Ethics Official, U.S. Department 
of Health and Human Services (Mar. 28, 2017).
    \28\ Inspyr Therapeutics, Products Pipeline (online at http://
www.inspyrtx.com/product-pipeline) (accessed Apr. 7, 2017)
---------------------------------------------------------------------------
    Though you will have divested your financial interest in the 
company, do you think you can truly be impartial and independent as the 
agency makes approval decisions for these products?
    To avoid any appearance of impropriety, do you think it would be 
better to recuse yourself from these decisions?
    Answer 51. If confirmed I will undertake and perform the duties of 
FDA commissioner impartially, as a passionate advocate for public 
health and in the best interests of the American people, guided by the 
science that informs the FDA's work. I will abide by all applicable 
ethics laws and regulations, including those that govern recusals, and 
am committed to performing my official duties in a manner that gives 
the public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 52. Neuralstem is a biotechnology company that specializes 
in developing commercial-scale production of multiple types of central 
nervous system stem cells. While you were managing director of T.R. 
Winston's Investment Bank, T.R. Winston oversaw a $4,556,000 capital 
markets transaction in September 2014 and a $20,000,000 capital markets 
transaction in January 2014.\29\ Additionally, you have stated that you 
hold financial interests in this company. According to your OGE Form 
278, you have 22,308 warrants to purchase shares at $39 a share.\30\ 
You have not committed to recuse yourself from matters involving 
Neuralstem. Neuralstem has at least six products in clinical trials 
that will require FDA approval.\31\ For example, Neuralstem is 
expecting to initiate a Phase II trial evaluating NSI-189 a treatment 
for major depressive disorder (MDD). Do you think your previous 
business and financial ties to the company have compromised your 
ability to be impartial when approval decisions come before the agency?
---------------------------------------------------------------------------
    \29\ T.R. Winston & Company, Transactions (online at http://
www.trwinston.com/trans-
actions/) (accessed Apr. 7, 2017).
    \30\ Executive Branch Personnel Public Disclosure Report (OGE Form 
278e), Scott Gottlieb (U.S. Office of Government Ethics Certification 
Mar. 28, 2017).
    \31\ NeuralStem, Cell Therapy Treatments in Development (online at 
http://www.neural
stem.com/patient-info-treatments-in-development#celltherapy) (accessed 
Apr. 7, 2017)
---------------------------------------------------------------------------
    Answer 52. If confirmed I will undertake and perform the duties of 
FDA commissioner impartially, as a passionate advocate for public 
health and in the best interests of the American people, guided by the 
science that informs the FDA's work. I will abide by all applicable 
ethics laws and regulations, including those that govern recusals, and 
am committed to performing my official duties in a manner that gives 
the public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 53. Celgene is a global biotechnology company that is 
currently sponsoring more than 100 clinical trials examining on at 
least 25 compounds that Celgene may seek FDA approval.\32\ Celgene is a 
T.R. Winston client company, but your ethics agreement does not 
indicate whether you will not be recused from matters involving 
Celgene.\33\ Will you be recused from working on matters involving 
Celgene?
---------------------------------------------------------------------------
    \32\ Celgene, Product Pipeline (online at http://www.celgene.com/
content/uploads/product-pipeline.pdf) (accessed Apr. 7, 2017).
    \33\ Letter from Scott Gottlieb, M.D., to Elizabeth J. Fischmann, 
Esq., Associate General
Counsel for Ethics/Designated Agency Ethics Official, U.S. Department 
of Health and Human Services (Mar. 28, 2017).
---------------------------------------------------------------------------
    Answer 53. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 54. Two T.R. Winston companies in which you have a 
financial interest--Angion Biomedica Corp. and Emmaus Life Sciences--
have products in clinical trials. While I understand that you will 
divest yourself from these two companies pursuant to your ethics 
obligations, will you recuse yourself personally and substantially in 
any particular matter in which any of the companies listed above is a 
party?
    Answer 54. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 55. AMAG Pharmaceuticals--a T.R. Winston client company in 
which you do not have a financial interest--has at least two products 
in clinical trials. Your ethics agreement does not address whether you 
will be recused from matters involving AMAG Pharmaceuticals. Will you 
recuse yourself personally and substantially in any particular matter 
in which AMAG Pharmaceuticals is a party?
    Answer 55. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 56. You have served as an independent member of the board 
of directors for Gradalis, a position for which you earned 
approximately $65,000 last year.\34\ In addition, you have stated that 
you have a financial interest in the company--25,000 stock options to 
purchase shares at $3.16 a share and 25,000 options at $3.57 a share. 
You have noted that these are vested stock options and you intend to 
divest within 90 days of your confirmation.\35\ Further you have noted 
that you will recuse yourself from 1 year after your resignation, which 
should expire March 2018 since you resigned your position in March 
2017. Gradalis is a late-stage biopharmaceutical company developing a 
platform technology which may have multiple cancer indications, and 
currently have at least five products in clinical trials that may 
require FDA approval.\36\ Do you think your 1-year recusal sufficiently 
removes any bias posed by your investment and ties to this company?
---------------------------------------------------------------------------
    \34\ Executive Branch Personnel Public Disclosure Report (OGE Form 
278e), Scott Gottlieb (U.S. Office of Government Ethics Certification 
Mar. 28, 2017).
    \35\ Letter from Scott Gottlieb, M.D., to Elizabeth J. Fischmann, 
Esq., Associate General
Counsel for Ethics/Designated Agency Ethics Official, U.S. Department 
of Health and Human Services (Mar. 28, 2017).
    \36\ Gradalis, Platform & Pipeline (online at http://
www.gradalisinc.com/index.php/pipeline/pipeline.html) (accessed Apr. 7, 
2017).
---------------------------------------------------------------------------
    Will you recuse yourself for the 2 years laid out in the Trump 
ethics pledge for Gradalis? If not, why will you not take this extra 
step promised by the President who nominated you?
    Do you think it would be better and more likely to avoid conflicts 
if your recusal were longer?
    Answer 56. I have previously resigned from the Gradalis board and 
surrendered my stock options. 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 am committed to leading the FDA in an impartial manner 
that gives the American public confidence in the integrity of the FDA's 
decisionmaking process.

    Question 57. Daiichi Sankyo is a global pharmaceutical company; you 
have served as an independent member of the board of directors since 
April 2015 and you have agreed to resign upon your confirmation. You 
have agreed to recuse yourself for 1 year after your resignation from 
matters affecting Daiichi Sankyo, which has at least 28 products being 
tested in clinical trials that may seek FDA approval.\37\
---------------------------------------------------------------------------
    \37\ Daiichi-Sankyo, Pipeline Chart (Jan. 2017) (online at http://
www.daiichisankyo.com/rd/pipeline/development_pipeline/index.html).
---------------------------------------------------------------------------
    Do you think your 1-year recusal sufficiently removes any bias 
posed by your investment and ties to this company?
    Will you recuse yourself for the 2 years laid out in the Trump 
ethics pledge for Daiichi Sankyo? If not, why will you not take this 
extra step promised by the President who nominated you?
    Do you think it would be better and more likely to avoid conflicts 
if your recusal were longer?
    Answer 57. I have previously resigned from the Daiichi board of 
directors. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 58. GlaxoSmithKline is a global pharmaceutical company 
that you have served as member of the Product Investment Board (PIB), 
and you have agreed to resign upon your confirmation. You have agreed 
to recuse yourself for 1 year after your resignation from matters 
affecting GlaxoSmithKline, which has nearly 100 products being tested 
in clinical trials, for which it may seek FDA approval.
    Do you think your 1-year recusal sufficiently removes any bias 
posed by your investment and ties to this company?
    Will you recuse yourself for the 2 years laid out in the Trump 
ethics pledge for GlaxoSmithKline? If not, why will you not take this 
extra step promised by the President who nominated you?
    Do you think it would be better and more likely to avoid conflicts 
if your recusal were longer?
    Answer 58. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 59. In your ethics agreement, you explained that you 
established Innovating Healthcare LLC for the purposes of a single 
consulting project with Bristol-Myers Squibb. You have agreed to recuse 
yourself for matters involving Bristol-Myers Squibb for 1 year from the 
date you last provided service to the company. Bristol-Myers Squibb has 
at least 30 products being tested in clinical trials, for which it may 
seek FDA approval.
    Do you think your 1-year recusal sufficiently removes any bias 
posed by your investment and ties to this company?
    Will you recuse yourself for the 2 years laid out in the Trump 
ethics pledge for Bristol-Myers Squibb? If not, why will you not take 
this extra step promised by the President who nominated you?
    Do you think it would be better and more likely to avoid conflicts 
if your recusal were longer?
    Answer 59. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 60. You served as member of the board of director of 
Tolero Pharmaceuticals until December 2016. You have agreed to recuse 
yourself for 1 year after your resignation from matters affecting 
Tolero Pharmaceuticals, which has two products being tested in clinical 
trials, for which it may seek FDA approval.
    Do you think your 1-year recusal sufficiently removes any bias 
posed by your investment and ties to this company?
    Will you recuse yourself for the 2 years laid out in the Trump 
ethics pledge for Tolero Pharmaceuticals? If not, why will you not take 
this extra step promised by the President who nominated you?
    Do you think it would be better and more likely to avoid conflicts 
if your recusal were longer?
    Answer 60. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 61. In your ethics agreement, you explained that you 
provided consulting services for Vertex Pharmaceuticals through 
YourEncore. You have agreed to recuse yourself for matters involving 
Vertex Pharmaceuticals for 1 year from the date you last provided 
service to the company. Vertex Pharmaceuticals has at least seven 
products being tested in clinical trials, for which it may seek FDA 
approval.
    Do you think your 1-year recusal sufficiently removes any bias 
posed by your investment and ties to this company?
    Will you recuse yourself for the 2 years laid out in the Trump 
ethics pledge for Vertex Pharmaceuticals? If not, why will you not take 
this extra step promised by the President who nominated you?
    Do you think it would be better and more likely to avoid conflicts 
if your recusal were longer?
    Answer 61. 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 am 
committed to leading the FDA in an impartial manner that gives the 
American public confidence in the integrity of the FDA's decisionmaking 
process.

    Question 62. The FDA Commissioner will need to be deeply engaged 
when we face another public health crisis. Given the scope of your 
financial entanglements, I am concerned that you may be unable to 
effectively lead the agency in this scenario. You are, unfortunately, 
familiar with being recused when FDA responds to an emerging threat. 
When you were the agency's deputy commissioner in 2005, you could not 
participate in many decisions about how to combat the avian flu because 
you had worked for two drug companies--Roche and Sanofi--who worked to 
develop products to fight back against the deadly flu.\38\ Now, in 
order to comply with Federal conflict-of-interest and ethics laws, you 
have committed to recuse yourself from decisions related to more than 
20 companies where you hold, or previously held, positions. While this 
represents a small fraction of the medical product companies in which 
you have a financial stake, this includes seven pharmaceutical 
companies and two clinical lab companies. Of particular concern is your 
recusal from matters involving GlaxoSmithKline. GSK is one of the top 
vaccine makers in the world, and they have been involved in developing 
vaccines in response to the Ebola and Zika outbreaks.\39\ You received 
hundreds of thousands of dollars in compensation from the company in 
the last several years.\40\ It seems possible--if not likely--that they 
would be involved in a response to the next disease outbreak. Any of 
these 20 companies could be called on to assist in the response to a 
public health crisis. Would the American people be better served in a 
time of crisis by an FDA Commissioner who was not recused from matters 
related to such a large number of companies and whose focus was 
guaranteed to be on the crisis and not on the sidelines?
---------------------------------------------------------------------------
    \38\ http://archive.boston.com/business/healthcare/articles/2005/
11/12/fda_official_recused
_in_flu_fight/.
    \39\ https://www.bloomberg.com/news/articles/2016-09-08/glaxo-
proposes-global-body-to-
tackle-outbreaks-like-zika-ebola.
    \40\ https://www.wired.com/2017/03/trumps-fda-pick-friends-big-
pharma-doesnt/.
---------------------------------------------------------------------------
    Answer 62. I was compensated by GSK, for my services on the product 
investment board, through a retainer in the amount of $60,000 annually. 
I was also reimbursed for out-of-pocket travel costs to attend 
meetings. If confirmed, I intend to lead the FDA as an impartial and 
passionate advocate for the public health and am confident that I can 
fully perform the duties of the FDA commissioner. I do not believe that 
the recusals set forth in my ethics agreement will impair my ability to 
discharge the responsibilities of this office. All nominees come to 
their positions with a range of experiences, which necessitate some 
recusals to ensure compliance with relevant ethics standards. It is 
routine in those circumstances for other senior agency officials to be 
involved in the matter and I have every confidence that if I am 
recused, my team at FDA will ensure that Congress's laws will be 
properly implemented and the FDA's mission fulfilled.
                              senator enzi
    Question 1. FDA's menu-labeling rule, even after an initial stay, 
will take effect 1 month from today. Grocery stores and other food 
retailers across America continue to be frustrated with FDA's handling 
of things, including for local and seasonal food items. Fresh and local 
food items may be sold at a few stores, under the same name, but the 
ingredients or recipe can vary, yet they would be considered ``standard 
menu items'' and subject to enforcement. The irony is that this will 
cause stores and restaurants to move away from fresh, local, and 
seasonal offerings. With just a month before the compliance date, we 
need FDA to act quickly to further delay, withdraw, or stay the rule so 
it can be rewritten to give businesses the flexibility to comply. Would 
you be willing to explore ways to encourage FDA to act before the 
compliance date to provide this much-needed flexibility for businesses?
    Answer 1. While I am broadly aware of the menu labeling issue, this 
is not a matter on which I am familiar with the technical specifics. As 
a general rule, I support providing clear, accurate, and understandable 
information to American consumers to help inform healthful dietary 
choices. I believe information about caloric content can be a useful 
tool. However, I am mindful of the unique challenges that developing 
and communicating such information can pose, particularly on small, 
independent businesses. If confirmed, I will commit to working with the 
agency's staff to quickly get up to speed on the regulatory history 
related to menu labeling, as well as FDA's latest thinking and actions. 
I would welcome the opportunity to work with Congress and stakeholders 
to ensure any regulatory requirements would promote public health by 
providing helpful information to consumers, while not placing 
unnecessary compliance burden on businesses, particularly small, 
independent ones.
                            senator sanders
    Question 1. The FDA's mission statement includes the directive to 
make medicines ``more effective, safer, and more affordable.'' Setting 
aside the ongoing debate over generic drug approvals, please discuss 
how you think FDA can make medicines more affordable.
    Answer 1. While drug pricing does not fall directly within FDA's 
purview, I believe the agency can play an important role on this 
important issue by taking steps to improve product competition. If 
confirmed, I will work to ensure FDA has the appropriate policies and 
processes in place to effectively facilitate product competition, 
especially for complex drugs that sometimes do not face effective 
generic competition even long after the patent expires.
    Reforming the regulatory pathway for complex generic products would 
address one key policy deficiency that results in unnecessary barriers 
to the development and review of generic competitors for some innovator 
products for which traditional bioequivalence and bioavailability 
testing alone are sometimes insufficient for proving sameness. FDA 
should also explore options to improve the efficiency and consistency 
of ANDA review processes and timelines, so that financial speculators 
cannot engage in a regulatory arbitrage, by dramatically hiking the 
price of some very old generic drugs because they know it can take 
years for new generic competitors to enter the market.

    Question 2. It has been reported that you have received millions of 
dollars from pharmaceutical companies. Please explain how you would 
address your myriad conflicts of interest.
    Do you believe you can be an effective Commissioner when you will 
need to recuse yourself so often? Do you think there is a tipping point 
where the conflicts are too great to overcome?
    Answer 2. If confirmed, I intend to lead the FDA as an impartial 
and passionate advocate for the public health and am confident that I 
can fully perform the duties of the FDA commissioner. 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 am committed to leading the FDA in an impartial manner that gives 
the American public confidence in the integrity of the FDA's 
decisionmaking process. I do not believe that the recusals set forth in 
my ethics agreement will impair my ability to discharge the 
responsibilities of this office. All nominees come to their positions 
with a range of experiences, which necessitate some recusals to ensure 
compliance with relevant ethics standards. It is routine in those 
circumstances for other senior agency officials to be involved in the 
matter and I have every confidence that, if I am recused, my team at 
FDA will ensure that Congress's laws will be properly implemented and 
the FDA's mission fulfilled.

    Question 3. During our meeting in my office, you stated that the 
Nation's opioid crisis would be among your top priorities. As I am sure 
you know, it has hit my State of Vermont very hard. You also noted that 
the FDA took incremental actions that never managed to get ahead of the 
opioid crisis.
    What role do you think FDA should play today in more aggressively 
addressing the opioid epidemic while also ensuring that Americans 
living with both acute and chronic pain do not suffer from poor pain 
management?
    How do we balance the need for patient access to effective pain 
relief medications while also preventing opioid addiction?
    Answer 3. Opioid abuse, misuse, and addiction constitute one of the 
most urgent and immediate public health threats facing our Nation. It 
is also the biggest public health crisis facing the FDA. The human and 
economic toll of this crisis is staggering. If confirmed, this will be 
my highest immediate priority. I will make sure FDA is aggressive, 
forward leaning, and fully engaged in combating this epidemic. I will 
work with FDA's staff to ensure FDA has the right policies and 
processes in place to:

     Facilitate the developments of new approaches and 
technologies to reduce the abuse/addictive potential of painkillers 
American patients use;
     Support the development of non-opioid analgesic 
alternatives for physicians and patients;
     Assess whether FDA's current approach to opioid regulatory 
decisions, including labeling, REMS, and physician/patient education 
are appropriate, robust, and fully effective;
     Encourage the development of new pharmacological tools for 
physicians and patients to both prevent opioid misuse and abuse, and 
support treatment and recovery for patients struggling to overcome 
opioid addiction;
     Enhance physician and patient educational materials to 
strengthen public awareness of the risks of opioids, as well as the 
FDA-approved resources available to them, using the full range of FDA's 
risk communication tools to better target this information;
     Taking steps to make sure that providers are appropriately 
educated on identifying, and helping to property intervene with, abuse-
prone patients;
     Re-assess whether FDA has the appropriate framework and 
authorities for evaluating the risk of abuse and diversion as a 
component of its review and approval process for opioids;
     Undertake a comprehensive effort to evaluate the full 
scope of the sources and threats from foreign-imported narcotics;
     Evaluate whether FDA should bring more alignment between 
the review and approval of different medical product platforms used in 
the treatment of pain to make sure the agency is adopting the best 
public health standard in assessing these products; and
     Collaborate effectively with other government agencies and 
external stakeholders to develop and execute comprehensive and 
effective strategies to win the battle against opioid abuse, misuse, 
and addiction. This includes steps for FDA to more closely collaborate 
and coordinate with DEA on the two agencies shared goals.

    Question 4. Tobacco use is the leading cause of preventable death 
and disability in the United States. Cigarette smoking claims nearly 
half a million lives every year and more than 8.5 million people suffer 
from tobacco-related chronic diseases. In 2006, you recognized that 
cigarette smoking is ``the single most preventable cause of death in 
the United States and is responsible for a growing list of cancers, as 
well as chronic diseases.'' But since then, you have made disturbing 
comments about where you stand on tobacco regulation. In 2009, you 
opposed FDA regulating tobacco because you said it would ``gut the 
agency's resources and distract it from our core mission.''
    Why should we confirm someone to be the head of the FDA who does 
not believe the FDA should regulate tobacco?
    Could you or any of the firms you have worked for financially 
benefit if the FDA weakens or eliminates regulations on tobacco or 
nicotine products?
    Answer 4. Through the Tobacco Control Act (TCA), Congress gave FDA 
regulatory responsibility over tobacco products. If confirmed, I will 
be committed to implementing the TCA, as intended by Congress. As I was 
not at FDA during the agency's initial TCA implementation activities, I 
am not fully acquainted with internal processes or specific decisions 
to-date. If confirmed, I will work with staff to quickly get up-to-
speed on this issue, and I will review current FDA policies, to ensure 
FDA treats products appropriately, implements provisions in a timely 
fashion, and in a manner that is consistent with congressional intent 
under the TCA. I believe responsibly implementing the TCA is an 
integral part of FDA's core mission to protect and promote public 
health. In pursuing these objectives, I will be guided only by the 
public health and the mandate of Congress.

    Question 5. While the law bans companies from using flavors like 
cherry, vanilla and cinnamon in cigarettes, there was one exemption 
from that list of flavors: Menthol. Today, nearly one in every three 
cigarettes sold in the United States are menthol cigarettes and there 
are an estimated 20 million people who smoke menthol cigarettes.
    Tobacco companies have long used aggressive marketing of menthol 
cigarettes to target our Nation's most vulnerable populations: Young 
people, women, LGBTQ populations and people of color. It is not a 
surprise that nearly 50 percent of all teenagers--many of whom are in 
middle school--who are addicted to cigarette smoking started by smoking 
menthol cigarettes because the minty flavor tastes better to first-time 
smokers.
    Women are 1.6 times more likely than men to smoke menthol 
cigarettes. Additionally, 8 in 10 African Americans, more than half (53 
percent) of Native Hawaiian and Pacific Islanders, and one-third of 
Latinos and Asians who smoke choose menthol cigarettes.
    One of the things that the 2009 law did was give the FDA the 
authority to ban menthol cigarettes. The 2011 TPSAC report concluded 
that the ``removal of menthol cigarettes from the marketplace would 
benefit public health in the United States.'' A separate study 
conducted by the FDA in 2011 and reported out in 2013 found that 
``menthol use is likely associated with smoking initiation by youth and 
young adults.'' This same report also found that ``menthol in 
cigarettes is likely associated with greater addiction'' and that 
menthol cigarettes post a greater risk to public health than non-
menthol cigarettes.
    Following these report findings, cigarette companies sued the FDA 
in 2011 in an attempt to prevent the FDA from acting on the TPSAC 
findings and recommendations. A tobacco-sympathizing judge (Judge Leon) 
initially directed the FDA to overlook and disregard the TPSAC report 
and findings. The FDA appealed the ruling and in January 2016, Judge 
Leon's decision was reversed, opening the door for the FDA to take 
action to regulate and even ban menthol cigarettes. Yet, menthol 
cigarettes remain on the shelves of stores across the country today.
    Given all that we know about menthol cigarettes--none of which is 
good--do you support banning menthol cigarettes from the U.S. market 
and, if so, would banning menthol cigarettes be an action you would 
take during your first year as Commissioner?
    Answer 5. I have not reviewed the scientific evidence related to 
the addition of menthol in cigarettes. If confirmed, I will commit to 
engaging with FDA's staff to quickly get up to speed on the regulatory 
history of this issue, and the agency's latest information, thinking, 
and actions. I would welcome the opportunity to work with Congress on 
this issue moving forward.

    Question 6. Marijuana is currently listed as a Schedule I substance 
(``drugs with no currently accepted medical use and a high potential 
for abuse'') under the Controlled Substances Act (CSA)--meaning under 
Federal law, marijuana is considered to be as dangerous as heroin, and 
more dangerous than opioids. The Drug Enforcement Agency could 
potentially take action to reschedule marijuana, pending evaluation 
from the FDA. If marijuana were rescheduled, the FDA would likely wind 
up with the authority to regulate marijuana and marijuana-derived 
drugs.
    Do you believe that marijuana is properly classified under the CSA?
    Do you think FDA should have the authority to regulate marijuana?
    Answer 6. I am aware that in July 2016, DEA determined, in 
consultation with HHS, that marijuana continues to meet the criteria 
for Schedule I control under the Controlled Substances Act. I cannot 
speak to decisions that the DEA might take in the future or the 
likelihood of FDA regulating marijuana. I do know that FDA is currently 
involved in supporting scientific research related to medicinal uses of 
marijuana and its constituents.
                              senator burr
    Question 1. The 21st Century Cures Act requires FDA to update 
guidance and regulations for regenerative therapeutic products and to 
hold a public meeting to encourage innovation. This is a great first 
step, and we are hopeful that you will prioritize the potential of 
these products as the new Commissioner of the FDA. If you are 
confirmed, how do you envision FDA's regulatory framework for these 
cutting edge treatments and therapies now and in the future?
    Answer 1. Regenerative medicine is one of the most innovative and 
promising emerging advancements in our scientific approaches to the 
treatment of human disease. Regenerative medicine appears to hold great 
promise for new therapeutic options for patients and physicians, 
particularly in areas of unmet or underserved medical need. However, as 
with all products FDA regulates, the agency must have the appropriate 
policies and processes in place to assess and ensure the safety and 
efficacy of regenerative medical products before they are approved for 
use by American patients. FDA must ensure patients and providers are 
appropriately educated about the potential risks and benefits of 
regenerative medicine therapies that fall within the scope of FDA's 
oversight, and that these products meet the agency's standard for 
safety and effectiveness. If confirmed, I will embrace the 
responsibility to facilitate important medical innovation in the 
regenerative medicine space, while maintaining the Gold Standard of 
safety and efficacy.

