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[Senate Hearing 107-730]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 107-730
 
                               NOMINATION
=======================================================================

                                HEARING

                               BEFORE THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION

                                   ON

MARK McCLELLAN, OF THE DISTRICT OF COLUMBIA, TO BE COMMISSIONER OF FOOD 
                               AND DRUGS

                               __________

                            OCTOBER 7, 2002

                               __________

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

                       U. S. GOVERNMENT PRINTING OFFICE
82-362                         WASHINGTON : 2003
____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

               EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut     JUDD GREGG, New Hampshire
TOM HARKIN, Iowa                     BILL FRIST, Tennessee
BARBARA A. MIKULSKI, Maryland        MICHAEL B. ENZI, Wyoming
JAMES M. JEFFORDS (I), Vermont       TIM HUTCHINSON, Arkansas
JEFF BINGAMAN, New Mexico            JOHN W. WARNER, Virginia
PAUL D. WELLSTONE, Minnesota         CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington             PAT ROBERTS, Kansas
JACK REED, Rhode Island              SUSAN M. COLLINS, Maine
JOHN EDWARDS, North Carolina         JEFF SESSIONS, Alabama
HILLARY RODHAM CLINTON, New York     MIKE DeWINE, Ohio

           J. Michael Myers, Staff Director and Chief Counsel
             Townsend Lange McNitt, Minority Staff Director

                                  (ii)

                            C O N T E N T S

                               __________

                               STATEMENTS

                        Monday, October 7, 2002

                                                                   Page
Kennedy, Hon. Edward M., a U.S. Senator from the State of 
  Massachusetts..................................................     1
Gregg, Hon. Judd, a U.S. Senator from the State of New Hampshire.     2
McClellan, Mark, to be Commissioner of Food and Drugs, Food and 
  Drug Administration, U.S. Department of Health and Human 
  Services.......................................................     7

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Mark McClellan...............................................    25
    Response to questions of Senator Kennedy.....................    26
    Response to questions of Senator Harkin......................    32
    Response to questions of Senator Mikulski....................    32
    Response to questions of Senator Jeffords....................    34
    Response to questions of Senator Bingaman....................    35
    Response to questions of Senator Murray......................    37
    Response to questions of Senator Reed........................    39
    Response to questions of Senator Clinton.....................    41
    Response to questions of Senators Graham and Nelson..........    45
    Response to questions of Senator Gregg.......................    46
    Response to questions of Senator Frist.......................    49
    Response to questions of Senator Collins.....................    51
    Response to questions of Senator Hutchinson..................    52
    Response to questions of Senator Frist.......................    52
    Response to questions of Senator Wellstone...................    53
    Letter to Senator Kennedy, dated Oct. 4, 2002, from Linda A. 
      Suydam, President, Consumer Healthcare Products Association    56

                                 (iii)

                               NOMINATION

                              ----------                              

                        MONDAY, OCTOBER 7, 2002

                                       U.S. Senate,
          Committee Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 1:36 p.m., in 
room SD-430, Dirksen Senate Office Building, Senator Kennedy 
(chairman of the committee) presiding.
    Present: Senators Kennedy, Bingaman, and Gregg.

                  Opening Statement of Senator Kennedy

    The Chairman. We will come to order.
    It is a privilege this morning to welcome the distinguished 
nominee to be the next Commissioner of Food and Drugs, Dr. Mark 
McClellan.
    Let me also extend the committee's welcome to his wife, 
Stephanie, and to his brother, Scott.
    Dr. McClellan has an impressive background. He is both an 
economist and a physician. He is a member of the President's 
Council of Economic Advisers and is also a major advisor on 
health policy to the President today. He was an associate 
professor of economics and medicine at Stanford University. He 
also served as deputy assistant secretary in the Department of 
Treasury. And, best of all, he received his medical degree, his 
doctorate in economics, and his master's degree in public 
health at Harvard and MIT.
    This nomination to a major public health position is long 
overdue. The question before the committee today is whether Dr. 
McClellan has the training, experience, and independence to 
serve as head of the country's most important public health 
regulatory agency--an agency that serves as the gold standard 
for the rest of the world.
    FDA's mission is to protect the public health. Its mission 
affects more than a quarter of every dollar spent in the U.S. 
economy. The products that it regulates--food, drugs, 
biologics, devices, supplements, and cosmetics--affect public 
health and safety every day.
    The agency also has a long and distinguished history of 
serving the public interest. It has a proud tradition of 
promoting the public interest ahead of special interests. It is 
an agency of skilled professionals who set high standards and 
demand excellence from the industries it regulates.
    Questions have arisen lately about the FDA's willingness to 
maintain this mission, this history, and this tradition. We 
have heard that agency morale has suffered in the absence of a 
commissioner and in the aftermath of a series of recent FDA 
decisions that suggest a less exacting, less rigorous approach 
by the agency in carrying out its mission.
    The issue is leadership. In this time of extraordinary 
medical breakthroughs, as new threats to public health arise, 
the FDA faces enormous challenges. The American people 
increasingly depend on the FDA to safeguard public health. Now 
is not the time for the FDA to retreat from these challenges or 
surrender its authority over public health.
    Dr. McClellan has been nominated to a position of great 
responsibility. I welcome him here to our committee and look 
forward to his testimony on these very important issues.
    Senator Gregg?

                   Opening Statement of Senator Gregg

    Senator Gregg. Mr. Chairman, thank you for scheduling this 
hearing so promptly. It is a pleasure to have Dr. McClellan be 
the nominee and be before the committee.
    The FDA mission is to promote and protect the public health 
by regulating the safety of food, drugs, cosmetics, and medical 
devices. The FDA regulates or approves about 25 percent of all 
consumer products in the United States and as a result is a 
very high-profile agency with broad and diverse responsibility.
    That said, the role of the FDA Commissioner is of vital 
importance to the public health and, as with any organization, 
it is less than optimal to have a vacancy at the top of the 
organization.
    Dr. Crawford has done an excellent job since taking on the 
role of deputy commissioner of the FDA this past year. However, 
the FDA faces a number of difficult and daunting tasks in the 
years ahead, and I think everyone will be better served once 
the FDA has a permanent commissioner at its helm.
    Obviously, Dr. McClellan has a tremendous resume--Harvard 
trained, which is a major plus--even if you come from New 
Hampshire, we consider that a plus----
    The Chairman. Thank you.
    Senator Gregg [continuing]. His experience as a physician 
as Stanford, his experience as an economist, his experience in 
the area of health policy have all been exemplary and really 
extraordinary.
    The FDA has a large portfolio, as I have mentioned, but 
there are a number of issues which we have to address with the 
FDA today that I think continue to make the issue of how we 
manage the FDA significant.
    First is the corporate culture at the FDA, or the agency 
culture. Unfortunately, there has been a fair amount of 
bureaucratic less than effectiveness there that has really 
increased the amount of time it has taken to get new treatments 
out.
    We also had significant erosion in the staff base as people 
have moved out of the agency, and that has caused a significant 
problem with having the technology and the knowledge base 
within the agency to approve drugs quickly.
    The FDA's approval time for new treatments has actually 
increased in the past year as many of these senior regulators 
have left the FDA.
    We have a big issue in the area of devices, where we need 
to put in place a user fee model such as we have in the drug 
approval area, and I understand the House is going to move on 
that language this week, and it is something that Senator 
Kennedy and I have worked hard on, and I hope we can move on it 
before we adjourn.
    Also, the FDA now takes on a major new responsibility in 
the area of bioterrorism and specifically, for example, in the 
area of approval of drugs to fight bioterrorist attacks, the 
most significant example being how we fast-track the approval 
of a smallpox vaccination so that our population will have that 
available to them.
    And then, of course, the decision to move the biotechnology 
drugs from the biologics division to the drugs division is 
obviously going to be a complex process but one which will 
hopefully, if properly implemented, improve the overall 
administration of the agency.
    So the FDA has many things on its plate. Another thing I 
should add is the protection of the food supply which has 
become a major concern in regard to the terrorism issue. So you 
have a lot of portfolio here to handle, Dr. McClellan, but we 
look forward to your doing it, and we appreciate your 
willingness to undertake this kind of task.
    The Chairman. Dr. McClellan, I want to extend the regrets 
of Senator Frist, who is not here today. He is attending the 
funeral of a friend. He extends his apologies to you, and his 
statement will be made a part of the record.
    [The prepared statement of Senators Kennedy and Frist 
follow:]

                 Prepared Statement of Senator Kennedy

    It's a privilege this morning to welcome the distinguished 
nominee to be the next Commissioner of Food and Drugs, Dr. Mark 
McClellan.
    Let me also extend the Committee's welcome to his wife, 
Stephanie, and his brother Scott.
    Dr. McClellan has an impressive background. He's both an 
economist and a physician. He is a member of the President's 
Council of Economic Advisers and he's also a major advisor on 
health policy to the President today. He was an associate 
professor of economics and medicine at Stanford University. He 
also served as deputy assistant secretary in the Department of 
Treasury. And, best of all, he received his medical degree, his 
doctorate in economics, and his master's degree in public 
health at Harvard and MIT.
    This nomination to a major public health position is long 
overdue. The question before the Committee today is whether Dr. 
McClellan has the training, experience and independence to 
serve as the head of the country's most important public health 
regulatory agency an agency that serves as the gold standard 
for the rest of the world.
    FDA's mission is to protect the public health. Its mission 
affects more than a quarter of every dollar spent in the U.S. 
economy. The products that it regulates food, drugs, biologics, 
devices supplements and cosmetics affect public health and 
safety every day.
    The agency also has a long and distinguished history of 
serving the public interest. It has a proud tradition of 
promoting the public interest ahead of special interests. It is 
an agency of skilled professionals who set high standards and 
demand excellence from the industries it regulates.
    Questions have arisen lately about the FDA's willingness to 
maintain this mission, this history, and this tradition. We 
have heard that agency morale has suffered in the absence of a 
Commissioner, and in the aftermath of a series of recent FDA 
decisions that suggest a less exacting , less rigorous approach 
by the agency in carrying out its mission.
    The issue is leadership. In this time of extraordinary 
medical breakthroughs and as new threats to public health 
arise, the FDA faces enormous challenges. The American people 
increasingly depend on the FDA to safeguard public health. Now 
is not the time for FDA to retreat from these challenges, or 
surrender its authority over public health.
    Dr. McClellan has been nominated to a position of great 
responsibility. I welcome him this morning, and look forward to 
his testimony on these very important issues.

                  Prepared Statement of Senator Frist

    I would have liked to have joined my colleagues at this 
hearing, but I remain in Tennessee to attend a funeral. Still, 
I welcome Dr. Mark McClellan before the Committee this 
afternoon.
    Dr. McClellan is not a stranger to the members of the 
Health, Education, Labor, and Pensions (HELP) Committee. During 
his service on the Council of Economic Advisors, many of us 
have benefitted from his expertise, clear-headed analysis, and 
sound advice concerning health policy matters.
    Dr. McClellan has served the President well. And I know 
that he will continue to serve the nation well as the next 
Commissioner of the Food and Drug Administration.
    Mark McClellan is an excellent choice to lead the FDA. He 
is a talented academician and economist who has helped 
challenge conventional thinking about important health policy 
matters through groundbreaking research. He is a gifted health 
policy analyst who has worked to improve the nation's health 
care system for all Americans. Perhaps most importantly, he is 
also a physician who has cared for patients and knows first-
hand that there are few greater callings than helping to heal 
one's fellow man.
    Mark McClellan is uniquely qualified to lead this important 
agency at this critical time.
    I want to thank Dr. Lester Crawford for the work he has 
done to provide a steady hand during these past several months 
as Acting Commissioner. I know he will continue to provide 
leadership and guidance during the upcoming transition and 
beyond.
    At the same time, I am pleased that the FDA will soon have 
a Commissioner confirmed by the United States Senate.
    The challenges confronting the next Commissioner of the FDA 
are great perhaps greater than at any other time in our 
nation's recent history.
    Of course, the FDA has an important, ongoing role to play 
in ensuring the safety and efficacy of drugs, biologics, food, 
cosmetics, blood products, and devices goods and products 
accounting for nearly one quarter of all consumer spending in 
the United States. But the FDA Commissioner must be more than 
simply the head of a large, regulatory government agency. He 
must also provide strong leadership on a broad range of 
critical health policy issues that directly affect the lives 
and well-being of every American.
    I'd like to highlight some of the issues on which it is 
critical that the FDA Commissioner provide leadership, at this 
time.
    The most significant issue we faced over the past year is 
terrorism. On September 11th we endured the most horrendous 
attack on American soil since Pearl Harbor. This week, we mark 
the one year anniversary of the worst attack of biological 
terrorism in this country. We cannot know when, where, or in 
what form the next attack will happen, but we must be prepared. 
This includes speeding the review and approval of rapid assays, 
vaccines, and other necessary bioterrorism countermeasures. 
Numerous scientists and research facilities are working to meet 
the call of the President and Congress to protect our homeland 
from outside threats. The FDA must help fashion an environment 
in which these discussions are encouraged and translated to 
medical practice.
    At the same time, we cannot ignore naturally emerging 
threats to the safety and sustainability of our blood, tissue 
and organ supply. Last week, it was reported that 40 people 
were exposed to Hepatitis C from a single organ and tissue 
donor and Salmonella was transmitted through blood 
transfusions. This is in addition to the growing body of 
knowledge we are amassing on West Nile Virus. Considered 
together with the existing shortage of blood, tissue and organ 
donors, the need to speed the development of new screening and 
purification products clearly illustrated.
    Finally, I would like to highlight the importance of 
promoting a regulatory environment that values innovations to 
improve patient care and consumer safety, while at the same 
time safeguarding the public health. But this must be done 
without contributing unnecessarily to overall rising health 
care costs or allowing basic medical treatments to be 
forgotten. We presently face just this situation with our 
nation's vaccine supply. Currently, only four manufacturers 
produce vaccines and they face the multiple challenges of a 
growing litigation crisis and changes in the FDA's regulatory 
oversight. While most of the recent childhood vaccine shortages 
have been alleviated, our system remains vulnerable to future 
shortages if we fail to act.
    Mark has my full support. I look forward not only to 
reviewing his testimony from this afternoon as to what his 
goals and priorities will be for leading the FDA, but also to 
continuing to work with him to improve the quality of health 
care for all Americans.
    Before we begin I have a statement from Senator Jeffords
    [The prepared statement of Senator Jeffords follows:]

