Hearing of the Senate Health, Education, Labor and Pensions Committee – Nomination of Margaret Hamburg to be Commissioner of the Food and Drug Administration

Hearing of the Senate Health, Education, Labor and Pensions Committee - Nomination of Margaret Hamburg to be Commissioner of the Food and Drug Administration

WITNESS: MARGARET HAMBURG, TO BE COMMISSIONER OF THE FOOD AND DRUG ADMINISTRATION

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SEN. 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 but we are 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 morning, this afternoon, as well.

And Dr. Hamburg, I know you have some family here today, so before we begin I would like you to -- if you wouldn't mind, introducing your family to the panel today.

MS. HAMBURG: It would be a great pleasure. This is my husband -- (off mike) -- and my daughter Rachel (sp), and Evan Brown (sp). I'm also joined today by my parents, Dr. Betty Hamburg and Dr. David Hamburg, and my mother-in-law, Betsy Brown (sp). And I want to thank you all for the kindness and support you've given me throughout this process. And I suspect I'll need more of that kindness and support should the Senate choose to confirm me.

(Laughter.)

SEN. 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 Ms. Hamburg as she -- Dr. Hamburg 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 shows his support for you as well.

Senator Lugar, if you're ready -- and I know you're on an extremely tight time frame, so before I make a statement I would be happy to yield to you to introduce Dr. Hamburg.

SEN. RICHARD LUGAR (R-IN): Well thank you very much, Chairman. I really appreciate that. I thank you for the opportunity to introduce Maggie 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 and for moving forward on this very important nomination. At a time of heightened awareness about the need for food safety oversight, (really ?) a 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.

Madame 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've 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 an approach that led to the Nunn-Lugar program, deactivating more than 7,200 nuclear warheads, many thousands of missiles, missile launchers, submarines and bombers. His leadership and his friendship have been extraordinary and his contributions to United States' national security immeasurable.

David Hamburg's commitment to his country's security have 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. And 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 NTI board of directors I've 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, her personal integrity and her remarkable dedication to public service. Together we've strongly supported the growing efforts of the Nunn-Lugar program and its partner programs at the department of State in the biological weapons field. They share a strong belief in the vigorous need for United States collaboration and cooperation with governments around the world in the area of infectious diseases and pathogens.

As these pathogens can now be modified and engineered to increase their lethality, and potential as threat, Dr. Hamburg and I have urged the United States 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 United States projects to assist in the establishment of systems designed to detect, characterize and respond to outbreaks of infectious diseases. I am pleased to report today 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 here internship and residency in internal medicine at the New York Hospital of Cornell University Medical Center, and was certified by the American Board of Internal Medicine. Dr. Hamburg served six 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 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 interest and science to shape policy needs and directives. I have always respected her counsel and appreciated her utmost professionalism.

I thank you again, madame chair, for this opportunity to present this distinguished nominee to the committee.

SEN. 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. But over the past eight 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've 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 don't 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 wind.

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 of NIH. Dr. Hamburg also has great leadership experience, serving from 1991 to '97 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 '92 and '97. She also worked to put in place programs designed to slow the spread of AIDS, (boost ?) childhood immunization rates, and developed one of the first programs to prepare the public for a terrorist attack using anthrax or other bio-chemical weapons.

And 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 Americas families confidence in our medicine and in our food. We need a highly qualified leader like Dr. Hamburg.

And 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. But I'm 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. So 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's going to help protect them from unsafe food or drugs, and who will always put science over politics.

So with that, I'm going to turn to Senator Hatch for his opening statement, and to any of our other colleagues who would like to give a short opening statement before we hear from Dr. Hamburg.

SEN. ORRIN HATCH (R-UT): Thank you so much, Madame Chairman. Dr. Hamburg, I'm very pleased you're willing to accept this job. This is a thankless job, in some ways. A very difficult job. It's filled with politics and controversy, and it shouldn't be.

