[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
__________
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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.]