                 Prepared Statement of Senator Jeffords

    Mr. Chairman, I want to commend you for the deliberate 
speed with which you are moving on the confirmation of Dr. 
McClellan as the Commissioner of the Food and Drug 
Administration. I have looked over his record and I am looking 
forward to hearing his statement and reviewing his responses to 
the questions he is asked today. Although the Administration 
has taken undue time in nominating someone for this important 
office. I think it too should be commended for nominating 
someone with the credentials and experience that Dr. McClellan 
brings.
    Dr. McClellan has earned a respected and widespread 
reputation across many disciplines in the arena of health 
sciences and health policy. He has served important roles as an 
appointee during President Clinton's administration and has 
continued his commitment to better health police during this 
Administration as a key advisor on the Presidents Council of 
Economic Advisors. As physician and as an economist. I think 
Dr. McClellan can bring an important expertise to the FDA.
    The Commissioner of the Food and Drug Administration serves 
one of the most important roles in our federal government, a 
role that is vital to maintaining and improving the health and 
well-being of all Americans. So it is even more important that 
we have someone with the experience and vision necessary to 
guide the agency.
    During my tenure as Chairman of this committee. I together 
with Senator Kennedy, had the opportunity to work in close 
collaboration with previous leaders of the FDA including Dr. 
David Kessler and Dr. Jane Henney. They worked closely with us 
as we sought ways to strengthen and modernize the agency. 
Together we were able to enact the Food and Drug Administration 
Modernization Act (FDAMA), a law that in part, sought to 
establish a new culture at the FDA. Through enactment of FDAMA 
we recognized that the FDA has a greater role to play beyond 
protecting the American public from unsafe foods and medicines; 
it also could enhance the public's health by fostering 
innovation in the medical sciences. It's my hope that as 
Commissioner, you will continue to uphold FDA's gold standard 
for safety and efficacy while exploring more ways to expedite 
products to the market for other serious and life-threatening 
diseases.
    Dr. McClellan, I'm certain that you appreciate the 
importance of the advances in biomedical research and how they 
have significantly improved the lives of the American people. 
While these improvements have not come Without cost, it appears 
the benefits more than compensate for the increased costs. One 
recent study concluded that the improvements in survival after 
a heart attack show that the money spent on innovative drugs 
and devices was well spent. Advances in cholesterol-lowering 
drugs, and drugs to treat depression and AIDS also have made 
significant improvements in quality and quantity of life.
    These significant improvements will be all the more 
important as our population ages and an ever-increasing cohort 
of Americans become eligible for Medicare. As new treatments 
for diseases associated with gain'' for example Alzheimer's 
Disease, become more available, will need a commitment from FDA 
to move these expeditiously through the FDA regulatory 
pipeline. There have been incredible inroads against diseases 
of the aged but more needs to be done to get these new 
treatments approved and to the patients that need them. While 
there are likely legitimate concerns about the overall cost of 
prescription drugs. it has been shown again and again that 
these treatments help reduce or avoid the much higher costs 
associated with surgeries and inpatient hospital care.
    Finally, on the issue of the cost of medicine. I would urge 
that you look to what processes can be put in place that would 
provide FDA with the assurance that drugs imported from Canada 
are safe and effective for personal use. Companies that 
manufacture medicines in foreign countries, but that are 
destined for U.S. consumers, voluntarily allow FDA to inspect 
its foreign facilities. This is the cost of doing business.
    I would hope that you might explore a similar approach for 
inspecting Canadian pharmacies and drug distributors so that 
they too might be approved for reimporting medicines into the 
United States.
    Dr. McClellan, thank you for appearing before our Committee 
today. You are about to engage in one of the most challenging 
positions in Washington. I'm confident that you will give it 
your best effort and will do it successfully.
    The Chairman. Dr. McClellan.

  TESTIMONY OF MARK McCLELLAN, TO BE COMMISSIONER OF FOOD AND 
DRUGS, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH 
                       AND HUMAN SERVICES

