[Senate Hearing 111-938]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 111-938
 
                   NOMINATION OF MARGARET A. HAMBURG

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                                   ON

 NOMINATION OF MARGARET A. HAMBURG, M.D., OF THE DISTRICT OF COLUMBIA, 
         TO BE COMMISSIONER OF THE FOOD AND DRUG ADMINISTRATION

                               __________

                              MAY 7, 2009

                               __________

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


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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

               EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut     MICHAEL B. ENZI, Wyoming
TOM HARKIN, Iowa                     JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland        LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico            RICHARD BURR, North Carolina
PATTY MURRAY, Washington             JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island              JOHN McCAIN, Arizona
BERNARD SANDERS (I), Vermont         ORRIN G. HATCH, Utah
SHERROD BROWN, Ohio                  LISA MURKOWSKI, Alaska
ROBERT P. CASEY, JR., Pennsylvania   TOM COBURN, M.D., Oklahoma
KAY R. HAGAN, North Carolina         PAT ROBERTS, Kansas          
JEFF MERKLEY, Oregon                 
SHELDON WHITEHOUSE, Rhode Island     

                                     
           J. Michael Myers, Staff Director and Chief Counsel

     Frank Macchiarola, Republican Staff Director and Chief Counsel

                                  (ii)

  
?



                            C O N T E N T S

                               __________

                               STATEMENTS

                         THURSDAY, MAY 7, 2009

                                                                   Page
Murray, Hon. Patty, a U.S. Senator from the State of Washington, 
  opening statement..............................................     1
Lugar, Hon. Richard G., a U.S. Senator from the State of Indiana.     2
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah......     5
Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio,......     6
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina.......................................................     7
Sanders, Hon. Bernard, a U.S. Senator from the State of Vermont..     8
Mikulski, Hon. Barbara A., a U.S. Senator from the State of 
  Maryland.......................................................     9
Hamburg, Margaret A., M.D., Vice President for Biological 
  Programs, Nuclear Threat Initiative, Washington, DC............     9
    Prepared statement...........................................    11
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming..    14
    Prepared statement...........................................    16
Dodd, Hon. Christopher J., a U.S. Senator from the State of 
  Connecticut....................................................    21
    Prepared statement...........................................    24

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Hon. Sam Nunn, a former U.S. Senator from the State of 
      Georgia, Co-Chairman and Chief Executive Officer, Nuclear 
      Threat Initiative, Washington, DC, NTI, letter.............    29

                                 (iii)

  


                   NOMINATION OF MARGARET A. HAMBURG

                              ----------                              


                         THURSDAY, MAY 7, 2009

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met at 2:15 p.m., in Room SD-430, Dirksen 
Senate Office Building, Hon. Patty Murray, presiding.
    Present: Senators Dodd, Mikulski, Murray, Sanders, Brown, 
Casey, Hagan, Whitehouse, Enzi, Burr, and Hatch.

                  Opening Statement of Senator Murray

    Senator Murray. We are going to begin this hearing on the 
Health, Education, Labor, and Pensions Committee.
    I am very pleased to be chairing this committee today on 
the hearing on the nomination of Margaret Hamburg for 
Commissioner of the Food and Drug Administration.
    Before I get started, I do want to extend all of our 
warmest wishes to Senator Kennedy who continues to be a great 
champion for high-quality health care for all Americans who 
would like to be here today. I am substituting in his absence 
and he is missed.
    Senator Enzi, our Ranking Member, will be joining us 
shortly, and I will allow him to make his statement after I do 
this afternoon as well.
    Dr. Hamburg, I know you have some family here today. So 
before we begin, I would like you, if you would not mind, to 
introduce your family to the panel today.
    Dr. Hamburg. It would be a great pleasure. This is my 
husband, Peter Brown, and my daughter Rachael and Evan Brown. I 
am also joined today by my parents, Dr. Betty Hamburg and Dr. 
David Hamburg, and my mother-in-law, Betsy Brown. I want to 
thank you all for the kindness and support you have given me 
throughout this process. I suspect I will need more of that 
kindness and support should the Senate choose to confirm me.
    Senator Murray. Well, you are fortunate to have a wonderful 
family who is seated here with you, and thank you, all of you, 
for being there behind Dr. Hamburg as she gives her testimony 
today.
    I am rambling for a minute while we wait for Senator Lugar 
to sit down and join us, and while he is doing that, I would 
like to ask unanimous consent to put in the record a statement 
from former Senator Nunn who also shares his support for you as 
well.
    [The information referred to above may be found in 
additional material.]
    Senator Murray. Senator Lugar, if you are ready--I know you 
are on an extremely tight timeframe. Before I make a statement, 
I would be happy to yield to you to introduce Dr. Hamburg.

                       Statement of Senator Lugar

    Senator Lugar. Thank you very much, Chairman. I really 
appreciate that. I thank you for the opportunity to introduce 
Peggy Hamburg whom the President has nominated to lead the Food 
and Drug Administration.
    I would first like to thank Chairman Kennedy, Ranking 
Member Enzi, and you, Senator Murray, for holding the hearing 
today, for moving forward on this very important nomination.
    At a time of heightened awareness about the need for food 
safety oversight, growing demand to address the cost and assure 
the quality of prescription drugs and medical devices, and the 
critical importance of addressing pandemics and biological 
threats, the FDA will play an increasingly integral role in the 
public health matters that impact our everyday lives.
    Madam Chairman, it is my privilege to recommend a signal 
leader to address these challenges and opportunities for 
reform.
    My association with Dr. Hamburg began through a close 
personal relationship with her father who is here today. I have 
known David Hamburg, the former President of the Carnegie 
Corporation of New York, for decades. David played a critical 
role in the formation of the Nunn-Lugar Cooperative Threat 
Reduction Program in 1991. He joined Sam Nunn and me on our 
first trip to the former Soviet Union where we found 
unfathomable risks and potential threats to our country. As the 
Red Army dissolved, the nuclear, chemical, and biological 
weapons stockpiles under its control were at risk of being 
stolen or sold to the highest bidder. David was a crucial ally 
in developing the approach that led to the Nunn-Lugar program 
deactivating more than 7,200 nuclear warheads, eliminating 
thousands of missiles, missile launchers, submarines, and 
bombers. His leadership and his friendship have been 
extraordinary and his contributions to U.S. national security 
immeasurable.
    David Hamburg's commitment to his country's security has 
been deeply ingrained in his daughter. In 2001, Dr. Peggy 
Hamburg joined the staff of the Nuclear Threat Initiative, 
reuniting the Hamburg family with my friend, former Senator Sam 
Nunn, one of the founders of NTI. In her original capacity as 
the founding Vice President for Biological Threats, Dr. Hamburg 
was instrumental in crafting the organization's global health 
and security initiative to address the broad range of naturally 
occurring and deliberate biological threats to health. She now 
serves the organization as senior scientist.
    As a member of the NTI board of directors, I have had the 
pleasure of working with Dr. Hamburg in her efforts to address 
threats posed by biological weapons, and through this 
relationship, I have always been impressed with her consummate 
knowledge of the issues, personal integrity, and her remarkable 
dedication to public service.
    Together we have strongly supported the growing efforts of 
the Nunn-Lugar program and its partner programs of the 
Department of State in the biological weapons field. We share a 
strong belief in the vigorous need for the United States' 
collaboration and cooperation with governments around the world 
in the area of infectious diseases and pathogens. As many 
pathogens can now be modified and engineered to increase their 
lethality and potential to spread, Dr. Hamburg and I have urged 
the U.S. Government to utilize the Nunn-Lugar program to help 
secure pathogen strains to ensure they do not fall into the 
wrong hands.
    Equally important, Dr. Hamburg was a strong supporter of 
U.S. projects to assist in the establishment of systems 
designed to detect, characterize, and respond to outbreaks of 
infectious diseases. I am pleased to report to date the Nunn-
Lugar program's biological threat reduction efforts are 
underway in more than a dozen countries.
    Prior to her work at NTI, Dr. Hamburg attended Harvard 
University where she received both her undergraduate and 
medical degrees. She went on to complete her internship and 
residency in internal medicine at the New York Hospital at 
Cornell University Medical Center and is certified by the 
American Board of Internal Medicine.
    Dr. Hamburg served 6 years as the Health Commissioner for 
New York City where she was in charge of food safety inspection 
and enforcement activities, including investigations of food-
borne outbreaks, food contamination, adverse outcomes from drug 
therapies, and restaurant concerns.
    In addition to her distinguished public accolades, 
fellowships, honorary degrees, and awards, Dr. Hamburg has also 
assumed leadership roles within the Department of Health and 
Human Services as Director of the National Institute of Allergy 
and Infectious Disease at the National Institutes of Health and 
as Assistant Secretary for Planning and Evaluation where she 
led the Department of Health and Human Services' first major 
bioterrorism initiative and Federal pandemic flu preparedness 
efforts.
    Dr. Hamburg's impressive career and remarkable breadth of 
knowledge and experience in public health would be a tremendous 
asset to the FDA and to our Nation. She has the ability to 
recognize the domestic and international health concerns facing 
our Nation, while balancing the interests and science that 
shape policy needs and directives. I have always respected her 
counsel and appreciated her utmost professionalism.
    I thank you again, Madam Chairman, for this opportunity to 
present this distinguished nominee to the committee.
    Senator Murray. Thank you very much, Senator Lugar, and we 
really appreciate your coming by and introducing Dr. Hamburg to 
all of us.
    At this time, I will proceed with my opening statement and 
again thank you, Dr. Hamburg, for being here today.
    You know, the Food and Drug Administration plays a crucial 
role in ensuring that drugs and medical devices are safe and 
that lifesaving drugs move safely from the laboratory to the 
patient. Over the past 8 years, American consumers have come to 
question the independence and effectiveness of this agency. I 
have always supported a strong and independent Food and Drug 
Administration. It is the only way in which the FDA can truly 
operate effectively and with the confidence of American 
consumers and health care providers. Americans must have faith 
that when they walk into their local grocery store or their 
pharmacy, that the products that they purchase are safe and 
effective and that their approval has been based on sound 
science, not political pressure or pandering to interest 
groups.
    A number of issues have come up recently that have 
highlighted just how important the FDA is in the lives of 
American families. We have all seen the importance of effective 
drug oversight with the recent concerns over medications like 
Vioxx. I hear from families all the time who tell me they do 
not want to have to worry that the peanut butter sandwich they 
packed for their child's lunch has been tainted or that the 
drugs they need to stay healthy could end up making them even 
worse.
    The FDA plays a critical role in protecting families across 
America, and we have to make sure that they have the leadership 
and resources to do that well.
    We also need to make sure that the FDA puts science ahead 
of politics. The health and well-being of the American people 
should not blow with the political winds. Part of the goal of 
improving health care in this country is ensuring Americans 
have access to safe, effective medicines in a timely fashion, 
and guaranteeing that the FDA remains the gold standard, when 
it comes to drug approval, is key to that effort.
    For all of those reasons, I believe that Dr. Hamburg is the 
right nominee to lead the FDA. As we heard in Senator Lugar's 
introduction, Dr. Hamburg is a highly qualified expert in the 
area of public health. Not only is she a Harvard-educated 
doctor, but she also has strong public health experience at 
both the U.S. Office of Disease Prevention and Health 
Promotion, as well as the National Institute of Allergy and 
Infectious Diseases at NIH.
    Dr. Hamburg also has great leadership experience serving 
from 1991 to 1997 as New York City's youngest-ever Health 
Commissioner. In this position, she designed an aggressive 
tuberculosis control program that is credited with lowering the 
city's TB rate by 46 percent between 1992 and 1997. She also 
worked to put in place programs designed to slow the spread of 
AIDS, helped boost childhood immunization rates, and developed 
one of the first programs to prepare the public for a terrorist 
attack using anthrax or other biochemical weapons.
    After serving at the Department of Health and Human 
Services in the Clinton administration, Dr. Hamburg became Vice 
President for Biological Programs at the Nuclear Threat 
Initiative, a foundation dedicated to reducing the threat to 
public safety from nuclear, chemical, and biological weapons.
    Dr. Hamburg has displayed strong leadership and ability 
over the course of her career and comes to us now highly 
qualified to lead the FDA and help restore America's families' 
confidence in our medicine and in our food. We need a highly 
qualified leader like Dr. Hamburg.
    I want to thank you, Dr. Hamburg, for taking the time to 
have a conversation with me a few weeks ago. I know that the 
FDA faces a number of significant challenges from concerns 
about available resources, to organizational challenges, to 
management issues. I am confident that although you have a 
tough job ahead of you, your experience, your ability and 
leadership are just what we need at the FDA.
    I hope I can encourage all of my colleagues to help us move 
Dr. Hamburg quickly through this process because, frankly, 
families across the country deserve an FDA Commissioner who is 
going to help protect them from unsafe food or drugs and who 
will always put science over politics.
    With that, I am going to turn to Senator Hatch for his 
opening statement and to any of our other colleagues who would 
like to do a short opening statement before we hear from Dr. 
Hamburg.
    Senator Hatch.