    Question 2. The Tobacco Control Act gave FDA the authority to 
regulate tobacco products. The tobacco industry has seen an evolution 
in the products available to consumers, and the FDA has deemed new and 
novel technologies to be regulated the same way as traditional 
combustible products. These products vary based on risk, and because of 
these new technologies, consumers have the opportunity to choose a less 
harmful product. If you are confirmed, how do you envision new 
technologies being reviewed by the Center for Tobacco Products at the 
FDA?
    Answer 2. If confirmed, I will be committed to implementing the 
TCA, as intended by Congress, including Section 911 related to modified 
risk products, which I recognize can provide helpful tools for current 
tobacco-users to transition off combustible tobacco. As I was not at 
FDA during the agency's initial TCA implementation activities, I am not 
fully acquainted with internal processes or specific decisions to-date. 
If confirmed, I will work with staff to quickly get up-to-speed on this 
issue, and I will review current FDA policies, including the deeming 
rule, to ensure FDA treats products appropriately, implements 
provisions in a timely fashion, and in a manner that is consistent with 
congressional intent under the TCA. I believe responsibly implementing 
the TCA is an integral part of FDA's core mission to protect and 
promote public health.
                             senator casey
    Question 1. The FDA plays an important role in responding to real 
and potential biological threats. Under the Pandemic and All-Hazards 
Preparedness Reauthorization Act of 2013 (PAHPRA), the FDA has 
important authorities such as the Emergency Use Authorization and the 
so-called ``Animal Rule'' regulation that outlines how FDA will 
consider animal data when it would be impossible or unethical to test a 
medical countermeasure. Another important consideration is the need for 
robust medical countermeasure development. Instead of a piecemeal 
approach that tackles one threat at a time--the so-called ``one bug, 
one drug'' approach--there is great potential to develop products so 
that one product can tackle multiple threats. Will you commit to 
considering the potential scale and scope of potential medical 
countermeasures during the FDA review process?
    Answer 1. I recognize the important role FDA plays in supporting 
the development of medical countermeasures. I commit to considering the 
potential scale and scope of potential medical countermeasures during 
the FDA review process.

    Question 2. Back in 2009, you wrote quite extensively about the 
Federal Government's response to the H1N1 pandemic flu, \41\ both 
praising the speed of the Federal Government's decision to order 
vaccine and criticizing the speed at which the vaccines were produced 
and distributed. Since then, we have made significant improvements 
toward greater preparedness for influenza, including bringing new 
vaccine production capacity online and approving a new quadrivalent 
vaccine that protects against four strains of flu.
---------------------------------------------------------------------------
    \41\ American Enterprise Institute Health Policy Outlook, November 
2009, and the Wall Street Journal, https://www.wsj.com/articles/
SB10001424052748704335904574497324151841690.
---------------------------------------------------------------------------
    Do you agree that vaccines are an important part of our public 
health preparedness, and that we must continue to develop, produce and 
distribute vaccines (such as, but not limited to, flu vaccine) to 
improve the Nation's public health, preparedness and response 
capabilities for emergencies?
    Do you think we are better prepared to approve and make available 
vaccines for vaccine-preventable illnesses? What further steps would 
you take as Commissioner to promote preparedness?
    Answer 2. Yes, I strongly agree that vaccines are an important 
component of our public health preparedness. I believe that FDA has 
taken significant steps to support the development and approval of new 
vaccines. If confirmed, I will commit to ensuring that FDA has the 
appropriate policies and processes in place to protect and promote 
public health and working with FDA's partners to pursue a comprehensive 
strategy to increase our public health preparedness.

    Question 3. Dr. Gottlieb, during our meeting you raised the 
possibility of steps that the FDA can take to increase what you termed 
``product competition,'' or the availability of generics. Yet of the 
roughly 2,000 Abbreviated New Drug Applications pending as a part of 
the generic backlog, only 15 are for first-in-class generics or for 
drugs that currently have a single manufacturer on the market.
    I am not sure I understand how adding the tenth or twelfth generic 
of a common drug will address the high costs facing patients with 
branded drugs. What other steps would you take as Commissioner to 
increase generic competition?
    Additionally, 8 of the 10 drugs that experienced the greatest drug 
price increases in 2014 were generic medications, with multiple 
manufacturers. What will you do to address these price hikes?
    Answer 3. While drug pricing does not fall directly within FDA's 
purview, I believe the agency can play an important role on this 
important issue by taking steps to improve product competition.
    If confirmed, I will work to ensure FDA has the appropriate 
policies and processes in place to effectively facilitate generic 
market entry and competition, especially for complex drugs that 
sometimes do not face effective generic competition even long after the 
patent expires. Reforming the regulatory pathway for complex generic 
products would address one key policy deficiency that results in 
unnecessary barriers to the development and review of generic 
competitors for some innovator products for which traditional 
bioequivalence and bioavailability testing alone are sometimes 
insufficient for proving sameness. FDA should also explore options to 
improve the efficiency and consistency of ANDA review processes and 
timelines, so that financial speculators cannot engage in a regulatory 
arbitrage, by dramatically hiking the price of some very old generic 
drugs because they know it can take years for new generic competitors 
to enter the market.

    Question 4. If confirmed as FDA Commissioner, what strategies do 
you support to share meaningful data on the safety of medical devices 
with the public, so that doctors and patients can make informed 
decisions?
    Answer 4. I am a strong proponent of greater data transparency--for 
patients, physicians, and manufacturers. If confirmed, I will be 
committed to working with Congress, patients, industry, and 
stakeholders on the issue of data transparency and other ways FDA could 
potentially make important information available to the public.

    Question 5. You have been a proponent of loosened restrictions on 
direct-to-consumer advertising of prescription drugs. If confirmed, 
what principles will guide you in revising industry guidance on direct-
to-consumer advertising of prescription drugs to assure that patients 
have accurate information on the safety and efficacy?
    Answer 5. I believe that providing consumers and providers with 
truthful, non-misleading, science-based information can promote public 
health by empowering Americans to make informed decisions about their 
health. This is especially true when it comes to truthful, non-
misleading clinical information provided in a non-promotional context, 
which is the context for many of my prior statements on this topic. If 
confirmed, I will work with FDA staff to review FDA's current policies 
related to these issues. I would approach any policy considerations 
related to the sharing of truthful, non-misleading information mindful 
of the existing statute and regulations, and FDA's mission to protect 
and promote public health.

    Question 6. In April 2015, the FDA published Guidance for Industry 
on abuse-
deterrent opioids, which stated that the Agency considers the 
development of opioids that are formulated to deter abuse as a ``high 
public health priority.'' In its 2016 action plan on opioids and in a 
fact sheet posted on Monday January 9, 2017, the FDA stated its strong 
support for transitioning from the use of non-abuse-deterrent opioids 
to opioids with meaningful abuse-deterrent formulations and stated,

          ``The FDA looks forward to a future in which most or all 
        opioid medications are available in formulations that are less 
        susceptible to abuse than the formulations that lack abuse-
        deterrent properties.''

    What further actions can and should the FDA take to transition the 
market to one in which patients receive abuse-deterrent opioids?
    Answer 6. Opioid abuse, misuse, and addiction constitute one of the 
most urgent and immediate public health threats facing our Nation. It 
is also the biggest public health crisis facing the FDA. The human and 
economic toll of this crisis is staggering. If confirmed, this will be 
my highest immediate priority. I will make sure FDA is aggressive, 
forward leaning, and fully engaged in combating this epidemic. I will 
work with FDA's staff to ensure FDA has the right policies and 
processes in place to:

     Facilitate the developments of new approaches and 
technologies to reduce the abuse/addictive potential of painkillers 
American patients use;
     Support the development of non-opioid analgesic 
alternatives for physicians and patients;
     Assess whether FDA's current approach to opioid regulatory 
decisions, including labeling, REMS, and physician/patient education 
are appropriate, robust, and fully effective;
     Encourage the development of new pharmacological tools for 
physicians and patients to both prevent opioid misuse and abuse, and 
support treatment and recovery for patients struggling to overcome 
opioid addiction;
     Enhance physician and patient educational materials to 
strengthen public awareness of the risks of opioids, as well as the 
FDA-approved resources available to them, using the full range of FDA's 
risk communication tools to better target this information;
     Taking steps to make sure that providers are appropriately 
educated on identifying, and helping to property intervene with, abuse-
prone patients;
     Re-assess whether FDA has the appropriate framework and 
authorities for evaluating the risk of abuse and diversion as a 
component of its review and approval process for opioids;
     Undertake a comprehensive effort to evaluate the full 
scope of the sources and threats from foreign imported narcotics;
     Evaluate whether FDA should bring more alignment between 
the review and approval of different medical product platforms used in 
the treatment of pain to make sure the agency is adopting the best 
public health standard in assessing these products; and
     Collaborate effectively with other government agencies and 
external stakeholders to develop and execute comprehensive and 
effective strategies to win the battle against opioid abuse, misuse, 
and addiction. This includes steps for FDA to more closely collaborate 
and coordinate with DEA on the two agencies' shared goals.

    Question 7. The Food and Drug Administration has moved forward with 
Food Safety Modernization Act implementation by finalizing seven rules 
required under the act. However, there are several required rules that 
remain to be addressed, including enhanced recordkeeping requirements 
for high-risk foods, in-store consumer notification of reportable foods 
and accreditation standards for food laboratories. There are also 
multiple guidance documents meant to help producers and food processors 
comply with FSMA that have yet to be developed.
    Will you commit to developing these important rules and guidance 
documents by the end of 2018?
    Answer 7. The Food Safety Modernization Act (FSMA) provides FDA 
with important tools and authorities to support its responsibility to 
ensure the safety of our Nation's food supply. If confirmed, I will 
work to ensure the agency has the appropriate policies, processes, and 
resources in place to implement FSMA, as intended by Congress. I am 
committed to timely implementation of the provisions of FSMA, 
consistent with congressional intent. FDA should implement FSMA in a 
way that protects and promotes public health by enhancing food safety, 
while also collaborating with the U.S. Department of Agriculture, State 
officials, and other government agencies to conduct regulatory 
activities in a manner that takes into account the unique challenges 
faced by small farmers and small businesses.

    Question 8. The Food and Drug Administration is responsible for the 
safety of about 80 percent of the U.S. food supply. The Food Safety 
Modernization Act enhanced FDA's ability to do more to prevent 
foodborne illness, rather than responding to foodborne illness 
outbreaks. This goal will only be realized if FDA is given the funding 
necessary to help train growers and food processors, update IT 
infrastructure and develop its own staff of skilled professionals. Will 
you commit to advocating for the funding necessary to successfully 
implement FSMA and protect our Nation's food supply?
    Answer 8. The Food Safety Modernization Act (FSMA) provides FDA 
with important tools and authorities to support its responsibility to 
ensure the safety of our Nation's food supply. If confirmed, I will 
work to ensure FDA has the appropriate policies, processes, and 
resources in place to implement FSMA, as intended by Congress.

    Question 9. According to the U.S. Department of Agriculture 
National Agriculture Statistics Service, PA is home to 17,000 bee 
colonies, producing 901,000 lbs. of honey for a value of $3.26 million 
in 2016. Countries like China continue to smuggle potentially unsafe 
honey into the United States, which has a serious impact on jobs and 
economic growth in Pennsylvania. Will you work to establish a Federal 
standard of identity for honey to ensure that consumers and producers 
are protected from substandard or falsely labeled honey?
    Answer 9. This is not an issue that I have previously considered, 
but I will look forward to working with you to better understand and 
advance policy in this area, if I am confirmed. I have always been a 
proponent of accurate labeling.

    Question 10. In May 2016, FDA published its final Nutrition and 
Supplement Facts Label rule to update the nutrient fact label. This 
rule required the declaration of the amount of added sugar in a 
product. While I support the declaration of added sugars so that 
consumers can make healthy choices for themselves and their family, I 
am concerned that this designation could cause confusion for consumers 
with regards to products like a jar of honey or maple syrup when the 
sugar content is naturally occurring.
    According to FDA's final rule on the nutrient fact label, a jar of 
honey would be required to label the sugar content in the honey as an 
``Added Sugar,'' rather than solely the ``Total Sugars'' in the 
product. An ``Added Sugar'' declaration for a jar of honey or maple 
syrup could imply to consumers that the sugar in honey is added, rather 
than naturally occurring. This could be misleading for consumers and 
not accurately convey the sugar content of the product.
    When crafting the final guidance for industry on added sugars will 
you provide clarity to the honey and maple syrup industry on the 
labeling of the sugar content of their packaged product (ex. a jar of 
honey)?
     How do you believe that the sugar content of a jar of honey or 
maple syrup should be declared? Should packaged honey and maple syrup 
be subject to the ``Total Sugars'' declaration, rather than the ``Added 
Sugars'' declaration?
    Answer 10. This is not a discussion that I have been privy to 
although I am familiar with the Nutrition and Supplement Facts Label 
rule. I believe in transparency for consumers, and that information 
must be understandable and clear and science-based. If confirmed, I 
commit to looking into this issue related to the labeling of sugars in 
honey and maple syrup.

    Question 11. Nutrition during pregnancy is critical for the health 
of the mother and developing fetus. It is vital that pregnant and 
nursing women have access to nutrition information that is rooted in 
science to ensure that they can make healthy decisions for their 
family. In 2014, FDA and EPA issued draft-updated advice about seafood 
consumption for pregnant and nursing women. That advice recommended 
that pregnant women, nursing women, women who may become pregnant and 
young children should eat more fish that is lower in mercury in order 
to benefit from important nutrients that can aid growth and 
development. These recommendations were consistent with the 2010 
Dietary Guidelines for Americans. In January 2017, FDA and EPA 
published revised advice for seafood consumption for these target 
groups of women and children.
    Will you ensure that future nutrition guidance related to seafood 
consumption for pregnant women, nursing women, women who may become 
pregnant and young children be based on the most current and relevant 
nutrition science?
    How do you intend to work with EPA to accomplish this?
    Answer 11. If confirmed, I will ensure FDA's advice concerning 
seafood consumption by pregnant and nursing women is based on the most 
current and relevant nutritional science and appropriately takes into 
account both the nutritional benefits, and any toxicological risks 
associated with seafood consumption. I will also work to ensure 
effective collaboration between FDA and the U.S. Environmental 
Protection Agency (EPA) on this issue, and a range of other public 
health matters over which both agencies share regulatory authority.
                            senator isakson
    Question 1. A GAO report in September 2015, requested by this 
committee, noted that it is illegal under current law to compound 
animal drugs using bulk active ingredients. While the report noted that 
a limited amount of compounding from bulk is needed to meet unmet 
medical needs, some pharmacies are endangering animal health by 
producing large quantities of near copies of approved animal drugs and 
mass marketing them essentially acting as manufacturers while skirting 
the safety and efficacy protections of the FDA approval process.
    The GAO strongly urged the Agency to provide clear final guidance 
outlining conditions under which FDA will generally not take 
enforcement actions for violations of specific provisions of the Food, 
Drug and Cosmetic Act with respect to animal drug compounding. FDA 
released draft guidance to this effect in 2015 and the comment period 
for that draft ended in November 2015. When will the agency move to 
protect animal health and issue this final guidance for animal drug 
compounding?
    Answer 1. Ensuring the safety of compounded animal drugs is an 
important part of FDA's mission to protect and promote public health. 
If confirmed, I will commit to engaging with FDA's staff to quickly get 
up to speed on the regulatory history of this issue, and the agency's 
latest information, thinking, and actions. I would welcome the 
opportunity to work with Congress on this issue moving forward to make 
sure the agency is taking timely steps on this matter and implementing 
the laws and regulations consistent with the intent of Congress.

    Question 2. Dr. Gottlieb, as you know, the majority of OTC 
medicines are regulated under the OTC Monograph system, which is built 
around notice and comment rulemaking. These burdensome regulations make 
changes, such as label warnings or new dosage forms, cumbersome and 
slow. Shifting these decisions to the drug center within FDA will add 
efficiency to scientific and medical determinations by removing 
decisionmaking layers, while continuing to include due process 
controls. Monograph reform will also allow for greater innovation and 
offerings for consumers. It is also my hope that this will address the 
15-year backlog sunscreen ingredient applications, as well as currently 
marketed products in the stayed final monograph.
    Will you commit to working with Senator Casey and myself on 
Monograph reform?
    Answer 2. OTC products play an important role in our Nation's 
healthcare system. I believe that the current monograph system for 
regulating OTC medicines should be evaluated to determine whether 
certain improvements may benefit public health. I am aware of some of 
the current proposals for improving on the monograph process. If 
confirmed, I will commit to working with you, Senator Casey, and 
members of your staffs on this important issue.

    Question 3. I am interested in acceleration of translating 
scientific research into more effective treatments for cancer and other 
diseases. The emergence of several notable efforts to conduct 
observational research of cancer patients and collect large amounts of 
data--including clinical outcomes, demographic information, and 
molecular profiles--to create ``learning systems'' to accelerate 
research and improve the quality of care.
    A notable example of this is a partnership called the Oncology 
Research Information Exchange Network--or ORIEN for short. ORIEN is a 
national partnership in which 15 of the Nation's top cancer centers 
have agreed to use the same protocol to enroll patients and collect and 
share data on patient outcomes and molecular profiles. As I understand 
it ORIEN is the largest big-data effort of its kind, with more than 
170,000 patients consented. In addition to using this system to work 
together to tackle major cancer research projects, ORIEN is also 
partnering with pharmaceutical companies who can use the data to speed 
up the process of finding the right patients for clinical trials to get 
new drugs to the market faster.
    Another example of a ``big data'' approach to observational 
research in cancer is the American Society for Clinical Oncology's 
``CancerLinQ'' program, which is also now aggregating and analyzing 
large amounts of patient data to support clinical decisions in cancer 
care.
    To what extent could these new health learning systems be of use to 
the Food and Drug Administration in the evaluation of emerging cancer 
treatments or related tasks, such as looking at the efficacy of 
sequences of treatments involving drugs that have already been 
approved? Would you see any impediment to working in partnership with 
ORIEN, ASCO and similar organizations to expand the FDA's current 
capacity for drug evaluation and research in oncology?
    Answer 3. As the delivery of cancer care becomes more personalized, 
and more closely tied to information about the molecular signatures of 
individual patients, approaches that enable the collection of better, 
patient-specific data are going to become increasingly important not 
only in informing the regulatory process, but also the delivery of care 
and the practice of oncology medicine and personalized medicine. I am 
committed to finding ways that FDA can more closely partner with, and 
leverage these opportunities to inform its own work and help fulfill 
the public health mission of these efforts advance opportunities for 
improved patient care.

    Question 4. Dr. Gottlieb, in 1978 FDA committed to address the 
overregulation of medical gases, like Oxygen, by creating separate 
regulations for medical gases as a unique class of drug products. 
Thirty-nine years later, FDA has not followed through on its commitment 
to create an appropriate framework specific to medical gases. In 2012, 
Congress enacted historic and bipartisan reforms at the request of the 
medical gas industry and pharmacists to require FDA to follow through 
on its 1978 commitment to address the overregulation of medical gases 
in the Food and Drug Administration Safety and Innovation Act (FDASIA). 
In November 2016, FDA issued a final rulemaking that addressed some 
medical gas labeling issues, however FDA did not, as intended by FDASIA 
and reiterated to FDA in the fiscal year 2016 Appropriations report 
language, modify current regulations to address the overregulation 
regulation of medical gas, such as the medical air labeling, adverse 
event reporting, expiration dating, calculation of yield and a host of 
other safety and enforcement issues identified by the medical gas 
industry as necessary to appropriately regulate medical gases. If 
confirmed as Commissioner of FDA, would you ensure that FDA fully 
implements Section 1112 of FDASIA by working with stakeholders to 
either incorporate by reference industry consensus standards or issue 
new final rulemakings on medical gas to address these unique medical 
gas regulatory issues?
    Answer 4. If confirmed, I am committed to implementing all 
congressional laws, including Section 1112 of FDASIA. I look forward to 
working with you on this issue.

    Question 5. I am interested in bringing more predictability and 
consistency to the device inspections process. For routine inspections, 
FDA should be able to give companies advance notice that they will be 
inspecting, as well as providing regular communications throughout the 
inspection process. Additionally, should FDA find an issue that needs 
to be addressed during an inspection, companies have 15 days to submit 
a remediation plan to FDA but there's no such timeline for FDA to 
respond to companies to communicate whether the remediation plan meets 
FDA expectations. I believe it makes sense for FDA inspections to be 
done in a risk-based system, meaning that FDA should focus its 
resources on those inspections that will have the most meaningful 
impact on patient safety. Will you commit to working with me and 
Senator Bennet on this issue?
    Answer 5. I agree that predictability and consistency are very 
important aspects of the FDA device inspections process. I also agree 
that across its regulatory portfolio, FDA should be taking a risk-based 
approach to its work in order to make sure the agency is maximizing its 
resources in pursuit of its important public health mission to protect 
and promote public health. If confirmed, I commit to working with you, 
Senator Bennet, and members of your staff on this issue.
                            senator franken
    Question 1. The MDUFA agreement includes funding for implementation 
of NEST and requires a pilot project to test the NEST system to 
facilitate pre-market approval of medical devices. Will the pilot 
projects be designed to support the generation and collection of data 
on devices, even after they come to market? How will this data be used 
to develop a more active post-market surveillance system?
    Answer 1. The reauthorization proposals for PDUFA, MDUFA, GDUFA, 
and BsUFA were developed and submitted to Congress prior to the end of 
the previous Administration. I was not involved with the FDA-industry 
technical negotiations on any of these proposals.
    However, I am supportive of data transparency and recognize the 
importance of collecting valid data that can be used to bring new 
medical devices to market, expand indications for approved medical 
devices, and enhance the agency's ability to collect important patient 
safety information. If confirmed, I will commit to working with staff 
to quickly get up to speed on this issue and help the agency evaluate 
whether NEST could be an appropriate tool for post-market surveillance.

    Question 2. When I met with you in my office prior to your 
nomination hearing, you explained that while the industry funding will 
help develop NEST, the FDA will need to update its tools to fully 
realize the potential of NEST and other initiatives. What is the FDA's 
role in this process and does the FDA have the resources it needs to 
make these updates?
    Answer 2. FDA will play an important role in developing NEST but 
the system will be owned and operated by multiple stakeholders. I 
support a properly resourced FDA that also has the modern tools it 
needs in order to use data in pursuing its public health goals and, if 
confirmed, will work to ensure that FDA is well-positioned to carry out 
its mission.