But you're coming in at a time when, with real effort, you can help -- you can help produce the greatest campus for food and drugs in the history of the world. But it has taken us since 1992, when we passed the FDA Revitalization Act, to get us to where we are today and we're still not there. So I hope you'll (take that home ?) because once we have the highest facilities and the best equipment, then we'll be able to attract some of the best scientists in addition to those who have agreed to serve out there so far. It's about time to bring all these folks into one central campus where instead of 30-35 different places all over the greater Washington area, where some of them worked in less than desirable conditions.

So you have a great opportunity here to really lead. But that's only part of it. We need to make this safety and efficacy process move more smoothly. We need to attract the top people to be able to take some of the heavy burdens off those who have been carrying it for so long. We need to -- we need to work on all kinds of projects that will help the health care in this particular country.

And as you know, we're working on health care reform as we speak in this committee and in the Finance Committee. And we're far from getting that right now, getting that done or getting it done in a way that will be more desirable. But you can probably do more, in some ways, at FDA than we're (liable to ?) in Congress.

So this is a very, very important position. I take tremendous interest in it, as I think does everybody on this committee, every single person. I just wanted 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.

And I just hope that you'll do everything you possibly can to upgrade that agency even more than it is. And I think it's 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.

And handled properly, I think we can -- we can, I think, even augment the safety and efficacy process for companies so that we can do much more innovation than we've done in the past. But we do need to move it along. We do need to make sure that people get 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're going to be working in.

And that doesn't just include the drug areas, it's going to include biologics. Hopefully we'll do a follow-on biologics bill that will work with the appropriate data (specific ?) period that you just have to have to be equivalent to Hatch-Waxman. And, of course, medical devices, etcetera, etcetera plus all the other foods and so forth that this agency handles. You're going to be handling between 20 (percent) and 25 percent of all the consumer products in America.

So this is not some itty-biddy job. This is a big time job that really is going to take a lot of your time and a lot of effort. And we need to give you the right kind of support and help. But I think you -- don't be afraid to advocate for that and for more money and for more facilities and to get that campus at White Oak completely completed.

Well, I'm 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.

SEN. MURRAY: Thank you, Senator Hatch.

Senator Brown.

SEN. SHERROD BROWN (D-OH): Thank you, Madame Chair, and thank you, Dr. Hamburger. It's great to see you again and 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, and your work there will be particularly important.

Several years ago when I was with Senator (Byrd ?) 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. And what was so telling is at the beginning of the hearing the first thing they told us was that 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 tuberculosis, with multi-drug resistant tuberculosis, in New York; what you did in Rickers Prison. I know that you understand that the reason that multi-drug 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 on public health, and how the government simply wasn't doing in public health what it should have been doing, as it has not done prior to the TB multi-drug resistant outbreak. We've 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, Madame Chair, I just want to recount a couple of other things. When Dr. Hamburg was in my office, I appreciated your comments on follow-on 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 kinds of contaminants in pharmaceuticals and food.

And I appreciate your comments about what do we do as more drug companies outsource more of their production? And the previous FDA told us on this committee -- because I presided one day a year or so ago -- that these drug companies moved to China not just to save costs and 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. So hopefully you can continue to pursue that issue because nothing is more important than pharmaceutical and food safety for the people of this country. So I'm thrilled that you want to be FDA Commissioner. I look forward to voting for you on this committee and look forward to supporting you on the floor.

Thank you.

SEN. MURRAY: I'm not sure if any of our other Senators want to do an opening statement or if we want to go to questions? I'll go to Senator Burr and then Senator Sanders for a quick opening statement.

SEN. RICHARD BURR (R-NC): Thank you, Madame Chairman. I think when you have an exceptionally qualified individual that's 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's 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 devices development as well as the importance of a sound science-based standard to protect our food supply. She has run a large and unwieldy government agency for six years, as the commissioner for health in New York City, at a time 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. But that's 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 life-saving drug and/or pull harmful products off the marketplace.

Dr. Hamburg should know when the Senate confirms you, I hope to work with you and ensure that the FDA is, one, adequately funded. But I would also hope that you take this opportunity to improve the culture at the FDA. And 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'm hopeful you'll be there to guide it.