                       Statement of Senator Hatch

    Senator Hatch. Thank you so much, Madam Chairman.
    Dr. Hamburg, I am very pleased that you are willing to 
accept this job. This is a thankless job in some ways. It is a 
very difficult job. It is filled with politics and controversy, 
and it should not be. But you are coming in at a time when, 
with real effort, you can help produce the greatest campus for 
food and drugs in the history of the world. It has taken us 
since 1992 when we passed the FDA Revitalization Act, to get us 
to where we are today, and we are still not there. I hope you 
will drive that home because once we have the highest 
facilities with the best equipment, then we will be able to 
attract some of the best scientists in addition to those who 
have agreed to serve out there so far. It is about time to 
bring all these folks into one central campus instead of having 
30-35 different places spread all over the greater Washington 
area, where some of them worked in less than desirable 
conditions.
    You have a great opportunity here to really lead, but that 
is only part of it. We need to make the safety and efficacy 
process move more smoothly. We need to attract top people to be 
able to take some of the heavy burdens off those who have been 
carrying them for so long. We need to work on all kinds of 
projects that will help health care in this particular country. 
As you know, we are working on health care reform as we speak 
in this committee and in the Finance Committee, and we are far 
from getting that right now, getting that done, or getting it 
done in a way that will be more desirable. You can probably do 
more in some ways at FDA than what we are going to do in 
Congress.
    This is a very, very important position. I take tremendous 
interest in it, as I think does everybody on this committee.
    I want you to know that I support you and that I intend to 
help you not only to get through this process, but also to do 
your job out there. I hope that you will do everything you 
possibly can to upgrade that agency to even more than it 
currently is. I think it is one of the most important agencies 
in the world. I believe that it does more good for people than 
almost any other Federal agency. It handles so many important 
issues that really are absolutely crucial to the health care of 
our people and not just here, but around the world.
    Handled properly, I think we can even augment the safety 
and efficacy process for companies so that we can do much more 
innovation than we have done in the past. We do need to move it 
along. We do need to make sure that people are given fair 
hearings, and that they are treated properly and that we do 
everything we can to spur on innovation and creativity in this 
country, especially in all of the areas that you are going to 
be working in. That does not just include the drug area. It is 
going to include biologics. Hopefully, we will do a follow-on 
biologics bill that will work with the appropriate exclusivity 
period that you just have to have to be equivalent to Hatch-
Waxman. Of course, medical devices, etc., plus all of the other 
foods and so forth that this agency handles.
    You are going to be handling between 20 and 25 percent of 
all the consumer products of America. This is not some itty-
bitty job. This is a big-time job that really is going to take 
a lot of your time and a lot of effort. We need to give you the 
right kind of support and help, and I think you should not be 
afraid to advocate for that and for money and for more 
facilities and to get that campus at White Oak completed.
    I am sorry I took so long, but I just wanted to let you 
know that I feel very deeply about FDA and want to help you in 
every way I possibly can.
    And I want to thank the chairman for allowing me these few 
minutes.
    Senator Murray. Thank you, Senator Hatch.
    Senator Brown.

                       Statement of Senator Brown

    Senator Brown. Thank you, Madam Chair.
    Thank you, Dr. Hamburg. It is great to see you again. Thank 
you for your terrific public service.
    I agree with Senator Hatch that FDA is one of the most 
important agencies in our Government and, frankly, in the 
world. Your work there will be particularly important.
    Several years ago, when I was with Senator Burr on the 
House Energy and Commerce Health Subcommittee, I remember the 
FDA came and did a presentation on sort of the status of the 
FDA. This was in the early Bush years. What was so telling is 
at the beginning of the hearing, the first thing they told us 
was thanks to the FDA and other agencies, that the U.S. drug 
companies' market share in Europe had increased dramatically, 
as if that was the major function of the Food and Drug 
Administration. I look to you and understand that your work in 
public health will not put that as the major priority, what the 
drug companies want.
    Several years ago, the FDA used to be one of the greatest 
public health agencies in the entire world. I think its 
reputation, its integrity, its closeness to the industry has 
compromised that, and I look to you to restore that greatness 
and the agency's reputation, its integrity, its competence. I 
think you can do that.
    I watched you from afar in the early 1990s with what you 
did with multidrug-resistant tuberculosis in New York and what 
you did at Ryker's Prison. I know that you understand that the 
reason that multidrug-resistant tuberculosis became such a 
humanitarian disaster and such a fiscal disaster for the city 
of New York was that we had relaxed our vigilance in public 
health. The government simply was not doing in public health 
what it should have been doing, as it has not done prior to the 
TB multidrug-resistant outbreak. We have seen some of the same 
relaxation or indifference, if you will, to public health in 
the last few years, and I know that your role at FDA will help 
us to answer that.
    Briefly, Madam Chair, I just want to recount a couple of 
other things. When Dr. Hamburg was in my office, I appreciated 
your comments on following biologics, to move on that, on the 
backlog of generic drug applications at FDA and the importance 
of that, and also protecting the food supply and the drug 
supply. We know that, in part, because of our trade practices, 
as we import products from around the world, we also import too 
often contaminated ingredients in prescription drugs. We import 
toys that are unsafe because of lead-based paint. We import 
other kind of contaminants in pharmaceuticals and food.
    I appreciated your comments about what do we do as more 
drug companies outsource more of their production. The previous 
FDA told us in this committee, as I presided 1 day, a year or 
so ago, that these drug companies move to China not just to 
save costs in wages but also because the safety regimen is not 
as tough on them in China as they produce ingredients and ship 
them back to the United States. I hope we can continue to 
pursue that issue because nothing is more important than 
pharmaceutical and food safety for people of this country.
    I am thrilled that you want to be FDA Commissioner. I look 
forward to voting for you in this committee and look forward to 
supporting you on the floor.
    Thank you.
    Senator Murray. I am not sure if any of other Senators want 
to do an opening statement or if we want to go to questions. I 
will go to Senator Burr and Senator Sanders, for a quick 
opening statement.