    Question 3. Rising drug prices continues to be problem in the 
United States and over 70 percent of Americans think that Congress 
should address the issue. If appointed as commissioner, will you commit 
to working with the HELP committee to address skyrocketing drug prices 
through actions under the FDA's purview? What proposals do you think 
have the biggest potential to lower costs?
    Answer 3. While drug pricing does not fall directly within FDA's 
purview, I believe the agency can play an important role on this 
important issue by taking steps to improve product competition. If 
confirmed, I will work to ensure FDA has the appropriate policies and 
processes in place to effectively facilitate generic market entry and 
competition, especially for complex drugs that sometimes do not face 
effective generic competition even long after the patent expires. 
Reforming the regulatory pathway for complex generic products would 
address one key policy deficiency that results in unnecessary barriers 
to the development and review of generic competitors for some innovator 
products for which traditional bioequivalence and bioavailability 
testing alone are sometimes insufficient for proving sameness. FDA 
should also explore options to improve the efficiency and consistency 
of ANDA review processes and timelines, so that financial speculators 
cannot engage in a regulatory arbitrage, by dramatically hiking the 
price of some very old generic drugs because they know it can take 
years for new generic competitors to enter the market.

    Question 4. In 2001, the FDA withdrew Avastin, a drug approved for 
breast cancer through an accelerated approval pathway with surrogate 
endpoint data, due to findings that the drug was not as effective as 
was indicated by the surrogate endpoint. What did you take away from 
FDA's experience with Avastin and had you been commissioner in 2011, 
would you have made a different decision? Would you have overruled your 
top cancer scientists and drug experts on Avastin?
    Answer 4. Insofar as I am not privy to all of the details related 
to the 2011 withdrawal from the market of Avastin, I do not believe it 
would be appropriate to opine on all of the things that I 
hypothetically might, or might not have done differently in that 
situation. Maintaining the Gold Standard of safety and efficacy for 
medical products is fundamental to FDA's mission to protect and promote 
public health. If confirmed, I will uphold the Gold Standard by 
ensuring FDA makes regulatory decisions based on sound science, good 
regulatory practices, and the support of a strong scientific staff.

    Question 5. Based upon the outcome in the case of FDA's withdrawal 
of Avastin to treat breast cancer and your published criticism of the 
FDA's decision, what assurances can you give that indicate that you 
will be willing to take action to protect public safety by removing a 
product from the market if and when later stage studies show drugs to 
be ineffective or unsafe?
    Answer 5. FDA's ability and obligations to remove a drug from the 
market, or in this case rescind a specific indication from drug 
labeling, if a drug fails to meet the required standard in a 
confirmatory trial, is an important component of the accelerated 
approval process, as established by Congress. If confirmed, I will 
follow the science and support the staff in upholding congressional 
intent in the conduct of the drug review program.

    Question 6. Congress passed the Pediatric Device Consortia Program 
in 2007 to help address the slow rate of innovation in pediatric 
medical devices but pre-market approvals for pediatric devices still 
only comprise 5 percent of pre-market approval submissions. What more 
can the FDA do to foster the development of new pediatric medical 
devices and improve the number of approvals?
    Answer 6. I agree that FDA should support the development of safe 
and effective pediatric medical devices. I am aware of a number of 
efforts FDA is undertaking in this area, including data collection on 
barriers to the development of and the unmet needs for pediatric 
medical devices. If confirmed, I will continue FDA's work and consider 
additional efforts in this area.

    Question 7. The passage of the Biologics Price Competition and 
Innovation Act (BPCIA) created a pathway for biosimilar entry. Yet, the 
FDA is still in the developing stages of developing and implementing 
this pathway. There are a number of outstanding issues that make it 
harder for FDA to implement the biosimilar pathway and increase 
competition to lower prices. What is FDA's role in encouraging more 
manufacturers to develop biosimilars for the U.S. market?
    Answer 7. I fully support the BPCIA. FDA can most effectively 
support a robust biosimilar marketplace by providing clarity about a 
consistent, transparent, science-based regulatory process for 
biosimilars. If confirmed, I will work to ensure the agency has the 
appropriate policies and processes in place to fully implement the law, 
as intended by Congress.

    Question 8. There are currently 182 drugs on the market that no 
longer have patent protection but also do not have any generic 
competition. Further, there are more than 500 drugs with only one 
marketed generic. In these situations, brand companies are able to 
price their product however they choose without market competition to 
drive down prices. What is the FDA's role in monitoring, identifying, 
and remedying market situations that lead to access barriers for 
patients or price gouging by manufacturers?
    Answer 8. While drug pricing does not fall directly within FDA's 
purview, I believe the agency can play an important role on this issue 
by taking steps to improve product competition. If confirmed, I will 
work to ensure FDA has the appropriate policies and processes in place 
to effectively facilitate generic market entry and competition, 
especially for complex drugs that sometimes don't face effective 
generic competition even long after the patent expires.
    Reforming the regulatory pathway for complex generic products would 
address one key policy deficiency that results in unnecessary barriers 
to the development and review of generic competitors for some branded 
drugs for which traditional bioequivalence and bioavailability testing 
alone are sometimes insufficient for proving sameness. FDA should also 
explore options to improve the efficiency and consistency of ANDA 
review processes and timelines, so that financial speculators cannot 
engage in a regulatory arbitrage, by dramatically hiking the price of 
some very old generic drugs because they know it can take years for new 
generic competitors to enter the market.
                              senator paul
    Question 1. Since passage of the Drug Quality Security Act in 2013, 
the FDA has implemented and enforced the law in a manner inconsistent 
with clear congressional intent. The agency has used guidance documents 
to assert regulatory authority over State-licensed compounding 
pharmacies and to treat them like drug manufacturers, and overly 
restricted the geographic limits for compounding in hospital systems. 
If confirmed as Commissioner, can you can you commit to taking a fresh 
look at the FDA's interpretation of the DQSA to assure that any 
regulations or guidance documents issued or related enforcement actions 
undertaken against pharmacies are consistent with the DQSA as written 
and in a way that better balances public safety with patient access to 
critical medications?
    Answer 1. 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. I will commit to 
working with your office to make sure we are appropriately pursuing the 
goals of DQSA, including protecting the role for the safe practice of 
pharmacy medicine.

    Question 2. Currently, FDA has a number of tools at its disposal to 
allow for innovative clinical trial design and for the consideration of 
foreign drug data in the drug approval process. Will you consider using 
or expanding the use of FDA's current authorities to expedite 
consideration of drugs approved in other countries?
    Answer 2. FDA has taken certain steps to bring more harmonization 
between international regulatory authorities in various aspects of its 
review programs, and make better use of regulatory data generated from 
oversees regulatory processes. If confirmed, I would commit to 
continuing to work with the FDA staff to look at additional ways that 
the agency can leverage the expertise and experience of its foreign 
counterparts.

    Question 3. OTC medicines are a cost-effective first-line therapy 
for many conditions, and the Rx-to-OTC switch often has a positive 
impact on the healthcare system and drives down costs. Since 1976, 106 
ingredients have made the Rx-to-OTC switch since 1976. Furthermore, 
FDA's OTC monograph approval work is far from complete.
    What do you believe is the appropriate role of FDA in the Rx-to-OTC 
process and what can the agency do to improve the process, and 
ultimately provide greater access to OTC drugs?
    There are two older types of insulin available in OTC form. 
Understanding that that appropriate guidance from a health care 
professional is important, will FDA continue to consider whether 
additional formulations of drugs such as insulin can be safely 
available to patients over-the-counter?
    Answer 3. I believe that there may be additional policy steps we 
can take to leverage opportunities to facilitate more patient access to 
OTC medicines and that this is an important public health goal. For 
example, I believe that the current monograph system for regulating 
over-the-counter drugs should be evaluated to see if improvements can 
be made. I recognize the potential public health benefit inherent in 
the increased availability of OTC drugs and, if confirmed, will work to 
improve this important regulatory pathway.

    Question 4. Recently, there have been a number of older, off-patent 
drugs, such as insulin and tetracycline, that have seen large price 
increases. Understanding that FDA does not have direct control over 
drug prices, what role do you believe the agency can play in working to 
address this problem?
    Answer 4. While drug pricing does not fall directly within FDA's 
purview, I believe the agency can play an important role on this 
important issue by taking steps to improve product competition. If 
confirmed, I will work to ensure FDA has the appropriate policies and 
processes in place to effectively facilitate generic market entry and 
competition, especially for complex drugs, including potentially some 
insulin products, that sometimes don't face effective generic 
competition even long after the patent expires. Reforming the 
regulatory pathway for complex generic products would address one key 
policy deficiency that results in unnecessary barriers to the 
development and review of generic competitors for some branded products 
for which traditional bioequivalence and bioavailability testing alone 
are sometimes insufficient for proving sameness. FDA should also 
explore options to improve the efficiency and consistency of ANDA 
review processes and timelines, so that financial speculators cannot 
engage in a regulatory arbitrage, by dramatically hiking the price of 
some very old generic drugs because they know it can take years for new 
generic competitors to enter the market.

    Question 5. The FDA's tobacco ``deeming rule'' threatens to upend 
the tobacco industry subject to this regulation. In particular, I am 
concerned that the regulation puts vapor, cigars, and other deemed 
products at a significant disadvantage to combustible cigarettes, which 
were allowed to remain on the market when Congress subjected them to 
FDA review. Furthermore, some of these products may present harm 
reduction opportunities for tobacco users. Will you commit to working 
to make this regulation more reasonable, so that it is workable for 
companies trying to keep products on the market?
    Answer 5. If confirmed, I will be committed to implementing the 
TCA, as intended by Congress, including Section 911 related to modified 
risk products, which I recognize can provide helpful tools for current 
tobacco-users to transition off combustible tobacco. As I was not at 
FDA during the agency's initial TCA implementation activities, I am not 
fully acquainted with internal processes or specific decisions to-date. 
If confirmed, I will work with the professional staff to quickly get 
up-to-speed on this issue, and I will review current FDA policies, 
including the deeming rule, to ensure FDA treats products 
appropriately, implements provisions in a timely fashion, and in a 
manner that is fully consistent with congressional intent under the 
TCA. I believe that responsibly implementing the TCA is an integral 
part of FDA's core mission to protect and promote public health.

    Question 6. A midnight rule proposed by FDA under the Obama 
administration intends to limit a specific chemical compound's (NNN) 
presence in smokeless tobacco to presently unachievable levels. 
Approximately 1,200 Kentucky farm jobs and an additional 600 Kentucky 
manufacturing jobs are at risk from this proposed rule because nearly 
all of this dark tobacco is grown within a 50-mile radius of 
Hopkinsville, KY. If this rule were to be finalized, these jobs would 
either be eliminated or moved overseas. As commissioner, how will you 
work to balance regulating chemicals like NNN with the importance of 
these farming and manufacturing jobs?
    Answer 6. I have not been privy to the development of this proposed 
rule although I understand the comment period has been extended. If 
confirmed, I will commit to reviewing the scientific evidence and 
working with you on this issue.

    Question 7. Last year, DEA, with FDA's input, decided not to change 
the controlled substance schedule for cannabis. Also, last year, FDA 
approved the second cannabis-based drug. I believe continued research 
in this area is critical to understand the potential medical benefits 
of cannabis and cannabis-based products. What role can FDA play in 
continuing to consider the therapeutic benefits and provide access to 
patients where appropriate?
    Answer 7. I am aware that in July 2016, DEA determined, in 
consultation with HHS, that marijuana continues to meet the criteria 
for Schedule I control under the Controlled Substances Act. I cannot 
speak to decisions that the DEA might take in the future, but I do know 
that FDA is currently involved in supporting scientific research 
related to medicinal uses of marijuana and its constituents. If 
confirmed, I am committed to continuing this research.

    Question 8. FDA, along with USDA and DEA, published guidance last 
August on industrial hemp. This guidance went far beyond what Congress 
had explicitly constructed in statute by narrowing the definition of 
hemp, restricting commerce from hemp pilot programs, and prohibiting 
transportation of hemp plants and seeds across State lines. As 
commissioner, how would FDA work with the industrial hemp industry to 
ensure it is able to continue thriving?
    Answer 8. I have not been involved in this issue so I cannot 
comment directly. However, I will note that I am committed to 
implementing congressional laws as they are intended. If confirmed, I 
will commit to working with you to address this issue.

    Question 9. Obamacare authorized the creation of a Federal menu 
labeling standard. On May 5, 2017, businesses will have to comply with 
FDA's Federal menu labeling rule. With this rule, businesses could face 
criminal penalties for violation. To provide context for how difficult 
this could be, a pizza company based in Kentucky determined there are 
over 30 million pizza combinations an individual could order at their 
restaurants. This rule would require them to post calorie counts for 
all those possible combinations on a menu in their restaurants, even 
though it already publicly provide all this information on its Web 
site. If an employee accidentally puts an extra handful of cheese on 
the pizza, those calories will inevitably be off--and now they will be 
subject to criminal penalties. As commissioner, how would you move 
forward with implementation of this rule and provide flexibility to 
business owners and their employees?
    Answer 9. While I am broadly aware of the menu labeling issue, this 
is not a matter on which I am familiar with the technical specifics. As 
a general rule, I support providing clear, accurate, and understandable 
information to American consumers to help inform healthful dietary 
choices. I believe information about caloric content can be a useful 
tool. However, I am mindful of the unique challenges that developing 
and communicating such information can pose, particularly on small, 
independent businesses. If confirmed, I will commit to working with the 
agency's professional staff to quickly get up to speed on the 
regulatory history related to menu labeling, as well as FDA's latest 
thinking and actions. I would welcome the opportunity to work with 
Congress and stakeholders to ensure any regulatory requirements would 
promote public health by providing helpful information to consumers, 
while not placing unnecessary compliance burden on businesses, 
particularly small, independent ones.
                             senator bennet
    Question 1. Antibiotic resistance is a real and growing public 
health crisis. The Centers for Disease Control and Prevention (CDC) 
estimates that at least 23,000 people die every year in the United 
States from resistant infections.
    Last year I worked with Senator Hatch on the PATH Act, which 
creates a new pathway for antibiotics to treat potentially deadly 
infections for which there are no other treatment options. The 
legislation was passed in the 21st Century Cures Act. This law allows 
FDA to approve these drugs on the basis of limited data sets, and also 
puts important protections in place to ensure these drugs are used only 
by patients for whom the benefit would outweigh the risk.
    If you are confirmed, will you commit to fully implementing this 
law including the provisions designed to ensure that these drugs go to 
the patients who actually need them?
    Answer 1. The availability and appropriate prescribing of 
antibiotics are vital to our Nation's public health. Additionally, 
antibiotic resistance is a significant and growing public health 
challenge facing our Nation. Within its statutory authorities, FDA 
should encourage the development of new antibiotics and ensure proper 
labeling to help address the issue of inappropriate prescribing and/or 
use. If confirmed, I would commit to fully implementing, in a timely 
fashion and consistent with congressional intent, the PATH Act for 
antibiotics.

    Question 2. Clinical trials are a necessity to understand the 
safety and efficacy of new medicine, but participation in trials is 
remarkably low. One reason for this is the eligibility criteria for 
potential patients can be quite restrictive. This can result in trials 
conducted with patients that are not reflective of the people that will 
ultimately use the drug.
    What would be needed for FDA to play a more active role in 
determining clinical trial eligibility criteria?
    What can the FDA do to help trials be more representative of the 
overall population?
    Would efforts to expand eligibility criteria help more patients 
with rare diseases enroll in clinical trials?
    Answer 2. I think it is very important that clinical trials capture 
the diversity of the population who will likely use the medical product 
once it is marketed and becomes available. If confirmed, I will work to 
ensure that FDA policies support the conduct of clinical trials that 
represent the clinical diversity of the intended patient population, 
including through the implementation of Section 907 of the Food and 
Drug Administration Safety and Innovation Act (FDASIA). With respect to 
rare diseases in particular, I would be committed to working with your 
office and other stakeholders to address ways that FDA can encourage 
more patients with rare diseases to enroll in clinical trials.

    Question 3. Currently, we hear from Coloradans who have a loved one 
suffering from a severe terminal illness and have no choices in terms 
of drugs already approved. For those who have no treatment options and 
are unable to participate in a clinical trial, they understandably seek 
access to unapproved experimental treatments.
    When you previously spoke as the Deputy Commissioner for Medical 
and Scientific Affairs you stated that ``participation in clinical 
trials is the best way for patients to get access to unapproved 
drugs.''
    What else can the FDA do to ensure that these patients can explore 
all of their options?
    Is there a way that FDA can collect safety and efficacy data from 
expanded access cases in a way that gives companies regulatory clarity 
while providing another option for patients?
    Answer 3. FDA works to inform potential participants on a wide 
range of issues related to clinical trials. For example, FDA created 
the Office of Health and Constituent Affairs to serve as a contact for 
patients. NIH also plays a key role in maintaining ClinicalTrials.gov, 
a data base which anyone, including providers, patients, and family 
members, can use to search for information about current, ongoing 
clinical research studies. Nothing prohibits FDA from collecting safety 
and efficacy data during expanded access cases. However, the conditions 
and circumstances of expanded access cases do not generally lend 
themselves to determining the efficacy of a drug. If confirmed, I 
commit to looking into this issue and working with you on it. I am 
committed to exploring ways that we might improve expanded access 
programs to provide patients with terminal diseases more options to get 
access to promising experimental medicines, and perhaps learn more from 
these access programs without creating any additional burdens or 
disincentives for sponsors who are seeking to make drugs available to 
terminal patients within the scope of the laws and regulations 
governing these programs.
                            senator collins
    Question 1. FDA's menu-labeling rule, even after an initial stay, 
will take effect 1 month from today. Grocery stores and other food 
retailers across America continue to be frustrated with FDA's handling 
of things, including for local and seasonal food items. Fresh and local 
food items may be sold at a few stores, under the same name, but the 
ingredients or recipe can vary, yet they would be considered ``standard 
menu items'' and subject to enforcement. The irony is that this will 
cause stores and restaurants to move away from fresh, local, and 
seasonal offerings. With just a month before the compliance date, we 
need FDA to act quickly to further delay, withdraw, or stay the rule so 
it can be rewritten to give businesses the flexibility to comply. Would 
you be willing to explore ways to encourage FDA to act before the 
compliance date to provide this much-needed flexibility for businesses?
    Answer 1. While I am broadly aware of the menu labeling issue, this 
is not a matter on which I am familiar with the technical specifics. As 
a general rule, I support providing clear, accurate, and understandable 
information to American consumers to help inform healthful dietary 
choices. I believe information about caloric content can be a useful 
tool. However, I am mindful of the unique challenges that developing 
and communicating such information can pose, particularly on small, 
independent businesses. If confirmed, I will commit to working with the 
agency's staff to quickly get up to speed on the regulatory history 
related to menu labeling, as well as FDA's latest thinking and actions. 
I would welcome the opportunity to work with Congress and stakeholders 
to ensure any regulatory requirements would promote public health by 
providing helpful information to consumers, while not placing 
unnecessary compliance burden on businesses, particularly small, 
independent ones.

    Question 2. The safety of personal care products is an issue of 
interest to many Americans. The average consumer uses 10 personal care 
products every day, yet the laws governing the cosmetics and personal 
care products industry have not been updated since 1938, and States 
have been acting on their own in the absence of a national safety 
standard. 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. If confirmed, I commit to working with you and others in 
Congress to explore options to potentially modernize FDA's authorities 
related to the regulation of cosmetic products.

    Question 3. Dr. Gottlieb, in our meeting we discussed the Aging 
Committee's investigation into the sudden price-spikes of decades old 
drugs and the report we issued outlining a number of potential 
bipartisan solutions to help improve access to affordable medications. 
You spoke about a number of regulatory obstacles to making drugs 
generic. Would you share with the committee any ideas you have, related 
to REMS or easing other regulatory obstacles, that could increase 
generic entry?
    We discussed unintended impacts of the FDA risk-evaluation and 
mitigation strategies (REMS) on generic competition. Some drug 
companies have used REMS to prevent potential generic competitors from 
getting access to the drug for the FDA required bioequivalence studies. 
Two weeks ago, Dr. Janet Woodcock testified that the FDA had reported 
150 cases of REMS abuse to the FTC. What can the FDA do to ensure the 
safe handling of these drugs while still promoting generic entry?
    The need for more affordable, complex drugs is also great. Last 
summer, for example, we saw the Mylan EpiPen price increase by 500 
percent. For complex products, such as auto-injectors and metered-dose 
inhalers, what role can the FDA play in helping sponsors get generic 
competition approved?
    Answer 3. My understanding is FDA has already taken action to 
instruct manufacturers that they may make samples of products subject 
to a REMS available to prospective generic competitors for the purpose 
of bioequivalence studies without running afoul of their legal 
requirements. It is important to note though, that appropriate safety 
precautions must be in place under specific circumstances, given the 
unique patient safety and public health risks associated with certain 
REMS products. But we need to make sure our policies are striking the 
right balance between safety and access, and evaluate carefully if 
regulations meant to improve safety are also becoming an unintended 
barrier to access and competition. If manufacturers inappropriately 
refuse to provide their product to prospective generic competitors, 
this would be a concern to FDA and become a matter for potential 
enforcement action by the Federal Trade Commission. While drug pricing 
does not fall directly within FDA's purview, I believe the agency can 
play a key role on this important issue by taking steps to improve 
product competition. If confirmed, I will work to ensure FDA has the 
appropriate policies and processes in place to effectively facilitate 
generic market entry and competition, especially for complex drugs that 
sometimes do not face effective generic competition even long after the 
patent expires and other places where there are specific issues that 
make it hard for generic manufacturers to copy certain products and 
demonstrate sameness under FDA's existing guidance. Reforming the 
regulatory pathway for complex generic products would address one key 
policy deficiency that results in unnecessary barriers to the 
development and review of generic competitors for some branded products 
for which traditional bioequivalence and bioavailability testing alone 
are sometimes insufficient for proving sameness. FDA should also 
explore options to improve the efficiency and consistency of ANDA 
review processes and timelines, so that financial speculators cannot 
engage in a regulatory arbitrage, by dramatically hiking the price of 
some very old generic drugs because they know it can take years for new 
generic competitors to enter the market.

    Question 4. Alzheimer's disease is one of the greatest public 
health threats of our time. More than five million Americans are living 
with Alzheimer's and other dementias. It is the sixth leading cause of 
death, and yet there is no cure, treatment, or means of prevention. 
Researchers are making major advancements in understanding the 
pathology of Alzheimer's beyond the amyloid beta and tau proteins. 
Today scientists are finding new genetic links, neuroprotective 
factors, and brain wide connectivity patterns associated with dementia 
risk. With the advancements of these biomarkers, we are poised to make 
progress in cures. How can the FDA support drug development using these 
biomarkers?
    Answer 4. Alzheimer's disease is, indeed, a major public health 
challenge today, and absent the discovery and development of new 
medicines that can slow, reverse, and perhaps even prevent the onset of 
the disease, the future impact Alzheimer's disease is staggering, in 
terms of human suffering and societal cost. If confirmed, making 
certain FDA has the right policies and processes in place to 
effectively encourage the development of safe and effective new medical 
products for Alzheimer's disease--to prevent its onset, to slow its 
progression, and one day to cure it--will be one of my highest 
priorities. I will work to ensure the agency consistently uses sound, 
rigorous, 21st century regulatory science, tools and approaches to 
facilitate the discovery and development of drugs for Alzheimer's 
disease. The use of well-validated biomarkers could be an important 
component of the future of Alzheimer's research and development. In 
short, patients with Alzheimer's disease, their families, and our 
Nation as a whole will benefit from the development of new Alzheimer's 
treatment options. If confirmed, I look forward to working with 
Congress, other government agencies like the NIH, industry, academia, 
and the patient and stakeholder communities to ensure FDA does 
everything it can to play its important role in tackling this 
challenging public health issue.

    Question 5. This is an exciting time for biologic products and 
regenerative medicine. In laboratories across America, every day we are 
learning something new. We are on the verge of real breakthroughs that 
may change disease trajectories fundamentally. In this era of discovery 
in biomedical research, we must promote and incentivize success. 
Developing biologic products and regenerative therapies is unique 
compared to traditional targeted drugs. In some cases, different 
endpoints may be needed. What role do you see for the FDA in 
facilitating new endpoints?
    Answer 5. New areas of biologics and regenerative medicine are some 
of the most innovative and promising emerging advancements in our 
scientific approaches to the treatment of human disease. Regenerative 
medicine, in particular, appears to hold great promise for new 
therapeutic options for patients and physicians, particularly in areas 
of unmet or underserved medical need. I believe more generally, FDA 
should lean forward in defining the regulatory principles on which the 
safety and effectiveness of these new areas of medicine are going to be 
judged by the agency, in order to help facilitate their development. 
This includes the development of appropriate endpoints for evaluating 
the safety and effectiveness of new areas of biological products and 
regenerative medicine. If confirmed, I will embrace the responsibility 
to facilitate important medical innovation, while maintaining the 
agency's Gold Standard of safety and efficacy.