    Dr. McClellan. Mr. Chairman, Senator Gregg, I want to thank 
you for your distinguished committee's consideration of my 
nomination as Commissioner of Food and Drugs.
    In my current job and in previous jobs in government and in 
academics, I have appreciated the opportunity to work with you 
on a range of health care issues. In the short time since my 
nomination was announced, I particularly appreciated the time 
that you have made and that other members of this committee 
have made to talk with me about critical FDA concerns. It has 
been a sobering and exhilarating dialogue and one that I look 
forward to continuing with all of you.
    I especially want to thank my wife, Stephanie. If not for 
her endless hard work and countless sacrifices to get us here, 
we really would not be here today.
    I have come to appreciate through this process more clearly 
than ever that the professional FDA staff have unique and 
extremely challenging responsibilities. As new biomedical 
breakthroughs lead to the development of more diverse, more 
complex, individualized medical treatments, FDA will face new 
challenges in assuring their safety and effectiveness without 
necessarily restricting their access or adding to their costs.
    The 21st century has also witnessed a new era of terrorist 
threats to our Nation's security, and FDA has critical 
responsibilities here as well. We must take new steps to keep 
our foods and other consumer products secure by developing new 
capabilities to prevent, detect, and respond to threats to 
these products, which are among the safest in the world.
    The challenges of transparent and responsive regulation 
have also never been greater. Consumers are more interested 
than ever in steps they can take to avoid health risks and to 
lead healthier lives; yet patients and physicians are often 
overwhelmed by the volume of information available on medical 
treatments, and they need help in sorting out reliable, 
accurate information that they can use. And all of those 
affected by FDA regulations need clear, predictable, and 
sensible guidance.
    Consequently, the challenges and rewards of working at FDA 
have never been greater. The need has never been greater for 
familiarity with cutting-edge techniques of risk analysis, for 
clear understanding of increasingly sophisticated food and 
health sciences, for taking advantage of increasingly rich 
health information systems, and for supporting the capacity to 
make informed and timely regulatory decisions.
    It is an honor to have the opportunity to help the FDA meet 
these critical responsibilities as well as many others. But it 
is a special privilege to be able to do so at a time when 
Congress and the President, as a result of the bipartisan 
leadership of this committee, have recently enacted legislation 
to provide the most significant new resources and tools to 
fulfill these responsibilities in more than a generation.
    It is my hope that the Senate will be able to complete this 
year's impressive legislative achievements for supporting FDA 
in meeting the challenges ahead by enacting the Medical Device 
User Fee and Modernization Act and the Animal Drugs User Fee 
Act. I understand that the House intends to pass a bipartisan 
agreement on H.R. 3580 shortly, as Senator Gregg mentioned. The 
administration strongly supports action this year to resolve 
the remaining issues in these bills.
    If confirmed, my greatest privilege will be to become part 
of the FDA's main asset--the almost 10,000 professional staff 
who make it possible every day for over 280 million Americans 
to have confidence in the foods that they eat, the personal 
products they use, and the medical treatments that improve 
their lives.
    In recent years, FDA has taken many steps to help make sure 
that its professional staff have the work environment needed to 
fulfill these critical responsibilities. But with the new 
challenges facing the agency, the need to fill literally 
hundreds of new professional positions as well as to plan for 
the reality that one-third of the FDA work force will be 
eligible for retirement as soon as 5 years from now, enhancing 
the FDA work environment must be a top priority of the 
Commissioner. There is no element more critical to effective 
regulation than the FDA work force itself.
    In the time since my nomination has been under 
consideration, I have had the opportunity to talk with some of 
the FDA professionals as well as FDA veterans, and I look 
forward to spending a lot more time with them. I am especially 
grateful to Deputy Commissioner Les Crawford who, as Senator 
Gregg has mentioned, has done a terrific job so far in managing 
issues at FDA. Les not only has tremendous FDA experience and 
expertise; he is also a very effective manager and a friend. I 
am extremely lucky to have the opportunity to work with him to 
lead the FDA.
    In closing, I wanted to make a couple of promises. First, 
if confirmed as commissioner, I pledge to listen. Transparency 
and responsiveness start with the interactions between the 
commissioner's office and Congress. You should always get clear 
explanations from me and my staff and a fair and complete 
hearing of your point of view.
    Second, I will make decisions that you will not always 
agree with. My grandfather, Page Keeton, used to say, ``If you 
haven't made anybody mad, you haven't done anything.'' I think 
the lessons he taught me from his experience as a law school 
dean and an academic expert who often got involved in difficult 
public policy issues will be extremely helpful for the pace, 
the complexity, and the sensitivity of many of the issues 
facing FDA.
    By listening to the points of view of all involved and by 
ensuring that sound science, careful empirical analysis, and 
ethical integrity are the foundation for FDA's decisions, I 
hope to make it possible for us to work together effectively to 
meet the challenges ahead.
    My mother, who has dabbled in politics herself, likes to 
say, ``It is not the dollars you make, it is the difference you 
make.'' The 21st century FDA combines a long tradition of 
excellence in protecting and improving the public health, 
technical and scientific expertise, and strong bipartisan 
support for strengthening its ability to carry out its many 
critical responsibilities. It is a great place to make a 
positive difference in the lives of all Americans.
    I want to thank the committee again for considering my 
nomination to serve in this important role, and I am happy to 
take any questions you may have.
    The Chairman. Thank you very much.
    We will have 10-minute rounds, and I will ask staff to 
watch the time.
    Dr. McClellan, there have been some disturbing signs that 
FDA may be backing away from its current authority or that it 
is not committed to enforcing the legal requirements. A May 
Federal Register Notice on the First Amendment invited 
regulated industries to identify regulations that should be 
eliminated or modified, and this notice has led to industry 
calls to weaken product warnings.
    Today the FDA requires specific warnings on all drugs and 
devices, including the warning against childhood poisoning on 
iron supplements, and multivitamins with iron. Iron is the 
leading cause of poisoning deaths in children under the age of 
6.
    There are hundreds and thousands of such accidents every 
year. Do we really want to leave these warnings to the 
marketplace?
    The agency wants to reclassify colored contact lenses as 
cosmetics, which would leave them basically unregulated even 
though they pose the same health risks as other contact lenses. 
These are contact lenses that can cause eye infection, severe 
pain, and even blindness. A Cleveland teenager, Roby Rouse, was 
left nearly blind in one eye because of colored contact lenses. 
Roby has had a corneal transplant, but her doctor says it is 
too soon to say that she will fully recover.
    And The Wall Street Journal reported recently that the 
number of warning letters from the agency to industry has 
dropped by well over half after a new requirement that the 
chief counsel's office review them.
    So the question really is about your commitment to using 
and preserving the full authority of the FDA to ensure the 
safety and effectiveness of the products it regulates.
    Dr. McClellan. Senator Kennedy, as you noted in your 
opening remarks, the FDA plays an essential role in American 
society. It is critical to assuring the public that the 
treatments, the products, and related issues are safe and 
effective.
    I do not see any intent to move away from the FDA's 
emphasis on safe and effective treatments being available, safe 
and effective products. The FDA has a critical role as well in 
making sure that any health claims made about products are 
truthful and not misleading. This is, as you pointed out, the 
core of the FDA's mission, and we need to and I would intend to 
make sure that that mission is fulfilled.
    As we go into the 21st century, and as I mentioned in my 
opening remarks and you did as well, there are new challenges 
facing FDA. That means we may need to take a fresh look at how 
some of these issues are approached. But I think that by 
applying careful science, including good state-of-the-art risk 
management techniques, better use of available information to 
identify risks when they do occur, and hopefully, a 
collaborative environment between FDA and this Congress in 
approaching these tasks, we will be able to meet all of those 
responsibilities.
    The Chairman. So I gather from your response that in any 
kind of challenge in the courts, you will come out firmly in 
support of FDA authority.
    Dr. McClellan. Well, I think the FDA's statutory 
responsibilities from the Food, Drug, and Cosmetic Act are 
critical to its ability to carry out these functions.
    I am concerned that in some recent court cases--Western 
States is one example--the U.S. Supreme Court has ruled that 
FDA may have gone in the wrong direction or overstepped some of 
the statutory or constitutional authorities in carrying out its 
mandates. That was true in Western States, it was true in a 
Brown and Williamson decision for tobacco regulation.
    I think this goes to the issue that I talked about earlier, 
that as we learn more from the U.S. Supreme Court and as the 
challenges facing the FDA evolve, the activities of the FDA 
need to evolve with it. But that does not mean retreating from 
the agency's critical mission of making sure that foods are 
safe and making sure that medical treatments are safe and 
effective.
    The Chairman. For more than 40 years, the FDA has exercised 
authority to specify the language of warnings on products, both 
foods and drugs. Is there any reason that you would take a 
position to the contrary?
    Dr. McClellan. A key part of the FDA's authority involves 
regulation of labeling. Regulation of labeling requires that 
the statements made about the product are truthful and not 
misleading and that information on warnings are conveyed. I 
think the question is often in practice for the specific 
products at stake, how do you convey those kinds of warnings 
and that information most effectively, and that is where I 
think a lot of science can come in, both science about the 
products, science about how the public understands and 
interprets information on labels and how to make it used most 
effectively. That is exactly the kind of thing that is an 
important challenge for the FDA in the years ahead.
    The Chairman. There is a tension between the producer 
wanting to maximize sales, yet the FDA wanting to minimize 
risk. So there is a tension involved in the development of mere 
guidelines for warnings. Are you saying that, although you will 
consider the best science that is available, you will come down 
squarely to support safety for consumers and information for 
consumers.
    Dr. McClellan. The FDA has a critical role to play in 
making sure that treatments available are safe and effective, 
and I would come down squarely on the side of defending the 
FDA's ability to maintain safe and effective treatments, and 
also in terms of labeling, to make sure that any kind of health 
claims are truthful and not misleading.
    The Chairman. Do you believe there is a problem with 
requiring specific words for warning, and do you share my 
concern that a company may try to minimize the risk to 
consumers by artfully wording the warning?
    The point I am getting at is, do you agree that there is a 
value to having the same warning on each product so that 
consumers will not be confused by differently worded warnings 
that may be interpreted by consumers to mean that products 
present different relative risks?
    Dr. McClellan. Well, I think it is certainly critical for 
the FDA to pay attention to ways to make sure information can 
be communicated clearly and effectively to consumers. As you 
know, with the diversity of products on the market, it is very 
hard to come up with a comprehensive label or set of labels 
that is applicable to each and every product. You may end up 
with a laundry list of 50 or 100 specific warnings, most of 
which may not be particularly relevant to an individual product 
and which may deter the consumer from focusing on the 
information that is most relevant to him or her.
    So I do believe that the FDA has an important role to play 
in making sure that information about warnings and health risks 
is communicated. I am not sure that I can make a general 
statement about one particular label for the whole diversity of 
products out there.
    The Chairman. On the issue of off-label use, do you agree 
with me that while off-label use can be beneficial, it also has 
great potential to harm the public? For example, the off-label 
use of some drugs like fen-phen, or the anti-arrhythmic drug 
Encainide or Flecainide, has caused, as I understand it severe 
injury or death to thousands of consumers.
    Dr. McClellan. There certainly are examples of off-label 
uses of drugs leading to adverse impacts on patients. Encainide 
is one example, fen-phen as well. I think that FDA can do a lot 
to monitor whether or not drugs in actual practice are causing 
safety problems and are putting consumers at risk and putting 
patients at risk.
    The Chairman. As I understand it, when Encainide and 
Flecainide were used for this off-label use, studies were 
finally done that confirmed that actually, the drugs caused 
severe heart ailments. The studies estimated that hundreds if 
not thousands of patients actually died because of off-label 
use.
    Do you believe that this toll on public health from off-
label use justifies FDA requirements that drugs promoted for 
these uses must be shown to be safe and effective for them?
    Dr. McClellan. I think the FDA does have a substantial 
amount of authority to work with manufacturers to try to 
develop better evidence on off-label use. As you well know, Mr. 
Chairman, the whole Phase IV process in the FDA drug approval 
process is geared to understanding risks of treatments that are 
proved in actual practice.
    FDA does not regulate as a general matter the practice of 
medicine, but often has collected or worked with manufacturers 
to collect more information about off-label use. And as you 
also know from the legislation on prescription drug user fees 
that was recently reauthorized this year, there are some 
additional provisions related to expanding and increasing FDA's 
activity in postmarketing monitoring. And I certainly look 
forward to working with you and the committee in the months 
ahead to implement those provisions and to find ways to 
identify safety problems with off-label use as quickly as 
possible when they do occur.
    The Chairman. The amount of resources and attention to 
safety it increased very, very significantly in the user fee 
bill, and this is something that we want to ensure is utilized 
and utilized effectively.
    In 1997, the Congress passed a bipartisan compromise that 
allows companies to provide off-label information under tightly 
controlled circumstances if certain conditions are met, most 
importantly, if the company has completed or commits to 
completing clinical studies to verify the use.
    Will you support and enforce that law?
    Dr. McClellan. Well, the provisions that you are referring 
to in the FDA Modernization Act as I understand it have been 
interpreted by FDA to comprise a safe harbor. So a company that 
is engaged in some kind of promotion of off-label use that also 
explains a clear plan for providing evidence, Phase IV type 
evidence, on off-label use, is permitted to go ahead and do so.
    As a more general matter, it is clear from the fact that 
the Prescription Drug User Fee Act included additional 
provisions related to off-label use and Phase IV testing and 
postmarket surveillance that more can be done to ensure that we 
are developing the most accurate information about off-label 
use and that manufacturers are not promoting that information 
incorrectly.
    I would like to go back to one of the clear themes that I 
hope will be a hallmark, if I am confirmed, of my work as 
commissioner, and that is that the FDA is in the business of 
making sure that information provided about new products is 
truthful and not misleading. And while there are some gray 
areas involving some aspects of postmarket surveillance, I 
think we have the potential to do a lot better in dealing with 
off-label use, thanks to the legislation that you have passed 
and thanks to our willingness to try to work together to get 
better information out about the safety of off-label uses.
    The Chairman. Senator Gregg?
    Senator Gregg. Thank you, Mr. Chairman.
    The biggest issue would be FDA's approval time and the 
balance between making sure that the medication or the drug is 
appropriate and works the way it is supposed to work and 
getting it out there fast enough so it saves people who need 
it. We have all heard the horror stories of people who might 
have been saved by it if the drug had gotten out.
    I guess my question to you is how do you see that struggle 
and how do you see the FDA expediting approval time without 
undermining the purpose of protecting the public?
    Dr. McClellan. I agree with you, Senator, that giving 
Americans quick access to safe and effective new treatments is 
one of the most critical roles at the FDA. There are a lot of 
statistics cited about approval times and the like.
    I think one thing that is clear from those statistics is 
that FDA has done better over the past decade as a result of 
the Prescription Drug User Fee Act, and so the reauthorization 
of that Act with some additional provisions to improve the way 
that the drug approval process can function at FDA I think will 
be a welcome help in doing both--achieving the goal of making 
sure the treatments are safe before they are approved and 
making sure that they can be provided quickly to the American 
pubic.
    I hope to work closely with staff at FDA on finding ways to 
improve the process, and I want to go back to something that 
both you and Chairman Kennedy mentioned at the outset here, 
which is that it is very important for FDA to have some 
leadership to help bring this priority home.
    Dr. Crawford has done a terrific job of identifying ways to 
help FDA management work more effectively, and I hope to build 
on that work as soon as I get out there. This is definitely 
going to be one of my top goals. And again, I do not think 
there needs to be a conflict between addressing safety concerns 
and managing risks appropriately and approving drugs quickly. I 
think we will have new resources thanks to the legislation that 
you all enacted to deal with drug approvals more quickly, and I 
hope to work with you all in the months and years ahead if 
confirmed to see that that happens.
    Senator Gregg. And the same would apply to devices?
    Dr. McClellan. And the same thing applies to devices. And 
there, as you know, Senator, I think the most important next 
step that could happen to speed the device approval process is 
action this year by Congress on medical device user fees and 
the Medical Device Modernization Act.
    We hope that that legislation, as you said at the outset, 
will pass this Congress and will be enacted into law. This is 
the right time for us to move forward on this. We have an 
opportunity to take a new look at as a result of the 
Prescription Drug User Fee legislation which is speeding and 
improving the safe approval of effective new drug treatments. 
This would also be a great time to improve the ability for the 
FDA Center for Devices and Radiologic Health to work more 
quickly and effectively as well.
    Senator Gregg. How do you see the FDA relating to the 
international community, especially the European community, in 
the process, where you are seeing especially in the device area 
the Europeans moving much faster than we are?
    Dr. McClellan. I think there is a lot that we can learn 
from the European processes. The FDA has tried to take some 