                       Statement of Senator Burr

    Senator Burr. Thank you, Madam Chairman.
    I think when you have an exceptionally qualified individual 
that has been nominated, you should take as much time to 
highlight those qualifications. Margaret Hamburg has the 
expertise and the experience to bring to the FDA that is both 
impressive and, I might say, needed. As a clinician, she has 
the scientific background necessary to understand the complex 
world of drugs and medical device development, as well as the 
importance of a sound, science-based standard to protect our 
food supply.
    She has run a largely and unwieldy government agency for 6 
years, as the Commissioner of Health in New York City, at times 
when New York City's Health Department was suffering from low 
morale and, in fact, a serious lack of focus. And I think she 
brought that back on course.
    The challenges of the FDA are not dissimilar today, as I 
shared with you in our meeting. The agency regulates 25 cents 
of every dollar of our economy. That is only one side of the 
coin. FDA must have the adequate resources and the ability to 
attract the best investigators, inspectors, and scientists to 
protect the public from food-borne illness, approve the next 
lifesaving drug, and/or pull harmful products off the 
marketplace.
    Dr. Hamburg, should--no--when the Senate confirms you, I 
hope to work with you to ensure that the FDA is, No. 1, 
adequately funded, but I would also hope that you take this 
opportunity to improve the culture at the FDA. I think I could 
broadly apply that to just about any Federal agency. The FDA is 
under siege, and we can ill-afford an agency worried to make 
important decisions that not only affect the health and the 
well-being of the American people, but our economy and our 
competitiveness in a global marketplace that continues to get 
more competitive.
    Clearly, there are several other issues to address and your 
input will be crucial. Follow-on biologics, as Senator Hatch 
mentioned, food safety, product liability and pandemic 
preparedness are just a few and FDA will play a major role in 
that. Medicine is on the cusp of a revolutionary shift in 
treating individual patients with therapies specific to their 
genetics and with new regenerative techniques. FDA will be the 
center of all these issues, and I am hopeful you will be there 
to guide it.
    Welcome today and welcome to your family.
    Senator Murray. Thank you very much.
    Senator Sanders, you had a short opening statement?

                      Statement of Senator Sanders

    Senator Sanders. Thank you, Madam Chair.
    Welcome, and we certainly look forward to working with you 
in the next several years.
    There is an issue that I have been working on for a number 
of years, when I was in the House and in the Senate, and that 
is the re-importation of prescription drugs. As you probably 
know, we in the United States pay in many instances far, far 
more for brand names than do our friends in Canada or in the 
United Kingdom. I find it very hard to believe, in a world of 
unfettered, free trade, which in many ways is causing us a 
whole lot of problems, that we cannot safely bring medicine in 
from Canada or the United Kingdom. I just do not believe it.
    For years, we have been hearing that the FDA was unable to 
make sure that the medicine coming into this country is safe. I 
hope that you will work on that issue. I think it is absolutely 
doable and I think that millions of people would be very 
grateful to see lower-cost prescription drugs in this country.
    A second area that I would hope that we could focus on is, 
as you well know, there are some studies out there which 
suggest that, if you can believe it, the younger generation 
will have a shorter life span than our generation because of 
obesity and all of the illnesses that go with that. I know you 
are familiar with this issue. Trying to get a handle on caloric 
intake of people, maybe making fast food chains publish in 
their menus the kinds of calories that people are absorbing, 
but in general, launching a significant effort to address the 
obesity crisis which leads to so many other illnesses.
    Those are a couple of issues that are of concern to me.
    Thank you very much. We look forward to working with you in 
the years to come.
    Senator Murray. Thank you.
    Dr. Hamburg, we will turn to your opening statement in just 
a minute.
    Senator Mikulski, you wanted a quick moment?

                      Statement of Senator Mikulski

    Senator Mikulski. Very quickly because we do want to hear 
from Dr. Hamburg.
    As the Senator who has FDA in her own State, I just want to 
give Dr. Hamburg a very cordial and enthusiastic welcome. I 
look forward to working with her to rebuild and recapitalize 
FDA.
    You have a strong civil service to work with at FDA. What 
they lacked was political leadership that did not put politics 
into FDA, and if we can restore the integrity of FDA where the 
people who work there can speak truth to power, I will believe 
that we will really be able to stand sentry over America's food 
and drug supply.
    I know that you have a wonderful family with you. You 
yourself said you feel very prepared for the challenges at FDA. 
You are the daughter of a psychiatrist, and you will need all 
the mental health that you can get.
    [Laughter.]
    We want to hear from you today and work with you in the 
future.
    I just want to note that the facilities at FDA have been 
enormously stressed, and we have worked at rebuilding them over 
the years on a bipartisan basis. I want to note the partnership 
that I have had with Senator Hatch in doing that. Now we are 
going to have the right buildings, but we want to make sure we 
have the right leadership. Thank you and I look forward to 
working with you.
    Senator Murray. Thank you very much, Senator.
    Dr. Hamburg, we will now turn to you for your opening 
statement. Again, welcome to you and to all your family who are 
here.

  STATEMENT OF MARGARET A. HAMBURG, M.D., VICE PRESIDENT FOR 
 BIOLOGICAL PROGRAMS, NUCLEAR THREAT INITIATIVE, WASHINGTON, DC

    Dr. Hamburg. Thank you very much, Madam Chairwoman and 
members of the committee. It is a privilege to be here today to 
discuss my nomination as Commissioner of the Food and Drug 
Administration. Let me also thank the members of this committee 
for the wise counsel that you gave me during my individual 
visits and for your courtesy in allowing me to appear before 
you today.
    I also want to thank my family for joining me today.
    I am deeply honored that President Obama has asked me to 
serve at the FDA at such a critical point in the agency's 
history. As a public health professional and a physician, I 
have devoted my entire career to improving the health and 
safety of Americans.
    Today, the agency is facing a range of new and daunting 
challenges. These include the globalization of food and drug 
production, the emergence of new and complex medical 
technologies, and the risk of deliberate adulteration, as well 
as terror attacks, on our food and drug supplies. The emergence 
of the novel influenza A, H1N1, virus in the last several weeks 
has highlighted the critical role played by FDA even further.
    If confirmed, I would look forward to working closely with 
this committee and with the dedicated, hard-working, and 
talented staff at the FDA to improve the effectiveness of the 
FDA in protecting health and safety.
    I want to share with you briefly my background and then 
discuss some of the key issues that face FDA.
    My expertise spans basic and clinical biomedical research, 
public health practice and policy, health agency management, 
global health, infectious diseases, bioterrorism, and emergency 
preparedness. I have had direct experience helping in 
developing policies and treatments for infectious diseases 
during my tenure at the National Institutes of Health.
    Then becoming Health Commissioner in New York City, I 
entered a department where morale was low and resources were 
scarce. As Commissioner, I embraced the mission of the agency 
and worked with the staff to implement science-based public 
health policies and practices. During this time, we increased 
the number of children who received immunizations and decreased 
the number of new HIV infections. Our rapid response to an 
epidemic of drug-resistant tuberculosis became a model 
worldwide. I was on the front lines overseeing food safety and 
a range of regulatory and enforcement activities in the 
Nation's largest city. Through our actions, we gave the city an 
energized department the public could trust again.
    I later served as the Assistant Secretary for Planning and 
Evaluation, or ASPE, at the U.S. Department of Health and Human 
Services, where I led the staff in the formulation and analysis 
of health policies for the Federal Government. During that 
time, I worked closely with the FDA on food safety and security 
issues and on strategies to expand the availability of new 
drugs and vaccines, diagnostics, and medical devices.
    While serving as ASPE, I also created the HHS bioterrorism 
initiative and led a major effort to develop an influenza 
pandemic preparedness plan for the Nation.
    These are some of the experiences that have shaped my 
outlook on how to conceive and implement effective approaches 
to protecting health and safety. They will also help me address 
the priorities that will guide my work, if confirmed, as FDA 
Commissioner.
    To me, this means operating an agency that is accessible 
and transparent, strengthening the FDA's science base, hiring 
and retaining the best and the brightest scientists that FDA 
can recruit, and ensuring that FDA has the resources and 
capacity to understand the latest advances in science and apply 
them to regulatory and public health issues. The FDA must 
carefully protect scientific integrity as the cornerstone of 
the regulatory process.
    Let me now turn to a few specific priorities.
    First, if confirmed, I will review FDA's work on the H1N1 
influenza outbreak to determine if there are additional steps 
FDA can take to make safe and effective medical products and 
laboratory tests available. I look forward to being actively 
involved in discussions within HHS on such critical questions 
as to what vaccine to make, how much to make, whether to alter 
seasonal flu vaccine manufacturing, and ultimately, whether to 
recommend vaccination for the American people.
    I will focus on improving food safety. Domestically, this 
means taking advantage of the growing consensus among experts 
and industry that now is the time to shift to a food safety 
system that puts prevention first. Important steps must be 
taken to better protect the Nation's food supply from farm to 
fork, to strengthen our food safety system so we prevent 
outbreaks from occurring in the first place. Globally, this 
means FDA's attention and energies must be given to import 
safety and working more closely with our international allies.
    Equally important, we must continue to make advances in the 
safety of medical products. Using the authorities granted in 
2007 legislation passed by this committee, the agency can now 
build safety considerations into every aspect of product 
development. Close monitoring after marketing will be critical 
to identifying early safety signals and to acting quickly to 
protect the public.
    We must also foster innovation. There has never been a time 
when advances in science and technology have offered so many 
opportunities to bring new medical products to the marketplace 
and to the people who need them. As FDA Commissioner, I would 
strive to lead an agency that appropriately balances innovation 
with regulation.
    A fifth priority is accountability. Responsibility to 
ensure the integrity of our food and drug supply is a shared 
responsibility throughout the life cycle of a product. The FDA 
has responsibility to ensure that its work is driven by the 
best possible science and is undertaken with integrity, 
openness, and credibility. Responsibility must also lie with 
the food and drug producers themselves.
    The FDA touches every American through every stage of life. 
The agency regulates almost one-quarter of all the products 
Americans consume, including much of the food we eat, the drugs 
we take, biologics like vaccines, the medical devices our 
doctors use, veterinary medicines, pet food, cosmetics, and 
numerous other products.
    The American people place a huge trust in the FDA. It is 
critical that we take steps to boost their confidence, 
particularly when it comes to the safety of drugs and food.
    Madam Chairwoman and members of the committee, I have 
devoted my professional life to protecting the health of the 
American people. In the positions in which I have been honored 
to serve, I have been able to reform the machinery of 
government to offer this protection, serve the public, work 
across party lines, and provide better health and safety 
outcomes for the public. It is to these objectives that I will 
devote myself if the committee and the Senate confirm my 
nomination as FDA Commissioner.
    I am happy to answer any questions that you may have.
    [The prepared statement of Dr. Hamburg follows:]

            Prepared Statement of Margaret A. Hamburg, M.D.