    Question 5. In 2011, FDA issued an Advisory on glass lamellae 
formation in certain injectable drugs. This action was taken out of 
concern for the impact of glass contamination on drug quality and 
patient safety. The Advisory noted at the time that ``there is the 
potential for drugs administered intravenously that contain these 
fragments to cause embolic, thrombotic and other vascular events.'' I 
understand that it has been discovered recently that glass issues, in 
addition to glass lamellae formations, can increase the presence of 
glass in injectable drugs beyond the level previously known when the 
Advisory first was issued. This potential to cause harm to patients 
presents a public health risk. If confirmed, what action would you plan 
to take to address these glass issues and when?
    Answer 5. I recognize the potential safety concern related to the 
use of glass vials and, if confirmed, will ensure that FDA is taking 
every necessary step to address this issue.

    Question 6. I mentioned during our meeting the FDA's proposed rule 
on electronic prescribing information and its implication for rural 
pharmacists. I continue to be concerned that it 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 or terrorist attack. 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 6. Ensuring that accurate, science-based information about 
medical products is readily accessible to patients and providers is an 
issue that is critically important to public health. Drug labeling is 
FDA's primary vehicle for communicating risk information to consumers 
and providers and it needs to be readily accessible to patients. If 
confirmed, I will commit to engaging with the agency's professional 
staff to quickly get up to speed on this issue. I would welcome the 
opportunity to work with you on this issue moving forward.

    Question 7. Another area of increasing concern is the overuse of 
antibiotics in agriculture and the rise of antibiotic-resistant 
bacteria. Preserving the effectiveness of medically important 
antibiotics used to treat human and animal bacterial diseases is 
critical and has been described as the single most important challenge 
in infectious disease. The CDC estimates that at least 2 million 
illnesses and 23,000 deaths caused by antibiotic-resistance occur every 
year in the United States. I have introduced legislation with Senator 
Feinstein aimed at reducing the overuse of antibiotics in agriculture. 
Will you continue to support ways that the FDA, in cooperation with 
other Federal agencies, can address the growing problem of antibiotic-
resistant bacteria and the overuse of antibiotics in agriculture?
    Answer 7. Antibiotic resistance is a significant and growing public 
health challenge facing our Nation. In addition to measures FDA should 
take to address this issue within the context of human use, the agency 
must effectively collaborate with other government agencies and public 
health authorities to develop policies and processes to address the 
issue of antibiotic use in animals intended for human consumption. If 
confirmed, I will ensure FDA remains engaged on this important public 
health issue. This includes making sure that animal drug labeling 
reflects the most up-to-date science, and working closely with the U.S. 
Department of Agriculture, the Centers for Disease Control, the U.S. 
Department of Defense, and other appropriate government agencies. FDA 
should also consider input from other important stakeholders, such as 
the farmers, the agriculture industry, and veterinarians. FDA's 
implementation of a voluntary plan with industry to phaseout the use of 
certain antibiotics is an important step in the right direction.
                           senator whitehouse
    Question 1. The FDA is currently implementing the 21st Century 
Cures Act, including its provisions on improving coordination between 
the relevant centers during the review of a combination product. Though 
FDA seems to be making progress on improving this review process, I 
think it is important that we continue to monitor this issue and be 
ready to make bigger changes to the combination products approval 
process if they are needed. As Commissioner, will you commit to keeping 
the HELP Committee updated on FDA's work to improve the combination 
products review process, and to propose any recommended legislative 
updates in a timely manner?
    Answer 1. I recognize the importance of FDA's combination product 
review program and, if confirmed, will commit to implementing 21st 
Century Cures and working with you and the other Senators on the HELP 
Committee on any related legislative proposals.

    Question 2. You have written extensively on your views regarding 
the regulation of medical software and apps. In a 2014 Wall Street 
Journal commentary titled, ``Why Your Phone Isn't as Smart as It Could 
Be,'' you wrote ``The FDA should exempt the majority of mobile-health 
apps from premarket review.'' Last Congress, members of this committee 
led by Senators Hatch and Bennet worked to define FDA's authority over 
medical software as part of the 21st Century Cures Act. In that law, we 
exempted many forms of low-risk software, such as software intended to 
encourage a healthy lifestyle, from FDA oversight.
    Do you believe that there are additional types of medical software 
that should be exempted from FDA oversight? If so, which ones and why?
    Answer 2. I support tools that can help provide consumers with more 
information about their health. FDA must clearly define when an app is 
a medical device subject to its regulation, and when it falls outside 
FDA's framework or is low risk, and therefore appropriate to be exempt 
from the full scope of FDA's pre-market requirements. For products 
subject to FDA's pre-market requirements, the agency should use a risk-
based approach in regulating consumer apps and other medical software, 
and, if confirmed, I look forward to helping further refine FDA's 
approach and implement the related provisions of 21st Century Cures in 
a timely fashion and consistent with congressional intent.

    Question 3. In the 21st Century Cures Act, Congress established an 
administrative process that FDA can use to bring medical software that 
is exempted from regulation back under FDA oversight if it is 
reasonably likely to have ``serious adverse health consequences.''
    How would you determine whether a piece of medical software or an 
app poses an adverse health threat?
    Under what circumstances would you conclude that this 
administrative process should not be used if medical software is 
determined to have a risk of serious adverse health consequences?
    Answer 3. If confirmed, I look forward to working with the FDA's 
professional staff to properly implement this framework, consistent 
with congressional intent. I would also commit to working with you and 
your colleagues in Congress, to keep you informed about FDA's 
implementation efforts.

    Question 4. In the same Wall Street Journal commentary referenced 
in question 2, you suggested that FDA should employ ``post-market 
controls'' to make sure mobile health apps are meeting expectations. 
What types of post-market controls should FDA use to make sure such 
software--as you wrote--``meets expectations''?
    Answer 4. Controls should be used to ensure, among other things, 
that mobile health apps are providing consumers with data that is 
accurate and reliable. If confirmed, I would work with Agency staff to 
develop appropriate post-market controls that ensure the safety of 
consumers but continue to allow for innovation in product development.

    Question 5. The Centers for Disease Control and Prevention 
estimates that 2 million people develop antibiotic-resistant infections 
in the United States each year, resulting in at least 23,000 deaths. 
The World Health Organization has concluded that antibiotic resistance 
. . . ``is one of the biggest threats to global health'' . . . One area 
in which CDC, FDA, and the agriculture sector has made strides in 
recent years is the judicious use of medically important antimicrobial 
drugs in food-producing animals. Do you believe FDA should have a role 
in improving antimicrobial stewardship? What is that role?
    Answer 5. Antibiotic resistance is a significant and growing public 
health challenge facing our Nation. In addition to measures FDA should 
take to address this issue within the context of human use, the agency 
must effectively collaborate with other government agencies and public 
health authorities to develop policies and processes to address the 
issue of antibiotic use in animals intended for human consumption. If 
confirmed, I will ensure FDA remains engaged on this important public 
health issue, making sure that animal drug labeling reflects the most 
up-to-date science, and working closely with the U.S. Department of 
Agriculture, the Centers for Disease Control, the U.S. Department of 
Defense, and other appropriate government agencies, among other steps. 
I believe it is a priority for FDA to continue to play an important 
role in improving antimicrobial stewardship.

    Question 6. Stakeholders within the animal health sector 
acknowledge the need for better data and more timely information about 
the use of antibiotics in production agriculture and its role in 
antibiotic resistance. As you may know, the National Antimicrobial 
Resistance Monitoring System (NARMS), jointly coordinated by CDC, FDA, 
and the USDA, analyzes trends in antibiotic resistance by collecting 
bacteria samples from animal and meat products as well as cases of 
human foodborne illness. This allows the aforementioned Federal 
agencies to accelerate their response to emerging public health 
threats. Do you support the NARMS initiative and intra-agency efforts 
to conduct surveillance of antibiotic resistance across the food chain?
    Answer 6. I fully support efforts that will help facilitate the 
collection of more and better information about foodborne illness and 
emerging and resistant infections.

    Question 7. As you know, earlier this year President Trump signed 
an Executive order instituting a hiring freeze for the executive 
branch. The order did not state how the freeze would affect many 
agencies, including the FDA. The 21st Century Cures Act recently 
provided the FDA with new hiring authorities, and a significant portion 
of user fee dollars goes toward supporting the hiring of FDA review 
staff in the drug and device centers.
    Do you agree that FDA's approval process would benefit if it could 
promise higher salaries to attract scientific expertise? If so, what 
steps will you take to advocate for an exemption for FDA from the 
hiring freeze?
    Do you believe the FDA will be able to fulfill its mission if the 
freeze prevents you from hiring new staff?
    Answer 7. I was not involved with the development of the 
Administration's Federal workforce proposals, including the hiring 
freeze Executive order. FDA's ability to fulfill its mission to protect 
and promote public health depends on its world-class workforce of 
talented and dedicated public servants. If confirmed, I will commit to 
working with my colleagues in the Administration, as well as Congress, 
to ensure FDA is appropriately resourced and staffed.

    Question 8. Regulatory capture has been a concern within regulated 
industries since Woodrow Wilson. In the case of FDA, industry is not 
only regulated by the agency, but is also its funder.
    According to the Congressional Research Service, when the 
prescription drug user fee agreement was first authorized, user fees 
funded 10 percent of the Human Drug Program's activities. In 2016, it 
was nearly 65 percent. The medical device user fees covered 16 percent 
of the device center's costs in 2006, compared with 35 percent in 2015. 
As Commissioner, what specific steps will you take to ensure the FDA is 
able to maintain its independence so it can continue to put public 
health and safety first when reviewing drug and device applications?
    Answer 8. As you note, user fees have grown to provide a 
significant portion of FDA's funding. At the same time, I have 
confidence that these fees are structured in a way that does not allow 
regulated industry to exert inappropriate influence on the agency. 
Maintaining the Gold Standard of safety and efficacy for medical 
products is fundamental to FDA's mission to protect and promote public 
health. If confirmed, I will uphold the Gold Standard and the 
independence of FDA's review process by ensuring FDA makes regulatory 
decisions based on sound science, good regulatory practices, and the 
support of a strong scientific staff.

    Question 9. Many of my Senate colleagues and I have called on the 
FDA to issue advice to pregnant women about the safe consumption of 
seafood that is based on the latest nutrition science. FDA research 
shows that maternal seafood consumption offers significant 
neurodevelopmental benefits for children. FDA committed to completing 
the seafood advice in 2011, but only did so on January 18, 2017. While 
I was pleased to see the advice finalized, it is now inconsistent with 
the Dietary Guidelines issued by the Department of Health and Human 
Services and the Department of Agriculture.
    Have you reviewed FDA's advice on safe seafood consumption for 
pregnant women?
    Do you believe Federal guidance in this area should be based on the 
best available science?
    If you are confirmed, will you work with the relevant Federal 
agencies to ensure the guidance about seafood consumption for pregnant 
women is consistent?
    Answer 9. If confirmed, I will ensure FDA's advice concerning 
seafood consumption by pregnant and nursing women is based on the most 
current and relevant nutritional science and appropriately takes into 
account both the nutritional benefits, and any toxicological risks 
associated with seafood consumption. I will also work to ensure 
effective collaboration between FDA and the U.S. Environmental 
Protection Agency (EPA) on this issue, and a range of other public 
health matters over which both agencies share regulatory authority.

    Question 10. According to the Centers for Disease Control and 
Prevention, tobacco use is the leading cause of preventable death in 
the United States, responsible for 1,300 deaths every day. I think 
tobacco use needs more regulation, not less, which is why last Congress 
I cosponsored the Tobacco to 21 Act, which would have raised the 
minimum legal age for the sale of tobacco from 18 to 21. A number of 
States and localities across the country have already recognized the 
benefits of this policy and taken action to raise the age to 21. As FDA 
Commissioner, you would be charged with working to enhance the health 
and well-being of Americans, and there is clear evidence that access to 
tobacco products does nothing but detract from it.
    Do you believe FDA should have a role in regulating tobacco 
products?
    As Commissioner, will you support efforts to restrict the sale of 
tobacco to young Americans?
    Answer 10. Through the Tobacco Control Act (TCA), Congress gave FDA 
regulatory responsibility over tobacco products. If confirmed, I will 
be committed to implementing the TCA, as intended by Congress. I fully 
support efforts to restrict the illegal sale of tobacco products to 
minors and reduce smoking rates in this country. I believe responsibly 
implementing the TCA is an integral part of FDA's core mission to 
protect and promote public health.

    Question 11. Will you support the ongoing efforts of the Center for 
Tobacco Products to monitor retailer, manufacturer, importer, and 
distributor regulatory compliance, as well as educate the public about 
the health effects of tobacco use?
    Answer 11. Yes. Ensuring compliance and educating the public are 
important public health responsibilities for FDA, and an important 
component of the goals of the TCA.

    Question 12. In May 2016, the FDA announced changes to the 
Nutrition Facts label for packaged foods in an effort to make it easier 
for consumers to understand and make informed food choices. One 
significant change is that the label will now include ``added sugars,'' 
including the grams of sugar and the percentage of a ``Daily Value'' 
that is included in a product. Evidence shows that while the sugars 
found in fruits and other natural foods can be part of a healthy diet, 
consuming large amounts of added sugar can make it difficult to meet 
your body's nutritional needs. Will you ensure that the Nutrition Facts 
label update, including the ``added sugar'' line, is implemented by the 
current compliance date of July 2018?
    Answer 12. I believe consumers should have access to standard, 
understandable, and accurate information that they can use to make 
educated decisions about a healthful diet. If confirmed, I will commit 
to engaging with the agency's professional staff to quickly get up to 
speed on this issue. I would welcome the opportunity to work with you 
on this issue moving forward.

    Question 13. It has been reported that President Trump, who has 
publicly questioned the safety of vaccines and perpetuated the myth 
that vaccines cause autism, will convene a Commission on Vaccine 
Safety. The scientific community has overwhelmingly concluded vaccines 
are safe and have saved countless lives. As FDA Commissioner under 
President Trump, you may be charged with implementing an anti-vaccine 
agenda.
    Do you commit to protecting access to life-saving vaccinations?
    Do you commit to ensuring that information about vaccine safety and 
efficacy that is disseminated by the Trump administration reflects the 
best available scientific evidence?
    Answer 13. As I stated during my confirmation hearing before the 
committee, this scientific question pertaining to vaccine safety and 
autism is perhaps one of the most rigorously and exhaustively studied 
public health questions in modern times. I believe the science with 
respect to the question of there being any causal link between 
childhood vaccines and autism is clear and settled. Vaccines are safe 
and effective, and they are among the most impactful tools we have at 
our disposal to protect and promote public health. If confirmed, I will 
advise my colleagues and superiors within the Administration about the 
scientific validity and public health value of vaccines and will 
promote sound vaccination public policies.

    Question 14. I have heard from medical device companies in Rhode 
Island who are pleased with the medical device user fee agreement that 
has been negotiated between FDA and industry, and would like to see it 
enacted by Congress as negotiated. Yet, with only a few months left 
before the agreements expire, President Trump has proposed doubling the 
amount of user fees collected by the FDA. Have you reviewed the MDUFA 
IV agreement, and do you support its enactment as negotiated?
    Answer 14. The reauthorization proposals for PDUFA, MDUFA, GDUFA, 
and BsUFA were developed and submitted to Congress prior to the end of 
the previous Administration. I was not involved with the FDA-industry 
technical negotiations on any of these proposals. I was also not 
involved in the development of the President's Blueprint Budget. I 
recognize these user fee programs are critically important to FDA, and 
the patients the agency serves, as they provide significant resources 
to support FDA's regulatory activities related to innovative and 
generic medicines, biosimilars, and medical technologies. In order to 
ensure FDA is adequately resourced to facilitate the discovery, 
development, and regulatory review of safe and effective medical 
products to help American patients, if confirmed, I will work with my 
colleagues in the Administration, Congress, industry, and stakeholders 
to reauthorize these critical user fee programs in a timely manner.

    Question 15. In addition to challenges obtaining FDA approval, 
innovative technologies can face additional hurdles getting authorized 
for reimbursement once they are approved. There have been efforts to 
make these two processes move on a parallel path, instead of one after 
the other. In your role as FDA Commissioner, would you support efforts 
to make these two approval processes work in tandem instead of 
separately?
    Answer 15. I have been supportive of the concept of parallel 
review. If undertaken appropriately, it could facilitate more timely 
patient access to safe and effective new FDA-approved medical products. 
If confirmed, I would look forward to working with my colleagues at CMS 
on this issue.

    Question 16. Our prescription drug market relies on competition to 
keep costs down for consumers. Generic competitors help give patients 
more options and drive down drug prices across the board. However, some 
brand-name drug manufacturers have engaged in behavior that makes it 
more difficult for potential generic competitors to obtain samples of 
their drugs--samples they need to be able to prove substantial 
equivalence and get approval from the FDA. Or they refuse to agree on a 
shared safety protocol for the drug, another FDA requirement. Last 
Congress, I cosponsored the CREATES Act, which would have allowed a 
generic company facing one of these delay tactics to bring action in 
Federal court to obtain the sample it needs, or enter into court-
supervised negotiations for a shared safety protocol. Will you support 
efforts to remove the incentives for companies to engage in these delay 
tactics and improve opportunities to create generic competition?
    Answer 16. My understanding is FDA has already taken action to 
instruct manufacturers that they may make samples of products that are 
subject to REMS available to prospective generic competitors for the 
purpose of bioequivalence studies without running afoul of their legal 
requirements. It is important to note though, that appropriate safety 
precautions must be in place under specific circumstances, given the 
unique patient safety and public health risks associated with certain 
REMS products. We need to make sure our policies are striking the right 
balance between safety and access, and evaluate carefully if 
regulations meant to improve safety are also becoming an unintended 
barrier to access and competition. If manufacturers inappropriately 
refuse to provide their product to prospective generic competitors, 
this would be a concern to FDA and become a matter for potential 
enforcement action by the Federal Trade Commission. While drug pricing 
does not fall directly within FDA's purview, I believe the agency can 
play a key role on this important issue by taking steps to improve 
product competition. If confirmed, I will work to ensure FDA has the 
appropriate policies and processes in place to effectively facilitate 
generic market entry and competition, especially for complex drugs that 
sometimes do not face effective generic competition even long after the 
patent expires and other places where there are specific issues that 
make it hard for generic manufacturers to copy certain products and 
demonstrate sameness under FDA's existing guidance. Reforming the 
regulatory pathway for complex generic products would address one key 
policy deficiency that results in unnecessary barriers to the 
development and review of generic competitors for some branded products 
for which traditional BE/BA testing alone are sometimes insufficient 
for proving sameness.

    Question 17. Increasing generic competition is one way the FDA can 
support efforts to lower prescription drug prices. One issue in the 
generic drug program has been deficient applications, requiring FDA and 
the sponsor to go through multiple review cycles before a product can 
be approved. The GDUFA II agreement includes changes that would give 
sponsors more opportunities to address deficiencies in their 
applications before FDA decides it does not have enough information to 
proceed with its review.
    Do you support efforts like those in GDUFA II to reduce the number 
of review cycles for generic drug applications?
    How else can the FDA work with sponsors to reduce the number of 
review cycles needed and get products to market faster?
    Answer 17. The reauthorization proposals for PDUFA, MDUFA, GDUFA, 
and BsUFA were developed and submitted to Congress prior to the end of 
the previous Administration. I was not involved with the FDA-industry 
technical negotiations on any of these proposals. While drug pricing 
does not fall directly within FDA's purview, I believe the agency can 
play an important role on this important issue by taking steps to 
improve product competition. If confirmed, I will work to ensure FDA 
has the appropriate policies and processes in place to effectively 
facilitate generic market entry and competition, especially for complex 
drugs that sometimes do not face effective generic competition even 
long after the patent expires. FDA should also explore options to 
improve the efficiency and consistency of ANDA review processes and 
timelines, so that financial speculators cannot engage in a regulatory 
arbitrage, by dramatically hiking the price of some very old generic 
drugs because they know it can take years for new generic competitors 
to enter the market.

    Question 18. While much of the conversation about high drug prices 
has focused on innovative blockbuster drugs, like treatments for 
hepatitis C, the prices of many older drugs are rising too. I heard 
from the medical director of a health center in Providence that some of 
her patients can no longer afford insulin, a drug that has been around 
in some form for nearly a century. An insulin biosimilar was finally 
brought to market at the end of 2016, and more products are in 
development now, but Americans should not have to wait nearly 100 years 
to be able to purchase a lower cost version of a drug.
    What will you do to ensure drug companies can not abuse their 
patent protections to keep generic competitors out of the market?
    What steps will you take to incentivize potential competitors to 
use the generic and biosimilar approval pathways to improve 
competition, even for decades-old drugs?
    Answer 18. If confirmed, I will work to ensure FDA has the 
appropriate policies and processes in place to effectively facilitate 
generic market entry and competition, especially for complex drugs that 
sometimes do not face effective generic competition even long after the 
patent expires. This could include certain insulin products. I am also 
committed to working with the FDA professional staff to make sure the 
agency has appropriate standards and guidance in place that help 
balance the mandate to ensure with the safety and effectiveness of 
biosimilars while creating efficient pathways for inclusion of the sort 
of labeling claims on these products that will help facilitate their 
broader adoption and product competition that can enhance patient 
access.

    Question 19. Last year, the FDA announced it would prioritize the 
review of generic products that would compete with ``sole-source'' 
products, or drugs that have only one manufacturer. However, other 
uncompetitive markets that have supply shortages or limited competition 
could also be improved by approving competitors more quickly. Should 
the FDA prioritize generic applications for market deficiencies caused 
by factors other than there being a single manufacturer?
    Answer 19. If confirmed, I am fully committed to looking at 
additional ways that FDA can take steps, under the agency's existing 
legal authorities, to facilitate more product competition and generic 
market entry as a way to enhance patient access to medicines.

    Question 20. Many agencies responsible for the approval of 
prescription drugs in other countries take cost-benefit analyses and 
comparative-effectiveness research into account during the approval 
process. Although the FDA does not make decisions about the prices of 
drugs or whether health insurance programs will cover them, could the 
consideration of comparative-effectiveness research help inform the 
FDA's decisionmaking?
    Answer 20. The legal standard for FDA drug approval is whether a 
drug is safe and effective for its intended use. I am committed to 
working with Congress to consider additional ways that FDA could 
potentially improve the quality of data used to inform the agency's 
decisionmaking while maintaining its Gold Standard of safety and 
efficacy.