Welcome today and welcome to your family.

SEN. MURRAY: Thank you very much. And Senator Sanders, do you have a short opening statement?

SEN. BERNARD SANDERS (I-VT): Thank you, Madame Chair. And welcome and we certainly look forward to working with you in the next several years. There's an issue that I have been working on for a number of years when I was in the House and in the Senate, 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.

And I find it very hard to believe that we cannot, 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 -- medicine from Canada or the United Kingdom. I just don't believe it. And for years we've 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 mean, I think it's 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 the younger generation will have a shorter lifespan than our generation because of obesity and all of the illnesses that go with that. And I know you're familiar with this issue, but 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 illnesses. So there's 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.

SEN. MURRAY: Thank you. Dr. Hamburg, we'll turn to your opening statement in just a minute. I understand Senator Hagen you will submit a statement for the record. I appreciate that.

Senator Mikulski, you wanted a quick moment.

SEN. BARBARA MIKULSKI (D-MD): Very quickly because we're dealing with, you know, Dr. Hamburg. As the Senator who has FDA in her home state, I just wanted to give Dr. Hamburg a very cordial and enthusiastic welcome. And 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 didn't 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 beautiful family with you. You yourself said you feel very prepared for the challenges at FDA. You're the daughter of a psychiatrist, and you'll need all the mental health that you can get.

We want to hear from you not only today, but work with you in the future. I just want to note that your facilities at FDA have been enormously stressed and we've worked at rebuilding them over the years on a bipartisan basis. I want to note the partnership that I've had with Senator Hatch in doing that, and I think we can ensure -- it's not only having the right building, but making sure we have the right leadership.

Thank you and I look forward to working with you.

SEN. 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.

DR. HAMBURG: Thank you very much, Madame 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 just 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'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 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've had direct experience helping and 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 world-wide.

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, 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 policy 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 systems 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 and to every aspect of product development. Close monitoring of the marketing would 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 market place and to the people who need them.

As FDA Commissioner, I would strive to lead an agency that appropriately balances innovation with regulation. Our fifth priority is accountability. Responsibility to insure the integrity of our food and drug supply is a shared responsibility throughout the life cycle of the product.

The FDA has responsibility to insure 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 most 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 foods.

Madame Chairwoman and members of the committee, members, 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 had 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 to 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.

SEN. 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. I just have a couple of questions. You and I had the opportunity to meet in my office, so I wanted to just sort of ask you two -- 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 and we have to restore America's confidence actually that our food supply is being effectively regulated.

I think this is going to require additional resources and authority so that we will be able to respond in the time of crisis and it is going to require strong FDA leadership, someone who can work with our farmers and our food processors, all 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. So I want 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 death 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's 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, so this is quite a challenge. Clearly at the present time, we don't 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 at the present time, we are not able to inspect all of the food production facilities either domestically or internationally into the levels that we would like, not by any means, so we need to certainly increase the numbers of inspections but we also have to be smarter about how we do inspections. We want to really -- 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 and we need to have clear strategies for enforcement and the tools to achieve our goal but 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 we are at the point of vulnerability where we can target our efforts to reduce risks 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 and we clearly need to work in greater partnership across agencies of the federal government, across levels of governments, 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 define a strategy to address them and I look forward to working with you on that.

SEN. MURRAY: Alright, I appreciate that and I just have a minute left tonight. I just wanted to ask you -- Senator Mikulski brought it up as well that we are seeing a trend of politicizing public health decisions and just this year employees of the FDA sent letters to President Obama outlining mismanagement at the agency and asking that he ensure that professionalism is returned to the agency. A can you just tell us if you are aware of that and --

DR. HAMBURG: I am aware of that. I'm very concerned by some of what I've heard. I hope that if confirmed as commissioner, I can, through my leadership, create an environment where scientist 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 decision making of the FDA.

SEN. MURRAY: I appreciate that very much. Senator Enzi?