    Mr. Chairman, Ranking Member Enzi, and members of the committee, it 
is a privilege to be here today to discuss my nomination to be 
Commissioner of the Food and Drug Administration (FDA). Thank you, 
Senator Lugar, for that kind introduction. Let me also thank members of 
this committee for the wise counsel I have received from you in 
private, and for your courtesy in allowing me to appear before you this 
afternoon.

                              INTRODUCTION

    I am deeply honored that President Obama has asked me to serve at 
the FDA at such a critical point in the Agency's history. As a public 
health professional and physician, I've devoted my entire career to 
improving the health and safety of Americans.
    Today, the Agency is facing a range of new and daunting challenges. 
These include the globalization of food and drug production, the 
emergence of new and complex medical technologies, and the risk of 
deliberate terror attacks on our food and drug supplies.
    The emergence of the novel Influenza A (H1N1) virus in the last 
several weeks has highlighted the critical role played by FDA even 
further.
    If confirmed, I would look forward to working closely with this 
committee and with the dedicated, hard-working, and talented staff at 
the FDA to improve the effectiveness of the FDA in protecting the 
health and safety of the American people.

                             MY BACKGROUND

    I want to share with you briefly my background and then discuss 
some of the key issues that face the FDA.
    My expertise spans basic and clinical biomedical research, public 
health practice and policy, health department management, global 
health, infectious diseases, bioterrorism and emergency preparedness.
    I have direct experience helping develop policies and treatments 
for infectious diseases during my tenure at the National Institute of 
Allergy and Infectious Diseases at the National Institutes of Health.
    When I became Health Commissioner in New York City, I entered a 
department where morale was low and resources were scarce. As 
Commissioner, I embraced the mission of the agency and worked with the 
staff to implement science-based public health policies and practices. 
During this time, we increased the number of children who received 
immunizations and decreased the number of new HIV infections. Our rapid 
response to an epidemic of drug-resistant tuberculosis became the model 
worldwide. I was on the front lines overseeing food safety and a range 
of regulatory and enforcement activities in the Nation's largest city. 
Through our actions, we gave the city an energized department the 
public could trust again.
    I later served as the Assistant Secretary for Planning and 
Evaluation (ASPE) at the U.S. Department of Health and Human Services, 
where I led the staff in the formulation and analysis of health 
policies for the Federal Government. During that time, I worked closely 
with the FDA on food safety and security issues, and on strategies to 
expand the availability of new drugs and vaccines, diagnostics, and 
medical devices.
    While serving as ASPE, I also created the HHS bioterrorism 
initiative and led a major effort to develop an influenza pandemic 
preparedness plan for the Nation.

                        APPROACH AND PRIORITIES

    These are some of the experiences that shaped my outlook on how to 
conceive and implement the most effective approaches to protecting 
health and safety. They will also help me address the priorities that 
will guide my work, if confirmed, as Commissioner of the Food and Drug 
Administration.
    To me, this means operating an agency that is accessible and 
transparent, strengthening FDA's science base, hiring and retaining the 
best and brightest scientists that FDA can recruit, and ensuring that 
FDA has the resources and capacity to understand the latest advances in 
science and apply them to regulatory and public health issues. The FDA 
must carefully protect scientific integrity as the cornerstone of the 
regulatory process.
    Let me now turn to a few specific priorities.
    First, if confirmed, I will review FDA's work on the H1N1 influenza 
situation to determine if there are additional steps FDA can take to 
make safe and effective medical products and laboratory tests 
available. I look forward to being actively involved in discussions 
within HHS on such critical questions as how much vaccine to make, 
whether to alter seasonal flu vaccine manufacturing, and, ultimately, 
whether to recommend vaccination for the American people.
    Second, I will focus on improving food safety. Domestically, this 
means taking advantage of the growing consensus among experts and 
industry that now is the time to shift to a food safety system that 
puts prevention first. Important steps must be taken to better protect 
the Nation's food supply--from farm-to-fork--to strengthen our food 
safety system so we can prevent outbreaks from happening in the first 
place. Globally, this means increasing FDA's attention and energies to 
import safety and working more closely with our international allies.
    Third, we must continue to make advances in the safety of medical 
products. Using the authorities granted in 2007 legislation passed by 
this committee, the agency can now build safety considerations into 
every aspect of product development. Close monitoring after marketing 
will be critical to identifying early safety signals and to acting 
quickly to protect the public.
    A fourth priority is fostering innovation. There has never been a 
time when advances in science and technology have offered so many 
opportunities to bring new medical products to the market and to the 
people who need them. As FDA Commissioner I would strive to lead an 
agency that appropriately balances innovation with regulation.
    A fifth priority is accountability. Responsibility to ensure the 
integrity of our food and drug supply is a shared responsibility 
throughout the lifecycle of a product. The FDA has responsibility to 
ensure that its work is driven by the best possible science, and is 
undertaken with integrity, openness and credibility. Responsibility 
must also lie with the food and drug producers themselves.

                               CONCLUSION

    The FDA touches the life of every American, through every stage of 
life. The agency regulates almost one-quarter of all the products 
Americans consume--including much of the food we eat, the drugs we take 
to improve our health, the medical devices our doctors use, biologics 
like vaccines, veterinary medicines, cosmetics, and numerous other 
products.
    The American people place a huge amount of trust in the FDA. It is 
critical that we take steps to boost their confidence, particularly 
when it comes to the safety of drugs and foods.
    Mr. Chairman and Ranking Member Enzi, members of the committee, I 
have devoted my professional life to protecting the public health of 
the American people.
    In the positions in which I have been honored to serve, I have been 
able to reform the machinery of government to offer this protection, 
serve the public, work across party lines, and provide better health 
and safety outcomes for the public. It is to these objectives that I 
will devote myself if the committee and the Senate confirm my 
nomination as Commissioner of the FDA.
    I'm happy to answer any questions the committee may have.

    Senator Murray. Thank you very much, Dr. Hamburg. I 
appreciate that.
    Senator Enzi is going to submit his statement for the 
record. So we will go straight to questions, and I appreciate 
your accommodation on that.
    Senator Murray. I just have a couple of questions. You and 
I had the opportunity to meet in my office. I just wanted to 
ask you two questions.
    One was that our next FDA Commissioner is going to have a 
very important role to play in the safety of our Nation's food 
supply and is going to have to restore America's confidence 
actually that our food supply is being effectively regulated. I 
think it is going to require additional resources and authority 
so that we will be able to respond in a time of crisis. It is 
going to require a strong FDA leadership, someone who can work 
with our farmers and our food processors, all of the executive 
branch, and Congress to make those improvements.
    We have seen report after report saying that FDA has failed 
to pay proper attention to many risks consumers are facing just 
from the food we eat. I wanted to ask you if you can tell us if 
you intend to increase FDA focus on high-priority food issues.
    Dr. Hamburg. Absolutely, Senator. This is one of my highest 
priorities, and I think we all share the concerns you mentioned 
about the recent outbreaks and the illness and sometimes deaths 
caused by food-borne disease in our country. This is a critical 
time for us to really modernize our food safety systems and 
really to put in place the kinds of programs and approaches 
that will better serve our Nation in a world that is 
transforming rapidly where we not only have huge challenges 
with respect to the domestic food supply but also the challenge 
of the imported food. Today, almost 15 percent of the food on 
our tables actually comes from overseas, 60 percent of our 
fruits and vegetables and almost 80 percent of our seafood I 
believe. This is quite a challenge.
    Clearly, at the present time, we do not have an approach 
that is either adequately resourced or sufficiently modern to 
address the many challenges before us, and I would work very 
hard to move us swiftly and surely in new directions.
    Clearly, inspection is an important element of what we 
would do, and at the present time, we are not able to inspect 
all of the food production facilities, either domestically or 
internationally, at the levels that we would like, not by any 
means. We need to certainly increase the numbers of 
inspections, but we also have to be smarter about how we do 
inspections.
    I think the FDA at this point needs to focus on prevention. 
Responding to an outbreak is important, of course, and the more 
efficiently and effectively we can do it, the more lives will 
be saved. We need to have clear strategies for enforcement and 
the tools to achieve our goal. We also need to really take a 
risk-based approach to prevent these problems from occurring in 
the first place, and that means that we need to really target 
the highest risk products and look at the life cycle of a 
product and where are the points of vulnerability where we can 
target our efforts to reduce risk so that we can ensure a safer 
food supply. We need to leverage existing science so that we 
can better detect problems and address them.
    We clearly need to work in greater partnership across 
agencies of the Federal Government, across levels of 
government--State and local public health departments are 
critical partners in our efforts to control food-borne 
disease--and of course, work with industry. We need to 
strengthen, modernize, and work in partnership with clear 
policies, definition of our goals and objectives, and to find a 
strategy to address them. And I look forward to working with 
you on that.
    Senator Murray. I appreciate that.
    I have a minute left, and I wanted to ask you about 
something that Senator Mikulski brought up as well. We are 
seeing a trend of politicizing public health decisions. Just 
this year, employees at the FDA sent letters to President Obama 
outlining mismanagement at the agency and asking that he ensure 
that professionalism is returned to the agency. Can you just 
tell us if you are aware of that?
    Dr. Hamburg. I am aware of that. I am very concerned by 
some of what I have heard. I hope that, if confirmed as 
Commissioner, I can, through my leadership, create an 
environment where scientists feel very free to raise issues and 
concerns without any fear of retaliation, an environment that 
will foster open debate. I think science is best served by 
robust discussion, and I think that we need to have a clearly 
defined process to ensure the integrity of the science-based 
decisionmaking at the FDA.
    Senator Murray. I appreciate that very much.
    Senator Enzi.