steps, as I understand it, in recent years to be clear about 
when information from drug trials conducted in other countries 
can be used. There are some important concerns there about 
making sure that the requisite human subjects protections 
apply, that the studies are well-designed and well-executed and 
so forth, and I think that is a good example of where 
leadership in identifying opportunities for harmonizing 
clinical trial requirements and the like where we do not 
sacrifice the importance in this country of making sure that 
drugs are safe and effective and meet minimum standards, but 
where we can potentially move more quickly to get drugs 
approved by working more synchronously with other countries.
    Senator Gregg. I am interested in your thoughts on direct-
to-consumer advertising.
    Dr. McClellan. Is that just the general thoughts, or----
    Senator Gregg. Your thoughts.
    Dr. McClellan. I think direct-to-consumer advertising--the 
FDA has looked at this recently as well, and FDA, like many 
independent experts, has noted some significant advantages from 
direct-to-consumer advertising for treatment of conditions that 
are seriously undertreated in the U.S. population, resulting in 
needless reductions in quality of life and even more frequent 
deaths. Good examples of conditions where direct-to-consumer 
advertising has led to more treatment of patients who were 
previously undertreated include high blood pressure and 
depression.
    So direct-to-consumer advertising is clearly playing an 
important role in helping patients find out about treatments 
that can be effective for them. At the same time, the FDA does 
have a critical role in making sure that any kind of 
advertising is truthful and not misleading, and I think the FDA 
will continue to make sure that those kinds of conditions are 
met while encouraging the use of appropriate direct-to-consumer 
advertising.
    Senator Gregg. Well, if a drug works--and it would not be 
on the market unless it worked--why should it have to be 
advertised, when that is just going to add to the cost?
    Dr. McClellan. It is a good question, but very often, many 
patients are not familiar with the treatments that are 
available for their conditions. Many physicians in advertising 
to physicians may learn something about the new treatments 
available for them to use as well.
    What is important from the FDA's standpoint is that the 
information provided to help inform patients and medical 
professionals about the value of new treatment is truthful and 
not misleading.
    Senator Gregg. What about the issue of using outside 
experts in the evaluation process? How much more aggressive 
should we be on that?
    Dr. McClellan. Well, my understanding is that the FDA has 
actually had some good experience to date in using third 
parties for independent, careful scientific review of new 
products. And I know that that is an issue that is currently 
under consideration in the medical device legislation.
    My impression is that to date that program has been quite 
successful, so it seems like expanding that program in a 
limited way as part of the medical device legislation could be 
a useful step forward.
    Senator Gregg. Thank you.
    The Chairman. If I could, isn't one of the reasons that 
direct-to-consumer advertising be accurate is because 
advertising can raise false hopes among the public, and can 
create enormous demand for certain products, and can even lead 
to the use of products that might not be safe? Direct-to-
consumer advertising for drug products has increased 
dramatically, hasn't it?
    Dr. McClellan. Yes, sir. There is a lot of television and 
radio advertising for drugs. I think something like 80 drugs 
are the subject of significant advertising today. Again that 
goes to the point of making truthful information, accurate 
information, more widely available to Americans can be a huge 
help in assisting them in finding ways to treat conditions that 
they previously may have been suffering through, like 
depression, diabetes, and the like.
    So I think that that goes to the importance of direct-to-
consumer advertising but also the importance of FDA's role in 
making sure that such advertising is truthful and not 
misleading.
    Senator Gregg. In working up that formula as to how you 
address this, I hope you will also put into that formula how 
much the consumer pays to resolve the issue of the cost of the 
advertising.
    Dr. McClellan. That is right. That is part of the calculus. 
The FDA I do not think has a whole lot of authority to think 
about the cost implications of direct-to-consumer advertising. 
I think the main focus of the FDA statutory authority is on 
truthful, not misleading, advertising. But certainly within 
that rubric, the major benefits, the major risks of advertising 
should be brought out, so if there are any significant 
complications associated with the new treatment, that is 
something that the public deserves to know about as well as its 
potential benefits. Those complications can also lead to added 
costs, too.
    The Chairman. Senator Bingaman?
    Senator Bingaman. Thank you, Mr. Chairman.
    I would like to, Dr. McClellan, ask you a couple of 
questions in your current capacity and then move to a couple of 
questions related to the position for which you have been 
nominated.
    As a physician, I am sure you are aware that the College of 
Obstetricians and Gynecologists and the American Academy of 
Pediatrics have firm positions that a pregnant woman and an 
unborn child need to be treated together. And the 
administration has come out with its new regulations just the 
other day related to coverage for an unborn child under the 
CHIP program, but as I understand the position the 
administration took, it felt that the statute did not allow 
coverage of pregnant women as part of that.
    We have a bill that has been introduced--Senator Bond is a 
prime sponsor on it--to correct this problem, and it is S. 724, 
which is ``The Mothers and Newborns Health Insurance Act.'' We 
tried to get permission to raise that and pass it last week. It 
came out of the Finance Committee unanimously, and we are 
trying to pass it through the floor.
    Senator Nickles objected on the basis that he believed the 
administration opposed the legislation. Are you familiar with 
what the administration's position is on this legislation, and 
if it is something that is opposed, what reason would be 
offered?
    Dr. McClellan. Senator Bingaman, let me start by thanking 
you on behalf of the administration now in the capacity of my 
current job for the work that you have done for quite some time 
now to further the interests of the health of pregnant women 
and their unborn children and, after birth, the young children 
as well.
    The administration completely shares that goal, and we too 
believe that effective treatment of an unborn child during 
pregnancy is critical. There is overwhelming evidence that that 
leads to better birth outcomes and better long-term outcomes 
for the child.
    We know also that there had been a somewhat long-term 
legislative effort to try to pass legislation like S. 724, your 
bill--I know that that is something that you have been working 
on for quite some time--and the fact that such legislation had 
not occurred was one of the primary factors that led to the 
regulatory initiative that Secretary Thompson had announced 
earlier this year and in turn, it was announced as a final rule 
last month on coverage for unborn children.
    As I think Secretary Thompson has made clear in his 
comments about that new rule, that rule does provide States 
with the authority that they need to provide coverage for 
preventive care during pregnancy and other associated services 
related to the unborn child.
    Because of interpretations of the SCHIP law that this 
administration has already undertaken, it is already possible 
for States that wish to enact waivers to do so to cover 
pregnant women as well.
    So I think the administration's position is that we 
strongly agree with your goal; our concerns about this not 
being enacted in legislation sooner was what led to HHS' 
promulgation of a proposed rule to provide coverage for unborn 
children. That rule is now final, so unborn children can get 
preventive care, pregnant women can be covered, and States if 
they wish to do so can also cover infants after birth through 
CHIP.
    So I think we have tried to do the best we can within 
current law in the face of no action on this issue by Congress 
in the last couple of years to achieve your goal. And I think 
our main focus at this point is on seeing if we can go further 
in the very limited time that remains to do more for providing 
appropriate coverage. We have a number of initiatives on 
lowering health care costs and increasing health insurance 
coverage that we would like to see acted upon before the 
session ends, and that is where our main focus is right now.
    Senator Bingaman. But your view is that this coverage of 
pregnant women under CHIP, that option is already there for 
States?
    Dr. McClellan. As a result of the final rule that was 
promulgated by HHS last month, yes.
    Senator Bingaman. Let me ask about the effort that both the 
chairman and ranking member of the Senate Finance Committee are 
making to pass bipartisan legislation entitled ``Beneficiary 
Access to Care and Medicare Equity Act of 2002.'' This is the 
legislation that tries to maintain reimbursement levels for 
some of the providers as well as maintain access. What is the 
administration's position on that? Do you support that effort 
or not?
    Dr. McClellan. Well, our first priority on Medicare 
legislation is improvements in Medicare benefits. Senator 
Bingaman, as you know, Medicare coverage has become seriously 
outdated since its enactment over 30 years ago. Even though 
private plans started covering prescription drugs back in the 
sixties, Medicare still does not do so.
    The administration has had a lot to say about the adequacy 
of provider payments and various components of Medicare, and I 
think that our staff would be happy to provide you with some of 
that information from CMMS, the Center for Medicare and 
Medicaid Services, if that would be helpful. And no question 
that very complex administered price systems in Medicare do not 
function efficiently in making accurate payments to all 
Medicare providers.
    But the President's priority for Medicare this year has 
been and remains improving benefits for seniors, and we 
appreciate the efforts by Chairman Kennedy and by members on 
both sides of the aisle to try to enact legislation to do that, 
and I think that that is where our focus still remains.
    One of the unfortunate side effects of legislation that 
only or primarily increases provider payments in Medicare is 
that it also increases beneficiary premiums and beneficiary 
copayments. So, for example, in the recent proposal agreed to 
by Chairman Baucus and Senator Grassley, while that bill 
provided something like $48 billion in additional payments to 
providers to address some of the concerns that you mention, it 
also added on something like $13 billion in additional payments 
in terms of premiums and copayments for beneficiaries, and that 
is just not the administration's first priority. The 
administration's first priority is taking steps to make health 
care more affordable and more accessible for seniors starting 
with prescription drugs but extending to more affordable health 
insurance options across the board, and that remains our first 
priority for new spending.
    Senator Bingaman. So the bottom line would be that you 
would not at this time support the Baucus-Grassley proposal.
    Dr. McClellan. Our bottom line at this time is that we 
would still hope that the Senate can find a way to provide 
prescription drug coverage and other benefit improvements in 
Medicare. That is our first priority, and I believe, as I have 
said on previous occasions, where there is a will, there is a 
way, and we hope that the Senate leadership can find a way to 
improve Medicare benefits, that it is overdue and desperately 
needed by America's seniors.
    Senator Bingaman. Chairman Kennedy just asked a little 
while ago about FDA's authority on food labeling, and part of 
that, of course, is authority to try to promote better 
nutrition. Would you support special health messages on foods 
that are particularly high in saturated fat, sodium, added 
sugars, those types of things that have been shown to lead to 
particular heart problems and diabetes and other health 
problems?
    Dr. McClellan. As I understand it, the FDA has been looking 
at some of those issues, issues such as levels of unsaturated 
fats in the diet and so forth, that seem to have some important 
relationships to important medical complications, and that is 
an issue that I would like to look into further as 
commissioner.
    As always, the decisions of FDA should be guided by the 
best science on risk management, the best knowledge about how 
consumers are going to interpret information that is provided, 
and I look forward to working with you on that if confirmed.
    Senator Bingaman. One other item the FDA has indicated an 
intent with regard to is to publish a rule requiring the use of 
bar codes for human drug and biological products. I guess 
Secretary Thompson has stated on several occasions that bar-
coding is critically important to patient safety and that the 
FDA is working on such a rule.
    Do you support the use of universal product-numbered bar 
codes on all drugs and biologics at each unit of packaging? Do 
you think that is a wise action to go?
    Dr. McClellan. I certainly think, Senator--and I know you 
share this concern as well--that avoidable medical errors are 
far too common in our health care system, and absent steps in 
the right direction to reduce risks of errors, as medical care 
continues to get more complex, and patient treatments continue 
to become more individualized and customized, the risk of 
medical errors is going to go up.
    Secretary Thompson I think has an appropriate level of 
interest in the potential for electronic labeling to help 
prevent medical errors by making sure that the right patient 
gets the right treatment at the right time. I am not sure 
whether what he has advocated or what the FDA would consider 
doing would apply to specific labels on each and every drug and 
biological product. I think there are important considerations 
that have to be taken into account with respect to the costs 
for hospitals and other health care providers to obtain the 
equipment needed to use the labeling information appropriately, 
and that needs to be accounted for in any kind of regulation.
    But I certainly share the goal of trying to take steps to 
make it easier for health care professionals to do the right 
thing. They have a very complex and demanding job that is 
getting more complex and difficult by the day, and anything 
that we can do at the FDA to help them out and reduce risk to 
patients at the same time seems like the right way to go.
    Senator Bingaman. Thank you, Mr. Chairman.
    The Chairman. We have covered a variety of different health 
issues. I want to just mention to my very good friend from New 
Mexico that of course the CHIP program was really just devised 
for children. I am a strong believer that we need it for 
expectant mothers, and we have some States that have had some 
of those programs, including California, and it was cut back. A 
few of the States have had that program, and it is enormously 
important.
    We do not even have the resources to cover the needy 
children, and one of the dilemmas that we have is that we are 
pitting children against children, the children who need 
attention versus other children, and that is a very, very 
unfortunate kind of dilemma to be caught up in, and that comes 
back to the issue of priorities in terms of budgeting.
    So hopefully, we can find resources--and I am strongly 
supportive of what we are trying to do with Senator Bingaman's 
bill. I am also a continued advocate for trying to make sure 
that we cover the children who should be covered and need to be 
covered under the CHIP program and still are not.
    Let me just go on to a few other items that are of 
particular interest to the committee and then come back to 
clarify a few issues.
    One is that my good friend Senator Mikulski, who is so 
involved in giving the assurance of health care assistance in 
the TAA, the Trade Assistance Adjustment Act. In the trade 
adjustment legislation, which passed in July, there are some 
drafting errors that may prevent any retirees from getting 
coverage and that leave many eligible workers without benefits. 
There is a concern about the 3 months of prior coverage that is 
required in order for much-needed market protections to apply 
to those seeking coverage.
    I know that you share a great interest in seeing the new 
benefits are made workable, and I know that you have been 
working on these health care issues as well. And we have 
enjoyed working with you in a very constructive way. We have 
not made all the progress that I would like to have made, but 
it has been a very positive and constructive relationship, as 
far as I am concerned.
    It would be enormously helpful, since you have a good deal 
of understanding and awareness of this, if I were to be able to 
tell Senator Mikulski that you will try to see if we cannot get 
that particular provision worked out in some way.
    Dr. McClellan. I would be happy to talk with her more 
directly about her specific concerns with the bill. As you 
know, Senator, we have tried very hard to bridge what many 
perceive as big philosophical gaps on covering the uninsured, 
and we have made some real progress this year.
    Obviously, we have a long, long way to go, but implementing 
the Trade Adjustment Assistance tax credit effectively will be 
an important step in that direction.
    The Chairman. Well, I agree with you that we wrestled 
around on those issues and then the committee made a judgment. 
I am not looking to reopen the whole issue. I am really just 
looking for what was the understanding within the legislation. 
That is what my remark referred to.
    Dr. McClellan. We will be happy to take a closer look.
    The Chairman. If you could try to do that, I would very 
much appreciate it.
    Senator Clinton as well as Senator Dodd and myself and 
others are concerned about the pediatric rule. You are 
familiar--the FDA has currently undertaken a regulatory review 
of the pediatric rule. Can you assure the committee that you 
will not take action to weaken the protections in the pediatric 
rule or weaken the enforcement so that pediatric studies for 
drugs are delayed if completed at all?
    Dr. McClellan. This is another case that I just want to--
for those of you who have been following the controversies 
about this from a distance--not so much you, Mr. Chairman, but 
others--my understanding is that the pediatric rule is still in 
full force and effect at HHS and at FDA right now.
    The Chairman. Right.
    Dr. McClellan. My understanding is also that this is 
another area where the Congress has made substantial progress 
in improving or giving the FDA the opportunity to improve 
access to safe and effective new drugs, and there is far too 
little information available on labeling information, risks, 
and appropriate use of many drugs in children.
    The Best Pharmaceuticals for Children Act passed last year 
I think will go a long way toward helping to address those 
concerns. And I certainly look forward to working with you and 
this committee to make sure we are implementing the goals of 
that legislation and our shared goal of making sure that 
children have access to appropriate treatments and safe 
treatments as quickly as possible.
    I want to work together on that.
    The Chairman. Well, that is very helpful, and we appreciate 
that, because there are enormous challenges, as you have 
pointed out, in terms of what the implications have been on 
children. As you well know, for years, the testing was done on 
men and not on women, and was not considered in children, and 
we are trying to bring sound science to these decisions.
    Do I understand, then, that your position would be to 
defend the current authority against legal challenge?
    Dr. McClellan. My position would be--I have not followed 
the details of the rule and the implementation of the new law 
as closely as I would like to. I do know that one of the most 
controversial elements of the pediatric rule, which was the 
authority that the FDA asserted in the original rule to 
basically compel manufacturers to do additional testing in 
children, has not been employed to date, was not employed in 
the previous administration and has not been used yet.
    So my goal is really in making sure that we have the most 
effective set of policies in place between the pediatric rule 
and however it can be improved and the new legislation and any 