SEN. MICHAEL B. ENZI (R-WY): Thank you, Madame Chairman and 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 and I think it's very beneficial for us and probably daunting for you to be coming on at this point in time that I appreciate the expertise that you have in the area of pandemics, we may need it and with your expertise hopefully we won't, that you will also be in charge of trillion dollars worth of products every year and that has been given to the food safety. I don't know how many trillion we do in food. Well, we've had some hearings on food safety before and 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 and I think it's got to be one of the unusual things in government to have three agencies doing that and you'll get to participate in that and of course we'll be interested in any suggestions for how we can do it better. Now, one of the questions that I asked everybody that comes before this committee, this used to be one of the most contentious committees and I think it's now one of the most productive committees and that's because we have learned to cooperate and work together to get a lot of things done. So what I always ask is in order to continue to sponsor that kind of a relationship whether it's Democrat or 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. I think, should I be confirmed as the FDA commissioner --

SEN. 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.

SEN. ENZI: I appreciate that and 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're going to be working to make sure that the ever-greening in it is solid and we'll be wanting that back and again and so we'll be asking for some inputs from you and again it's kind of a simple question and I would expected that you would help but I'll ask that question anyway.

DR. HAMBURG: Well I think that as you have pointed it out there are a number of pieces with legislation around following biologics and it's 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 but they are expensive and many of these products gets one manufacturer in the near term as you well know many of these of products will be losing their patent protection and so thinking about establishing a pathway for this so called biosimilars I think it is very important.

It has the opportunity to expand the manufacturing, base of more products will be available and also could yield significant savings but there are challenges involved in it and it will take careful deliberations on the part of Congress and serious work on the part of the 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 into the FDA. There's the challenge of really understanding how best to evaluate these biosimilars so that we can move them forward and to the American people with assurety of their safety and efficacy. But I think that it's something that is -- it is a very exciting opportunity I would certainly support establishing such a pathway and would look forward to working with you.

SEN. ENZI: It's definitely a balancing act as you mentioned. We want to make sure it's a streamline process.

We want to make sure that we don't stifle innovation but we want get the products on the market as fast as possible and I think we have a bill that kind of does that so we will be checking with you and looking for some help on that. It is a very bipartisan bill, one that we have worked on for a long a time. And I have run out of time.

SEN. MURRAY: Thank you very much. Senator Dodd?

SEN. DODD: Well, Madame 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'll defer to --

SEN. MURRAY: Senator Mikulski?

SEN. MILKULSKI: Thank you, Senator Dodd.

SEN. DODD: Thanks.

SEN. MIKULSKI: Dr. Hamburg I want to pick up on the employee issue that Senator Murray raised. And a group of our constituents in the CDRH wrote me in October of '08 saying that they were forced to recommend the clearances of devices over their objection and I understand it's been referred to the IG. I will not go into that specific case but raise the issue of two things. One, whistle blowers, which in this case they said they were, and we gave the facts then to be investigated appropriately and then there's the descent channel where decisions are made but people wanted to raise a descent or something might be going on and raise a descent. My question to you, organizationally and as essentially the CEO of FDA, how will you handle -- what organizational mechanisms will you have for whistle blower concerns to rise to the top of you and also would you consider even having some type of mechanism for a decent channel of communication so that you would be aware with the 4,000 people who worked for you if they have flashing yellow lights about decision making?

DR. HAMBURG: Well let me first begin, Senator Mikulski, by thanking you for all the hard work you've done to make White Oaks 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 work force within FDA. So I think that is the contributor to the kind of positive constructive work environment about which our concerns 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 and 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 and in the final analysis I think that that is the best way for decisions to be made lively --

SEN. 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 and I look forward to voting for you but I think we would like to know if someone feels they are a whistle blower, where can they go, is there a direct channel in which they wouldn't be muscled, presuming you wouldn't try to but doing that and also for that and we'd like to talk with you about that and perhaps that we do better for -- but I know you are going to do the culture and then you are going to have this --

DR. HAMBURG: Absolutely leadership is important but as you say what are -- the structures and policies is also a key and to answer your question for that you know I would have to spend some time to look closely at these issues and certainly some of the concerns that had been raised publicly and by members of Congress about events in the past are of great concern to me and I would --