                   Opening Statement of Senator Enzi

    Senator Enzi. Thank you, Madam Chairman.
    I appreciate that I got an opportunity to meet with Dr. 
Hamburg before and that she has already answered a lot of 
questions for me. I think it is very beneficial for us and 
probably daunting for you to be coming on at this point in 
time. I appreciate the expertise that you have in the area of 
pandemics. We may need it, and with your expertise, hopefully 
we will not.
    You will also be in charge of a trillion dollars' worth of 
products every year, and that does not even get into the food 
safety. I do not know how many trillion we do in food. We have 
had some hearings on food safety before, and while we always 
need improvement, one of the things that I have really been 
impressed with from those hearings is we have three agencies 
that cooperate and are able to take relatively few samples out 
of thousands of possible problems and isolate a problem and get 
that food off the market and find out where it came from. I 
think it is has to be one of the unusual things in Government 
to have three agencies doing that. You will get to participate 
in that. Of course, we will be interested in any suggestions 
for how we can do it better.
    Now, one of the questions that I ask everybody that comes 
before this committee--this used to be one of the most 
contentious committees, and I think it is now one of the most 
productive committees. That is because we have learned to 
cooperate and work together to get a lot of things done. What I 
always ask is, in order to continue to sponsor that kind of a 
relationship, whether it is a Democrat or a Republican, would 
you be willing to promptly respond to any written or phone 
inquiries, sharing information whenever it becomes available, 
and directing your staff to do the same?
    Dr. Hamburg. Senator Enzi, I pledge to you that I am more 
than willing to cooperate as fully as possible and would ask 
the staff at the FDA to be responsive in every way possible, 
should I be confirmed as FDA Commissioner.
    Senator Enzi. Thank you.
    Dr. Hamburg. I think that cooperation is vital and I think 
that really strengthening the working relationships with 
Congress is a very important aspect of what the FDA needs to do 
at the present time.
    Senator Enzi. I appreciate that.
    My next question kind of follows along that line. Senator 
Hatch and I and Senator Kennedy and last year Senator Clinton 
worked on some biologic drugs, biosimilars, and we came up with 
a bill, and we are going to be working to make sure that the 
evergreening in it is solid and wanting to get that back in 
again. We will be asking for some input from you. Again, it is 
kind of a simple question. I would expect that you would help. 
But I will ask that question anyway.
    Dr. Hamburg. I think that as you point out, there have been 
a number of pieces of legislation around follow-on biologics, 
and it is a very important topic, a very exciting area of 
modern science as well with opportunities to greatly improve 
the health of the American people. Right now, biologics 
represent very important medications and they are making a huge 
difference in the lives of many Americans. They are expensive, 
and there are for many of these products just one manufacturer. 
In the near term, as you well know, many of these products will 
be losing their patent protection and so thinking about 
establishing a pathway for these so-called biosimilars, I 
think, is very important. It has the opportunity to expand the 
manufacturing base so more products will be available and also 
could yield significant savings.
    There are challenges involved in it, and it will take 
careful deliberations on the part of Congress and serious work 
on the part of FDA. Clearly, we need to find a strategy that 
balances the continuing requirements for innovation with the 
desire to have more available and more affordable products. And 
for the FDA there is the challenge of really understanding how 
best to evaluate these biosimilars so that we can move them 
forward to the American people with a surety of their safety 
and efficacy. I think that it is something that is a very 
exciting opportunity. I would certainly support establishing 
such a pathway and would look forward to working with you.
    Senator Enzi. It is definitely a balancing act, as you 
mentioned. We want to make sure it is a streamlined process. We 
want to make sure that we do not stifle innovation, but we want 
to get the products on the market as fast as possible. I think 
we have a bill that kind of does that. We will be checking with 
you and looking for some help on that. It is a very bipartisan 
bill and one that we have worked on for a long time. I have run 
out of time.
    [The prepared statement of Senator Enzi follows:]