    Question 21. Both the PDUFA and GDUFA fee structures include 
mechanisms to reduce the financial burden for small companies. Do you 
support efforts like these to make the new drug and abbreviated new 
drug application processes more accessible to small, innovator 
companies? What else would you do to ensure small companies are not 
priced out of the FDA review process?
    Answer 21. I support policies that appropriately take into 
consideration the unique challenges posed by small companies. Among the 
many steps that we can take to ensure small and sometimes 
undercapitalized companies are not priced out of the FDA review process 
is to make sure the regulatory requirements are consistent, 
transparent, efficient and based on the most modern science. FDA must 
also take a risk-based approach to regulation, so that we are not 
imposing unnecessary regulatory costs that are not achieving their 
intended public health purpose.
                            senator cassidy
    Question 1. The literature often speaks of the activated patient--
one engaged in their own health care. Ideally, each patient would be 
engaged in their own health care decisions, and would choose the most 
efficient expenditure of their health care dollar. However, in health 
care, a given patient may have a plethora of options from which to 
choose--this can be very true in the device space.
    Patients are seeing an increasingly crowded field of devices. 
However, it is very difficult for a typical patient to find the device 
that would produce the best value for somebody with similar health 
status. As a provider for 30 years, I can tell you that providers are 
in the same boat--data on outcomes for medical products and services 
certainly exist, but are not readily consumable.
    Currently, the FDA regulatory structure incentivizes device makers 
to make their products as similar to each other as possible, in order 
to avoid lengthy and expensive premarket approvals. Dr. Gottlieb, do we 
reduce incentives for patient-focused innovation in the device industry 
this way?
    For drugs, the FDA uses a rating system to differentiate between 
drugs that provide a substantial improvement over current standards of 
care--priority-rated drugs--and those that bat par with existing 
options. While there is little reward for those more substantive 
improvements today, this priority rating system has been well-developed 
between patient groups, clinical experts, industry, and the FDA--and 
serves as a clear signal to the health care system and to patients.
    Dr. Gottlieb, could a parallel effort by the FDA in the device 
space help us identify those devices which show big steps forward in 
patient outcomes? Could this be done some time after market 
introduction, based upon real world evidence?
    Answer 1. If confirmed, I would be committed to working with you to 
explore additional ways we might modernize the medical device review 
process to ensure a proper balance between the need to ensure the 
safety and effectiveness of these products, and appropriate steps to 
facilitate innovation. Medical devices are important tools in the hands 
of physicians, and much of the impactful innovation in devices have 
been through successive improvements made over periods of time, often 
based on the real world experience of providers. From a public health 
perspective, we should support a regulatory process that helps 
facilitate this sort of continuous innovation that can improve the 
safety and effectiveness of products.

    Question 2. It seems as though some drugs attain orphan drug status 
for treating a subset of a condition, but go on to gain additional 
approvals for treating the condition more broadly. Orphan products may 
face a different set of standards for approval, and earn a different 
amount of market exclusivity, compared with non-
orphan products. Dr. Gottlieb, what are your thoughts on our incentive 
structure for orphan drugs, and how these incentives interact with 
those drugs indicated for populations larger than orphan size?
    Answer 2. The Orphan Drug Act has played an important role in 
incentivizing manufacturers to develop treatments for rare diseases. 
Given the small patient populations and inherent challenges associated 
with clinical trials for rare diseases, I believe we must protect these 
incentives and assess whether additional incentives may be necessary to 
spur the development of safe and effective new treatments for patients 
with rare diseases. We must also make sure that the Orphan Drug Act 
isn't being used in ways that Congress did not intend. If confirmed, I 
pledge to work with Congress, patients, industry, and other 
stakeholders to make sure the Orphan Drug Act continues to achieve its 
important public health goals.
                            senator baldwin
    Question 1. Wisconsin has been a leader in advancing new 
technologies to better diagnose and screen for disease. An innovative 
company in Madison was the first to receive FDA approval for a new 
stool-based DNA test for colorectal cancer. But, in recent years, we 
have seen significant growth of the laboratory-developed test (LDT) 
industry, which are not approved by FDA. I am concerned with this 
uneven oversight of critical diagnostics, and believe that FDA 
oversight of LDTs must be appropriately updated and modernized. You 
have stated that ``the regulation of lab tests is best left to a more 
robust CLIA [or framework through CMS], and not FDA.'' \42\ If 
confirmed, would you support FDA as the primary regulator of 
diagnostics, including LDTs?
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    \42\ http://www.aei.org/publication/theranos-woes-offer-lesson-in-
how-labs-should-be-regula-
ted/.
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    Answer 1. Defining an appropriate regulatory framework for 
Laboratory Developed Tests (LDTs) is important to FDA's mission to 
protect and promote public health. In order to both protect patient 
safety and encourage innovation and patient access, I believe we must 
strike the right balance between Clinical Laboratory Improvement 
Amendments (CLIA) and FDA regulation and regulatory requirements. If 
confirmed, I would commit to working with Congress and stakeholders to 
develop appropriate LDT regulatory policies.

    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. This is unfair and 
I, along with thousands of farmers across America, am very frustrated 
that FDA has not enforced its own regulations. If confirmed, how will 
you enforce FDA regulations against all plant-based imitation products 
that use dairy terms?
    Answer 2. While I am not personally familiar with the current 
discussion inside FDA related to this specific issue, I strongly 
support accurate product labeling and consistent and effective 
implementation of laws Congress passes and the rules FDA promulgates. 
If confirmed, I will commit to engaging with the agency's professional 
staff to quickly get up to speed on this issue. I would welcome the 
opportunity to work with you on this issue moving forward.

    Question 3. Dairy farmers have been waiting for FDA to address this 
for years without action, and they are tired of waiting. That is why I 
introduced the DAIRY PRIDE Act earlier this year--my bill would require 
FDA to enforce its own regulations within 60 days. But the agency 
should be doing this already. If confirmed, will you commit to 
beginning enforcement within 60 days?
    Answer 3. If confirmed, I commit to implementing congressional laws 
according to the timelines prescribed by the law and to working with 
your office on this issue.

    Question 4. According to the Institute of Medicine, nearly 50 
percent of all cancer patients experience distress. Further, studies 
suggest that distress in cancer patients leads to higher healthcare 
costs, less compliance with treatment pathways and poorer health 
outcomes. While we have seen significant advancements in biomedical 
treatments, there remain barriers to more effective development of 
therapies. I am encouraged by FDA's enhanced focus on considering 
patient experience data when assessing treatments. I believe that FDA 
should explore mechanisms to capture data beyond just disease symptoms 
and physical functioning to include psychosocial health measures, 
including distress screening (e.g., concerns related to disruption of 
work/family life [due to the regimen], concerns related to nutrition, 
financial impact and others). This would provide meaningful patient 
feedback about issues that may not be identified through the current 
measures being used in the clinical trial process. How would you work 
to enhance FDA's patient-reported outcomes work to include 
comprehensive and reliable measures on patient experiences that capture 
physical and psychosocial symptoms?
    Answer 4. I strongly agree that patient experiences, preferences, 
and perspectives should play an important and appropriate role in FDA's 
regulatory policymaking and decisionmaking. Among other approaches, I 
have advocated that we continue to advance well-validated, scientific 
tools for incorporating Patient Reported Outcomes (PROs) as endpoints 
in clinical trials. I support these and other measures that would allow 
meaningful patient feedback to be incorporated into regulatory 
decisionmaking to better define patient-experience data that may not be 
identified through the current measures being used in the clinical 
trial process. If confirmed, I look forward to working with you on this 
issue.

    Question 5. You have argued that the FDA should allow drug 
companies to promote uses for drugs that have not yet been FDA 
approved--a position the drug industry shares--because FDA labels, are 
``slow to incorporate important medical results about the effectiveness 
of medical products.'' \43\ The agency has been working to improve the 
accuracy of labels. For instance, FDA proposed a rule to ensure that 
labels for generics drugs were rapidly updated to include the latest 
safety information. However you, along with the generic drug industry, 
opposed FDA finalizing this rule. You have said this is because it 
would ``expose the generic-drug industry to the same kind of costly 
product liability suits that plague branded-drug makers'' \44\ I am 
concerned with these seemingly contradictory positions that suggest--at 
least when it comes to drug labels--a potential bias in favor of 
positions supported by the biggest industry stakeholder. As FDA 
Commissioner, responsible for guaranteeing that patients have the most 
up-to-date and accurate information about drugs, what principles would 
you use to determine the best communication and labeling standards?
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    \43\ http://healthaffairs.org/blog/2008/04/23/from-fda-a-good-
framework-for-distributing-in-formation-on-off-label-uses/.
    \44\ https://www.aei.org/publication/how-obamas-fda-keeps-generic-
drugs-off-the-market/.
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    Answer 5. I believe it is important that generic drug labels be 
kept up-to-date and generic manufacturers engage in appropriate post-
market safety surveillance. The FDA proposed rule would alter the legal 
responsibilities of generic firms. If confirmed, I will work with 
agency's staff as we consider future regulatory actions. As a general 
matter, I am philosophically in favor of approaches to enable providers 
to get more and timelier truthful, non-misleading information about the 
medical products they prescribe, in a non-promotional context.

    Question 6. Among its many roles, FDA plays a key part in helping 
ensure that U.S. companies that export foods such as dairy products are 
able to keep tapping into those foreign markets and thereby support 
American jobs. Can you assure me FDA will prioritize working with its 
interagency partners to swiftly resolve export certification issues in 
order to keep those foreign markets open to U.S. products?
    Answer 6. I will commit to working with our interagency partners on 
this issue. I recognize the importance of maintaining access to these 
foreign markets for our U.S. companies.
                             senator hatch
    Question 1. Dr. Gottlieb, one issue that was not really addressed 
by the 21st Century Cures law as enacted is how reimbursement and 
coding issues can affect the availability of needed treatments. While 
we recognize that reimbursement is not directly within the purview of 
FDA, your mission in speeding safe and effective treatments and cures 
to patients has a direct relationship to how quickly patients can 
benefit from medical products FDA approves. This is particularly 
important for new and innovative products, both drugs and devices. It 
strikes us that your background at both CMS and FDA puts you in a 
unique position to make a valuable contribution toward addressing this 
issue. Our question is simple: When confirmed, will you take steps to 
partner with CMS to work on ways to make certain that new therapies in 
the critical areas you mentioned at your hearing are made available to 
patients as early as possible?
    Answer 1. I believe my prior experiences at both FDA and CMS will 
help guide my work as Commissioner, if confirmed. As you mentioned, 
reimbursement and coding issues are outside the purview of FDA, but I 
agree that there are areas where CMS and FDA could work more closely 
together to increase the availability of innovative therapies. I commit 
to working with my colleagues at CMS and you on this issue.

    Question 2. Since its inception, the Orphan Drug Act has fueled 
treatment discoveries, and even cures, for rare diseases that would 
probably remain untreated to this day without the Orphan Drug Act's 
incentives. We still have about 95 percent of the over 7,000 identified 
rare diseases remaining with no FDA-approved treatment option. Many of 
these disorders have prevalence rates of several hundred to several 
thousand patients, leaving little commercial incentive for investment. 
As such, what do you anticipate doing to ensure that patients with 
these extremely rare conditions, and innovators, see FDA as an 
effective partner toward approving new treatments and cures?
    Answer 2. The Orphan Drug Act has played an important role in 
incentivizing innovators to develop treatments for rare diseases. Given 
the small patient populations and inherent challenges associated with 
clinical trials for rare diseases, I believe we must protect these 
incentives and assess whether additional incentives may be necessary to 
spur the development of safe and effective new treatments for patients 
with rare diseases. If confirmed, I pledge to work Congress, patients, 
industry, and other stakeholders to make sure the Orphan Drug Act 
continues to achieve its important public health goals. Given the 
unique challenges to developing drugs for extremely rare conditions, we 
also must continue to make sure that we are using the most modern 
regulatory science in order to make the process for developing safe and 
effective drugs targeted to extremely rare diseases as efficient as 
possible.

    Question 3. Every day, millions of Americans safely take one or 
more dietary supplements. As consumers continue to take greater control 
of their health, it is important that they have access to safe products 
that fit their needs. The FDA currently has the oversight authority to 
remove any product it finds is unsafe and to take enforcement action to 
remove the product from the market. Dr. Gottlieb, do you believe the 
FDA's current regulatory framework under DSHEA provides for adequate 
enforcement tools to remove unsafe dietary supplements from the market?
    Answer 3. As someone who uses dietary supplements every day, I 
believe they serve an important role in health promotion for millions 
of Americans and I support consumer access to these products. I believe 
the regulatory framework established under DSHEA is the right one, and 
if confirmed, I would commit to enforcing DSHEA, as intended by 
Congress.

    Question 4. One of the world's most pressing health problems is the 
emergence of bacterial infections that are resistant to antibiotics. 
According to the Centers for Disease Control and Prevention (CDC), 
every year at least 2 million Americans get sick with antibiotic-
resistant infections. Sadly, an estimated 23,000 people die as a 
result. As bacterial strains consistently evolve and adapt to current 
drug therapies, providers struggle to improve upon documented over-
prescription of antibiotics. Moreover, the Nation faces a lack of new 
antibiotics in the development pipeline, leading researchers to 
estimate that 10 million people annually could die from drug resistant 
infections by the year 2050.
    While reducing the inappropriate and unnecessary use of antibiotics 
can slow how quickly bacteria become resistant to currently utilized 
drug therapies, this alone is unlikely to solve the problem. 
Manufacturers must develop new antibiotics. Yet reduced antibiotic 
discovery, gaps in scientific research, and poor return on investment 
pose significant barriers to developing new, novel antibiotics. 
Congress has responded with a number of initiatives to respond to this 
crisis. Specifically, in 2012, legislation I authored called the 
Generating Antibiotic Incentives Now (GAIN) Act was signed into law. 
This law gave companies enhanced tools that encourage development of 
new antibiotics and allowed an expedited FDA approval process for 
antibiotics that treat life-threatening infections. Last Congress, I 
also authored legislation that was included in the 21st Century Cures 
Act to speed the research and development of new antibiotics that would 
address an unmet medical need by establishing a limited population 
antibiotic approval pathway that allowed smaller, faster clinical 
trials. These laws have had an impact, but more action is needed to 
increase development of novel therapies.
    Dr. Gottlieb, in 2013, you co-authored an article printed in The 
RPM Report titled ``Paying for New Drugs for New Bugs: Regulation is 
Only One Side of the Coin''. In that article you assert that, while the 
FDA and Congress are making headway to improve the regulatory 
environment for antibiotic development, that these changes are not 
sufficient without adjustments to reimbursement. What do you believe 
Congress should be doing, in consultation with the Administration, to 
spur innovation in the antibiotic class of prescription drugs?
    Answer 4. As the nominee to be the next Commissioner of Food and 
Drugs, I do not believe it would be appropriate to comment on questions 
about issues that are outside the jurisdiction of FDA. With regard to 
FDA's role in this important issue, I believe the availability and 
appropriate prescribing of antibiotics are vital to our Nation's public 
health. Additionally, antibiotic resistance is a significant and 
growing public health challenge facing our Nation. Within its statutory 
authorities, FDA should encourage the development of new antibiotics 
and ensure proper labeling to help address the issue of inappropriate 
prescribing and/or use. If confirmed, I would commit to fully 
implementing the law as it relates to these issues, and in particular, 
the Limited Population Approval Pathway for antibiotics.

    Question 5. The 21st Century Cures Act requires FDA to update 
guidance and regulations for regenerative therapeutic products and to 
hold a public meeting to encourage innovation. This is a great first 
step, and we are hopeful that you will prioritize the potential of 
these products as the new Commissioner of the FDA. If you are 
confirmed, how do you envision FDA's regulatory framework for these 
cutting-edge treatments and therapies now and in the future?
    Answer 5. Regenerative medicine is one of the most innovative and 
promising emerging advancements in our scientific approaches to the 
treatment of human disease. Regenerative medicine appears to hold great 
promise for new therapeutic options for patients and physicians, 
particularly in areas of unmet or underserved medical need. However, as 
with all products FDA regulates, the agency must have the appropriate 
policies and processes in place to assess and ensure the safety and 
efficacy of regenerative medical products before they are approved for 
use by American patients. FDA must ensure patients and providers are 
appropriately educated about the potential risks and benefits of 
regenerative medicine therapies that fall within the scope of FDA's 
oversight, and that these products meet the agency's standard for 
safety and effectiveness. If confirmed, I will embrace the 
responsibility to facilitate important medical innovation in the 
regenerative medicine space, while maintaining the Gold Standard of 
safety and efficacy.

    Question 6. There has been much discussion on the use of biomarkers 
in the context of rare disease drug development and the FDA has a 
formal procedure to qualify such biomarkers. To your knowledge, has the 
FDA ever qualified a biomarker as a surrogate efficacy outcome measure 
to expedite the full approval of therapeutics for rare diseases? How 
would you seek to balance discussions on the utility of biomarkers 
between fast and slow adopters at the agency?
    Answer 6. I am not aware of whether the FDA has ever qualified a 
biomarker as a surrogate efficacy outcome measure to expedite the full 
approval of therapeutics for rare diseases. If confirmed, I will ensure 
that FDA is using the most current science to maximize the potential of 
biomarkers to advance drug development and that we bring consistency 
across the agency with respect to the application of modern and well-
validated scientific and regulatory principles.

    Question 7. Dr. Gottlieb, 21st Century Cures contained provisions 
that specifically exempt certain low-risk software functions from FDA 
pre- and post-market regulatory requirements. However, the law provides 
a mechanism for the FDA to pull a product back under FDA jurisdiction 
if there is a determination that a product ``would be reasonably likely 
to have serious adverse health consequences.'' How do you plan to 
operationalize this provision in a way that provides as much clarity to 
innovators as possible?
    Answer 7. I support tools that can help provide consumers with more 
information about their health. FDA must clearly define when an app is 
a medical device subject to its regulation, and when it falls outside 
FDA's framework or is low risk, and therefore appropriate to be exempt 
from the full scope of FDA's pre-market requirements. For products 
subject to FDA's pre-market requirements, the agency should use a risk-
based approach in regulating consumer apps and other medical software, 
and, if confirmed, I look forward to helping further refine FDA's 
approach and implement the related provisions of 21st Century Cures.
                           senator murkowski
    Question 1. FDA's menu-labeling rule, even after an initial stay, 
will take effect 1 month from today. Grocery stores and other food 
retailers across America continue to be frustrated with FDA's handling 
of things, including for local and seasonal food items. Fresh and local 
food items may be sold at a few stores, under the same name, but the 
ingredients or recipe can vary, yet they would be considered ``standard 
menu items'' and subject to enforcement. The irony is that this will 
cause stores and restaurants to move away from fresh, local, and 
seasonal offerings. With just a month before the compliance date, we 
need FDA to act quickly to further delay, withdraw, or stay the rule so 
it can be rewritten to give businesses the flexibility to comply. Would 
you be willing to explore ways to encourage FDA to act before the 
compliance date to provide this much-needed flexibility for businesses?
    Answer 1. While I am broadly aware of the menu labeling issue, this 
is not a matter on which I am familiar with the technical specifics. As 
a general rule, I support providing clear, accurate, and understandable 
information to American consumers to help inform healthful dietary 
choices. I believe information about caloric content can be a useful 
tool. However, I am mindful of the unique challenges that developing 
and communicating such information can pose, particularly on small, 
independent businesses. If confirmed, I will commit to working with the 
agency's staff to quickly get up to speed on the regulatory history 
related to menu labeling, as well as FDA's latest thinking and actions. 
I would welcome the opportunity to work with Congress and stakeholders 
to ensure any regulatory requirements would promote public health by 
providing helpful information to consumers, while not placing 
unnecessary compliance burden on businesses, particularly small, 
independent ones.

    Question 2. Dr. Gottlieb, one issue that was not really addressed 
by the 21st Century Cures law as enacted is how reimbursement and 
coding issues can affect the availability of needed treatments. While 
we recognize that reimbursement is not directly within the purview of 
FDA, your mission in speeding safe and effective treatments and cures 
to patients has a direct relationship to how quickly patients can 
benefit from medical products FDA approves. This is particularly 
important for new and innovative products, both drugs and devices. It 
strikes us that your background at both CMS and FDA puts you in a 
unique position to make a valuable contribution toward addressing this 
issue. Our question is simple: When confirmed, will you take steps to 
partner with CMS to work on ways to make certain that new therapies in 
the critical areas you mentioned at your hearing are made available to 
patients as early as possible?
    Answer 2. I believe my prior experiences at both FDA and CMS will 
help guide my work as Commissioner, if confirmed. As you mentioned, 
reimbursement and coding issues are outside the purview of FDA, but I 
agree that there are areas where CMS and FDA could work more closely 
together to increase the availability of innovative therapies. I commit 
to working with my colleagues at CMS and you on this issue.
                             senator murphy
    Question 1. Dr. Gottlieb, in 1978 FDA committed to address the 
overregulation of medical gases, like Oxygen, by creating separate 
regulations for medical gases as a unique class of drug products. 
Thirty-nine years later, FDA has not followed through on its commitment 
to create an appropriate framework specific to medical gases. In 2012, 
Congress enacted historic and bipartisan reforms at the request of the 
medical gas industry and pharmacists to require FDA to follow through 
on its 1978 commitment to address the overregulation of medical gases 
in the Food and Drug Administration Safety and Innovation Act (FDASIA).
    In November 2016, FDA issued a final rulemaking that addressed some 
medical gas labeling issues, however FDA did not, as intended by FDASIA 
and reiterated to FDA in the fiscal year 2016 Appropriations report 
language, modify current regulations to address other aspects that are 
unique to medical gases. For example, the November 2016 rule did not 
address medical air labeling, adverse event reporting, expiration 
dating, calculation of yield and a host of other safety and enforcement 
issues identified by the industry as necessary to appropriately 
regulate medical gases.
    If confirmed as Commissioner of FDA, would you ensure that FDA 
fully implements Section 1112 of FDASIA by working with stakeholders to 
either incorporate by reference industry consensus standards or issue 
new final rulemakings on medical gas to address these unique medical 
gas regulatory issues?
    Answer 1. If confirmed, I am committed to implementing all 
congressional laws, including Section 1112 of FDASIA. I look forward to 
working with you on this issue.

    Question 2. In April 2016, the FDA proposed to ban electrical 
stimulation devices (ESDs) used for self-injurious or aggressive 
behavior because they present an unreasonable and substantial risk to 
public health and they have been used on children with intellectual and 
developmental disabilities as young as 9 years old. This step was the 
result of deliberative discussion and consideration about the harmful 
nature of these devices. The proposed rule stated that the FDA 
determined that ESDs presented a number of psychological and physical 
risks, including depression, fear, panic, aggression, pain, burns and 
errant shocks from device misapplication or failure. Moreover, ESDs 
have been associated with additional risks such as suicidality, chronic 
stress, acute stress disorder and hypervigilance. It is not surprising 
that this is the case because as Dr. Margaret Nygren from the American 
Association of Intellectual and Developmental Disabilities noted during 
the April 2014 advisory committee meeting,

      ``These devices are explicitly intended to inflict pain. The pain 
is not an unfortunate risk or byproduct of the intervention. With these 
devices, the pain is the intervention.''

    I, along with a number of my colleagues, wrote to then Commissioner 
Califf to support this proposed ban. In that letter, we stated, ``The 
use of these electric shock devices as aversive therapy for individuals 
with developmental disabilities is inhumane, especially since many of 
these individuals have difficulty communicating and alternative 
effective treatment options are available. Put simply, it is outrageous 
that this practice is allowed in the United States for this vulnerable 
population and it should be stopped immediately. As such, we urge you 
to finalize the proposed rule as quickly as possible.''
    Leading disability organizations and advocates also support 
finalizing the proposed ban. A letter from two dozen of these groups 
from July 25, 2016, stated,

          ``We applaud the FDA for taking this critically important 
        step, which we believe is long overdue. For too many decades, 
        children with disabilities have been subjected to physical and 
        psychological abuse through the use of these devices, and have 
        experienced pain, trauma, suffering and long-term harms.''

    If confirmed, would you ensure that the FDA moves forward with the 
proposed ban of electrical stimulation devices used to treat self-
injurious or aggressive behavior?
    Answer 2. While I am not personally familiar with the specific 
details of this issue, if confirmed, I commit to engaging with the 
agency's professional staff to get up to speed on this issue and 
reviewing the agency's scientific opinions and input from stakeholders, 
including Congress.