SEN. MIKULSKI: I'm going to jump in with one more question not to cut you off but I think we're on the same broadband here. I'm going to go to another issue which goes, the FDA has always focused on safety and that has to be an obsession. But I am also concerned about efficacy, which I believe should be a mandate. As we take a look at the whole idea of performing healthcare and probing 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 healthcare debate to give us ideas and recommendations on efficacy and have you had a chance to look with something like the Dartmouth Institute's idea on drug box labeling that would comment in the efficacy of a product?

DR. HAMBURG: You raise a very important points. I am not familiar with the Dartmouth box labeling approach but would love to learn more about it and I think that FDA clearly has an important role to play in, as you say, safety and efficacy are the core of its mission. I would very much look forward to be involved with healthcare 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 then doing a difference in health in this country.

SEN. MIKULSKI: Well my time is up. I hope you had the table too and I hope the FDA set the table because I do not want the person who determines what drugs the American people have access to or devices are 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, and also that would include interactions, but also what has the greatest efficacy and therefore get the most value for healthcare and I do not want the determination to be made by insurance gatekeeper. So we look forward to working with you so we can have a science-based and evidenced-based decision making. Thank you and good luck and I sure look forward to voting for you and working with you.

DR. HAMBURG: Thank you.

SEN. MURRAY: Thank you. Senator Hatch?

SEN. HATCH: Well, thank you Madame Chairman. During the announcement by President Obama to appoint you as FDA Commissioner, the President also appointed Dr. Josh Sharfstein (sp) as the principal FDA Deputy Commissioner. I am not sure that's ever done before. Has that ever been done before?

DR. HAMBURG: I can't answer that question Senator. I just don't know.

SEN. HATCH: I'd like to know the answer to that. It's just interesting to me. Do you know how you are going to divide the responsibilities out there between you and Dr. Sharfstein (sp)? If you worked on that or even thought of that?

DR. HAMBURG: If I will be the Commissioner, if confirmed by the Senate, and I look forward to taking on that role and I know that Dr. Sharfstein (sp) is very broadly knowledgeable about the FDA and he in fact is already there serving in an acting role and I will, I'm sure, benefit from his early experience there as I make the transition in, if the Senate does choose to confirm me --

SEN. HATCH: We'll he is. He is very knowledgeable.

DR. HAMBURG: I believe that there were reports from 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 be so honored to serve would I be the Commissioner.

SEN. HATCH: Okay. Well I think that's right. That's why I asked that question, not meant to find fault with anybody, I just wanted to know the answer to that. If you might know, the Dietary Supplement Health and Education Act of 1994 provides FDA with the authority of overseeing and regulate the supplement industry. In December 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act was also signed into law. This law requires mandatory reporting of serious adverse events reporting for dietary supplements and overthe-counter products. Do you agree with me and all former FDA commissioners that I have chatted with, that those ones are still adequate and that they gave 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 haven't been deeply involved in my other professional experiences and 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 that Congress has given FDA important authorities to support that role in terms of protecting the health and safety of Americans. The GAO, I know, took a recent look at some of what has been 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. But I think it is very, very important. We know that more than half of the 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.

SEN. HATCH: The GAO report has indicated that the biggest problem there is that you do not have enough funds. That's the problem. And I have heard Sen. Hagan and I are very much interested in the alternative medicine situation out there that we've put into law and we think it has given kind of short trips. I hope you look at that as well.

DR. HAMBURG: Okay.

SEN. HATCH: Let me just ask you one more question. You mentioned the tobacco issue. The Congress is considering legislation that would give the FDA a jurisdiction over tobacco. In designating the FDA as a regular trade 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 for public health and finally, if the tobacco legislation becomes a 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: Well 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 and that they are amusedly lethal but yet not highly regulated. This is a critical moment I think 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 the 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 but as I understand it, the legislation being considered thus building 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. And I think that I'm very comfortable moving forward if that is the will of Congress.