                   Prepared Statement of Senator Enzi

    I would like to begin by thanking Senator Murray for 
calling this hearing today, and by welcoming Dr. Hamburg. I 
would also like to thank Dr. Hamburg for her previous public 
service, and her willingness to once again go through the 
process of Senate confirmation. The vetting process for 
executive nominees is thorough, and not without some degree of 
personal and professional sacrifice. Thank you for your 
willingness to serve.
    Dr. Hamburg is an internationally recognized leader in 
public health and medicine, and an authority on global health, 
public health systems, infectious disease, bioterrorism and 
emergency preparedness. This background is especially important 
given that the swine flu (H1N1 influenza) has been on the front 
pages for nearly 2 weeks, and spread across several continents 
during that time. Dr. Hamburg, you have a tremendous amount of 
experience with emergency preparedness. Given this developing 
story, today I would like to learn more about your priorities 
for FDA in the area of bio-defense and pandemic flu 
preparedness.
    The FDA has a very broad and critical mission in protecting 
the public health. You will be in charge of an agency that 
regulates $1 trillion worth of products a year. The FDA ensures 
the safety and effectiveness of all drugs, biological products 
such as vaccines, medical devices, and animal drugs and feed. 
It also oversees the safety of a vast variety of food products 
as well as medical and consumer products, including cosmetics.
    As Commissioner of the FDA, you will be responsible for 
advancing the public health by helping to speed innovations in 
its mission areas, and by helping the public get accurate, 
science-based information on medicines and foods.
    Another core mission of FDA is approving drugs and ensuring 
their safety. However, the FDA can't ensure the safety of 
deadly products such as tobacco--it kills people, not cures 
them. Yet next week this committee is set to consider 
legislation that would require the FDA to regulate tobacco. At 
a time when Federal dollars are stretched and resources are 
limited, I have serious concerns about adding more statutory 
responsibilities at FDA. In addition, given the recalls of 
spinach, peanuts, and tomatoes over the past 2 years--FDA's 
resources are already stretched too thin on the food safety 
front. Dr. Hamburg, today I would like to hear more about your 
views on why the FDA should regulate tobacco.
    I represent a State that has substantial agricultural 
interests. Food safety and food labeling are critically 
important to me and my constituents. I look forward to hearing 
from you what the agency plans to do to continue protecting the 
American food supply.
    Dr. Hamburg, if confirmed, I look forward to working with 
you, Senator Kennedy and with the other members of this 
committee to protect and promote the public health, and to 
restore the FDA's status as one of the strongest regulatory 
agencies in the world. I have no doubt that, with the right 
leadership in place and with Congressional oversight, the FDA 
will again be the gold standard and our regulatory process the 
envy of the world.
    I look forward to hearing your testimony today.
    Senator Murray. Thank you very much.
    Senator Dodd.
    Senator Dodd. Madam Chairman, I arrived a little bit late, 
and I see some of my colleagues who have been here a little 
longer than I have. So I will defer.
    Senator Murray. Senator Mikulski.
    Senator Mikulski. Thank you, Senator Dodd.
    Dr. Hamburg, I want to pick up on the employee issue that 
Senator Murray raised. A group of our constituents in the CDRH 
wrote to me in October 2008 saying that they were forced to 
recommend the clearances of devices over their objection. I 
understand it has been referred to the IG. I will not go into 
that specific case, but raise the issue of two things. No. 1, 
whistle blowers, which in this case they said they were. We 
need the facts then to be investigated appropriately. Then 
there is the dissent channel where decisions are made but 
people wanted to raise a dissent or something might be going on 
and raise a dissent.
    My question to you organizationally and as essentially the 
CEO of FDA, how will you handle--what organizational mechanisms 
will you have for whistleblower concerns to rise to the top to 
you? Also would you consider even having some type of mechanism 
for a dissent channel of communication so that you would be 
aware, with the 4,000 people who work for you, if they had 
flashing yellow lights about decisionmaking?
    Dr. Hamburg. Let me first begin, Senator Mikulski, by 
thanking you for all the hard work you have done to make White 
Oak possible, working closely with Senator Hatch and so many 
others, because that facility is really an extraordinary 
undertaking, and it represents a great opportunity to improve 
morale and strengthen the cooperative nature of the workforce 
within FDA. I think that is a contributor to the kind of 
positive, constructive work environment about which you are 
concerned and about which I would deeply commit myself, if I 
was confirmed as FDA Commissioner, to support and strengthen.
    I think that whistle blowers serve a very important role in 
government in surfacing critical issues and concerns and making 
sure that they are addressed. As I indicated before, as leader 
of the FDA, I would very much want to create a culture that 
enabled all voices to be heard, that enabled serious 
discussions around important issues to involve every voice at 
the table. In the final analysis, I think that is the best way 
for decisions to be made, a lively--
    Senator Mikulski. Dr. Hamburg, I think culture is an 
important thing, but organizational mechanisms are another. I 
know you are just looking at FDA, and perhaps this is something 
that we should discuss more specifically, should you be 
confirmed. I look forward to voting for you. I think we would 
like to know if someone feels they are a whistleblower, where 
can they go. Is there a direct channel in which they would not 
be muzzled, presuming you would not try to? Also, toward that 
end, we would like to talk with you about that. Perhaps that 
would be better later. I know you want to do the culture and 
you want to have this----
    Dr. Hamburg. Absolutely, and leadership is important. But 
as you say, what are the structures and policies is also key. 
To answer your question for that, I would need to spend some 
time, look closely at these issues. Certainly some of the 
concerns that have been raised publicly and by Members of 
Congress about events in the past are of great concern to me, 
and I would review them.
    Senator Mikulski. I am going to jump in with one more 
question, not to cut you off. I think we are on the same 
broadband here.
    I want to go to another issue. The FDA has always focused 
on safety, and that has to be an obsession. I am also concerned 
about efficacy, which I believe should be a mandate. As we take 
a look at the whole idea of reforming health care and more 
access, one of the things that we have to be able to do is get 
value for what we pay for, which also goes to efficacy of 
pharmaceuticals, biologics, and medical devices.
    What role will you be playing in the health care debate to 
give us ideas and recommendations on efficacy, and have you had 
a chance to look at something like the Dartmouth Institute's 
idea on a drug box labeling that would comment on the efficacy 
of a product?
    Dr. Hamburg. You raise a very important point. I am not 
familiar with the Dartmouth box labeling approach but would 
love to learn more about it. I think that FDA clearly has an 
important role to play, and as you say, safety and efficacy are 
at the core of its mission. I would very much look forward to 
being involved with health care reform efforts around these 
important issues and making sure that drugs, vaccines, 
diagnostics, and devices are as appropriately used as possible 
to make a real and enduring difference in health in this 
country.
    Senator Mikulski. My time is up. I hope you are at the 
table too and I hope FDA is at the table because I do not want 
the person who determines what drugs the American people have 
access to or devices determined by insurance company formulary 
gatekeepers. I would hope that it would be based on efficacy, 
as well as safety, so that a clinician, when they prescribe, 
not only knows what is safe--also, that would include 
interactions--but also what has the greatest efficacy and 
therefore get the most value for health care. I do not want the 
determination to be made by an insurance gatekeeper. We look 
forward to working with you so we can have science-based, 
evidence-based decisionmaking.
    Thank you and good luck, and I sure look forward to voting 
for you and working with you.
    Dr. Hamburg. Thank you.
    Senator Murray. Thank you.
    Senator Hatch.
    Senator Hatch. Thank you, Madam Chairman.
    During the announcement by President Obama to appoint you 
as FDA Commissioner, the President also appointed Dr. Josh 
Sharfstein as the principal FDA Deputy Commissioner. I am not 
sure that has ever been done before. Has that ever done before?
    Dr. Hamburg. I cannot answer that question, Senator. I just 
do not know.
    Senator Hatch. I would like to know the answer to that. It 
is just interesting to me.
    Do you know how you are going to divide the 
responsibilities out there between you and Dr. Sharfstein? Have 
you worked on that at all or even thought about it?
    Dr. Hamburg. I will be the Commissioner, if confirmed by 
the Senate, and I look forward to taking on that role. I know 
that Dr. Sharfstein is very broadly knowledgeable about the 
FDA. He, in fact, is already there serving in an acting role, 
and I will, I am sure, benefit from his early experience there 
as I make the transition in, if the Senate does choose to 
confirm me.
    Senator Hatch. Well, he is very knowledgeable.
    Dr. Hamburg. I believe that there were reports in the press 
that were quite misleading--and perhaps I should take this 
opportunity to clarify them--that I would focus on food and 
tobacco, should that become part of the FDA's mandate, and he 
would focus on drugs. That is simply untrue. I am very eager to 
take on the broad range of challenges, and I, should I be so 
honored to serve, would be the Commissioner.
    Senator Hatch. I think that is right. That is why I asked 
that question. It is not meant to find fault with anybody. I 
just wanted to know the answer to that.
    As you might know, the Dietary Supplement Health and 
Education Act of 1994 provides FDA with the authority to 
oversee and regulate the supplement industry. In December 2006, 
the Dietary Supplement and Nonprescription Drug Consumer 
Protection Act was also signed into law. Now, this law requires 
mandatory reporting of serious adverse events for dietary 
supplements and over-the-counter products.
    Do you agree with me and all former FDA Commissioners that 
I have chatted with that those laws are still adequate and that 
they give the FDA sufficient authority to regulate the dietary 
supplement industry and to protect consumers?
    Dr. Hamburg. This is really a complex issue and one that I 
have not been deeply involved in my other professional 
experiences. It is one that I want to take time to study and 
examine and work with you and others.
    Clearly, the FDA has a very important role in assuring to 
the American people that these products that they take to 
improve their health and supplement their health will be what 
they claim to be and will be safe. I think the Congress has 
given FDA important authorities to support that role in terms 
of protecting the health and safety of Americans. The GAO took 
a recent look at some of what is being done in that area and 
made recommendations to the FDA about how they can do their job 
better and also some potential additional areas that need to be 
strengthened.
    I think it is very, very important. We know that more than 
half of American adults take these products and value them and 
trust them, and I think we all share the desire to make sure 
that their trust is grounded in the safety of these products.
    Senator Hatch. The GAO report has indicated that the 
biggest problem is that you do not have enough funds. That is 
the problem. Of course, Senator Harkin and I are very much 
interested in alternative medicine that we have put into law, 
and we think it is given kind of a short shrift. So I hope you 
look at that as well.
    Let me just ask one other question. You mentioned the 
tobacco issue. Congress is considering legislation that would 
give the FDA jurisdiction over tobacco and designating the FDA 
as a regulatory body goes against the agency's mission to 
``protect the public health.''
    Now, how does the FDA regulate a product that is neither 
safe nor beneficial to public health?
    And finally, if the tobacco legislation becomes law, how 
does the FDA intend to obtain the necessary resources in order 
to carry out this new responsibility, especially when it lacks 
the resources to conduct its current responsibilities?
    Dr. Hamburg. First, let me say, Senator, that I think that 
we all recognize that smoking represents a terrible burden to 
health in this country and that tobacco products are unlike any 
other products on the market, in that they are unusually lethal 
but yet not highly regulated. This is a critical moment for us 
to take a more aggressive look at how we can regulate tobacco 
products to reduce smoking and to reduce the risks of tobacco 
products to the American people.
    I think that the FDA is the appropriate agency to regulate 
tobacco. It has the scientific expertise, the regulatory 
experience, and the public health mission to do so, and I think 
that if done successfully, we can reduce smoking and we can 
help to make cigarettes less harmful.
    I have heard the concerns about whether or not this is a 
time when FDA can take on more tasks when it already has so 
many challenges before it, and it has for a very long time been 
under-resourced to do all of the important tasks already on its 
agenda. As I understand it, the legislation being considered 
does build in a mechanism to support the development of 
regulatory activities within the FDA to create a new center for 
tobacco product regulation and to hire the necessary staff. I 
think that I am very comfortable moving forward if that is the 
will of Congress.
    Senator Hatch. My time is up.
    Senator Murray. Thank you very much, Senator Hatch.
    Dr. Hamburg, I apologize. I am going to have to go to 
another meeting. We are going to do a little musical chairs 
here and Senator Dodd is going to take over the chairmanship of 
this committee for a short while and then pass it on to Senator 
Sanders about 3:30, is my understanding. I appreciate all of 
our colleagues' willingness to jump in and help as we started a 
little bit late. Some of us had some time commitments.
    I look forward to working with you as we move your 
nomination forward. And with that, I will turn the gavel and 
the speaking arrangement over to Senator Dodd.