additional rules needed to implement that to learn as much as 
possible as quickly as possible about the appropriate use of 
drugs in children. I will work with you on that.
    The Chairman. Good. Thank you.
    If I could, let me come back to just a couple of other 
areas. First, on the food warnings, I am a little uncertain 
about where you stand on FDA's authority to require 
specifically-worded product warnings.
    Let us take the example of food warnings on a food product. 
In this case, it is multivitamins that contain iron. There were 
reported instances in which young children ingested these 
products and died, so that iron poisoning was a leading cause 
of fatal poisoning in children.
    The CDC reported that five children age 11 to 18 died in 
Los Angeles during a 6-month period in 1992 and 1993, and FDA 
reports that over a decade, there were over 110 thousand 
incidents of children poisoned by iron supplements.
    FDA required the following warnings on the product: 
``Accidental overdose of iron-containing products is a leading 
cause of fatal poisoning in children under 6. Keep this product 
out of the reach of children. In case of accidental overdose, 
call''--do you believe there is a problem with requiring 
specific words for this kind of warning?
    Dr. McClellan. I think it is clearly within the FDA's 
authority when there is scientific evidence, empirical 
evidence, of a risk of an adverse event with a product or with 
misuse of a product to place appropriate information on the 
label.
    I have not looked closely at this particular example, so I 
don't know at this time whether that specific warning is one 
that is being implemented as effectively as possible. I would 
be happy to get back to you in writing on that if I have a 
chance to take a look at the specifics, if that specific 
warning is the one that you are interested in.
    The Chairman. Yes.
    I mentioned the contact lenses. Do yo believe that colored 
contact lenses that do not correct vision should be regulated 
as cosmetics or as devices?
    Dr. McClellan. I know this is a pending issue. It is not 
one that I have followed closely and certainly, if confirmed, 
is one that I would be delighted to talk with you about further 
and work with you on.
    On the one hand, as you know, Mr. Chairman, the contact 
lenses that are used for essentially recreational or cosmetic 
purposes do have some of the same kinds of health consequences 
as prescription contact lenses. On the other hand, there are 
concerns about whether such a lens can be regulated as a drug 
rather than a cosmetic, and I know that that is one of the 
difficult issues--one of the many difficult issues--facing FDA, 
and I would certainly like to make sure that we handle that 
appropriately.
    The Chairman. The reason I raise this is that the misuse of 
the contact lenses of inferior quality causes eye infection and 
severe pain. These are the ones that are used, as I understand, 
solely for cosmetics, allegedly for changing the color of one's 
eyes and so on. But even so, these are unregulated lenses that 
are being made and sold, and teenagers are swapping colored 
contact lenses as I understand it, with serious risk of 
infection. As you know, this is something that the division 
that deals with cosmetics--I believe they are people of good 
intention and hard work, but there are entirely different 
criteria, obviously, that are being used, where there is no 
required testing and no requirement for prescription or medical 
supervision, no requirement for directions for safe use, and no 
adverse event reporting for cosmetics.
    We have examples of individuals--I mentioned earlier Roby 
Rouse, who bought a pair of tinted green contact lenses, and as 
we understand it, the lenses nearly blinded her in one eye, and 
she had a corneal transplant.
    Then, this summer, there was a rash of injuries from 
contact lenses purchased from unregulated sources. A local 
doctor said: ``Any move to relax regulation would be extremely 
foolish. This physical device placed in an eye that rubs on the 
cornea can reduce the oxygen reaching the eye. The 
repercussions of this are huge. When you let someone think it 
is an inconsequential novelty, then they treat it with no 
respect.''
    So there is quite a bit of information about the dangers of 
these products, and I would ask you to take a look at that as 
well.
    Dr. McClellan. I will certainly do that.
    The Chairman. According to the FDA's website, the 
Reproductive Health Drug Advisory Committee currently has no 
members. I recently wrote to Secretary Thompson and expressed 
strong concern about troubling reports in The Washington Post 
and elsewhere that the Department is handpicking members for 
its advisory committee not on the basis of best expertise and 
objectivity but to provide predetermined advice.
    With these concerns in mind, we are now hearing that the 
Reproductive Health Advisory Committee will meet for the first 
time in 2 years this fall. With issues affecting choice and 
reproduction, I am sure that you understand how problematic it 
would be for FDA to have advisory committees which are 
ideologically suspect and not trusted for their objectivity and 
scientific integrity.
    Can you assure us that each of the vacancies on advisory 
committees will be filled by individuals who will be selected 
for their expertise and objectivity?
    Dr. McClellan. I think that expertise and objectivity are 
important criteria for selection. I would also like to add to 
that diversity of viewpoints. One of the themes that I would 
like to stress if confirmed is the importance of transparent 
and understandable regulation, and transparent regulation 
cannot happen unless a diversity of viewpoints--informed 
viewpoints, expert viewpoints--but if there are differences of 
view, diversity of viewpoints is important.
    So I would say number one that my own belief is that 
scientific expertise and diversity of viewpoints where 
appropriate are an essential element in advisory committees, 
and second, my understanding of the Federal Advisory Committee 
Act essentially requires that we, or HHS or FDA, do not 
handpick the members but follow an appropriate procedure for 
making sure that the people selected to an advisory committee 
are well-respected in the subject matter of the advisory 
committee and are going to carry out their jobs effectively.
    So I think you have both my commitment for making sure that 
diverse expert views are heard and the law on your side for 
this one. I do not know about all the--I remember that 
Washington Post report. I can say more generally that the 
accusations in there----
    The Chairman. It is troubling.
    Dr. McClellan [continuing]. Well, it is troubling. It just 
does not really comport with my experience of how HHS is 
filling its committees, either. I think they are looking for 
diversity of views and expertise as a general matter. But I 
will certainly watch that closely.
    The Chairman. On tobacco products, smoking is the number 
one preventable cause of death in America. It kills more than 
440,000 men and women. More than 90 percent of smokers start as 
children.
    Should the FDA, the Federal agency most responsible for 
protecting the public health, have authority to regulate the 
most lethal of all consumer products, and would you at least 
consider the issue. I am not going to ask you about supporting 
the enactment of legislation that Senator DeWine and I 
introduced, S. 2626, to give the Food and Drug Administration 
the power to effectively regulate tobacco products now, because 
I assume you have not had a chance to review it--unless you 
want to volunteer that you do support it. But I want to mention 
that Senator DeWine and I are serious about it, and we are 
going to reintroduce it in the first part of next year. We are 
committed to moving ahead.
    Have you formed any opinion about the role of the FDA with 
respect to and the tobacco products?
    Dr. McClellan. Before talking about the role of the FDA, 
let me just start out by saying as a physician that this is an 
avoidable health risk that I think it is very important that 
adults are well-informed about and that the government does at 
the Federal level to assist States and that the State level and 
local level does all it can to enforce the laws against tobacco 
smoking in youth.
    I think there are several things that the FDA can do. The 
reality is that the FDA, according to the recent U.S. Supreme 
Court decision in Brown and Williamson, cannot regulate 
tobacco, so that is not going to be on the table at least in 
the short run.
    In my role as commissioner, if I am confirmed, one of the 
things that I would like to do is make sure that good, accurate 
information about health risks gets out insofar as that is part 
of the FDA's jurisdiction, and especially to do what we can to 
help speed the approval of new treatments to help people quit 
smoking. There have been some promising developments in new 
treatments in recent years, new pharmacologic treatments that 
really do seem to work for people who had been unable to quit 
by other means, and I think there is more promising science 
ahead.
    I think one thing the FDA can do to help out under current 
law is to help make those products more available. And I will 
take you up on your offer of talking as we head into the next 
Congress about the next steps from here.
    The Chairman. Well, there are a number of different parts 
to that issue that we have to work on, and we intend to do 
that.
    Let me mention quickly some other areas. On dietary 
supplements, I expressed to you some concerns about the safety 
of some of dietary supplements, and you explained to me that 
the problem comes from the fact that these products are not 
preapproved, and FDA has the burden of developing the data 
necessary to take a dietary supplement off the market. But this 
is increasingly a matter of concern. I do not minimize the fact 
that this is a red hot issue in terms of the industry itself, 
but there are important health issues, and we want to be able 
to work with you on this.
    Post-marketing surveillance is extremely important for drug 
safety, and we have given new authority and resources to be 
able to do that effectively. We want to make sure that that is 
going to be a priority.
    And we have talked in my office about moving the biological 
therapeutics from CBER to CDER. If you would like to make a 
quick comment about that to assure me that there will be no 
diminution of the safety standards for approval of these 
products, which have special safety issues.
    Dr. McClellan. That is absolutely right. My understanding 
of the move is that it only applies to certain activities 
within CBER. The activities that would move over would be the 
biological products that are most like prescription drugs, and 
the hope is that that is going to result in more consistency 
and economies of scale from being able to integrate the review 
processes more effectively.
    CBER has many other critical roles related to tissues, 
vaccines, and many other areas that are going to continue, and 
my understanding is that the transfer is not associated with 
any reductions in force. Really, the goal is as you said, to 
help CBER and CDER deal with all of their immense 
responsibilities more effectively and efficiently.
    The Chairman. On food safety, we have given you additional 
authority, particularly with the dangers of bioterrorism. Only 
a small amount of food is actually inspected, and there are 
increased resources to be able to do that. We want to work with 
you closely on this issue. It is of great concern to members of 
this committee and many who are not; we want to make sure that 
you have sufficient authority to deal with foreign plants and 
all of the other kinds of products that need attention.
    Our committee, particularly Senator Frist and myself, is 
interested in antibiotic resistance. This is a matter of 
enormous concern. We do not really have breakthroughs for 
dealing with these kinds of issues from our major 
pharmaceutical companies, and this is incredibly important, and 
we want to try to work with you to see how we can deal with 
this issue.
    Human subject protection is again an area that Senator 
Frist and I have worked on. As we have seen the expansion of 
the life sciences, as we will in this century, we are going to 
have more research being done and more clinical trials. The 
protection of human subjects is enormously important. This 
committee held the initial hearings on the syphilitic study in 
Alabama, depoprovera in Tennessee, the sterilization of the 
Ralph girls, the CIA abuse of a substance which resulted in 
some human tragedies. So the whole area of protection of human 
subjects is enormously important.
    Our committee also held an important hearing with Senator 
Durbin on West Nile virus. This is an issue where the FDA is 
very much involved. It is a matter of enormous concern to 
families all over this country, and there is a promising way to 
help protect the safety of the blood supply with new 
technology. We want to make sure that the blood supply is 
protected, and this is something that is of enormous, enormous 
consequence.
    So these are some of the areas which we have not gotten 
into but the committee and its members are enormously 
interested in, so as you well understand, these are matters 
where the agency has important opportunities for leadership, 
and we want to be supportive of these efforts on your part.
    I am going to ask the members to submit their questions 
this evening, and we will keep the record open tomorrow. It is 
my hope that we can have a markup on your nomination on 
Wednesday. I intend to support your nomination. I think you 
have a great opportunity to provide important leadership, and 
we look forward to working with you. Hopefully, we will get 
this approved so we can get you on the job very quickly.
    [The prepared statement of Dr. McClellan may be found in 
additional material.]
    The Chairman. The committee stands in recess.
    Dr. McClellan. Thank you, Senator.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                  Prepared Statement of Mark McClellan
    Mr Chairman, Senator Gregg, distinguished members of the committee, 
thank you for your consideration of my nomination as Commissioner of 
Food and Drugs. In my current job, and in my previous jobs in 
government and academics, I have appreciated the opportunity to work 
with you on a range of health care issues. In the short time since my 
nomination was announced, I have particularly appreciated the time that 
you have made to talk with me about critical FDA concerns for the new 
Commissioner to address. It has been a sobering and exhilarating 
dialogue, one that I look forward to continuing with all of you.
    And I especially want to thank my wife Stephanie. If not for her 
endless hard work and countless sacrifices, we wouldn't be here today.
    I have come to appreciate more clearly than ever that the 
professional FDA staff have unique and extremely challenging 
responsibilities. And I am honored to have the opportunity to become 
part of that workforce.
    One of FDA's key goals in making safe and effective new treatments 
available as quickly as possible, but FDA's responsibilities for 
achieving this goal are becoming more complex and important than ever 
before. Many have called the twenty-first century the ``health 
century.'' Unprecedented progress in understanding the foundations of 
diseases and the code of life itself holds the promise of breakthrough 
treatments that can be tailored to the specific needs of individual 
patients. As these research breakthroughs lead to the development of 
more diverse, more complex, individualized treatments, FDA will face 
new challenges in assuring their safety and effectiveness without 
unnecessarily restricting their access or adding to their costs.
    The 21st century has also witnessed a new era of terrorist threats 
to our nation's security, and FDA has critical responsibilities here as 
well. FDA oversees the safety of 80 percent of the nation's food, 
including most of the growing volume of foods imported into the United 
States. We must take new steps to keep our foods and other consumer 
products secure, by developing new capabilities to prevent, detect, and 
respond to threats to these products, which are among the safest in the 
world.
    The challenges of transparent and responsive regulation have never 
been greater. In part, this is the result of positive trends. Consumers 
are more interested than ever in steps they can take to avoid health 
risks, and to lead healthier lives. In addition to assurances that 
their products are safe, they want more useful information about the 
health consequences of the products they use. Data that can be used to 
identify risky treatments and products on the market are improving. Yet 
patients and physicians are often overwhelmed by the volume of 
information available on medical treatments, and need help in sorting 
out reliable, accurate information that they can use. And all of those 
affected by FDA regulations from the smallest family-run specialty food 
company to the largest multinational corporation need clear, 
predictable, and sensible guidance.
    Consequently, the challenges and rewards of working at FDA have 
never been greater. The need has never been greater for familiarity 
with cutting-edge techniques of risk analysis, for clear understanding 
of increasingly sophisticated food and health sciences, for taking 
advantage of increasingly rich health information systems, and for 
supporting the capacity to make informed and timely regulatory 
decisions. As I said before, FDA is a unique place to work, one that 
requires bringing the best technical skills to bear on some of the most 
complex and important health issues affecting our country.
    It is an honor to have the opportunity to help the FDA meet these 
critical responsibilities, and many others. But it is a special 
privilege to be able to do so at a time when Congress and the 
President, as a result of the bipartisan leadership of this committee, 
have just given FDA the most significant new resources and tools to 
fulfill these responsibilities in more than a generation. As a result 
of bioterrorism legislation passed earlier this year, FDA is in the 
process of substantially expanding and improving its oversight of food 
safety. This will not only help protect against terrorist threats; it 
will also provide new opportunities to improve the safety of the foods 
and consumer products that Americans use. And with the reauthorization 
and improvement of the Prescription Drug User Fee Act, the FDA has the 
opportunity to make breakthrough drug treatments available more quickly 
than ever as well as to use better tools such as enhanced monitoring of 
drugs after they are approved to detect important safety problems that 
cannot be detected in clinical trials.
    It is my strong hope that the Senate will be able to complete the 
year's impressive legislative achievements for supporting FDA in 
meeting the challenges ahead, by enacting the Medical Device User Fee 
and Modernization Act and the Animal Drugs User Fee Act. I understand 
that the House intends to pass a bipartisan agreement on HR 3580 as 
soon as today. The Administration strongly supports action this year to 
resolve remaining issues, so that Senate action can also occur this 
year.
    If confirmed, however, my greatest privilege will be to become a 
part of the FDA's main asset: the ten thousand professional staff who 
make it possible, every day, for over 280 million Americans to have 
confidence in the foods they eat, the personal products they use, and 
the medical treatments that improve their lives. In recent years, FDA 
has taken many steps to help make sure that its professional staff has 
the work environment needed to fulfill its critical responsibilities 
including steps to make FDA a ``learning organization'' with FDA staff 
colleges and e-learning programs, and steps to accommodate the needs of 
a diverse workforce through flexible work hours and work locations, and 
child and elder care programs. But with the new challenges facing the 
agency, the need to fill literally hundreds of new professional 
positions, as well as plan for the reality that one third of the FDA 
workforce will be eligible for retirement in five years, enhancing the 
FDA work environment must be a top priority of the Commissioner. There 
is no element more critical to effective regulation than the FDA 
workforce itself.
    In the time since my nomination has been under consideration, I 
have had the opportunity to talk with some of the FDA professionals as 
well as FDA veterans, and I look forward to spending much more time 
hearing from them and working with them. I am especially grateful to 
Deputy Commissioner Les Crawford. Les not only has tremendous FDA 
experience and expertise, he is also an effective manager and a friend. 