SEN. MURRAY: Thank you very much Sen. Hatch. Dr. Hamburg I apologize, I am going to go to another meeting but we are going to do a little (musical chairs?) here and Sen. Dodd is going to take over the chairmanship of this committee for a short while and then pass on to Senator Sanders about 3:30 as my understanding. So I appreciate all of our colleagues' willingness to jump in and help as we got started a little bit late some time commitments but I look forward to working with you as we move your nomination forward and with that I will turn the gavel and the speaking over to Senator Dodd.

SEN. DODD: Thank you. Thank you very much, Madame Chairman and welcome doctor.

DR. HAMBURG: Thank you.

SEN. DODD: It's a pleasure to see you again and 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 to do this. I think probably this job; I know Secretary of Health and Human Services obviously is a critical job and Secretary of Education. I do not think any of us think that these jobs are any more important than the one that you are going to take on. We spent an awful lot of time in this committee over the years dealing with FDA issues and so I've grown very excited about your nomination. You bring a relative talent and experience.

This is going to be valuable to this committee but more importantly to the country. So I thank you for your willingness to do that. The questions I'd like to raise with you have a lot to do with pediatrics and I chair the subcommittee on children and families and have for a long time, and many members of this committee have been tremendously helpful over the years on a lot of these issues are dealing with pharmaceuticals for children and going back to the Family and Medical Leave Act that members of this committee, I think it was Senator Murray and Senator Hatch and others were very helpful on child care, and a lot of issues focusing on children. And 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 across the city. So when I saw that, I said I think I've got an ally in issues I'm about raise.

Because so often, the assumption is that we're just smaller versions of adults. And we've seen dreadful problems of either overdosing or under dosing or all sorts of things -- studies down under the Better Pharmaceutical Act for Children, which has proven with the studies that have been done how important this area is. And I notice with the H1N1 outbreak, again there's some questions that have occurred to me dealing with pediatric populations.

And you start talking about having adequate supplies of Tamiflu and the question is whether or not we're going to have adequate and appropriate testing of these vaccines given the age, by the way, I'm stuck with the age, the average age being 15, of those who have been affected. Not exclusively so, but the bulk of 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. And I'll go to a couple of other points on this thing, your reactions to that.

The combination of the migration, the inexorable link between human and animal health is raised. And I'm not suggesting, I call it H1N1 because I know the sensitivities of calling it Swine Flu, but there clearly is an external (ph) link between animal and human health. And while FDA deals with human health, and the Agriculture department deals with animal health, it seems to me that we've got to start thinking about how these two agencies begin to cooperate more effectively in these areas. And I don't think that's been the case.

And I just heard you talk about taking on additional responsibilities in response to Senator Hatch. But I'd be very interested in any thoughts you may have on that. And let me start with that question. And then I have some similar questions dealing with the follow on biologics and children as well in pediatrics. But let me start with --

MS. HAMBURG: Okay. With respect to 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've seen a surprising number of emerging infectious disease threats, including, of course H1N1, but also SARS, HIV, avian flu), West Nile, many, many important diseases with huge impacts on the American people. And the large majority of those cases have been what are called vilinosis (ph) or diseases that emerge in animal populations and merge over into human populations.

So it's a very important area of study that has huge impacts on health and society, more broadly. And it's an area that I've worked on in the past and from the perspective of FDA, I would want to continue to work on it. It's very, very important that, obviously the linkage that we're seeing now with H1N1 in the area of antibiotic resistance. How animal health and human health is addressed is also very, very keen. There's 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, you know, your leadership on this issue has been very important and really moving towards 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.

And of course, the same holds true when we're addressing the problem that is currently before us, of H1N1, making sure that children are not left out, because, 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 anti viral medications could be made available to a somewhat younger age population. And I think, you know, 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 that they need.