                       Statement of Senator Dodd

    Senator Dodd [presiding]. Thank you very much, Madam 
Chairman.
    Welcome, Doctor. It is a pleasure to see you again. Welcome 
to your family as well that are here, and congratulations on 
your willingness to accept this very important job, and 
congratulations to our President for seeking you out.
    I think probably this job--I know the Secretary of Health 
and Human Services is obviously a critical job as is the 
Secretary of Education. I do not think any of us think any of 
those jobs are any more important than the one that you are 
going to take on. We have spent an awful lot of time in this 
committee over the years dealing with FDA issues, and so I, for 
one, am very excited about your nomination. You bring a wealth 
of talent and experience that is going to be invaluable to this 
committee but, more importantly, to the country. I thank you 
for your willingness to do that.
    The questions I would like to raise with you have a lot to 
do with pediatrics. I chair the Subcommittee on Children and 
Families and have for a long time. Many members of this 
committee have been tremendously helpful over the years on a 
lot of these issues dealing with the better pharmaceuticals for 
children, going back to the Family Medical Leave Act that 
members of this committee, Senator Murray, Senator Hatch, and 
others were very helpful on, child care, a lot of issues 
focusing on children.
    The recent outbreak--and your experience, by the way--and I 
commend you. I was reading over what you had done as New York's 
Health Commissioner developing a successful tuberculosis 
control program and increased childhood vaccines availability 
across the city. When I saw that, I said I think I have an ally 
on the issues I am about to raise because so often the 
assumption is that children are just smaller versions of 
adults, and we have seen dreadful problems with overdosing or 
underdosing and all sorts of other things. Studies done under 
the Better Pharmaceutical Act for Children have proven, just 
how important this area is.
    I noticed with the H1N1 outbreak, again, there are some 
questions that have occurred to me dealing with pediatric 
populations and we start talking about having adequate supplies 
of Tamiflu and Relenza. The question is whether or not we are 
going to have adequate and appropriate testing of these 
vaccines, given the age, by the way--I was struck with the 
age--the average age being 15 of those who have been affected, 
not exclusively so, but the bulk of them in that age group, and 
really very little, if any, testing at all done with these 
vaccines as to what the effects are in children. So I was 
interested in that.
    There are a couple other points on this thing. Your 
reactions to that. The combination of the migration, the 
inextricable link between human and animal health is raised. I 
call it H1N1 because I know the sensitivities of calling it 
swine flu, but there clearly is an inextricable link between 
animal and human health. While FDA deals with human health and 
the Agriculture Department deals with animal health, it seems 
to me that we have got to start thinking about how these two 
agencies begin to cooperate more effectively in these areas. I 
do not think that has been the case.
    I just heard you talk about taking on additional 
responsibilities in response to Senator Hatch, but I would be 
very interested in any thoughts you may have on that. Let me 
start with that question. Then I have some similar questions 
dealing with the follow-on biologics in children, as well as in 
pediatrics.
    Dr. Hamburg. With respect to the last part of your question 
on animal and human health, the interconnection is very 
important, and if you look over the last couple of decades 
actually, we have seen a surprising number of emerging 
infectious disease threats including, of course, H1N1 but also 
SARS, HIV, avian flu, West Nile, you know, many important 
diseases with huge impacts on the American people. The large 
majority of those cases have been what are called zoonoses or 
diseases that emerge in animal populations and merge over into 
human populations. It is a very important area of study that 
has huge impacts on health and society more broadly, and it is 
an area that I have worked on in the past. And from the 
perspective of FDA, I would want to continue to work on it. It 
is very, very important.
    Obviously, the linkage that we are seeing now with H1N1 in 
the area of antibiotic resistance, how animal health and human 
health is addressed is also very, very key. There is a long 
list of arenas where that intersection is important, and I 
would be eager to pursue those issues from the role of FDA 
Commissioner.
    With respect to your pediatric questions, your leadership 
on this issue has been very important and really moving toward 
more and more focus on addressing the needs of the pediatric 
population for drugs, vaccines, and devices that are really 
tailored to the needs of children at different stages of 
development and not treating them like little adults. Of 
course, the same holds true when we are addressing the problem 
that is currently before us of H1N1, making sure that children 
are not left out simply because some of the studies might not 
have been done in that population group.
    You should know that the FDA has already moved to address 
some issues about making sure, through emergency use 
authorizations, that some critical antiviral medications could 
be made available to a somewhat younger age population, and I 
think we need to continue moving forward to think about 
pediatrics as a special population and continue to make sure 
that we can stimulate the investments to discover, develop, 
review, and make available the drugs and devices we need.
    Senator Dodd. That is very good, because in this particular 
case, you do have, as I said, that younger population. I would 
be very interested in that and the coordination between the 
Department of Agriculture and the FDA. There has not really 
been much in my view, and it seems to me it is long overdue. If 
you are going to have that migration problem, you have to look 
at it.
    I want to mention as well, too, the follow-on biologics. 
Again, as Senator Enzi pointed out, there has been a lot of 
work on this. I, along with others, authored that Better 
Pharmaceuticals Act for Children, which has been remarkable. It 
is actually way beyond the imaginations of any of us, who 
authored the bill, how much has actually been done under that 
bill to provide the kind of adequate testing on products used 
for children.
    We have not required this at all under the proposed follow-
on biologics legislation, and it is one of these things I would 
like very much for the FDA to insist that as we move forward 
with the follow-on biologics, if that is the case--I know it is 
a heated debate, but if we do so, that we are not going to have 
to go back through a whole legislative process again here to 
insist that there be adequate testing and so forth of these 
products to make sure that children are going to be safe.
    I raise that with you but would love to see some leadership 
out of the FDA that, instead of bucking some of these things, 
they would become an ally in the process. Maybe we have to 
legislatively. Someone could tell me maybe I am going to have 
to do that for some statutory reason, but if I do not, I would 
like to be able to have it handled otherwise.
    I have authored the legislation on pediatric medical 
devices as well for much of the same reason. I want to take the 
opportunity to thank the FDA, by the way. From the Office of 
Orphan Products development, they recently released the grant 
applications for $2 million in demonstration grants for 
improving pediatric device availability, which I authored and 
this committee supported, as part of the FDA amendments in 
2007. This bill provides grants to nonprofit pediatric medical 
device consortia of scientists and innovators, particularly 
small businesses, with technical and financial resources to 
improve the number of medical devices available to children. I 
would hope that you would continue supporting that effort.
    There are problems within the FDA's Center for Devices and 
Radiological Health. My time is expired here, but I would ask 
you maybe to respond in writing, if you might, what is your 
plan to restore confidence in the center, and how do you think 
the pediatric medical device development can be a part of that?
    My colleagues have questions for you as well. I do not want 
to interrupt their time.
    My focus is usually in this pediatric area and has been. I 
have a lot of interest, and I am excited about the fact you are 
going to have some colleagues joining you who come and bring 
particular expertise and experience in this arena, which is 
very exciting indeed.
    Congratulations to you.
    Dr. Hamburg. Thank you.
    Senator Dodd. I look forward to supporting your nomination 
and working with you in the coming months.
    Dr. Hamburg. Thank you.
    [The prepared statement of Senator Dodd follows:]