I am extremely lucky to have the opportunity to work with him to lead 
the FDA.
    In closing, I wanted to make a couple of promises. First, if 
confirmed as Commissioner, I pledge to listen. Transparency and 
responsiveness start with the interactions between the Commissioner's 
office and Congress. You should always be satisfied that you get clear 
explanations from me and my staff, and an opportunity to get a fair and 
complete hearing of your point of view. Second, I will make decisions 
that you will not always agree with. My grandfather, Page Keeton, used 
to say, ``If you haven't made anybody mad, you haven't done anything.'' 
I think the lessons he taught me, from his experiences as a law school 
dean and an academic expert who often got involved in difficult public 
policy issues, will be extremely helpful for the pace, complexity, and 
sensitivity of many of the issues facing FDA. By listening to the 
points of view of all involved, and by ensuring that sound science, 
careful empirical analysis, and ethical integrity are the foundation 
for FDA's decisions, I hope to make it possible for us to work together 
effectively to meet the challenges ahead.
    My mother, who has dabbled in politics herself, likes to say: 
``It's not the dollars you make, it's the difference you make.'' The 
21st-century FDA combines a long tradition of excellence in protecting 
and improving the public health, technical and scientific expertise, 
and strong bipartisan support for strengthening its ability to carry 
out its many critical responsibilities. It's a great place to make a 
positive difference in the lives of all Americans. I thank the 
committee for considering my nomination to serve in this important 
role, and I am happy to take any questions you may have.
      Response to Questions of Senator Kennedy From Mark McClellan
    Question 1. For more than 40 years, FDA has exercised the authority 
to specify the language of warnings on products, both foods and drugs. 
Is there any reason you would take a position to the contrary?
    This question was raised during the Senate HELP Committee's October 
7 confirmation hearing. At the hearing session I responded to the 
question when it was asked. Please do not hesitate to contact me again 
if you need information in addition to the response I provided at the 
hearing. If confirmed as Commissioner of Food and Drugs I will continue 
to consider the issues raised by your question.
    Question 2. Do you believe colored contact lenses that do not 
correct vision should be regulated as cosmetics or as devices?
    This question was raised during the Senate HELP Committee's October 
7 confirmation hearing. At the hearing session I responded to the 
question when it was asked. Please do not hesitate to contact me again 
if you need information in addition to the response I provided at the 
hearing. If confirmed as Commissioner of Food and Drugs I will continue 
to consider the issues raised by your question.
    Question 3. The Wall Street Journal reported recently that the 
number of warning letters from FDA has dropped by 64 percent since the 
FDA Office of Chief Counsel has begun reviewing them before issuance. 
The rationale for this policy is greater uniformity in their issuance.
    The Chief Counsel had publicly suggested that, in lieu of serial 
warning letters, ``FDA would likely move directly to litigation after 
the first [letter].''
    Has there been an increase in FDA enforcement actions and referrals 
to the Department of Justice, which the agency suggested would result 
from this new policy?
    I believe that effective enforcement is supported by consistency in 
warning letter communications and by ensuring that each letter provides 
a clear basis for enforcement action if remedial action is not taken. 
Timely review by the Office of Chief Counsel would seem to support both 
of these important prerequisites for effective enforcement. With 
respect to the Wall Street Journal accounts, my understanding is that 
before Deputy Secretary Claude Allen issued his directive last 
November, there was no central repository of such letters and no 
tracking system for them. Accordingly, it is virtually impossible to 
establish the accuracy of the Wall Street Journal's estimate. However, 
I understand that the Office of Chief Counsel has refused to concur in 
only about 6 percent of the 699 warning and untitled letters it 
reviewed between February 27 and September 5. In the vast majority of 
cases, the Chief Counsel review resulted in concurrence as well as 
changes intended to strengthen and improve the letters as a basis for 
enforcement actions.
    Given that OCC only started reviewing enforcement correspondence in 
March, it is likely too soon to tell whether there has been an increase 
in FDA enforcement actions and referrals to the Department of Justice, 
or an increase in the extent to which the letter recipients take 
corrective actions in response to the warnings. The purpose of the 
Deputy Secretary's directive is to promote a credible, risk-based 
enforcement strategy. I am committed to ensuring that FDA policies are 
designed to minimize risks to the public, including risk minimization 
through warning letters and an effective threat of enforcement actions. 
If confirmed, under my leadership FDA will follow up with enforcement 
actions when companies refuse to follow its regulations.
    Question 4. In your oral testimony, you stressed the need for a 
``diversity of viewpoints'' in selecting FDA advisory committee 
members. Perhaps consistent with your testimony, Time reported October 
5 that FDA may be considering selecting Dr. W. David Hager for the 
Advisory Committee on Reproductive Health Drugs. Dr. Hager reportedly 
refuses to prescribe contraceptives to unmarried women and recommends 
Scripture readings for premenstrual syndrome.
    In contrast, Time reports that FDA senior associate commissioner 
Linda Skladany rejected the nomination to this advisory committee of 
Dr. Michael Greene, director of maternal-fetal medicine at 
Massachusetts General Hospital and chair of Committee on Obstetric 
Practice of the American College of Obstetricians and Gynecologists 
(ACOG).
    What are Dr. Hager's credentials for this important committee? Is 
he being considered, as reported, to serve as chair? And if nominated, 
would he be recused from consideration of the citizens' petition filed 
by the Christian Medical Association that requests the withdrawal of 
mifepristone, which he is reported to have assisted in drafting?
    As you can see from Dr. Hager's resume (enclosed), as well as the 
October 8, 2002 letter to Time.com from Emery A. Wilson, M.D. (Dean and 
Associate Vice President for Clinical Services, University of 
Kentucky), his credentials for consideration as a member of the 
Reproductive Health Drugs Advisory Committee are exemplary.
    Dr. Hager and a number of other diverse candidates have been 
considered as members of this advisory committee. Once selected, all 
members of the advisory committee may receive consideration to serve as 
its chair. Accordingly, Dr. Hager would, as a member of the committee, 
be considered for chair.
    Question 5. Do you agree that the Advisory Committee on 
Reproductive Health Drugs should consist of individuals with an express 
commitment to protecting and improving women's reproductive health, as 
well as recognized, mainstream expertise in the fields of medicine or 
public health?
    Can you further assure the Committee that the vacancies on this and 
other FDA advisory committees will be filled by individuals who are 
selected for their expertise and objectivity--not on the basis of 
particular ideology, or views on single issues, such as abortion or the 
provision of contraceptives to unmarried women?
    The Reproductive Health Drugs Advisory Committee will consist of 
members with express commitment to protecting and improving women's and 
men's reproductive health, as well as recognized specific expertise in 
reproductive medicine and public health.
    In addition, the advisory committee will be composed of individuals 
selected for their expertise and scientific objectivity and 
understanding of public health issues. In accordance with the Federal 
Advisory Committee Act requirements, the committee will be balanced 
including as many diverse viewpoints as possible and practicable. To 
attain fairly balanced membership, the agency will consider a cross-
section of those directly affected, interested, and qualified, as 
appropriate to the nature and functions of the advisory committee.
    Question 6. In January 2002, the FDA issued draft guidance on 
disclosure of conflicts of interest for special government employees 
participating in FDA product-specific advisory committees. In that 
guidance, the FDA does not call for web-based disclosure of reported 
conflict-of-interest information but states that the information will 
be read into the record at the beginning of advisory committee 
meetings.
    Do you support public access to reported conflict-of-interest 
information through web-based, e-government strategies such as are 
implemented at the National Academy of Sciences?
    Public access to reported conflict-of-interest information through 
web-based, e-government strategies is a complex issue involving the 
Privacy Act, the Freedom of Information Act, and the Ethics in 
Government Act. At this time, Acknowledgement and Consent to Disclosure 
documents and Special Government Employee Waiver documents are all 
available to the public via the Freedom of Information Act; however, 
requests for these documents through FOIA have been minimal. To support 
e-government and web-based communication with our constituencies, the 
Agency provides Acknowledgement and Consent to Disclosure documents on 
the FDA Dockets Management web-site as a part of the advisory committee 
meeting transcripts.
    FDA staff have spoken with the National Academy of Sciences 
concerning their e-government strategy for public access to reported 
conflict-of-interest information; yet, the Academy was unable to direct 
us to information concerning their model. If confirmed, I will ask FDA 
staff to continue to look into the NAS strategy and other e-government 
models as potential benchmarks.
    Question 7. I am concerned that the transfer of review of 
biological therapeutics from the Center for Biologics Evaluation and 
Review (CBER) to the Center for Drug Evaluation and Research (CDER) 
will encourage medical officers and scientists at CBER to leave, or 
even consider leaving, the Agency. If these qualified professionals 
begin discussions regarding private sector employment, they may be 
``conflicted'' off product reviews under FDA's regulations. Won't this 
pose a serious risk of delay to biologic product reviews?
    First let me say that we value the reviewers and plan to assure 
them that the transfer of review locations does not minimize their 
importance to FDA. The conflict of interest laws and regulations help 
ensure that recommendations given to FDA are free of bias and help 
maintain public confidence in FDA and the important work of the Agency. 
To the extent that administering the Agency's conflict of interest 
obligations present challenges to the flow of work, I will work to 
minimize problems that may surface and maintain FDA's obligations to 
conduct a timely review of product applications.
    In addition, as a result of the transfer of the review of certain 
biologics applications from the Center for Biologics Evaluation and 
Research, where they are currently being reviewed, to the Center for 
Drug Evaluation and Research, there will be a larger pool of reviewers 
who are capable of conducting reviews. It is anticipated that this, 
coupled with the opportunity for CBER reviewers to work more 
efficiently on the critical programs remaining within CBER, will help 
to minimize the concerns suggested by your question regarding 
timeliness of reviews.
    Question 8. Since enactment of the Prescription Drug User Fee Act, 
FDA officials have publicly acknowledged the internal pressures on drug 
review staff to review applications to meet the PDUFA performance 
goals. One survey of such staff found that a third did not feel 
comfortable voicing dissenting scientific opinions, and many felt that 
approval decisions were too heavily influenced by the application 
sponsors.
    As Commissioner, what would you do to make sure that FDA scientists 
and review staff are able to openly express their opinions on product 
safety and other important issues within the Agency and at public 
advisory committee meetings?
    Open discourse within FDA about the safety and efficacy of products 
under the Agency's regulatory authority is essential to decision-making 
about these products. While I have not yet identified specific new 
measures designed to promote this principle, I intend to maintain an 
atmosphere of open dialogue among FDA's employees.
    Question 9. We found earlier this year that the drug industry was 
not fulfilling its commitments to complete post-market studies of drugs 
and biological products. Are you committed to seeing to it that these 
studies are completed, and informing us if the agency needs additional 
authority to enforce these commitments?
    Section 130 of the FDA Modernization Act requires the Secretary of 
Health and Human Services to publish in the Federal Register a report 
on the status of post marketing studies. FDA also intends to make 
information about the status of individual comments available on the 
FDA Internet site. I understand the importance of this requirement and 
will work to implement the requirements of Section 130. I am also aware 
that in Section 130, Congress instructed FDA to bring forward 
legislative recommendations regarding post marketing studies, and I 
will assess the need to make any such recommendations.
    Question 10. Despite continuing, substantial concerns about the 
risks of drugs taken during pregnancy, very little is known about the 
teratogenicity of the vast majority of agents to which pregnant women 
are commonly exposed. The FDA's Pregnancy Labeling Task Force was first 
established in 1996 with the mandate to examine current regulations, 
recommend changes, and consider related needs.
    After seven years, the Agency has not fulfilled this mandate by 
issuing new pregnancy guidelines to replace the current uninformative 
system. Continuing the current system where more than 80% of drugs, 
including basic medicines and lifesaving therapies, lack detailed 
information about the risks to the health of the mother and the child 
of is unacceptable.
    Can you give me an update on the progress of the Pregnancy Labeling 
Task Force? By what date to you expect them to release new pregnancy 
guidelines?
    I agree with you that far too little useful information is 
available to women and their physicians about the risks of drugs taken 
during pregnancy. My understanding is that, under FDA's Pregnancy 
Labeling Initiative, the Agency is drafting new regulations on the 
format and content of the pregnancy and lactation sections of the 
labeling for prescription medicines. The draft regulation has 
multidisciplinary consensus. I am advised that the goal is to publish 
this within the next 12 months. In drafting this proposed rule, the 
Agency has sought external input including a Part 15 hearing and three 
Advisory Committee meetings to specifically address labeling for 
pregnancy and lactation.
    We also need to develop a better knowledge base on medication risks 
during pregnancy. On September 23, 2002, FDA published a final guidance 
to industry on establishing pregnancy exposure registries. The goal of 
pregnancy exposure registries is to provide clinically relevant human 
data that can be used in a product's labeling to provide medical care 
providers with useful information for treating or counseling patients 
who are pregnant or anticipating pregnancy.
    Other pertinent scientific guidances under development address:
    The use of animal reproductive toxicology data (draft published 
November 2001)
    The use of human outcome data (draft published June 1999)
    The conduct of pharmacokinetic/pharmacodynamic studies during 
pregnancy
    The conduct of studies on the transfer of drugs into breast milk
    Risk management of known or highly suspect teratogenic medications.
    If confirmed, I will work to build on these efforts to improve the 
availability of useful information on medication risks during 
pregnancy.
    Question 11. The Public Health Service Act does not include 
provisions to allow for abbreviated biologics license applications. 
Some argue that this is appropriate because biotechnology products 
differ from traditional drug products in several critical respects, 
including molecular size and complexity as well as the relationship of 
manufacturing process to product safety and effectiveness. Certainly, 
biotechnology products that are intended to be similar but made through 
difference processes are not necessarily equally safe and effective.
    At the same time, others argue that the number, cost and importance 
of biologic products coming off patent in the future highlight the 
importance of establishing a generics biologics program in the near 
future.
    What are your views on these important issues?
    As a scientific matter, it is true that certain biological 
products, due to their inherent structural complexity, heterogeneity, 
and manufacturing process do not currently lend themselves to being 
copied generically. The feasibility of interchangeable or generic 
biologics should be assessed further and should rely upon scientific 
knowledge and experience as key factors.
    Question 12. The Hatch-Waxman Act creates a number of market 
exclusivities. Given your impressive economic credentials, and given 
that tens of millions of dollars or more are often at stake, I am 
confident that you are not surprised to learn that there has been an 
enormous amount of litigation over the meaning of a number of the 
provisions in Hatch-Waxman.
    Do you agree that, eighteen years after its enactment, there is a 
need for Congress to amend the 1984 Act, in a way to state as clearly 
as possible what the rules are and to reduce the costly legal fights 
between FDA, brand companies and generic companies--so that the FDA can 
get back to the job of approving drugs that are safe and effective; the 
brand companies can get back to the job of finding truly important 
drugs; and the generics can get back to the job of producing products 
that will save the public billions of dollars?
    I fully support the key goals of the Hatch-Waxman Act, including 
the provision of incentives for the research and development needed to 
create valuable new treatments, as well as an effective framework for 
generic drug competition after a fair patent term has expired. The 
development of many innovative drugs in the past two decades, as well 
as the shift of almost half of all prescriptions to generic drugs, is a 
testament to the importance of this Act. I also appreciate the goal of 
S. 812, to improve generic drug competition. As the detailed study of 
potential abuses of the automatic 30-month stay and other Hatch-Waxman 
provisions by the Federal Trade Commission has demonstrated, some 
provisions of the Act may not be functioning as intended. On the other 
hand, some features of S. 812 go beyond closing loopholes as 
recommended by FTC and would potentially delay access to new 
medications, and increase their costs, as a result of much more complex 
patent filing procedures and new litigation. As Commissioner, I look 
forward to working with Congress to take steps to address these 
important issues effectively.
    Question 13. Many promising new products combine drug, device or 
biologic technologies.
    How can FDA improve the timely and appropriate review and post-
market regulation of such combination products?
    As I indicated in my oral remarks, I believe that Congress should 
adopt the Medical Device Amendments of 2001, H.R. 3580, during the 
current session. As reported by the House Committee on Energy and 
Commerce, section 203 of the bill would establish an Office of 
Combination Products in a manner that is consistent with recent Agency 
actions to promote combination product reviews.
    Question 14. When I expressed to you concerns about the safety of 
some dietary supplements, you explained to me that the problem comes 
from the fact that these products are not pre-approved, and that FDA 
has the burden to develop the data necessary to take a dietary 
supplement off the market.
    How do you propose addressing this problem? Does FDA need more 
resources or should Congress consider changing the statute?
    While my examination of issues relating to dietary supplements has 
allowed me to appreciate the challenges the Agency faces under the 
Dietary Supplement Health and Education Act of 1994, at this time I do 
not have specific statutory changes to recommend. As Commissioner, I 