SEN. DODD: That's, I think because in this particular case you do have a population, that younger population, so I'd be very interested in that, and the coordination between the Department of Agriculture and the FDA, there hasn't really been much, in my view. And it seems that it's long overdue. If you're going to have that migration problem you've got to look at it. I want to mention as well too, is follow-on biologics. And again, I, as Senator Enzi pointed out, there's been a lot of work on this. I along with others, was the author of that Better Pharmaceutical Act for children, which has been remarkable in how much it's 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 for products for children.

But we haven't required this at all under the follow-on biologics. And so many things, I'd like very much for the FDA to insist that, as we move forward with the follow-on biologics, if that's the case, I know it's a heated debate, but if we do so, that we're not going to have to go back to a whole legislative process again, here to insist that there be adequate testing and so forth of these products to make sure the children are going to be safe, and things.

So I raise that with you, but would love to see some leadership out of the FDA, that instead of sort of bucking some of these things, to become an ally in the process. So I don't feel I have to go through -- and maybe we have to legislatively. If someone could tell me maybe I'm going to have to do that, for some statutory reason, but if I don't, I'd to be able to have it handled. Otherwise, any anticipated -- I've authored legislation on pediatric medical devices as well for much the same reason.

And I want to take the opportunity to thank the FDA, by the way. They, through the Office of Orphan Products Development, they recently released the grant applications for two million dollars in demonstration grants for improving pediatric device availability, which this committee and I've supported as part of the FDA amendments in 2007.

These provide grants to non profit pediatric medical device consortiums, which scientists and innovators, particularly small businesses, with technical and financial resources to improve the number of medical devices available to children. And I would hope that you would continue supporting that effort. There are problems within the FDA Center for Devices and Radiological Health. And my time has expired here, but I'd 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?

So, my colleagues have questions for you as well. I don't want to interrupt their time. But those are my focuses usually, in this pediatric area, and has been. So I have a lot of interest. And I'm excited about the fact, you're going to have some colleagues joining you who come and bring particular expertise and experience in this arena, which is very exciting indeed. But congratulations to you. And I look forward to supporting your nomination and working with you in the coming months.

MS. HAMBURG: Thank you.

SEN. DODD: With that, Senator Sanders.

SEN. SANDERS: Thank you, Mr. Chairman. Just two brief questions. As you know, the United States pays, I've found (ph) the highest prices in the world for prescription drugs. Same medicine sold in the United States is often sold at a much higher price than in Canada, 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's okay.

But somehow or another we're not able to import less expensive prescription drugs from industrialized, sophisticated countries like Canada, the United Kingdom. The drug companies have spent hundreds of millions of dollars trying to convince us that this just cannot be done. Just impossible. Well, Dr. Hamburg, do you think it's impossible? Do you think we can safely inspect the medicines coming from the U.K., Canada, other industrialized countries, so that we can save the people of those countries substantial amounts of money on their prescription drugs?

MS. 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'm sure you know, Senator Obama supports the importation of drugs so that, President Obama.

SEN. SANDERS: Yeah, I think he won the election. That's all right.

MS. HAMBURG: And he has actually given FDA $5 million dollars to begin a planning process to study how best safe importations 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 issue seriously.

SEN. SANDERS: That is an issue. But I just, every day millions of people are eating vegetables that come from small farms in Mexico. And we're eating food that comes from China. I kind of think we can do it. And 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 it.

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're all trying to deal with. My second issue, let me read you a quote, well not a quote, I'm paraphrasing, what I hope and expect will be -- (agent ?) take his seat -- David Kessler, you know, Dr. Kessler is 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 don't know if this theory is right or not.

But I think, generally speaking, we know that if we eat a lot of fat, salt and sugar, it's probably not so good for our health. And yet, every Saturday morning there are television commercials telling our kids pretty much to do just that. So my question is, as we're 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?

MS. HAMBURG: Well, these are very important concerns, and as you point out, the food we eat, as well as other aspects of lifestyle makes a huge difference on health. And throughout the life cycle 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're being exposed to is important. And labeling of --

SEN. SANDERS: What do we do about commercials -- I'm just hypothetically -- one of many examples, commercials on TV, which are encouraging kids to eat extremely unhealthy foods.