                   Prepared Statement of Senator Dodd

    Thank you Senator Murray. I want to welcome and 
congratulate Dr. Hamburg on her nomination to be Commissioner 
of the Food and Drug Administration (FDA).
    I also want to thank Dr. Hamburg for her long-standing 
public service and for taking on this newest challenge, leading 
the FDA. I cannot remember a time when the need for strong, 
independent leadership at the FDA was more critical. Dr. 
Hamburg's distinguished qualifications will serve her well as 
Commissioner of the FDA and I strongly support her nomination. 
I am joined by a wide range of organizations and individuals 
including former HHS Secretary and Governor Tommy Thompson in 
voicing strong support for Dr. Hamburg's nomination to be FDA 
Commissioner.
    The FDA regulates 25 percent of all products consumed by 
Americans. We rely on the FDA to ensure that our food is safe, 
and that the medicines we take won't harm us or our loved ones. 
Make no mistake about it--this position is as important as any 
that this committee we will consider.
    We are currently in a public health emergency because of 
the H1N1 flu outbreak which has infected 896 people in 41 
states and killed two people in the U.S. scandal after scandal 
with food and medical product safety--from tainted Heparin to 
contaminated spinach, peppers, and peanut butter--have rocked 
the Nation's confidence in the FDA's ability to keep Americans 
safe.
    On top of all that, the FDA's own house has not been in 
order. The last 8 years of repression, of dissent, and 
political ideology trumping science-based decisionmaking have 
left an agency weakened as a result. At the time of this 
committee's last consideration of a nominee to head FDA, a 
study conducted by the Union of Concerned Scientists found that 
almost half of FDA scientists surveyed reported that they knew 
of cases in which the Department of Health and Human Services 
or FDA political appointees had inappropriately injected 
themselves into FDA determinations or actions. The same study 
also found that about 38 percent of FDA scientists surveyed 
disagreed or strongly disagreed that the FDA is acting 
effectively to protect public health.
    Dr. Hamburg possesses the experience and leadership 
necessary to restore America's confidence in this vitally 
important agency. We can't afford to wait to confirm her. 
Thankfully, Secretary Sebelius is now in place and at the helm 
of the Department of Health and Human Services but it was not 
without unnecessary delay.
    I urge my colleagues not to use partisan, political delay 
tactics to prevent this committee or the Senate from moving Dr. 
Hamburg's nomination as quickly as possible. The American 
people deserve a Commissioner of the FDA, an agency that is 
playing a critical role in the Nation's response to the H1N1 
flu outbreak and countless other public health functions.
    In the coming weeks, two major pieces of health care 
legislation will be considered in the HELP Committee. In each 
instance, we would be doing a great disservice to the process 
by not having Dr. Hamburg confirmed. One is comprehensive 
health reform. The FDA has a role to play in that debate, 
especially as it relates to the creation of a pathway to 
approve follow-on biologics.
    The other is FDA regulation of tobacco. Tobacco use kills 
more than 400,000 Americans each year, making it the leading 
preventable cause of death. Each day 3,500 children try smoking 
a cigarette for the first time, with an additional 1,000 
children becoming regular, daily smokers. One third of these 
children will die prematurely from smoking. It is time for us 
to act.
    Next week this committee will take up and hopefully pass 
the Family Smoking Prevention and Tobacco Control Act. This 
landmark public health legislation has been championed for many 
years by Senator Kennedy and many others on this committee. It 
will give the FDA the authority to regulate the production, 
marketing, and sale of tobacco products--especially for 
children. This is not new legislation.
    The Senate passed similar legislation in 2004 by unanimous 
consent. The HELP Committee reported out a nearly identical 
bill last Congress after a lengthy markup. The House of 
Representatives passed the bill twice by overwhelming 
bipartisan majorities, once in the last Congress and once 
earlier this year. It is endorsed by over 1,000 national, 
State, and regional public health and faith based 
organizations. With this committee and the Senate poised to 
pass this legislation, we finally can see the finish line and I 
look forward to working with you to implement this important 
legislation.
    I have great confidence in the job Dr. Hamburg will do as 
commissioner of the FDA. I strongly support her nomination and 
urge her swift approval by this committee and the Senate.
    Senator Dodd. With that, Senator Sanders.
    Senator Sanders. Thank you, Mr. Chairman.
    Just two brief questions. As you know, the United States 
pays by far the highest prices in the world for prescription 
drugs. The same medicine sold in the United States is often 
sold at a much higher price than in Canada or the United 
Kingdom. I personally find it hard to understand how we can 
import food from small farms in Mexico and in the back woods of 
China, and that is OK, but somehow or another we are not able 
to import less expensive prescription drugs from 
industrialized, sophisticated countries like Canada or the 
United Kingdom.
    The drug companies have spent hundreds of millions of 
dollars trying to convince us that this cannot be done. Just 
impossible.
    Dr. Hamburg, do you think it is impossible? Do you think we 
can safely inspect the medicines coming from the UK, Canada, 
other industrialized countries so that we can save the people 
of this country substantial amounts of money on their 
prescription drugs?
    Dr. Hamburg. Senator Sanders, this is clearly an issue that 
we will be working on together, should you choose to confirm me 
as FDA Commissioner, and I look forward to that opportunity. As 
I am sure you know, Senator Obama supports the importation of 
drugs so that--President Obama----
    Senator Sanders. He won the election. That is right. I do 
know that. Right.
    [Laughter.]
    Dr. Hamburg. He has actually given FDA $5 million to begin 
a planning process to study how best safe importation can be 
done.
    It does raise some serious issues for the FDA in terms of 
how can we assure the safety that Americans count on. Some of 
the issues you just discussed about contaminated products from 
China and other problems with counterfeit drugs, which are 
becoming a very serious global concern, remind us that we need 
to take this very seriously.
    Senator Sanders. It is an issue. It is an issue, but every 
day millions of people are eating vegetables that come from 
small farms in Mexico, and we are eating food that comes from 
China. I kind of think we can do it. I think what you will have 
to be aware of is the drug companies will spend hundreds of 
millions of dollars trying to prevent us from doing that, and I 
hope we will be able to stand up to that pressure because high 
cost of prescription drugs is one of the reasons that health 
care is so expensive in America, which we are trying to deal 
with.
    My second issue. Let me read you a quote--well, not a 
quote. I am paraphrasing what I hope and expect will be--as you 
take his seat, David Kessler--you may know Dr. Kessler who was 
a former FDA Commissioner. In his new book, The End of 
Overeating, he says that foods high in fat, salt, and sugar 
alter the brain's chemistry in ways that compel people to 
overeat. Now, I do not know if his theory is right or not, but 
I think generally speaking we know that if we eat a lot of fat, 
salt, and sugar, it is probably not so good for our health. 
Yet, every Saturday morning there are television commercials 
telling our kids pretty much to do just that.
    So my question is, as we are concerned about obesity in 
this country and the health of our kids, which is a growing 
problem, what do you see the proper role of government is in 
terms of regulating the food industry?
    Dr. Hamburg. These are really important concerns. As you 
point out, the food we eat, as well as other aspects of 
lifestyle, make a huge difference on health and throughout the 
life cycle and starting early habits that are formed make a 
difference in a lifelong way.
    I think it is very important that the government lead the 
way with communicating critical information in terms of 
establishing guidelines and standards, and in many cases, 
mandating certain kinds of activities helping consumers to 
better understand the potential risks they are being exposed to 
is important and labeling of--
    Senator Sanders. What do we do about commercials, one of 
many examples, on TV which are encouraging kids to eat 
extremely unhealthy foods?
    Dr. Hamburg. I think that that is a bit beyond the scope of 
the FDA Commissioner, but it is a challenge. I think we know 
that what kids see on television, both infomercials and in the 
programming on television, influences behavior in ways that can 
be harmful to health.
    Senator Sanders. Correct me if I am wrong now. In New York 
State, there are fast food places obliged to indicate the 
calories of the food that they are serving?
    Dr. Hamburg. To be honest, I do not know the specifics. I 
know within New York City there have been activities 
undertaken--
    Senator Sanders [presiding]. I have seen that in New York 
City.
    Dr. Hamburg. Yes. I think it is an interesting and 
important model. It is one that I would like to learn more 
about. I think that the FDA has a very clear and important role 
in helping consumers to better understand the health quality of 
the food that they eat.
    Senator Sanders. My time has expired. Thank you very much, 
and I will certainly look forward to working with you in the 
years to come.
    Senator Casey. Dr. Hamburg, thank you very much for your 
willingness to serve. I want to commend you and your family for 
taking on this responsibility. I know this is not your first 
commitment to serve the public, but we are grateful that at 
such an important time in our country's history that you are 
willing to serve.
    And I want to say to your extended and immediate family, 
thank you for helping her do this. I am speaking directly to 
your children. You are part of this, and your support for your 
mother is very important to the work that she is doing. She is 
serving your country and you are helping her do it, and we are 
grateful for that.
    I wanted to focus really on one kind of broad issue. It is 
an issue that you addressed several times today and also, as 
well, in your testimony, at the bottom of page 2, onto page 3, 
food safety, in particular, the criticism which I do not think 
is isolated. I think there is a fairly substantial degree of 
consensus that there is at least concern about, if not a real 
hard and fast conclusion that many have reached--the authority 
to tackle or to confront the problems that arise with food 
presents. The authority for that and the mission for that does 
not reside in any one place, that it is too disparate or spread 
out. A, the lack of a single official who is working full-time 
on food safety; and B, kind of the direct line of authority but 
also budget authority.
    This is an age-old challenge we have in any government, 
especially a government as large as ours at the Federal level. 
There are some parallels, obviously a much different challenge 
when it comes to homeland security, for example. A 
determination was made that we should put that under our roof, 
so to speak. It seems like almost every agency in government 
has these debates about who or what is in that direct line of 
authority.
    I guess my question would be very simple. No. 1, do you 
believe that that needs to be corrected? Do you believe that 
that challenge of combating the problems with food safety needs 
to be in one person or one--some have recommended having a 
Deputy FDA Commissioner. If you either do not agree with that 
or have not had a chance to review--and you may not want to 
because you are just starting--would you make a commitment to 
examine it so you can report back to us?
    Dr. Hamburg. If confirmed, I would make one of my most 
immediate priorities looking at how FDA can further strengthen 
food safety and all of its component challenges. I think one 
piece of it, as you appropriately point out, is making sure 
that we have the right alignment of all the critical players 
both within FDA and the collaboration with all of the critical 
partners external to FDA. I do intend to look very closely at 
the organization of FDA and that we have the right team and 
expertise assembled to do what needs to be done.
    I also really feel very strongly that the components of 
partnership are very key because, as you pointed out, many of 
the responsibilities for food safety span numerous agencies, 
USDA of course being the major partner, but there are other 
partners at the Federal level as well and then at the State and 
local level and then with industry. Food safety is a shared 
responsibility across many different players and throughout the 
entire life cycle of the food we eat from the farm that it is 
grown on through the processing and the production facilities, 
through the distribution and the handling, and finally, when it 
gets into our households and on our table.
    I will be working very hard to strengthen food safety 
within FDA and would be delighted to discuss it further with 
you and other Members of Congress and welcome ideas and 
insights that all of you may have.
    Senator Casey. Thank you very much.
    The other question I had was--and I am over time now. I 
will try to be brief-- what you might call the magic wand 
question. If you had a magic wand and you could wave it to 
provide the resources and authority--not authority really, but 
just resources, budgetary resources that you would need. Where 
do you think the agency currently stands in terms of its 
resources to do the job you think it must do?
    Dr. Hamburg. I think that, unfortunately, for quite a long 
time now, the demands and the mission of FDA have far 
outstripped the available resources to enable FDA to do its job 
appropriately, efficiently, and with the kind of strength of 
scientists and personnel that we need. I know there is no magic 
wand, but I am eager to provide leadership to make sure that we 
have the best and the brightest staff and that we can not only 
recruit them, but that we can retain them, that we can 
strengthen our science base, which is so fundamental to all 
that we do, that we can restore the trust and confidence of the 
American people and of Congress in our ability to do the jobs 
before us. I look forward to taking on that challenge.
    Senator Casey. Thank you very much. Thanks for your public 
service, and good luck, as you get to the end of this process.
    Dr. Hamburg. Thank you.
    Senator Sanders. Let me conclude the hearing by wishing you 
the very best of luck. You are undertaking and going to be 
moving into a job of enormous consequence. There are very 
special interests out there who are prepared to spend huge sums 
of money and make a quick profit at the expense of the health 
and well-being of the American people. We look forward to 
working you to withstand that pressure.
    Let me just say members are strongly encouraged to submit 
their questions for the nominee by close of business tomorrow. 
The record will remain open for 10 business days for additional 
statements.
    The hearing is adjourned. Thank you very much for being 
with us.

                          ADDITIONAL MATERIAL

                  National Threat Initiative (NTI),
                                      Washington, DC 20006,
                                                       May 4, 2009.
Hon. Edward M. Kennedy, Chairman,
Committee on Health, Education, Labor, and Pensions,
428 Senate Dirksen Office Building,
Washington, DC 20510.

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

    Dear Ted and Mike: I am writing to express my strong support for 
the nomination of Dr. Margaret A. (Peggy) Hamburg as Commissioner of 
the Food and Drug Administration.
    Dr. Hamburg is a physician who is a nationally and internationally 
recognized leader in public health and medicine, and an authority on 
global health and safety, public health systems, infectious disease, 
bioterrorism and emergency preparedness. She has devoted her entire 
career to issues of protecting health and safety, and she did an 
outstanding job as New York City's Commissioner of Health and as 
Assistant Secretary for Planning and Evaluation at the U.S. Department 
of Health and Human Services. At HHS, Peggy led the way in both 
sounding the alarm as to the danger of bioterrorism and laying the 
foundation for a governmental response. Understanding the connection 
between infectious disease and national security, she initiated an 
effort to connect health officials and security officials on a regular 
basis to greatly improve the government's crisis response capability. 
After leaving HHS, Peggy provided the leadership for the Nuclear Threat 
Initiative (NTI) and other NGOs to contribute to this nexus between 
health and security.
    At NTI, which I co-chair, Peggy did an outstanding job launching 
and implementing our innovative biological program--now the Global 
Health and Security Initiative. Peggy has a rare and valuable talent 
for identifying emerging issues and developing creative and effective 
strategies to address them. She exerts firm leadership, but is a strong 
team player who is able to work effectively and collegially across many 
sectors, including government (local, State, Federal and 
international), industry (including the pharmaceutical and biotech 
industries), the non-profit sector, and academia.
    Peggy has worked hard to raise awareness about naturally occurring 
and deliberately caused threats to public health, including food 
safety. She has been deeply engaged in designing a program to develop 
and make available new drugs, vaccines and diagnostics to strengthen 
our defenses against threats to public health, especially in the 
context of emerging biological threats. She has also helped lead the 
way in creating early warning surveillance and cooperation across 
borders.
    My bottom line: Peggy has unquestioned integrity and good judgment 
and brings strong intellectual vigor to everything she does. She is a 
problem solver who has extensive public service experience, and she 
knows how to get things done. She is widely respected and is an 
excellent communicator. In addition, Peggy comes from a long line of 
distinguished public servants and is continuing the tradition of 
outstanding public service set by her parents Drs. David and Betty 
Hamburg.
    I strongly recommend her to you, the committee and the Senate. I 
hope that you will give her nomination favorable consideration.
            Sincerely,
                                                  Sam Nunn,
                           Co-Chairman and Chief Executive Officer.

    [Whereupon, at 4:02 p.m., the hearing was adjourned.]

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