will work with the Department and with Congress to implement the Act in 
accordance with Congressional intent. This includes taking steps soon 
to implement good manufacturing practices for dietary supplement 
manufacturers.
    Question 15. There have been more than 100 deaths among users of 
ephedra products reported to FDA. Many of these deaths are well-
documented, and occurred at the manufacturer's recommended doses.
    Do you support the removal of ephedra products from the market?
    As Deputy Commissioner Crawford testified on Tuesday, HHS and FDA 
recently initiated a number of important actions relating to ephedra. 
Last June, Secretary Thompson announced enforcement efforts against 
synthetic ephedrine alkaloids illegally marketed as dietary supplements 
and a comprehensive review of existing science on ephedra products to 
be conducted by Rand Corporation and overseen by the National 
Institutes of Health. More recently, FDA issued a cyber letter to the 
Internet promoter of Yellow Jackets for promoting and selling this 
herbal ephedra product as an alternative to illicit street drugs. FDA 
is also and is undertaking a number of investigations concerning 
ephedra products and manufacturers. FDA anticipates that the scientific 
review prepared by the Rand Corporation should be completed in February 
2003, I believe that this comprehensive review will provide an 
important basis for an possible further FDA actions under the Dietary 
Supplements Health and Education Act.
    Question 16. The National Academy of Sciences has warned that each 
year more than 60,000 children are born at risk for neurological 
problems due to mercury-contaminated seafood their mothers ate awhile 
pregnant. For more than a decade the FDA has failed to act on an NAS 
recommendation and a citizen petition to strengthen the Agency's 
mercury standard. Instead the FDA has issued consumption advisories, 
but has done nothing to exercise its legal authority to prevent 
mercury-contaminated fish from being sold to consumers.
    Other than issuing consumption advisories, what steps would you 
take to ensure that pregnant women and their children are protected 
form mercury-contaminated seafood?
    I agree with you that the FDA has a critical role to play in 
helping to ensure the safety of foods for pregnant women and their 
developing children. FDA staff reports that they recently held a public 
food advisory committee meeting on methylmercury and is including 
safety initiatives among its FY'03 priorities. Currently they are 
conducting an extensive public education campaign as well as outreach 
to physicians. Finally, special funding has been set aside for 
community outreach efforts in several different geographic locations to 
insure that the message reaches women in special populations at greater 
risk for illness. If I am confirmed, I will work closely with you to 
build on these steps to prevent mercury consumption during pregnancy.
    Question 17. FDA has taken recent action on regulating the use of 
medically important antibiotics as feed supplements to promote the 
growth of farm animals. This practice increases the prevalence of 
antibiotic-resistant infections. FDA recently took the positive step of 
proposing new rules for reviewing future applications for agricultural 
uses of these medications, but I remain concerned about antibiotics 
that are already on the market.
    Don't you agree that the antibiotics we rely on to protect our 
health from bioterrorism and other disease outbreaks should be reserved 
for human use-not fed to farm animals to spur their growth? What is 
your timetable for taking action on this issue?
    Controls to stop the development of antibiotic resistant organisms 
are an important public health goal embraced by the Department and the 
Agency, and we need to do more to address this important problem. I 
understand the draft guidance recently published by the Agency, 
``Evaluating the safety of antimicrobial new animal drugs with regard 
to their microbiological effects on bacteria of human health concern'' 
outlines an approach for evaluating antimicrobial resistance concerns 
associated with the approval of new antimicrobial products for food 
animals. The guidance also discusses the Agency's intent to apply a 
similar approach to currently approved antimicrobial drugs. I agree 
that the importance of a given drug for human medical therapy is a key 
factor to consider when assessing the safety of using the drug or 
related drug in animals, and this consideration is reflected in the 
draft guidance. The guidance applies to currently approved 
antimicrobial drugs for food-producing animals as well as to future 
applications. I understand that the Agency intends to prioritize its 
efforts to reassess currently approved drugs based on their importance 
to human medicine. If confirmed I would continue to support as a 
priority protecting the public health by controlling the development of 
antibiotic resistant organisms from animal and human uses.
    Question 18. FDA has an essential role in protecting the safety and 
well-being of patients who volunteer to serve as human subjects in 
clinical trials. Due to abuses and lapses in oversight, many patients 
are no longer confident that their safety will be properly protected in 
these trials.
    What actions would you take to restore that confidence and ensure 
that patients who volunteer to serve as human subjects are properly 
protected from harm?
    My examination of the issues relating to Human Subject Protection 
has allowed me to appreciate the importance of these issues, and I 
appreciate the bipartisan interest in determining whether further 
administrative or legislative actions are needed to ensure protection 
of research subjects. I look forward to working with the committee to 
evaluate what actions may be needed to better protect those who 
participate in clinical trials.
    Question 19. One promising way to help protect the safety of the 
blood supply is a new technology known as pathogen inactivation, which 
has the potential to rid the blood supply not only of the West Nile 
Virus, but also of other dangerous infectious agents.
    Should it be a priority for FDA to evaluate this exciting new 
technology?
    Several approaches are currently under study and may be effective 
at inactivating viruses such as West Nile Virus (WNV). In the event 
that other responses such as blood screening and testing prove to be 
difficult to implement in a timely manner, pathogen inactivation may 
prove valuable as an approach to reducing risk in blood products from 
high risk of developing severe disease. These approaches, however, must 
be carefully evaluated for their immediate and long-term safety. I 
understand that FDA is currently planning to specifically address the 
inactivation of WNV by such methods in conjunction with its upcoming 
(November 4 & 5) workshop on WNV donor blood testing. Developing safe 
and effective methods for detecting and eliminating blood supply risks 
such as West Nile Virus is a high priority. While the risk of any 
infection from a blood transfusion in the United States is extremely 
low, further steps to improve safety and increase the available supply 
of blood are needed.
    Question 20. What would you do to use Internet and other similar 
systems and standards to enhance the Agency's efficiencies in product 
approvals, inspections, and in the development of standards and 
guidance documents?
    The awards that FDA's web site have earned from organizations such 
as USA Today, Dow Jones Business Directory, Parenthood Web, the 
Emergency Nursing Association, the AgView Internet Search Service and 
other organizations is a testament to the Agency's efforts to achieve a 
high degree of openness and communication with the public and regulated 
industries. The Web pages of FDA centers share similar honors. I intend 
to build on this record and further enhance Agency efficiency in the 
areas you have identified.
    Question 21. The Center for Medicare and Medicaid Services has 
initiated its National Coverage Decision process for several new drugs 
and biologicals in some cases almost immediately after FDA approval of 
those new therapies.
    What role should FDA's decisions regarding safety and efficacy play 
in Medicare coverage? What is your opinion on whether there should be 
more interaction between FDA and CMS during the approval process for 
new therapies? What is your opinion of CMS making national 
determinations about coverage before new therapies have been marketed 
for some time?
    As you know, FDA does not make coverage decisions. Rather, it 
approves items like devices and drugs based on their safety and 
efficacy. CMS must make determinations for coverage based on medical 
necessity. These are different standards and may require different 
analyses.
    That said, I generally think increased interaction and cooperation 
among Federal agencies is wise, and I understand that CMS currently 
works collaboratively with FDA when gathering and considering evidence 
to make national coverage decisions. In addition, the staffs 
collaborate through interagency agreements, workgroups and task forces, 
and in consultative roles with respect to setting and enforcing quality 
standards, quality improvement and measurement activities, and 
coverage. I have worked closely with CMS Administrator Scully on many 
issues during my service in the White House, and if confirmed, I intend 
to explore additional areas where these two agencies can further 
improve their working relationship for the benefit of the American 
public.
                Response to Questions of Senator Harkin
    Question 22. Do you believe, as the previous FDA Commissioner did, 
that the Dietary Supplement Health and Education Act (DSHEA) provides 
FDA with adequate authority to protect the public from unsafe products 
and false and misleading claims?
    While my examination of issues relating to dietary supplements has 
allowed me to appreciate the challenges the Agency faces under the 
Dietary Supplement Health and Education Act of 1994, at this time I do 
not have specific statutory changes to recommend. As Commissioner, I 
will work with the Department and with Congress to implement the Act in 
accordance with Congressional intent.
    Question 23. Do you agree that all regulatory decisions by FDA 
related to dietary supplements should be based on sound science?
    Yes, regulatory decisions related to dietary supplements should be 
based on the best scientific information that is available.
    Question 24. It has been more than eight years since Congress 
passed the DSHEA, and there still are no Good Manufacturing Practices 
(GMPs) regulations, as called for in the statute. What steps will you 
take to ensure that the proposed rule on GMPs is promptly published and 
final regulations are promulgated?
    Publishing regulations on good manufacturing practices (GMPs) for 
dietary supplements is a priority for FDA's Center for Food Safety and 
Applied Nutrition (CFSAN), and I share this view. FDA has forwarded 
draft proposed GMP regulations to the Department of Health and Human 
Services. On October 4, 2002, the Department submitted this proposal to 
the Office of Management and Budget for 90-day review. If confirmed, I 
will work to implement GMPs for dietary supplement manufacturers as 
quickly as possible.
               Response to Questions of Senator Mikulski
    Question 25. I'm concerned about the length of time that it has 
taken to fund the planned consolidation of FDA's facilities. Your 
testimony talks about the importance of FDA's employees and the work 
done by FDA. I've been fighting for the funding that FDA needs to 
consolidate and upgrade its current facilities. I hope I can count on 
your support going forward in requests to the Administration for 
funding this consolidation. Will you advocate within the Administration 
for full funding of the FDA's consolidated facility in fiscal years 
2003-2005 to ensure timely completion of this long-delayed and crucial 
project?
    FDA Headquarters currently occupies approximately 40 buildings in 
more than 16 locations around Washington, D.C.; from Gaithersburg to 
Rockville to Laurel to College Park and northern Virginia. While it is 
not solely FDA's responsibility to ensure that sufficient funding will 
be available to achieve continued progress on this project during FY 
2004, I recognize the importance of this consolidation project for 
improving the FDA work environment, and will work to achieve the 
objectives set forth in P.L. 101-635 relating to consolidation.
    Question 26. As the architect of the Mammography Quality Standards 
Act (MQSA), I was troubled to learn of concerns raised over the last 
few months regarding physician interpretive skills for mammography. I 
have been working with other Members of this Committee on a bipartisan 
basis to make improvements to MQSA to help address these concerns. I 
look forward to building on the groundwork laid this year and enacting 
changes next year to help improve physician interpretive skills and 
other areas that may need to be improved. Will you work with me to help 
make these improvements to MQSA next year?
    As you know, the Mammography Quality Standards Act was enacted in 
response to serious concerns about the quality of mammography. It 
remains an essential tool for early detection and for combating 
mortality associated with breast cancer. This issue is of critical 
importance to millions of women in our country. At the same time, new 
technological developments such as digital, computer-assisted imaging 
and telemedicine are augmenting our technical capabilities to provide 
high-quality mammogram services.
    The MQSA authorization expired on September 30. The Administration 
supports reauthorization of the Act, and I would be happy to work with 
you to achieve this goal and to explore other steps that FDA can take 
to help make better mammography tools available to practitioners.
    Question 27. This week, the House of Representatives will pass the 
Medical Device User Fee and Modernization Act of 2002 (H.R. 3580). This 
is important legislation to improve the FDA's review and approval of 
medical devices and provide FDA with additional resources for medical 
device review and approval. Under this legislation, FDA would receive 
additional funding for medical device review from user fees from 
manufacturers and an additional authorization of $15 million per year 
for the Centers for Devices and Radiological Health (CDRH). Do you 
support adding the $15 million to the device center's budget in fiscal 
year 2003? Will you work to ensure that the President's budget for 
fiscal years 2004 and subsequent years includes this $15 million?
    The user fee program that has been negotiated over the last five 
months and that is a $50M program by year five. The goals that FDA 
agreed to meet are contingent on the Agency receiving $50M by year 
five. The industry agreed to fund up to $35M in user fees by year 5 and 
the remaining $15M is to come from appropriated dollars. I strongly 
support enactment of a new device user fee program in this session of 
Congress. If Congress passes the law that creates this user fee program 
for medical devices, I plan to work to ensure that the device program 
receives the funds it needs to adequately implement the program and 
meet the goals that are laid out in the draft goals letter.
    Question 28. I am pleased to see that your testimony underscores 
the importance of FDA's employees. They are dedicated and hard-working. 
Without them, FDA would not be able to carry out its mission to promote 
and protect public health. What steps would you take as Commissioner to 
help ensure that the FDA will recruit and retain the best and brightest 
employees in the coming years?
    Thank you for acknowledging the hard work and dedication of FDA's 
work force, and for your efforts to help improve the FDA work 
environment. FDA strives to hire the best and brightest people; this is 
essential for carrying out FDA's public health mission of consumer 
protection.
    In recent years, FDA has implemented a number of programs to help 
recruit and retain a high-quality work force, and I intend to build on 
these programs. Over the last five years FDA's recruitment tools have 
improved and the hiring process has been streamlined. These changes 
have allowed the Agency to hire people more quickly. The FDA Centers 
and the Office of Regulatory Affairs are active in recruiting people to 
work in their specific specialty areas.
    FDA has just completed its first full year of using the Automated 
Candidate Evaluation System (ACES). Major benefits of ACES include (a) 
the acceptance of online employment applications via the Internet; (b) 
improved applicant pool through exposure to the Internet; (c) automated 
applicant ratings and rankings through applicant responses; (d) 
automatic acknowledgement (via e-mail) to all applicants; and (e) 
through e-mail, a fast and easy method for communicating with all 
applicants. In addition to expanding its library of rating questions 
from 20 to 65 occupations, ACES was an instrumental tool in helping FDA 
to meet its critical staffing needs as a result of September 11. With 
respect to Office of Regulatory Affairs' (ORA's) Consumer Safety 
Officer hiring initiative, over 3,000 applications were handled for 
vacancies announced in 155 locations nationwide. The delegated 
examining unit issued hundreds of selection lists in a matter of weeks. 
It has been estimated that it would have taken (6) months to handle 
this workload under the manual process. Approximately 500 selections 
were made for Consumer Safety Officers under this hiring initiative, 
with approximately 300 additional selections made for a variety of 
other occupations within ORA.
    All of these ongoing efforts are important steps forward. If 
confirmed, I intend to work with FDA's human resource programs and 
other programs to improve them further and to take additional steps to 
recruit and retain the best possible workforce.
    Question 29. Since its creation in 1994, the FDA Office of Women's 
Health has sponsored research, conducted public education campaigns, 
encouraged the participation of women in clinical trials, and served as 
an advocate for women's health in agency decisions. Recognizing its 
important work, this Committee, as well as the House of 
Representatives, recently passed legislation that would statutorily 
authorize the Office of Women's Health at FDA.
    As Commissioner, will you support legislative efforts to authorize 
this Office? When appropriate, will you seek the advice and 
recommendations of the Office of Women's Health?
    I appreciate your recognition of FDA's Office of Women's Health 
(OWH) and your support for their activities. The proposed legislation 
is largely consistent with current program and activities of the 
office. OWH is an integral part of the Agency and I look forward to 
working with OWH to improve FDA's recognition of important women's 
health issues.
               Response to Questions of Senator Jeffords
    Question 30. As I mentioned in my opening statement, I am 
increasingly concerned that the FDA will be prepared to review 
treatments that become available for our aging populations. For 
example, Alzheimer's Disease is a serious disease that is afflicting 
the elderly in our country. The Alzheimer's Association estimates that 
4 million Americans have Alzheimer's Disease, and that number will grow 
to 14 million in 2050 unless a cure or prevention is found. My question 
is this how will the FDA handle treatments for diseases like 
Alzheimer's under your leadership? What will you do to make certain 
that the FDA speeds its review for safety and efficacy of any promising 
therapies for aging populations? Will you make sure that FDA uses the 
regulatory tools such as--``accelerated approval'' and ``fast track'' 
and ``approval based on surrogate markers''--on products for diseases 
like Alzheimer's Disease?
    As I expressed in my opening statement before the Senate Health, 
Education, Labor and Pensions Committee, I believe that giving 
Americans quick access to safe and effective new treatments is one of 
the most critical roles of FDA. The Agency already has established 
several procedures to accomplish this. If confirmed, one of my top 
priorities will be to work closely with FDA staff on ways to improve 
these procedures.
    I am very concerned about the plight of patients who suffer from 
serious illnesses, such as Alzheimer's Disease, but I am encouraged by 
recent progress and potential future developments in biomedical 
research in this area. FDA is continually striving to expedite the 
approval of safe and effective treatments for these conditions. I will 
work to ensure that the criteria for accelerated approval or fast track 
procedures are used appropriately for these treatments, in order to 
help expedite relevant approvals.
    Question 31. Thousands of American citizens are increasingly 