MS. HAMBURG: You know, I think that that is a bit beyond the scope of the FDA commissioner, but it is a challenge. And I think we know that what kids see on television, both in commercials and in the programming on television, influences behavior in ways that can be harmful to health.

SEN. SANDERS: When I was, correct me if I'm wrong now, but in New York State now, are fast food places obliged to indicate the calories of food that they're serving?

MS. HAMBURG: To be honest, I don't know the specifics.

I know within New York City there has been activities undertaken --

SEN. SANDERS: I've seen that in New York City.

MS. HAMBURG: Yes. And I think it's an interesting and important model. It's one that I'd like to learn more about. And I think that the FDA has a very clear and important role in helping consumers to better understand the health quality of the foods that they eat.

SEN. SANDERS: Okay, my time has expired. Thank you very much, and certainly look forward to working with you in the years to come.

SEN. ROBERT P. CASEY (D-OH) (?): Dr. Hamburg, thank you very much for your willingness to serve. And I want to commend you and your family for taking on this responsibility. I know this is your first, your first commitment to serve the public. We're grateful that at such an important time in our country's history that you're willing to serve. And I want to say to you, your extended and immediate family, thank you for helping her do this. Speaking directly to your children, you're part of this, and your support for your mother is very important to the work that she's doing.

So she's serving your country, and you're helping her do it. And we're grateful for that. I wanted to focus, really just on one kind of broad issue. An issue that you addressed several times today, and I think in also as well as in your testimony at the bottom of page two onto page three, food safety. And in particular the criticism, which I think is not, I don't think it's isolated. I think there's a fairly substantial degree of consensus that, there's at least concern about it if not a real hard and fast conclusion that many have reached, that the authority to tackle or to confront the threat that problems that arise with food presents, that that's not, the authority for that and the mission for that doesn't reside in any one place, that it's too, too disparate or spread out.

Any lack of a single official who's working full time on food safety, indeed a kind of a direct line of authority, but also a budget authority. And 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, not obviously much different, a much different challenge when it comes to homeland security, for example. But a determination was made that we should put that under one roof, so to speak.

But it happens in every, in every, it seems like every, almost every agency in government has these debates about who or what is in, in our direct line of authority? I guess my question would be very simple. Number one is, 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 commissioner, a deputy FDA commissioner. And if you either don't agree with that, or haven't had a chance to review it and may not want to, because you're just starting, would you make a commitment to examine it so you can report back us?

MS. HAMBURG: Well, if confirmed, I would make one of my most immediate priorities looking at how FDA can further strengthen food safety in all of its component challenges. And 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 varied too, 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 levels, and then with industry. So 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's grown on through the processing in the production facilities, through the distribution and the handling.

And finally, when it gets into our households and on our table, we'll be working very hard to strengthen food safety within FDA, and we'd be delighted to discuss further with you and other members of congress, and welcome ideas and insights that all of you may have.

SEN. CASEY (?): Thank you very much. The other question I have was, overtime now, try to be brief. Just the, what you might call a magic wand question. If you had a magic wand and you were, you could wave it to provide the resources and authority that, not authority really, but just resources, budgetary resources that you would need. Where do you think the agency currently stands in terms of its, just its resources to do the job you think it must do?

MS. HAMBURG: Well, I think that, unfortunately for quite a long time now, the demands and the mission of FDA has far outstripped the available resources to enable us, enable the FDA to do its job appropriately, efficiently, and with the kind of strengths of scientists and personnel that we need. I know there is no magic wand, but I'm eager to provide leadership to make sure that we have the best and 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 in the Congress, in our ability to do the jobs before us. And I look forward to taking on that challenge.

SEN. CASEY (?): Thank you very much. Thanks for your public service. And good luck as you get to the end of this process.

MS. HAMBURG: Thank you.

SEN. SANDERS: Let me just conclude the hearing by wishing you the very best of luck. You're undertaking, and that will 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 ten business days for additional statements. The hearing is adjourned. Thank you very much for being with us.

MS. HAMBURG: Thank you.

END.

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