    Question 3. The CDC estimates that 23,000 Americans die each year 
from drug-resistant infections. The World Health Organization predicts 
that without urgent action, we are headed toward a ``post-antibiotic'' 
future where common infections and minor injuries will once again kill.
    The over-use of broad-spectrum antibiotics is a major contributor 
to the rise of these super bugs. Antibiotic stewardship--more judicious 
use of antibiotics in medical practice--is therefore an important 
public health initiative. One way we can reduce the prescribing of 
broad-spectrum antibiotics is to make better use of penicillins, which 
are less costly, have fewer side effects and are not known to give rise 
to some of the most worrying resistant bugs, like C. difficile.
    More than 30 million people in the United States self-report as 
penicillin allergic. Most of these patients are prescribed a broad-
spectrum antibiotic in place of penicillin or amoxicillin. Yet, the 
American Academy of Allergy, Asthma and Immunology has said that less 
than 10 percent of those people actually have the allergy, and with 
improved penicillin allergy testing, we could make much better use of 
penicillins.
    The CDC and other public health organizations have been educating 
the community on the need for penicillin allergy testing to confirm 
current allergy, before resorting to non-penicillin broad spectrum 
antibiotics.
    Do you agree that penicillin allergy testing could help us be 
better stewards of the antibiotic drug supply and do you agree that it 
is important for public health that FDA work with sponsors to approve 
tests for penicillin allergy testing?
    Answer 3. Yes, I believe penicillin allergy testing could be an 
important piece of addressing antibiotic drug resistance, and that we 
should advance technologies that can help widen such testing and make 
sure that the testing that is done is safe and reliable. I look forward 
to working with CDC and other public health organizations on this 
issue.

    Question 4. How can the FDA promote research transparency and 
clinical data sharing so that patients, healthcare providers, and 
independent researchers have access to information about the risks and 
benefits of medical products? How can the FDA be more transparent with 
key decisions in its own review process for medical products?
    Answer 4. I am a strong proponent of data transparency--for 
patients, physicians, and manufacturers. I have long advocated that the 
FDA release more information related to its own review process that 
could be used to better inform consumers and product developers alike. 
If confirmed, I will be committed to working with Congress, patients, 
industry, and stakeholders on the issue of data transparency and new 
ways that FDA could potentially make the importance of its own 
information and deliberations more readily available to the public.

    Question 5. New innovations in wearable wellness technology are 
empowering consumers by providing access to health data, including 
steps taken, hours slept, and heart rate. It is my understanding the 
FDA's current policy is that these devices do not require FDA approval 
as long as the information is not used by a medical professional to 
make a diagnosis.
    As wearable technology continues to advance, such as warning 
consumers about an abnormal heart rate reading, where do you see the 
line between a medical device and a consumer application?
    Answer 5. I support tools that can help provide consumers with more 
information about their health. FDA must clearly define when an app is 
a medical device subject to its regulation, and when it falls outside 
FDA's framework or is low risk, and therefore appropriate to be exempt 
from the full scope of FDA's pre-market requirements. For products 
subject to FDA's pre-market requirements, the agency should use a risk-
based approach in regulating consumer apps and other medical software, 
and, if confirmed, I look forward to helping further refine FDA's 
approach and fully implement the related provisions of 21st Century 
Cures.

    Question 6. Connecticut is a State with a growing number of small 
farms. These small farmers face unique challenges when adapting to new 
food safety regulations. I have led my colleagues in letters urging the 
FDA to expedite implementation of Sec. 209 of the Food Safety 
Modernization Act (FSMA), which includes a provision that provides 
technical assistance and training for small farmers, small producers, 
and fruit and vegetable merchant wholesalers in order to reduce 
confusion surrounding new regulations and promote effective 
implementation.
    Can you commit to ensuring FSMA implementation will continue to 
have a focus on the unique challenges faced by small farmers?
    Answer 6. The Food Safety Modernization Act (FSMA) provides FDA 
with important tools and authorities to support its responsibility to 
ensure the safety of our Nation's food supply. If confirmed, I will 
work to ensure FDA has the appropriate policies, processes, and 
resources in place to implement FSMA, as intended by Congress. I agree 
that FDA should implement FSMA in a way that protects and promotes 
public health by enhancing food safety, while also collaborating with 
the U.S. Department of Agriculture, State officials, and other Federal 
and State Government agencies to conduct regulatory activities in a 
manner that takes into account the unique challenges faced by small 
farmers and small businesses.

    Question 7. Sesame is now one of the most prevalent, and most 
dangerous, food allergies in the United States. I have heard from many 
Connecticut constituents about the need for the FDA to require that 
sesame seeds and sesame products be labeled as such, in a manner 
similar to the other eight major allergens. Sesame allergies are 
particularly severe and, for some, sesame exposure can trigger fatal 
anaphylaxis. Allergists estimated 300,000 to 500,000 people in the 
United States have sesame allergies.
    Given the severity and number of sesame allergies, what is the FDA 
doing to address this problem? What more can the FDA do under its 
current authority in the Food Allergen Labeling and Consumer Protection 
Action to require sesame labeling?
    Answer 7. I am not aware of what FDA has reviewed or done to date 
with respect to sesame and labeling. If confirmed, I look forward to 
reviewing the Food Allergen Labeling and Consumer Protection Act to 
understand what authority FDA may have under the current law with 
regard to this issue.

    Question 8. Nationally, the production value of farmed oysters and 
clams is growing at a rate of 8 percent a year, with some areas of the 
country like the Northeast growing at a much higher rate of 31 percent. 
With this surge in production, producers in my home State of 
Connecticut are anxiously looking to expand to new markets. The EU and 
United States have been in trade negotiations to open up trade between 
two U.S. States--Massachusetts and Washington--and two EU countries--
Spain and the Netherlands. Negotiators finally arrived at a compromise 
that is designed to resolve the issue and technical audits were 
performed in 2015 that satisfied the health concerns of the respective 
health agencies. Connecticut producers are anxious for this agreement 
to be finalized so trade can begin and agencies can start discussions 
to further expand trade to new U.S. States and EU countries.
    What progress has the FDA made toward finalizing an equivalence 
determination with the European Union? What more can the FDA do to 
accelerate the process of finalizing this agreement and publish a 
notice in the Federal Register? What can we do to ensure that the other 
interested States gain access in a timely fashion?
    Answer 8. I am not aware of where FDA is in the process of 
finalizing an equivalence determination with the EU. I commit to 
reviewing this issue, and working with your office on this matter, if 
confirmed. If FDA is able to finalize the agreement, then I would work 
to ensure that other States interested in participating do not face 
lengthy waits.

    Question 9. Connecticut shade tobacco, which is used as a wrapper 
for premium cigars, has been grown in Connecticut for centuries and is 
sought after for its unique flavor profile. I recently wrote to the FDA 
about an issue Connecticut tobacco farmers face regarding potential 
misbranding of foreign tobacco products.
    Will you commit to working with me going forward to address this 
issue and assist Connecticut's small tobacco farmers?
    Answer 9. Yes, I commit to working with you on this issue, if 
confirmed.
                            senator roberts
    Question 1. FDA's menu-labeling rule, even after an initial stay, 
will take effect 1 month from today. Grocery stores and other food 
retailers across America continue to be frustrated with FDA's handling 
of things, including for local and seasonal food items. Fresh and local 
food items may be sold at a few stores, under the same name, but the 
ingredients or recipe can vary, yet they would be considered ``standard 
menu items'' and subject to enforcement. The irony is that this will 
cause stores and restaurants to move away from fresh, local, and 
seasonal offerings. With just a month before the compliance date, we 
need FDA to act quickly to further delay, withdraw, or stay the rule so 
it can be rewritten to give businesses the flexibility to comply. Would 
you be willing to explore ways to encourage FDA to act before the 
compliance date to provide this much-needed flexibility for businesses?
    Answer 1. While I am broadly aware of the menu labeling issue, this 
is not a matter on which I am familiar with the technical specifics. As 
a general rule, I support providing clear, accurate, and understandable 
information to American consumers to help inform healthful dietary 
choices. I believe information about caloric content can be a useful 
tool. However, I am mindful of the unique challenges that developing 
and communicating such information can pose, particularly on small, 
independent businesses. If confirmed, I will commit to working with the 
agency's staff to quickly get up to speed on the regulatory history 
related to menu labeling, as well as FDA's latest thinking and actions. 
I would welcome the opportunity to work with Congress and stakeholders 
to ensure any regulatory requirements would promote public health by 
providing helpful information to consumers, while not placing 
unnecessary compliance burden on businesses, particularly small, 
independent ones.

    Question 2. There has been much discussion recently about how FDA 
restricts what drug makers and medical device manufacturers can say 
about their products. Legislation has been introduced in the House of 
Representatives and there have been high profile lawsuits surrounding 
FDA's actions and the First Amendment. There are many treatments that 
have additional uses that are medically accepted, that doctors can 
prescribe for their patients, and that the Federal Government will even 
pay for--but FDA prohibits the manufacturers, who know the most about 
their products, from discussing those uses under most circumstances.
    Do you have ideas on how to modernize or improve how FDA regulates 
communication between doctors, patients and payers, while making sure 
information is truthful and not misleading? How do we strike the right 
balance to allow more communication while maintaining incentives to get 
additional indications for therapies approved?
    Answer 2. Medical product labels are one of the primary tools FDA 
uses to promote the appropriate use medicines and technologies and 
communicate risk information. It is important that information on 
product labels is accurate, clear, and scientifically based; and be the 
result of a sound regulatory process. Further, it is crucial that 
manufacturers continue to develop and submit to the agency clinical 
data demonstrating the safety and efficacy of medical products for new 
indications they seek to include on labeling and in their marketing 
communications with patients, payers, and providers. I also believe 
that patients and physicians make the best decisions when they have 
access to as much truthful, non-misleading, scientifically based 
information as possible. So, I believe and FDA has similarly maintained 
that there is some public health benefit in certain contexts of 
allowing non-promotional communication about truthful, non-misleading, 
clinical data that is not already incorporated into FDA-approved 
product labeling. If confirmed, I will commit to working with FDA's 
staff to get up to speed on the agency's latest thinking and actions on 
these matters, and providing clarity to manufacturers, payers, 
providers, and patients about acceptable, truthful and non-misleading 
communications related to clinical data not already incorporated in a 
label.

    Question 3. Various U.S. agencies, including the FDA, are tasked 
with implementing laws and furthering policies that are science-based 
regarding food and beverages. We expect the same from other countries 
and our partners abroad. Decisions based on science provide 
predictability and certainty for the value chain, as well as a level 
playing field for all countries. In late 2015, the World Health 
Organization International Agency for Research on Cancer (IARC) 
classified the consumption of red and processed meat as probably 
carcinogenic and carcinogenic to humans, respectively. While then USDA 
Secretary Tom Vilsack did publically state that U.S. dietary guidelines 
rely on science regarding healthful meat consumption, in December 2016, 
the Food Safety and Inspection Service was petitioned to inform the 
public about the ``risk'' of cancer from processed meat. This request 
relied strongly upon the IARC classification. In addition, when issuing 
draft guidance on sodium reduction in June 2016, FDA relied in part on 
a recommendation of the Dietary Guidelines Advisory Committee--which 
has specifically come under intense criticism for cherry-picking its 
science.
    Under your leadership, what efforts would the FDA undertake to 
ensure that the U.S. Government inquires and responds to these types of 
findings and data in a science-based manner? Individual countries also 
pass food and beverage safety labeling laws that are not grounded in 
sound science. How will the FDA support a strong U.S. Government signal 
to such countries regarding the need for science-based laws and 
regulations for food and beverages? How will FDA ensure that its own 
guidance and other decisions will be thoroughly science-based?
    Answer 3. I agree that FDA should base its regulatory decisions on 
sound and rigorous science. If confirmed, I will work to ensure that 
FDA possesses the scientific expertise necessary to inform these 
decisions.

    Question 4. Recently, FDA has been pursuing considerable regulatory 
change as it relates to the use of antibiotics in agriculture, 
specifically their use in animals. You will certainly get pressure to 
``do more'' and to limit certain uses of antibiotics, something the FDA 
has requested comment on regarding how to apply judicious use policies. 
Much scientific evidence has proven that healthy animals produce 
healthy food. Keeping animals from getting sick and preventing disease 
outbreaks should be a top priority. Allowing veterinarians and others 
in agriculture the flexibility to prevent disease outbreaks is critical 
for FDA to consider.
    Will you work with, and be responsive to, the concerns of the 
agriculture and veterinary industries on this issue?
    Answer 4. Antibiotic resistance is a significant and growing public 
health challenge facing our Nation. In addition to measures FDA should 
take to address this issue within the context of human use, the agency 
must effectively collaborate with other government agencies and public 
health authorities to develop policies and processes to address the 
issue of antibiotic use in animals intended for human consumption. If 
confirmed, I will ensure FDA remains engaged on this important public 
health issue, making sure that animal drug labeling reflects the most 
up-to-date science, and working closely with the U.S. Department of 
Agriculture, the Centers for Disease Control, the U.S. Department of 
Defense, and other appropriate government agencies. FDA should also 
consider input from, and be responsive to, other important 
stakeholders, such as the farmers, the agriculture industry, and 
veterinarians. If confirmed, I would commit to working closely with 
these important stakeholders.
                             senator warren
    Question 1. Approximately 48 million Americans experience age-
related hearing loss, including over half of adults between the ages 
70-79.\45\ Yet only a small share of Americans with hearing loss--
around 14 percent--use assistive hearing technologies, primarily 
because they cannot afford to buy costly hearing aids.\46\ Hearing aids 
are not covered by Medicare or most private insurance plans, and out-
of-pocket costs for a single hearing aid average $2,400--far out of 
reach for many consumers.\47\ Senators Grassley, Isakson, Hassan, and I 
recently introduced bipartisan legislation that would make certain 
types of hearing aids available over the counter (OTC).\48\ In December 
2016, the FDA announced a commitment to examining OTC hearing aids and 
said it will no longer enforce the medical waiver requirement 
associated with hearing aids. In making this announcement, FDA 
Commissioner Califf stated that the guidance would support consumer 
access, ``while the FDA takes the steps necessary to propose to modify 
our regulations to create a category of OTC hearing aids that could 
help many Americans improve their quality of life through better 
hearing.'' \49\
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    \45\ Frank R. Lin, John K. Niparko, and Luigi Ferrucci. 2011. 
``Hearing Loss Prevalence in the United States,'' Archives of Internal 
Medicine 171: 1851-53 (online at: http://www.ncbi
.nlm.nih.gov/pmc/articles/PMC3564588/).
    \46\ National Academies of Sciences, Engineering, and Medicine. 
2016. Hearing Health Care for Adults: Priorities for Improving Access 
and Affordability. Washington, DC: The National
Academies Press (online at: http://www.nationalacademies.org/hmd/
Reports/2016/Hearing-Health-Care-for-Adults.aspx).
    \47\ President's Council of Advisors on Science and Technology, 
Aging America and Hearing Loss: Imperative of Improved Hearing 
Technologies (October 2015) (online at: https://www.whitehouse.gov/
sites/default/files/microsites/ostp/PCAST/pcast_hearing_tech_lette_
report_final.pdf), p.1. National Academies of Sciences, Engineering, 
and Medicine. 2016.
Hearing Health Care for Adults: Priorities for Improving Access and 
Affordability. 
Washington, DC: The National Academies Press (online at: http://
www.nationalacademies.org/hmd/Reports/2016/Hearing-Health-Care-for-
Adults.aspx), p. 21-2. Sergei Kochkin. 2007. 
``MarkeTrak VII: Obstacles to Adult Non-User Adoption of Hearing 
Aids,'' The Hearing Journal 
60: 24-50 (online at: http://www.betterhearing.org/sites/default/files/
hearingpediaresources/
MarkeTrak%20VII%20bstacles%20to%20adult%20nonuser%20adoption%20of%20hear
ing%20aids
.pdf). Karl E. Strom. 2014. ``HR 2013 Hearing Aid Dispenser Survey: 
Dispensing in the Age of Internet and Big Box Retailers,'' The Hearing 
Review 21 (4): 22-28 (online at: http://www.hearingreview.com/2014/04/
hr-2013-hearing-aid-dispenser-survey-dispensing-age-internet-big-
boxretailers-comparison-present-past-key-business-indicators-
dispensing-offices/).
    \48\ S. 670 (115th Congress)--Over the Counter Hearing Aid Act of 
2017 (online at:
https://www.warren.senate.gov/files/documents/
3_21_17_Hearing_Aids_Bill_Text.pdf).
    \49\ FDA, ``Immediately in Effect Guidance Document: Conditions for 
sale for air-conduction hearing aids--Guidance for industry and FDA 
staff '' (Dec. 12, 2016) (online at: http://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
UCM531995.pdf); FDA News Release, ``FDA takes steps to improve hearing 
aid accessibility'' (online at: http://www.fda.gov/NewsEvents/Newsroom/
PressAnnouncements/ucm532005.htm).
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    Do you agree that over the counter hearing aids would expand access 
to hearing aids to millions of Americans with hearing loss who struggle 
to afford these devices?
    If confirmed, will you commit to work toward making safe and 
innovative hearing aids intended to be used by adults to compensate for 
mild to moderate hearing impairment available over the counter?
    If confirmed, what steps will you take to implement the FDA's 
stated commitment to creating a category of OTC hearing aids?
    Do you agree that a key step in improving access to OTC hearing 
aids will be pre-empting the many State requirements that now regulate 
access to hearing aids?
    If confirmed, what steps will you take to develop a clear OTC 
access standard by pre-empting these State requirements?
    Answer 1. I have not been privy to the discussions that FDA has had 
related to this matter, although I am aware the agency announced a 
commitment to examining OTC hearing aids. If confirmed, I commit to 
reviewing the scientific evidence and to working with you, Senators 
Grassley, Isakson, and Hassan, and other Members of Congress on this 
issue.

    Question 2. The Department of Health and Human Services (HHS) 
Office of Inspector General (OIG) recently released preliminary results 
of an ongoing review, finding that procedures associated with fixing 
seven faulty cardiac implants cost Medicare $1.5 billion and resulted 
in an additional $140 million in out-of-pocket costs to Medicare 
beneficiaries.\50\ The OIG recommended that the Center for Medicare and 
Medicaid Services (CMS) collaborate with the Accredited Standards 
Committee X12 (ASC X12) to include medical devices' unique device 
identifier (UDI) on health insurance claim forms. In October 2016, ASC 
X12 voted in favor of a technical solution to this issue.\51\
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    \50\ Letter from HHS Inspector General, Daniel Levinson, to Andrew 
Slavitt, Acting
Administrator, Centers for Medicare and Medicaid--``Early Alert: 
Incorporating Medical Device-Specific Information on Claim Forms (A-01-
16-00510)'' (September 30, 2016) (online at: https://oig.hhs.gov/oas/
reports/region1/11600510.pdf).
    \51\ American Hospital Association, ``Standards organization 
approves UDI changes'' AHA News Now (September 20, 2016) (online at: 
http://news.aha.org/article/160920-standards-organiza-
tion-approves-udi-changes).
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    In a July 2016 joint letter to X12, the FDA and CMS identified 
several benefits to collecting device identifiers on medical claims 
form, including: Strengthening capacities to evaluate product 
performance and safety concerns for specific models of medical devices, 
improving surveillance efforts, helping support device innovation, 
allowing providers and payers to compare costs and outcomes by device 
model, and supporting program integrity efforts.\52\ Inclusion of UDIs 
in claims is also supported by clinical societies like the American 
Academy of Orthopedic Surgeons (AAOS),\53\ and by members of both 
parties in Congress.\54\ FDA has agreed to develop a list of specific, 
high-risk implantable devices for which reporting on claims will be 
recommended.\55\
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    \52\ Letter from CMS Acting Administrator Andrew M. Slavitt and FDA 
Commissioner Robert M. Califf to Gary Beatty, Chair, Accredited 
Standards Committee X12 (July 13, 2016) (online at: http://
pascrell.house.gov/sites/pascrell.house.gov/files/wysiwyg_uploaded/
LETTER_FDA
%20CMS%20Beatty%20Letter%20on%20UDI%20in%20Claims%207.13.16.pdf).
    \53\ American Academy of Orthopedic Surgeons letter to FDA 
Commissioner Margaret A.
Hamburg (Nov. 7, 2012) (online at: http://www.aaos.org/uploadedFiles/
PreProduction/Advocacy/Federal/FDA/
UDI%20Proposed%20Rule%20Comment%20Draft_final.pdf); Multi-organization 
letter to CMS (December 15, 2015) (online at: https://s3.amazonaws.com/
assets.fierce
markets.net/public/004Healthcare/external/
Public+health%2C+clinician+and+stakeholder+com
ments+in+support+of+UDI+in+EHRs+12-15+FINAL.pdf).
    \54\ Letter from Senator Warren and Senator Grassley to Gary 
Beatty, Chair of ASC X12 (Aug. 29, 2016) (online at: http://
www.warren.senate.gov/files/documents/2016-8-29_UDI_letter_
to_ASC_X12.pdf).
    \55\ American Hospital Association, ``Standards organization 
approves UDI changes'' AHA News Now (September 20, 2016) (online at: 
http://news.aha.org/article/160920-standards-organi
zation-approves-udi-changes).
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    The AAOS stated in a 2015 letter to then-Acting FDA Commissioner 
Stephen Ostroff that UDIs ``will significantly enhance post-market 
surveillance activities by providing a standard and unambiguous way to 
document device use in electronic health records, clinical information 
systems, claims data sources, and registries.'' \56\ Do you agree that 
including device identifier information in medical claims could support 
the evaluation of medical devices after approval?
---------------------------------------------------------------------------
    \56\ American Academy of Orthopedic Surgeons letter to Acting FDA 
Commissioner Stephen Ostroff (Oct. 26, 2015) (http://www.aaos.org/
uploadedFiles/PreProduction/Advocacy/Federal/FDA/
AAOS_FDA%20Comment%20Letter%20on%20MDEpiNet%20Report_FINAL%20%20.pdf).
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    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?
    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, as well as to patient health?
    What steps will you take to develop a list of high-risk implantable 
devices and support the inclusion of device identifiers for these 
devices on claims forms? More specifically:

      What criteria should be used to determine whether a 
device should be included on the list?
      What factors should FDA consider in deciding what these 
criteria should be?
      How will FDA support providers and insurers who wish to 
exchange device identifier information, even for devices not included 
on the FDA's high-risk list?

    Answer 2. I am committed to reviewing the work done to date by 
staff at CMS and FDA on this issue. Policies that can help us identify 
problems with devices are important, and if confirmed, I look forward 
to working with my colleagues at CMS and the X12 Committee to explore 
these policies. These considerations should also include achieving 
interoperable electronic health records with UDIs--a goal that is 
consistent with the health information technology provisions in 21st 
Century Cures.

    Question 3. Once relatively simple, well-understood pathology tests 
used for diagnostic purposes, lab-developed tests (LDTs) have become 
more advanced and a staple of clinical decisionmaking. They are often 
now used to diagnose high-risk, but relatively common, diseases. 
Increased understanding of genetics and the role particular genes play 
in disease has led to the creation of new, more complex, medical 
diagnostic technology. LDTs hold great promise to customize healthcare 
to be more efficient and targeted for an individual patient. However, 
because of their increasing prevalence in the clinic, it is imperative 
that they perform reliably and accurately. Incorrect results mean that 
patients either will not seek out the care and therapy that is needed, 
or will be subject to treatments that do not work or are harmful.\57\ 
FDA, which has authority under the Food, Drug and Cosmetic Act to 
regulate LDTs, released draft guidance in October 2014 after years of 
delay.\58\ However, in November 2016, FDA stated that it would not 
release final guidance during the Obama administration. If you are 
confirmed Commissioner--
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    \57\ FDA, ``The Public Health Evidence for FDA Oversight of 
Laboratory Developed Tests: 20 Case Studies'' (November 16, 2015) 
(online at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/
Reports/UCM472777.pdf).
    \58\FDA, ``Draft Guidance for Industry, Food and Drug 
Administration Staff, and Clinical 
Laboratories'' (October 3, 2014) (online at: http://www.fda.gov/
downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/
ucm416685.pdf).

      What role do you believe that FDA should play in ensuring 
that LDTs provide clinically relevant information to the physicians and 
patients who rely on them for making decisions impacting patient health 
and well-being?
      Do you agree that high-risk LDTs that inform clinical 
diagnoses should be clinically validated?
      How will you ensure patient safety by implementing risk-
based oversight and regulation of LDTs?
      How will you direct FDA to ensure reliability of LDTs, 
particularly those that are moderate- or high-risk?
      What steps should FDA take to improve reporting by 
clinicians and patients of faulty or unreliable LDTs?
      What steps should be taken when such LDTs are identified?

    Answer 3. Defining an appropriate regulatory framework for 
Laboratory Developed Tests (LDTs) is important to FDA's mission to 
protect and promote public health. In order to both protect patient 
safety and encourage innovation and patient access, I believe we must 
strike the right balance between Clinical Laboratory Improvement 
Amendments (CLIA) and FDA regulation and regulatory requirements. If 
confirmed, I would commit to working with Congress and stakeholders to 
develop appropriate LDT regulatory policies.

    Question 4. Ensuring a safe and adequate blood supply is a critical 
aspect of our public health system. The Food and Drug Administration 
(FDA) develops blood donation policy for the Nation's blood banks--a 
task that is even more important as we respond to emerging diseases 
such as the Zika virus 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.\59\ In June 2016, FDA started collecting 
public input on scientifically sound solutions to risk-based screening, 
and the information collection period closed in November 2016.\60\ 
Building on these steps will require leadership from the next FDA 
Commissioner.
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    \59\ Ayako Miyashita and Gary J. Gates, ``Update: Effects of 
Lifting Blood Donation Bans on Men Who Have Sex with Men,'' The 
Williams Institute (September 2014) (online at: http://
williamsinstitute.law.ucla.edu/wp-content/uploads/Blood-Ban-update-Jan-
2015.pdf). See for example: ``American Red Cross reports severe winter 
blood shortage,'' WTHITV.com (January 4, 2017) (online at http://
wthitv.com/2017/01/04/american-red-cross-reports-severe-winter-blood-
shortage/) and ``San Antonio in extreme blood shortage,'' KHOU.com 
(January 10, 2017) (online at http://www.khou.com/news/local/texas/san-
antonio-in-extreme-blood-shortage/384692455).
    \60\ Federal Register Notice 81 FR 49673 ``Blood Donor Deferral 
Policy for Reducing the Risk of Human Immunodeficiency Virus 
Transmission by Blood and Blood Products; Establishment of a Public 
Docket; Request for Comments'' (https://www.federalregister.gov/
documents/2016/07/28/2016-17804/blood-donor-deferral-policy-for-
reducing-the-risk-of-human-immunodeficiency
-virus-transmission-by).
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    If you are confirmed as Commissioner--

    Are you committed to implementing a risk-based blood donation 
deferral policy for all donors?
    As FDA Commissioner, how would you support the FDA's efforts to 
move to a risk-based referral policy for all blood donors?
    How do you anticipate using public comments received during the 
comment period for the FDA's recent request for information to 
implement a risk-based deferral system for all donors? More 
specifically:

      Will you commit to developing a risk-based onsite 
questionnaire to be used at blood donation clinics?
       When can we expect FDA to release a draft of a risk-
based questionnaire?
      Will you commit to gathering stakeholder input on the 
questionnaire?
      Over what time period will you test the questionnaire and 
gather input?
      Will you commit to integrating stakeholder input into the 
questionnaire? How will you perform that integration?

    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?
    Answer 4. 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.

    Question 5. There is strong and growing evidence that antibiotic 
use in food animals can lead to antibiotic resistance in humans, yet 
the use of medically important drugs in food animals continues to grow. 
According to the FDA, ``Domestic sales and distribution of medically 
important antimicrobials approved for use in food producing animals 
increased by 26 percent from 2009 through 2015, and increased by 2 
percent from 2014 through 2015.'' \61\
---------------------------------------------------------------------------
    \61\ Food and Drug Administration, ``2015 Summary Report on 
Antimicrobials Sold or
Distributed for Use in Food-Producing Animals'' (December 2016) (online 
at: http://www.fda
.gov/downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/
UCM534243.pdf).
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    The 2014 National Strategy for combating 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.'' \62\
---------------------------------------------------------------------------
    \62\ ``National Strategy for Combating Antibiotic-Resistant 
Bacteria,'' The White House (September 2014) (online at: https://
www.whitehouse.gov/sites/default/files/docs/carb_national_
strategy.pdf), p.4.

    This initiative has enabled significant progress in establishing 
policies that better protect lifesaving antibiotics. FDA policies 
(Guidance for Industry (GFI) #209 and #213 and the Veterinary Feed 
Directive Final Rule) now make the use of antibiotics to promote animal 
growth illegal and subject all remaining uses of antibiotics to 
veterinary oversight. However, more work could be done to strengthen 
FDA policies aimed at preventing bacterial drug resistance.
    As FDA Commissioner, will you commit to continuing this important 
collaborative work with the Secretaries of Agriculture and Defense to 
combat antibiotic-resistant bacteria?
    Will you ensure that FDA staff time is dedicated to continuing the 
relationship with USDA and DOD in service of the important goal of 
reducing antibiotic overuse and misuse in animals?
    Using low doses of antibiotics for long periods of time--as called 
for by many growth promotion indications--can lead to resistance, yet 
many commonly used antibiotics do not come with instructions regarding 
treatment time limits. Without instructions on the label, there is no 
mechanism for enforcement. The FDA recently sought comments on a plan 
to establish treatment time limits for medically important 
antimicrobial drugs when administered to animals.\63\ This comment 
period closed on March 13, 2017.
---------------------------------------------------------------------------
    \63\ Food and Drug Administration, ``The Judicious Use of Medically 
Important Antimicrobial Drugs in Food-Producing Animals; Establishing 
Appropriate Durations of Therapeutic
Administration; Extension of Comment Period'' (Nov. 29, 2016) (online 
at: https://www.
federalregister.gov/documents/2016/11/29/2016-28660/the-judicious-use-
of-medically-import
ant-antimicrobial-drugs-in-food-producing-animals-establishing).
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    Will you commit to ensuring that this process for establishing 
treatment time limits continues in a timely manner once the comment 
period closes? When can we expect a proposed regulation?
    GFI #213 describes principles that veterinarians should consider 
when determining the appropriateness of antibiotic use for disease 
prevention. While the FDA ``intends to work with veterinary and animal 
producer organizations to reinforce the importance of these 
principals,'' \64\ not all stakeholders agree on the need to reduce 
antibiotic use or on the impact that the FDA's policies will have on 
the amount of drugs used. Given the documented disagreements among 
stakeholders, and given that veterinary adherence to appropriate 
antibiotic prescribing guidelines is a critical part of FDA's policies, 
FDA oversight is particularly important. Will you commit to putting in 
place a protocol to monitor and report on veterinary compliance with 
GFI#213's appropriate antibiotic prescribing guidelines?
---------------------------------------------------------------------------
    \64\ Kraus, Thomas A., Associate Commissioner for Legislation, FDA 
to Senators Warren,
Feinstein and Gillibrand, Sept. 8, 2014; FDA, Guidance for Industry 
#213: New Animal Drugs and New Animal Drug Combination Products 
Administered in or on Medicated Feed or Drinking Water of Food 
Producing Animals: Recommendations for Drug Sponsors for Voluntarily 
Aligning Product Use Conditions with GFI #209 (December 2013), p. 7.
---------------------------------------------------------------------------
    GFI #213 was released in 2012, but only just fully implemented on 
January 3, 2017. If confirmed, your agency will have the responsibility 
for measuring whether or not this policy successfully reduces 
antibiotic resistance in humans and taking additional action if it does 
not. What metrics would you use to evaluate whether the FDA's policies 
(Guidance for Industry (GFI) #209 and #213 and the Veterinary Feed 
Directive Final Rule) have been successful or unsuccessful at reducing 
the misuse and over-use of antibiotics in animal agriculture?
    If FDA's guidance documents succeed in reducing the use of 
dangerous antibiotics, what changes should we expect to see in sales 
data and in the Veterinary Feed Directive? When do you expect to see 
those changes?
    The FDA and USDA have both acknowledged that collecting data that 
shows how antibiotics are used on farms is vital to enhanced 
monitoring, however they have not yet enacted a joint plan. The 
Antimicrobial Resistance Action Plan, released by the USDA's Animal and 
Plant Health Inspection Service (APHIS) National Animal Health 
Monitoring System (NAHMS), proposed initiatives include on-farm 
studies.\65\ Will you commit to working with USDA to prioritize the 
collection of on-farm data on antibiotic use?
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    \65\ ``Proposed Initiatives from the USDA Antimicrobial Resistance 
Action Plan,'' APHIS, April 2015 (Online at: https://
www.aphis.usda.gov/animal_health/nahms/amr/downloads/Pro-
posedInitiatives.pdf).
---------------------------------------------------------------------------
    A report published in October 2016 by the European Medicines Agency 
shows that sales of antimicrobials used in animals in Europe fell 
between 2011 and 2014.\66\
---------------------------------------------------------------------------
    \66\ European Medicines Agency, ``Sales of veterinary antimicrobial 
agents in 29 European countries in 2014,'' Oct. 14, 2016. (Online at: 
http://www.ema.europa.eu/docs/en_GB/document_
library/Report/2016/10/WC500214217.pdf).

      What policies in selected countries in the European Union 
do you believe have led to that reduction?
      As FDA Commissioner, which of these policies will you 
look to as an example of how we can better manage the use of 
antibiotics in food animals in the United States?
    Answer 5. Antibiotic resistance is a significant and growing public 
health challenge facing our Nation. In addition to measures FDA should 
take to address this issue within the context of human use, the agency 
must effectively collaborate with other Federal and State government 
agencies and public health authorities to develop policies and 
processes to address the issue of antibiotic use in animals intended 
for human consumption. If confirmed, I will ensure FDA remains engaged 
on this important public health issue, making sure that animal drug 
labeling reflects the most up-to-date science, and working closely with 
the U.S. Department of Agriculture, the Centers for Disease Control, 
the U.S. Department of Defense, and other appropriate government 
agencies. While I am familiar with the EMA report, I have not reviewed 
it in detail. If confirmed, I would commit to reviewing it further and 
sharing my views on any lessons we could learn from that experience. 
FDA should also consider input from other important stakeholders, such 
as the farmers, the agriculture industry, and veterinarians. FDA's 
implementation of a voluntary plan with industry to phaseout the use of 
certain antibiotics is an important step in the right direction.

    Question 6. Compounding pharmacies serve individual patients who 
need specialized drugs. Without these customized products, some of the 
most vulnerable patients would not be able to get the precisely 
formulated medications they need. While intending to provide special 
services for individual patients, the lack of regulation and oversight 
of compounding pharmacies led to tragedy in 2012, when a widespread 
fungal meningitis outbreak caused by contaminated compounded drugs from 
New England Compounding Center (NECC) impacted over 20 States. The 
outbreak resulted in over 750 people falling ill, including 64 
deaths.\67\ The following year, Congress passed the bipartisan Drug 
Quality and Security Act (DQSA), which clarified and enhanced FDA's 
authority to regulate drug compounding.\68\ Since then, the FDA has 
issued a number of draft and final guidances and rules, performed over 
300 inspections of drug compounders, and found numerous violations, 
causing some facilities to close and recall their products.\69\ The FDA 
Commissioner oversees the agency's activities regarding implementation 
of DQSA and ensures the safety and health of the American people by 
regulating the safety and efficacy of domestic and imported 
pharmaceutical products, including compounded drugs. If you are 
confirmed Commissioner--
---------------------------------------------------------------------------
    \67\ Centers for Disease Control and Prevention, ``Multistate 
outbreak of fungal meningitis and other infections--Case count'' (Oct. 
30, 2015) (https://www.cdc.gov/hai/outbreaks/meningitis-map-
large.html). Accessed Jan. 17, 2017.
    \68\ H.R. 3204, Drug Quality and Security Act (113th Congress) 
(https://www.congress.gov/bill/113th-congress/house-bill/3204).
    \69\ See for example, Christine Blank, Drug Topics, ``FDA 
temporarily shutters `filthy' compounding pharmacy'' (May 12, 2016) 
(http://drugtopics.modernmedicine.com/drug-topics/news/fda-temporarily-
shutters-filthy-compounding-pharmacy); Food and Drug Administration, 
``Well Care Compounding Pharmacy issues voluntary statewide recall of 
all sterile compounded products due to lack of assurance of sterility 
concerns'' (May 17, 2016) (http://www.fda.gov/Safety/Recalls/
ucm501543.htm); Mintz Levin Cohn Ferris Glovsky and Popeo PC, Lexology, 
``Health care enforcement review and 2017 outlook: FDA's wide-ranging 
activities'' (Jan. 4, 2017) (http://www.lexology.com/library/
detail.aspx?g=efefdb42-b573-4193-990a-2f903cb866f0). Accessed Jan. 17, 
2017. ``Drug Compounding: FDA has Taken Steps to Implement Compounding 
Law, but Some States and Stakeholders Reported Challenges,'' GAO 
(November 2016) (online at: http://www.gao.gov/assets/690/681096.pdf ). 
Accessed April 5, 2017.
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    Will you agree that effective Federal oversight of compounding 
facilities is essential in preventing disease outbreak and danger to 
patients?
    Will you commit to protect patients through strong enforcement of 
the DQSA?
    Will you commit to supporting FDA's efforts in carrying out 
inspections of compounding facilities?
    What specific steps will you take to ensure patient health and 
safety for patients who need compounded drugs?
    Answer 6. Congress clarified FDA's regulatory authorities related 
to compounding by passing the Drug Quality and Security Act (DQSA). If 
confirmed, I am committed to implementing DQSA, as intended by 
Congress, to both protect patient safety, and allow for safe and 
appropriate practice of pharmacy compounding. The practice of pharmacy 
compounding can serve an important role, allowing providers to develop 
individualized formulations of certain medicines for specific patients 
with unique needs. However, I know that there are examples of actors 
operating as manufacturers of unapproved new drugs under the guise of a 
pharmacy license, violating the careful framework created by Congress, 
circumventing the FDA oversight that Congress intended for certain 
products, and putting patient safety at risk.

    Question 7. On January 18, 2017, the FDA and the Environmental 
Protection Agency (EPA) released final advice on fish consumption, 
clarifying appropriate amounts of fish consumption for pregnant and 
breast feeding women, and parents with young children.\70\ Many 
pregnant and breast feeding women rely on Federal nutrition advice, and 
so over the past few years, my colleagues and I have pushed for the FDA 
to finalize updated advice on fish consumption for pregnant women that 
reflects the most up-to-date, scientific information.
---------------------------------------------------------------------------
    \70\ FDA News Release, ``FDA and EPA issue final fish consumption 
advice'' (Jan. 18, 2017) (http://www.fda.gov/NewsEvents/Newsroom/
PressAnnouncements/ucm537362.htm).
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    As a doctor, do you agree that pregnant women should have access to 
the latest science-based nutrition advice so that they can make healthy 
nutrition decisions before and after pregnancy?
    If confirmed Commissioner, what additional steps will you take to 
ensure that this final advice is consistent with the latest nutritional 
science?
    If this advice is confirmed to be consistent with the latest 
nutritional science, what steps will you take to work with appropriate 
stakeholders to ensure that this final advice is clearly communicated 
to pregnant women?
    Answer 7. As a doctor, I do agree that pregnant women should have 
access to the latest science-based nutrition advice so that they can 
make healthy nutrition decisions before and after pregnancy. If 
confirmed, I will ensure FDA's advice concerning seafood consumption by 
pregnant and nursing women is based on the most current and relevant 
nutritional science and appropriately takes into account both the 
nutritional benefits, and any toxicological risks associated with 
seafood consumption. I will also work to ensure effective collaboration 
between FDA and the U.S. Environmental Protection Agency (EPA) on this 
issue, and a range of other public health matters over which both 
agencies share regulatory authority.

    Question 8. In March 2016, the FDA issued a request for comment 
entitled, ``Refurbishing, Reconditioning, Rebuilding, Remarketing, 
Remanufacturing, and Servicing of Medical Devices Performed by Third 
Party Entities and Original Equipment Manufacturers.'' \71\ In October 
2016, the agency held a public workshop, in which they heard from a 
variety of stakeholders, including OEMs, third party vendors, 
healthcare technology management professionals, and trade associations. 
This action was taken because of concerns over ``quality, safety, and 
continued effectiveness of medical devices'' that have been subject to 
third-party repair and servicing.\72\ As you know, determining industry 
best practices and appropriate regulation of third-party repair of 
medical devices is an important part of ensuring patient safety.
---------------------------------------------------------------------------
    \71\ ``Refurbishing, Reconditioning, Rebuilding, Remarketing, 
Remanufacturing, and Servicing
of Medical Devices Performed by Third Party Entities and Original 
Equipment Manufacturers; Request for Comments,'' [Docket No. FDA-2016-
N-0436] Federal Register (March 4, 2016) (online at: https://
www.gpo.gov/fdsys/pkg/FR-2016-03-04/pdf/2016-04700.pdf).
    \72\ ``Public Workshop--Refurbishing, Reconditioning, Rebuilding, 
Remarketing, Remanufacturing, and Servicing of Medical Devices 
Performed by Third-Party Entities and Original Equipment 
Manufacturers,'' FDA (October 27-28, 2016) (online at: https://
www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/
UCM525760.pdf).
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    If confirmed FDA Commissioner, do you agree that it is important to 
ensure the safety and efficacy of medical devices that are repaired and 
serviced by third-party entities?
    How will you continue to engage with stakeholders, such as patient 
groups, healthcare technology managers, and the medical device 
industry, in responding to the comments received through the FDA's 
Request for Comment and public workshop?
    What specific steps would you recommend the FDA take to address the 
comments received by the agency?

      What would the timeframe for those actions be?
      How would the actions you propose be impacted by the 
regulatory freeze initiated by President Trump?
    Answer 8. An important part of FDA's responsibility to protect and 
promote public health is upholding the Gold Standard of safety and 
efficacy for medical products American patients use. With regard to the 
issue of medical devices that are serviced by 3d parties, if confirmed, 
I will commit to quickly engaging with FDA's professional staff to get 
up to speed on this issue, including a review of the public comments 
received by the agency. 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 efficacy of 
medical devices.

    Question 9. The Food, Drug, and Cosmetic Act prohibits the 
marketing of medical products for uses not approved by the FDA. In 
January 2017, FDA issued two draft guidance documents on off-label 
communications to promote medical products, and the 21st Century Cures 
Act made changes to the safe harbor requirements for the communication 
of health care economic information (HCEI) between medical product 
companies and payers.\73\ I am concerned that, should you be confirmed 
FDA Commissioner, you would aim to loosen restrictions on off-label 
promotion even further. Even though physicians can already use their 
expert judgment to prescribe drugs for off-label use, you have 
advocated allowing companies to actively promote their products for 
non-FDA-approved indications.\74\
---------------------------------------------------------------------------
    \73\ See for example, David C. Gibbons, Dara Katcher Levy, ``Slower 
than Molasses in January, FDA Moves to Provide Guidance on Product 
Communications by Pharmaceutical and Device Manufacturers,'' FDA Law 
Blog (March 2, 2017) (online at: http://www.fdalawblog.net/
fda_law_blog_hyman_phelps/2017/03/slower-than-molasses-in-january-fda-
moves-to-provide-guidance-on-product-communications-by-pharmaceu.html).
    \74\ See for example, Bronwyn Mixter, ``Trump's FDA Nominee Spurs 
Concerns About Drug Approvals, Off-Label Promotion,'' Bloomberg BNA 
(March 14, 2017) (online at: https://www.bna.com/trumps-fda-nominee-
n57982085167/).
---------------------------------------------------------------------------
    Do you believe that medical product companies should be given 
greater latitude to promote their products for non-FDA-approved 
indications?
    If confirmed Commissioner, would you commit to not loosening 
restrictions on off-label communications to physicians and payers?
    Answer 9. Medical product labels are one of the primary tools FDA 
uses to promote the appropriate use of medicines and technologies and 
communicate risk information. It is important that information on 
product labels is accurate, clear, and scientifically based; and be the 
result of a sound regulatory process. Further, it is crucial that 
manufacturers continue to develop and submit to the agency clinical 
data demonstrating the safety and efficacy of medical products for new 
indications they seek to include on labeling and in their marketing 
communications with patients, payers, and providers. I also believe 
that patients and physicians make the best decisions when they have 
access to as much truthful, non-misleading, scientifically based 
information as possible. Toward these same ends, FDA has consistently 
acknowledged that there is some public health benefit of allowing 
certain non-
promotional communication about truthful, non-misleading, clinical data 
that is not already incorporated into FDA-approved product labeling. 
Indeed, FDA has carved out certain ``safe harbors'' for such 
communications. If confirmed, I will commit to working with FDA's staff 
to get up to speed on the agency's latest thinking and actions on these 
matters.

    Question 10. America is in the midst of an opioid epidemic, which 
is devastating communities in every State. According to the Centers for 
Disease Control, 33,000 Americans died of an opioid overdose in 2015--
that's an average of 91 people every day. Nearly half of all opioid 
overdose deaths involved a prescription opioid and three out of four 
new heroin users abused prescription opioids before moving to heroin. 
We must take action to address this epidemic.
    What role do you believe the FDA has in combating this epidemic?
    If you are confirmed as Commissioner, what FDA authorities could 
you use to help address the opioid crisis?
    Both the FDA's Opioid Action Plan and the Comprehensive Addiction 
and Recovery Act emphasize the role that the FDA's advisory committees 
should play in the decision to approve opioid medications. If you are 
confirmed as Commissioner, would you pledge to respect the advice of 
the FDA's advisory committees in their recommendations with regard to 
the safety and public health risks of dangerous and addictive opioids?
    If you are confirmed, what will you do to improve physician 
education on the safe prescribing of opioid medications?
    If you are confirmed, what will you do to improve physician 
education on the safe prescribing of benzodiazepines to patients who 
may already be prescribed opioid medications?
    Answer 10. Opioid abuse, misuse, and addiction constitute one of 
the most urgent and immediate public health threats facing our Nation. 
It is the biggest public health crisis facing the FDA. The human and 
economic toll of this crisis is staggering. If confirmed, this will be 
my highest immediate priority. I will make sure FDA is aggressive, 
forward leaning, and fully engaged in combating this epidemic. I will 
work with FDA's staff to ensure FDA has the right policies and 
processes in place to:

     Facilitate the developments of new approaches and 
technologies to reduce the abuse/addictive potential of painkillers 
American patients use;
     Support the development of non-opioid analgesic 
alternatives for physicians and patients;
     Assess whether FDA's current approach to opioid regulatory 
decisions, including labeling, REMS, and physician/patient education 
are appropriate, robust, and fully effective;
     Encourage the development of new pharmacological tools for 
physicians and patients to both prevent opioid misuse and abuse, and 
support treatment and recovery for patients struggling to overcome 
opioid addiction;
     Enhance physician and patient educational materials to 
strengthen public awareness of the risks of opioids, as well as the 
FDA-approved resources available to them, using the full range of FDA's 
risk communication tools to better target this information;
     Taking steps to make sure that providers are appropriately 
educated on identifying, and helping to property intervene with, abuse-
prone patients;
     Re-assess whether FDA has the appropriate framework and 
authorities for evaluating the risk of abuse and diversion as a 
component of its review and approval process for opioids;
     Undertake a comprehensive effort to evaluate the full 
scope of the sources and threats from foreign imported narcotics;
     Evaluate whether FDA should bring more alignment between 
the review and approval of different medical product platforms used in 
the treatment of pain to make sure the agency is adopting the best 
public health standard in assessing these products; and
     Collaborate effectively with other government agencies and 
external stakeholders to develop and execute comprehensive and 
effective strategies to win the battle against opioid abuse, misuse, 
and addiction. This includes steps for FDA to more closely collaborate 
and coordinate with DEA on the two agencies shared goals.

    Question 11. Nearly 2,000 opioid-related deaths occurred in 
Massachusetts during 2016.\75\ HHS data also shows that the State had 
the highest rate of opioid-related emergency room visits among the 30 
States analyzed in a recent Federal report.\76\ Access to the 
prescription drug naloxone, a medication that can arrest or reverse an 
opioid overdose, saves lives in Massachusetts. However, more could be 
done to expand access to naloxone. In August 2016, the FDA outlined the 
steps it was taking to ensure greater access to naloxone, including 
``helping manufacturers pursue approval of an OTC naloxone product, 
including helping to develop the package label that would be required 
for such a product.'' \77\ The FDA indicated that it had created a 
model Drug Facts Label and accompanying pictogram that could provide 
consumers with necessary information about how to use naloxone safely, 
and was engaged in label comprehension testing of this model label.
---------------------------------------------------------------------------
    \75\ Massachusetts Department of Public Health, ``Data Brief: 
Opioid-related Overdose Deaths Among Massachusetts Residents'' 
(February 2017) (online at: www.mass.gov/eohhs/docs/dph/stop-addiction/
current-statistics/data-brief-overdose-deaths-february-2017.pdf).
    \76\ Matt Rocheleau, ``Mass. Had Highest Rate of Opioid-Related ER 
Visits,'' The Boston Globe
(April 3, 2017) (online at: https://www.bostonglobe.com/metro/2017/04/
02/mass-had-highest-rate-opioid-related-visits/
6vJ4kwtO1dvQGf7TGuXueN/story.html).
    \77\ Karen Mahoney, ``FDA Supports Greater Access to Naloxone to 
Help Reduce Opioid Overdose Deaths,'' FDA Voice (August 10, 2016) 
(online at: https://blogs.fda/gov/fdavoice/index.php/2016/08/fda-
supports-greater-access-to-naloxone-to-help-reduce-opioid-overdose-
deaths/).
---------------------------------------------------------------------------
    Do you agree that expanding access to naloxone, including by making 
it safely available over the counter, is an important part of FDA 
efforts to address the opioid epidemic?
    What is the current status of FDA efforts to develop and test a 
package label for an OTC naloxone product?
    What efforts does the FDA have underway to encourage physicians to 
co-prescribe naloxone with opioid medications?
    What additional steps could the FDA take to safely facilitate 
increased rates of co-prescribing of naloxone with opioid medications?
    What additional steps can the FDA take to work with interested 
manufacturers to continue expanding access to naloxone?
    Answer 11. I support increased access to drugs like naloxone, which 
can arrest or reverse opioid overdoses. I am not aware of the current 
status of FDA efforts to develop and test a package label for an OTC 
naloxone product or closely familiar with the FDA efforts currently 
underway to encourage physicians to co-prescribe naloxone with opioid 
medications. If confirmed, I will commit to working with FDA staff to 
quickly get up to speed on this specific issue. More broadly, opioid 
abuse, misuse, and addiction constitute the most urgent and immediate 
public health threat facing our Nation. It is the biggest public health 
crisis facing our Nation, and it will be my highest immediate priority 
if confirmed to lead FDA.

    Question 12. Increased sharing of clinical trial data could 
strengthen academic research, improve the practice of medicine, and 
protect the integrity of the clinical trials system.\78\ I have 
supported the proposal advanced by the International Committee of 
Medical Journal Editors to require that researchers share data as a 
condition of publication in major medical journals,\79\ but there are a 
variety of approaches to expanding data sharing and transparency that 
could improve medical research.
---------------------------------------------------------------------------
    \78\ Elizabeth Warren, ``Strengthening Research through Data 
Sharing,'' New England Journal of Medicine 2016; 375:401-3 (online at: 
http://www.nejm.org/doi/full/10.1056/NEJMp160
7282).
    \79\ Taichman DB, Backus J, Baethge C, et al. Sharing clinical 
trial data--a proposal from the International Committee of Medical 
Journal Editors. N Engl J Med 2016;374:384-6.
---------------------------------------------------------------------------
    Unfortunately, some efforts to improve data sharing have been 
hampered by incomplete compliance with Federal requirements. A 2015 
study published in the British Medical Journal, found that several 
major drug companies have not met the standards for clinical trial 
results reporting under the Food and Drug Administration Amendments Act 
(FDAAA) of 2007.\80\ FDAAA established civil monetary penalties of up 
to $10,000 per day for non-compliance, and yet the FDA has never 
imposed such penalties. 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.\81\
---------------------------------------------------------------------------
    \80\ Jennifer E. Miller, David Korn, and Joseph S. Ross, ``Clinical 
trial registration, reporting, publication and FDAAA compliance: A 
cross-sectional analysis and ranking of new drugs approved by the FDA 
in 2012,'' BMJ Open 2015;5:e009758. doi: 10.1136/bmjopen-2015-009758.
    \81\ Department of Health and Human Services, ``Clinical Trials 
Registration and Results Information Submission: Final Rule,'' 42 CFR 
Part 11, Federal Register 81:183 (online at: https://www.gpo.gov/fdsys/
pkg/FR-2016-09-21/pdf/2016-22129.pdf).
---------------------------------------------------------------------------
    What do you believe the impact of greater transparency of clinical 
trial data and results would be on--

      1.  Clinical trial efficiency
      2.  The cost of drug development
      3.  Drug safety
      4.  Biomedical innovation

    If you are confirmed Commission, what specific steps would you take 
to increase sharing of clinical trial data?
    You have supported making FDA's complete response letters publicly 
available to improve information about why the agency has rejected a 
company's application.

      What would be the impact of making complete response 
letters publicly available on:

          1. Clinical trial efficiency
          2. The cost of drug development
          3. Drug safety
          4. Biomedical innovation

      If you are confirmed as Commissioner, will you commit to 
making complete response letters publicly available?
      What specific steps would you take to make complete 
response letters publicly available?

    If you are confirmed Commissioner--

      How will you ensure compliance to the disclosure policy 
implemented by FDAAA?
      Will you enforce the law using civil monetary penalties 
or by other means?
    Answer 12. I am a strong proponent of data transparency--for 
patients, physicians, and manufacturers. I have long advocated that the 
FDA release more information related to its review process that could 
be used to better inform consumers and product developers alike. This 
includes the complete response letters, after proper redaction of 
commercial confidential information. If confirmed, I will be committed 
to working with Congress, patients, industry, and stakeholders on the 
issue of data transparency and new ways that FDA could potentially make 
important information more readily available to the public.

    Question 13. Recent news reports have discussed,

        ``a surge in human infections of a deadly bird flu in China 
        [that] is prompting increasing concern among health officials 
        around the world . . . [and that] poses the greatest risk of a 
        pandemic threat if it evolves to spread readily from human to 
        human.'' \82\ I recently sent a letter with Senator Patty 
        Murray and Representatives Pallone, DeGette, and Green 
        expressing my concern over the impact of a series of actions 
        taken by President Trump on the Nation's preparedness for a 
        pandemic flu outbreak.\83\
---------------------------------------------------------------------------
    \82\ Lena H. Sun, ``Surge in Human Cases of Deadly Bird Flu is 
Prompting Alarm,'' Washington Post (March 3, 2017) (online at: https://
www.washingtonpost.com/news/to-your-health/wp/2017/03/03/surge-in-
human-cases-of-deadly bird-flu-is-prompting-alarm/?postshare=847148855
6990075&tid=ss_tw&utm_term=.40b2cf15e3cb).
    \83\ Letter from Senators Warren and Murray and Representatives 
Pallone, DeGette, and Green to HHS Secretary Tom Price and Acting CDC 
Director Anne Schuchat (March 17, 2017) (online at: https://
www.warren.senate.gov/files/documents/2017_3_13_Letter_to_CDC.pdf).
---------------------------------------------------------------------------
    I am also concerned that, during your previous tenure at the FDA, 
you had to recuse yourself from pandemic planning efforts inside the 
agency, due to your conflicts of interest with companies that 
manufactured flu vaccines.\84\ You have indicated to the Office of 
Government Ethics that--if confirmed as Commissioner--you will recuse 
yourself from participating personally or substantially in any 
particular matter involving specific parties in which New Enterprise 
Associates, American Pathology Partners, or Collective Health is a 
party or represents a party, or in which a former client is a party or 
represents a party.
---------------------------------------------------------------------------
    \84\ Diedtra Henderson, ``FDA Official Recused in Flu Fight,'' 
Boston Globe (November 12, 2002) (online at: http://archive.boston.com/
business/healthcare/articles/2005/11/12/fda_official_
recused_in_flu_fight/).
---------------------------------------------------------------------------
    What role does the FDA play in preparing for a pandemic flu 
outbreak?
    Are New Enterprise Associates, American Pathology Partners, 
Collective Health parties, or do they represent any parties, that has 
any involvement with flu vaccines, flu preparedness, or flu response?
    Are any of your former clients a party, or do they represent any 
party, that has any involvement with flu vaccines, flu preparedness, or 
flu response?
    Will this commitment to recuse yourself from participating 
personally or substantially in any particular matter involving these 
specific parties affect your ability to engage in pandemic planning 
efforts as FDA Commissioner, should you be confirmed in this role?
    Answer 13. The FDA's medical product centers play an important role 
in preparing for pandemics by assisting in and fostering the 
development and approval of safe and effective medical products, such 
as vaccines, drugs, diagnostic tests, masks and gloves, to help respond 
to emerging public health threats. Career officials, without the 
involvement of the Commissioner, typically handle this work. The 
Commissioner has broad leadership, policy and advocacy roles but is 
rarely involved in individual product development and approval matters. 
To my knowledge, New Enterprise Associates is not invested in entities 
that have a direct interest in flu vaccines, flu preparedness, or flu 
response. I do not believe Collective Health and American Pathology 
Partners are engaged in such efforts as they are healthcare services 
companies. I believe GlaxoSmithKline, a former client, develops flu 
vaccines and other products for flu response but I do not know whether 
it or any other entity may become involved with flu response efforts 
during my public service. For all of these reasons, I do not believe 
that the recusals set forth in my ethics agreement would impair my 
ability to fully perform my duties with respect to pandemic response. 
Moreover, should a circumstance arise that requires my recusal, my 
deputy or another senior FDA official will handle that matter. I am and 
will remain committed to pandemic preparedness and have every 
confidence that my team at FDA will ensure that the FDA's mission with 
respect to this important public health concern is fulfilled. Finally, 
I would like to clarify that contrary to certain erroneous press 
reports, I was not recused from pandemic planning efforts during my 
prior tenure at the FDA. Rather, I was only recused from certain 
matters related to particular individual companies that manufactured 
vaccines.

    Question 14. FDA's work is supported by highly skilled, 
professional employees who uphold the agency's mission and protect 
public health in the United States.
    If you are confirmed as Commissioner, will you work cooperatively 
with employees and employees' representatives, including unions?
    Should you be confirmed, will you meet with national leadership of 
employees' union representatives soon after you begin your duties?
    Answer 14. FDA's ability to fulfill its mission to protect and 
promote public health depends almost entirely on its world-class 
workforce of talented, dedicated public servants. If confirmed, I look 
forward to building strong and trusting relationships with the agency's 
career employees, and their representatives.
                             senator kaine
    Question 1. During the hearing, I appreciated your interest in 
addressing the opioid epidemic. According to the CDC, opioid-related 
overdose deaths in the United States have quadrupled in the last 
decade. During this same time period, prescriptions for opioids have 
also increased. Do you agree voluntary opioid prescribing guidelines 
can be a useful tool to help inform physicians in treating pain and in 
opioid prescribing?
    Answer 1. I agree that better information about appropriate 
prescribing can be an important tool in combating this epidemic by 
helping ensure physicians are properly informed about the risks and 
benefits of opioid prescribing, and in particular, in educating 
providers about identifying and prescribing opioids in patients at risk 
for abuse. We need to enhance physician and patient educational 
materials to strengthen public awareness of the risks of opioids, as 
well as the FDA-approved resources available to them, using the full 
range of FDA's risk communication tools.

    Question 2. Do you agree that a focus on abuse deterrent 
formulations by FDA, while important, are not the only steps the Agency 
can help reduce opioid addiction?
    Answer 2. Given the tragic scope and urgency of this crisis, FDA 
has to take an all of the above approach to addressing this epidemic. 
The opioid crisis is a human tragedy of enormous scope and should be 
the FDA's highest public health priority. It is the biggest crisis 
facing the agency. ADFs are just one tool in addressing this crisis. 
Among other steps that, I believe, FDA can take to address the opioid 
epidemic, I am committed to helping:

     Facilitate the developments of new approaches and 
technologies to reduce the abuse/addictive potential of painkillers 
American patients use;
     Support the development of non-opioid analgesic 
alternatives for physicians and patients;
     Assess whether FDA's current approach to opioid regulatory 
decisions, including labeling, REMS, and physician/patient education 
are appropriate, robust, and fully effective;
     Encourage the development of new pharmacological tools for 
physicians and patients to both prevent opioid misuse and abuse, and 
support treatment and recovery for patients struggling to overcome 
opioid addiction;
     Enhance physician and patient educational materials to 
strengthen public awareness of the risks of opioids, as well as the 
FDA-approved resources available to them, using the full range of FDA's 
risk communication tools to better target this information;
     Taking steps to make sure that providers are appropriately 
educated on identifying, and helping to property intervene with, abuse-
prone patients;
     Re-assess whether FDA has the appropriate framework and 
authorities for evaluating the risk of abuse and diversion as a 
component of its review and approval process for opioids;
     Undertake a comprehensive effort to evaluate the full 
scope of the sources and threats from foreign imported narcotics;
     Evaluate whether FDA should bring more alignment between 
the review and approval of different medical product platforms used in 
the treatment of pain to make sure the agency is adopting the best 
public health standard in assessing these products; and
     Collaborate effectively with other government agencies and 
external stakeholders to develop and execute comprehensive and 
effective strategies to win the battle against opioid abuse, misuse, 
and addiction. This includes steps for FDA to more closely collaborate 
and coordinate with DEA on the two agencies shared goals.

    Question 3. As we discussed when we met, I was extremely concerned 
about the action the Agency took with regards to Zohydro and the 
approval of Oxycontin for children despite the recommendations from an 
Advisory Committee. Can you address under what circumstances the Agency 
should override recommendations from an advisory committee?
    Answer 3. I believe FDA should have the benefit of independent 
advice from the outside experts who serve on Advisory Committees. I 
understand that this advice is often critical to FDA as they consider 
challenging regulatory decisions. However, I also recognize that FDA 
retains the ultimate responsibility to consider the totality of 
evidence in making a final agency determination.

    Question 4. You also discussed abuse-deterrent formulations for 
opioids. Do you agree that a focus on abuse deterrent formulations by 
FDA, while needed, fall well short of how the Agency can help reduce 
opioid dependence?
    Answer 4. Please see my response to this question in your question 
No. 2.

    Question 5. You have argued that drug manufacturing standards to 
assure safe products are a cause of price spikes and drug shortages. 
Specifically, you said in Forbes In August 2016 when discussing the 
application of regulations to generic manufacturers:

          ``In a push to reduce the risk of contamination, the agency 
        in 2009 forced generic-drug makers to retool their sterile 
        manufacturing plants and make production lines less intricate. 
        The abruptness of the change caused many facilities to be shut 
        down, creating drug shortages and driving up prices.''

    Do you believe that the regulation is not the only cause of spiking 
drug prices? What are other causes of drug price spikes and how would 
you use your role as Commissioner to address this issue?
    Answer 5. Regulatory factors relating to manufacturing are only one 
factor causing price spikes for certain drugs. In many cases, the 
issues causing specific drugs to experience sharp increases in price 
are different. While drug pricing does not fall directly within FDA's 
purview, I believe the agency can play an important role on this 
important issue by taking steps to improve product competition. If 
confirmed, I will work to ensure FDA has the appropriate policies and 
processes in place to effectively facilitate generic market entry and 
competition. Reforming the regulatory pathway for complex generic 
products would address one key policy deficiency that results in 
unnecessary barriers to the development and review of generic 
competitors for some innovator products for which traditional 
bioequivalence and bioavailability testing alone are sometimes 
insufficient for proving sameness. FDA should also explore options to 
improve the efficiency and consistency of ANDA review processes and 
timelines, so that financial speculators cannot engage in a regulatory 
arbitrage, by dramatically hiking the price of some very old generic 
drugs because they know it can take years for new generic competitors 
to enter the market.

    Question 6. You have acknowledged that high drug prices are a 
problem for consumers, and said in an FDA speech on 9/20/2005,

          ``Many people are rightly concerned about the high prices on 
        many drugs, especially people who can least afford to pay for 
        medicines because they lack good health insurance, or have no 
        health insurance at all.''

    But you are also an opponent of the Affordable Care Act. You have 
referred to the ACA's Essential Health Benefits as ``politically 
crafted.'' [Forbes, 2/19/2016] Do you consider the inclusion of 
prescription drug coverage as an essential health benefit to be 
politically crafted? Do you think more people will have access to 
prescription drugs if we repeal the ACA?
    Answer 6. As the nominee to be the next Commissioner of Food and 
Drugs, I do not believe it would be appropriate to comment on questions 
about issues that are outside the jurisdiction of FDA.
                             senator hassan
    Question 1. As you know, the recommendations of FDA physicians and 
scientist reviewers about safety and efficacy, approval, and labeling 
of products--including those related to women's reproductive health--
should be based solely on scientific evidence. Do you commit to 
allowing FDA physicians and scientist reviewers to make decisions on 
safety and efficacy, approval, and labeling of products related to 
women's reproductive health, including new and existing drugs and 
devices, without political interference or interference from you, 
should you be confirmed as FDA Commissioner?
    Answer 1. Maintaining the Gold Standard of safety and efficacy for 
medical products is fundamental to FDA's mission to protect and promote 
public health. If confirmed, I will uphold the Gold Standard by 
ensuring FDA makes independent regulatory decisions based on sound 
science, good regulatory practices, and the support of a strong 
scientific staff. This applies to all clinical areas, including 
products related to women's reproductive health.

    Question 2. In a 2012 op-ed published in the Wall Street Journal, 
you questioned the role of the Drug Enforcement Agency (DEA) in 
regulating opioid use and abuse. You said that the DEA may be the 
``wrong enforcer'' and that their tactics are ``imprudent.''
    Since you penned that piece, the number of opioid deaths in the 
country has exploded, surpassing 33,000 in 2015. We know that 
prescription opioids have contributed to our current epidemic. Further, 
we know that the DEA is authorized through the Controlled Substances 
Act to play a law enforcement role in the opioid crisis and to set 
limits on overall active ingredient allowed in the marketplace.
    In light of our current opioid epidemic, have your views on the 
DEA's regulation of opioids changed?
    At the time that you wrote this article, were you being paid by or 
representing pharmaceutical distributors or any entity in the opioid 
industry? If so, which ones?
    Did any individual or organization connected to or hired by an 
opioid manufacturer or distributor assist in the drafting of this op-
ed? If so, who helped you and in what capacity?
    Answer 2. I believe now, as I did at the time that I wrote the op 
ed, that there needs to be closer coordination and collaboration 
between the law enforcement and public health entities charged with 
combating this tragic human crisis. This is especially true when it 
comes to DEA and FDA. I believe the two agencies need to be working 
closely together to combat this crisis, and such coordination would be 
a top priority of mine if I were confirmed into this role. I also 
believe that the tools and approaches for achieving that purpose have 
evolved as the crises has grown larger and more intractable since the 
time I wrote that op ed. I was the author of the op ed article and was 
representing my personal views on this policy matter. As is customary, 
I do research and communicate with sources in advance of writing 
articles. I was paid by the Wall Street Journal in connection with this 
op-ed.

    Question 3. In the aforementioned article, you advocate for having 
some of DEA's current authorities transferred to the Department of 
Health and Human Services (HHS), including having HHS take on the 
``responsibility for apportioning active ingredients to manufacturers 
of narcotics,'' commonly referred to as ``quotas.''
    In your capacity as an FDA official, did you ever advocate for the 
DEA to increase, or directly or indirectly ask the DEA to increase, any 
opioid quota, including any quotas for active opioid ingredients? If 
so, why?
    If the above answer is yes, were your activities advocating for the 
DEA to increase, or asking the DEA to increase, any opioid quota, 
including any quotas for active opioid ingredients, undertaken on 
behalf of or intended to benefit a particular person or company? If so, 
please identify that person or company and explain the rationale for 
your involvement.
    Answer 3. At various times, DEA has advocated that the quota for 
active pharmaceutical ingredients used to manufacture opioid drugs be 
limited, while FDA has, at the same time, maintained that such limits 
could contribute to a drug shortage for appropriate patients. This 
engagement is a matter of public record. These discussions are a 
reflection of the careful balancing that must occur between the need to 
maintain access to important medicines for appropriate patients, while 
taking the necessary steps to address the tragic and rampant abuse and 
diversion of opioid drugs. Drug shortages are an issue of critical 
concern for FDA. I recall the issue of quotas being raised to me by FDA 
career staff and some interactions between FDA and DEA on this subject. 
My involvement in these matters was to support the science-based 
positions of the FDA's professional staff. None of my actions were 
undertaken on behalf of, or intended to benefit, a particular person or 
company. Rather, my role was to represent the agency's public health 
positions. FDA's positions in these matters were taken in consideration 
of issues related to abuse and diversion, consistent with the FDA's 
regulatory and public health mandates. However, since my tenure at FDA 
more than a decade ago, the scientific and public health consensus 
about the proper ways to combat the opioid health crisis have evolved 
sharply as this epidemic has grown in scope and severity and become our 
Nation's most urgent public health crisis and a tragedy of enormous 
proportion. I also believe, based on this collected experience, that it 
is even more critically important that FDA and DEA collaborate very 
closely in order to properly confront this human tragedy. Seeking such 
collaboration would be one of my highest priorities, if confirmed.

    Question 4. In your article, you said that other public health 
agencies within HHS would be better able to judge ``distinctions 
between illicit diversion and the legitimate practice of medicine.''
    Effectively, you suggest transferring the regulatory and 
enforcement components from an agency equipped for those roles to an 
agency that has little capacity to execute them. With its current 
authority and resources, it is unlikely HHS would be able to 
effectively take on this role.
    Describe how agencies within HHS--which President Trump wants to 
cut by $15 billion in 2018--would be able to effectively absorb the 
DEA's roles in regulating overprescribing from pharmacies and 
providers?
    Answer 4. Given the tragic scope and urgency of this crisis, FDA 
has to take an all-of-the-above approach to addressing this epidemic. 
The opioid crisis is a human tragedy of enormous scope and should be 
the FDA's highest public health priority. It is the biggest crisis 
facing the agency. Among other steps that, I believe, FDA can take to 
address the opioid epidemic, I am committed to helping:

     Facilitate the developments of new approaches and 
technologies to reduce the abuse/addictive potential of painkillers 
American patients use;
     Support the development of non-opioid analgesic 
alternatives for physicians and patients;
     Assess whether FDA's current approach to opioid regulatory 
decisions, including labeling, REMS, and physician/patient education 
are appropriate, robust, and fully effective;
     Encourage the development of new pharmacological tools for 
physicians and patients to both prevent opioid misuse and abuse, and 
support treatment and recovery for patients struggling to overcome 
opioid addiction;
     Enhance physician and patient educational materials to 
strengthen public awareness of the risks of opioids, as well as the 
FDA-approved resources available to them, using the full range of FDA's 
risk communication tools to better target this information;
     Taking steps to make sure that providers are appropriately 
educated on identifying, and helping to properly intervene with, abuse-
prone patients;
     Re-assess whether FDA has the appropriate framework and 
authorities for evaluating the risk of abuse and diversion as a 
component of its review and approval process for opioids;
     Undertake a comprehensive effort to evaluate the full 
scope of the sources and threats from foreign-imported narcotics;
     Evaluate whether FDA should bring more alignment between 
the review and approval of different medical product platforms used in 
the treatment of pain to make sure the agency is adopting the best 
public health standard in assessing these products; and
     Collaborate effectively with other government agencies and 
external stakeholders to develop and execute comprehensive and 
effective strategies to win the battle against opioid abuse, misuse, 
and addiction. This includes steps for FDA to more closely collaborate 
and coordinate with DEA on the two agencies' shared goals.

    [Whereupon, at 12:37 p.m., the hearing was adjourned.]