looking across our border to Canada to purchase the medicines they need 
at a price they can afford. Traditionally, the FDA has chosen to ``look 
the other way'' with respect to these elderly citizens as they bring 
medicines back into the U.S. for personal use. Despite efforts of the 
drug industry to portray the specter of counterfeit drugs smuggled into 
the U.S. by terrorists, there has been little, if any evidence to show 
that people taking medicines obtained in Canada are at any increased 
risk for adverse reactions than U.S. consumers. In the first instance, 
I would like an assurance from you, that under your leadership at the 
FDA, citizens will not be unduly encumbered from obtaining medicines 
from Canada for their personal use. Second, please describe what steps 
the FDA might take, or what legislative authority might be needed, so 
that FDA can make the practice of personal reimportation of 
prescription drugs acceptable to the Agency from the perspective of 
ensuring safety and efficacy.
    From a public health standpoint, importing prescription drugs for 
personal use is a potentially dangerous practice. Neither FDA nor the 
American public have any assurance that unapproved products from 
foreign sources are effective or safe, or have been produced under U.S. 
good manufacturing practices. Because FDA does not regulate foreign 
distributors or pharmacies, these products may not have been stored 
under proper conditions, or may not be the real products. I am wary of 
subjecting patients to these risks.
    The Federal Food, Drug, and Cosmetic Act prohibits the importation 
of unapproved new drugs, including foreign-made versions of U.S. 
approved drugs, that have not been approved by FDA for marketing in the 
United States. I understand that FDA does allow Agency field personnel 
to use their enforcement discretion and allow entry of unapproved 
prescription drugs for personal use in limited circumstances. However, 
my belief is that legislation to provide better prescription drug 
coverage with more effective price competition in the United States 
legislation such as you and the President have supported is a much more 
effective solution to the problem of high prescription drug costs for 
many seniors and others in the United States.
    Question 32. I was glad to read in your statement of your support 
for the legislation currently under consideration that would strengthen 
the Agency's ability to review medical devices. As you know, the Food 
and Drug Administration Modernization Act (FDAMA) sought to provide the 
Agency with new tools to address the rapidly changing technologies 
associated with medical devices. Please describe for which class of 
products the Congress should consider extending the use of third-party 
reviewers and third-party inspectors. Also, please describe what steps 
you think are necessary to prepare the Agency for these rapidly 
changing technologies, for example: should the Agency establish an 
Office of Combination Products and, if so how should it function?
    I support using third parties to supplement the Agency's medical 
device good manufacturing practice inspections. Due to resource 
constraints, the Agency has been unable to inspect device facilities as 
completely as desired. A third party program would supplement the 
Agency's efforts and provide greater coverage. As with the current 
third party review program, adequate protections must be in place and 
there must be an opportunity to evaluate the success of the program. 
Further, as FDA gains additional experience with the third party review 
program, I believe it would be appropriate to evaluate additional use 
of outside experts in this area.
    Finally, the Agency has recently taken steps to facilitate the 
review of combination products by the Agency. FDA has established a 
Combination Products Program within the Office of the Ombudsman. The 
new program serves as a focal point and advocate for combination 
product issues. The goal is to develop policies and procedures that 
facilitate the review of combination products and to monitor the 
progress of premarket reviews of combination products. I support these 
efforts and intend to build on them if confirmed.
               Response to Questions of Senator Bingaman
    Question 33. As a physician, you certainly are aware that the 
American College of Obstetricians and Gynecologists and the American 
Academy of Pediatrics believe that a pregnant woman and the ``unborn 
child'' must be treated together. As you are aware because of your role 
as advisor to the President on health issues, in regulations that the 
Administration recently published as a final rule on October 2, 2002, 
the Administration allows for coverage of an ``unborn child'' through 
the State Children's Health Insurance Program (SCHIP) but felt the 
statute did not allow coverage of pregnant women.
    In issuing the regulation, the rule acknowledges the problem of not 
providing coverage to the woman as well. As the rule reads, ``We 
welcome all of these suggestions for expanding health insurance 
coverage [to pregnant women] and indeed States and the Secretary have 
already used the flexibility in current regulations. However, there are 
still gaps. We also welcome support for the action of the Secretary in 
granting waivers to States But the Secretary's ability to intervene 
through one mechanism (a waiver) should not be the sole option for 
States and may in fact be an inferior option. Waivers are discretionary 
on the part of the Secretary and time limited while State plan 
amendments are permanent, and are subject to allotment neutrality.''
    Among other things, the rule notes that if you are only covering 
the fetus then women lose a number of important aspects of care during 
all the stages of a birth pregnancy, delivery, and postpartum care. As 
a physician, do you agree with the clinical guidelines of the American 
College of Obstetricians and Gynecologists and the American Academy of 
Pediatrics that it would be preferable for both the pregnant woman and 
the ``unborn child'' to receive health coverage?
    Do you acknowledge the a woman could very well be denied the 
following services:
    During Pregnancy: Cancer, medical emergencies, accidents, broken 
bones, mental illness, or even life-saving surgery of a pregnant woman 
if the fetus is determined to be viable?
    During Delivery: Eepidurals in current circumstances in certain 
states?
    During the Postpartum Period: All health coverage from the time the 
child is born, including but not limited to treatment of hemmorage, 
infection, episiotomy repair, C-section repair, family planning 
counseling, treatment of complications after delivery (including, once 
again, life-saving surgery), and postpartum depression?
    Senator, thank you for raising the important issue of prenatal and 
maternal care at the hearing on October 7. I stand by the response I 
gave at that time, and I look forward to working with you on this and 
other issues, should I be confirmed.
    Question 34. Secretary Thompson has made a number of statements 
over the past year in support of passage of legislation, including 
specific references to S. 724, the ``Mothers and Newborns Health 
Insurance Act.'' The Senate is now trying to pass the legislation and 
we heard on the Senate floor from Senator Nickles that the 
Administration may be opposing this legislation.
    Dr. McClellan, what is the position of the Administration on the 
passage of S. 724? If opposed, what are the specific reasons for this 
change in position and who made this decision.
    Senator, thank you for raising the important issue of prenatal and 
maternal care at the hearing on October 7. I stand by the response I 
gave at that time, and I look forward to working with you on this and 
other issues, should I be confirmed.
    Question 35. The Chairman and Ranking Member of the Senate finance 
committee just introduced bipartisan legislation, S. 3018, the 
Beneficiary Access to Care and Medicare Equity Act of 2002. In your 
current capacity, can you tell us whether the Administration supports 
this legislation. If not supportive, can you specifically tell us what 
the Administration is objecting to in the bill?
    Senator, thank you for raising this important issue at the hearing 
on October 7. I stand by the response I gave at that time, and I look 
forward to working with you on this and other issues, should I be 
confirmed.
    Question 36. In your current capacity, can you tell us if the 
Administration supports the extension of the QI-1 program? If so, will 
the Administration support an extension of this important program to 
low-income seniors and people with disabilities immediately as a free-
standing piece of legislation or part of a bigger Medicare/Medicaid 
package?
    The Administration strongly agrees with you that the QI-1 program 
provides an important protection for our nation's most financially 
vulnerable seniors and disabled citizens and the President included an 
extension of the program in his budget request. The Administration 
would not object to the Senate taking this measure up as a free-
standing bill.
    Question 37. According to the Department of Health and Human 
Services, Americans' poor diet and sedentary lifestyles cause between 
310,000 and 580,000 deaths annually.
    How would you use FDA's food labeling and other authority to 
promote better nutrition? Would you support special health messages on 
foods high in saturated and trans fat, sodium, added sugars, and other 
constituents that promote cardiovascular disease, diabetes, and other 
health problems?
    I believe that Americans want more reliable and useful information 
to help guide their dietary choices. To help Americans get the 
information they want to make informed dietary choices, I will consider 
ways to provide more effective labeling information and will encourage 
efforts by the Agency to use additional resources to better educate 
consumers on how to use the information available on food labels to 
improve their diets, and, thereby, their health. These efforts are 
particularly successful when done in collaboration with other federal 
and state agencies, food industry, public health, and consumer 
organizations who share a desire to promote better nutrition across 
America.
    Question 38. A factor that may be increasing antibiotic-resistant 
infections in people is the widespread uses of medically important 
antibiotics in food animals. A recent review of the literature by an 
expert panel convened by the Alliance for the Prudent use of 
Antibiotics concluded that antibiotic use in agriculture posed a health 
risk and should be strictly controlled, particularly for healthy 
animals.
    What role do you believe that antibiotic use in livestock and 
poultry plays in the emergence of resistant bacteria in people, 
particularly foodborne bacteria? What is your view of the recent FDA's 
Center for Veterinary Medicine (CVM) draft guidance document 
``Evaluating the safety of antimicrobial new animal drugs with regard 
to their microbiological effects on bacteria of human health concern?'' 
Will you push for a rapid finalization of this document, and when would 
you anticipate a final document would be ready? Once finalized, in what 
timeframe would currently available antibiotics be considered using 
this guidance document? Does CVM have adequate resources to complete 
its assessment of virginiamycin in a timely manner, while still 
participating in the hearing on the proposed ban of fluorquinolone use 
in poultry?
    The development of antibiotic resistance is an important public 
health priority. If confirmed, I would continue to support as a 
priority protecting the public health by controlling the development of 
antibiotic resistant organisms from animal and human uses.
    FDA believes that a great deal of scientific evidence exists 
showing that food-producing animals serve as reservoirs of both 
commensal and pathogenic bacteria that may be transferred to humans by 
consumption of contaminated food products. Additional evidence has 
shown that with the use of antimicrobial drugs in these animals, the 
bacteria may become resistant to drugs that are also used to treat 
human illness, potentially making human illnesses more difficult to 
treat. The new draft guidance document that CVM published on September 
13 represents the Agency's approach to dealing with this public health 
concern. The goal of FDA's approach to the issue is to protect public 
health by preserving the long-term effectiveness of human antimicrobial 
drugs, while providing for the safe use of antimicrobials in food-
producing animals. FDA's draft guidance is consistent with the approach 
advocated by the World Health Organization and other international 
health organizations.
    I understand that the draft guidance document published on 
September 13, 2002 has a 75-day comment period. CVM held a public 
meeting on October 2 to further explain the draft guidance and 
encourage comments. CVM expects that all comments can be addressed and 
the guidance revised by Spring 2003. Currently available antibiotics 
will be reviewed in priority order based on their importance in human 
medical therapy, as resources permit. CVM anticipates having available 
for comment a draft assessment of the risk from use of virginiamycin in 
food-producing animals contributing to Synercid resistant Enteroccocus 
faecium in humans later this year.
    Question 39. The FDA has stated its intent to publish a rule 
requiring the use of bar codes for human drug and biological products. 
In addition, Secretary Thompson has stated on numerous occasions that 
bar coding is critically important to patient safety and that the FDA 
is working on a rule. The FDA believes, according to documents included 
in the Federal Register, that the use of such technology will reduce 
medical errors.
    Do you support the use of universal product numbered bar codes on 
all drugs and biologicals at every unit of packaging? If so, are you 
committed to publishing a rule in the very near term?
    Senator, I appreciate the discussion we had of this question during 
my oral testimony. If you need additional information, please let me 
know. I look forward to working with you toward our shared goal of 
eliminating avoidable medical errors.
                Response to Questions of Senator Murray
    Question 40. Will you as the head of FDA work with those of us in 
the Senate who hope to codify the Pediatric Rule? If not, what steps 
are you planning on implementing to ensure that FDA aggressively fights 
to implement the Rule and defend the Rule in court?
    I know that the health of America's children is a top priority of 
the Department and I share this priority. We are determined to make 
certain that children's medications are safe and effective. I will work 
to see that by having drugs available that are properly studied for use 
in children, our nation's children will receive the safe and effective 
medical care they deserve.
    With the Best Pharmaceuticals for Children Act (BPCA), Congress 
provided the government with a very important tool to address specific 
pediatric needs. This law and its new tools resulted in questions being 
raised regarding the continued need for the Pediatric Rule promulgated 
by FDA in 1998. On April 19, 2002, the Department strongly reiterated a 
commitment to further ensuring the safety and effectiveness of drugs 
used to treat children, including continuation of the Pediatric Rule. 
As Commissioner, I will continue to enforce FDA's rule requiring 
companies to take steps to ensure drugs are properly labeled for 
pediatric use based on scientific studies.
    In an advance notice of proposed rulemaking published on April 24, 
2002, FDA sought public comment on how best to implement the BPCA and 
what additional steps, if any, need to be taken to ensure that drugs in 
children are adequately studied. The comment period has closed and FDA 
is currently reviewing the submissions. I will certainly support these 
efforts.
    Question 41. Safe and effective drugs are the gold standard of the 
FDA. However, we know there are risks associated with almost any drugs. 
It is important for the FDA to evaluate the risks v. benefits of any 
drug. Different representatives of this Administration have made 
conflicts statements with regard to the official position on the drug 
mifepristone. A drug that has been safely used by more than a million 
women, but anti-choice organizations that fought the approval of this 
drug, have now called for the FDA to reverse it's position and pull the 
drug from the market. The petitions also call on FDA to impose much 
greater labeling restrictions that would make the drug all but 
unavailable in most parts of the country.
    The FDA has already ruled on safety of this drug. However, I am 
concerned about efforts by this Administration to turn the clock back 
for women.
    As the new Administrator of FDA what criteria will you utilize in 
reviewing these petitions? Will science remain the guiding force or 
with this be a political decisions? If the FDA does review the drug, 
will the risks of unintended pregnancy be part of the evaluation? There 
are significant risks for many women from an unintentional pregnancy. 
This drug offers a safe and effective method of terminating a 
pregnancy. The risks of carrying the pregnancy to term must be part of 
any science-based review.
    The Agency's review and approval of any drug adheres strictly to 
its statutory mandate and mission as a science-based public health 
regulatory agency. The appropriate legal and scientific standards are 
applicable to the review of all citizen's petitions, including this 
one. If confirmed, I intend to carry out my important statutory 
responsibility to monitor the safety of all approved drugs in actual 
practice. The enhanced post-marketing surveillance provisions in the 
recently-enacted Prescription Drug User Fee Act provide new tools and 
opportunities to do so.
    Question 42. As you may know, medical device technology has a very 
short life span. Timely approval of new life saving medical devices is 
important for both the manufacturer and the patient. Increasing delays 
only deny access to these new devices and delay the development of even 
better, safer technology. As the new Administrator of FDA, will you be 
supportive of an FDA device user fee to provide additional resources? 
What measures will you implement to ensure that devices are approved or 
reviewed in a timely manner? Can the Agency rely on third party 
reviewers or experts without jeopardizing the integrity of the FDA 
approval process?
    I support Congressional action in this session to enact device user 
fees, building on the intense and productive negotiations over over the 
past five months. The device review program is in great need of 
additional resources, which that program would provide. These 
additional resources would go a long way toward helping the responsible 
Centers review new technologies in a more timely manner. Moreover, the 
program would permit the Agency work with the device industry to 
improve the quality of device applications, potentially reducing costs 
as well as time to approval.
    My view is that the Agency can and should take advantage of outside 
expertise, especially when that expertise can supplement our own 
experts. I believe that, with adequate procedures in place, the use of 
such third parties would enhance rather than jeopardize the review 
process.
    Question 43. One of the areas that I have focused a great deal of 
my energies has been in the area of gender bias in research and 
development of new drugs and devices. Beginning in 1993, we have seen a 
dramatic improvement at NIH of support for research involving women. 
Women are no longer simply ``little men,'' but include in more and more 
research supported by NIH. We have a long way to go but we have made 
some progress. FDA plays a critical role in this process. FDA must 
approval research protocols involving human subjects and must work to 
ensure that drug manufacturers conduct Phase III and Phase IV Clinical 
trials, often involving women.
    However, without the leadership and pressure from the FDA, many 
drug manufacturers will not include women in clinical trials or seek 
FDA labeling approval for drug impact on women, especially pregnant 
women. As the new Administrator of FDA, what leadership role will you 
play in eliminating the gender bias in research? Will this 
Administration continue the work of the previous Administration in 
working with the manufacturers to ensure proper labeling for women?
    The enrollment of women volunteers in clinical trials for 
medications and devices will help assure the safety of these products 
in female populations. I understand that FDA recently provided a report 
to Congress describing the development of a demographic information and 
data repository. If fully developed, this database will increase the 
Agency's ability to consider pharmaceutical effects not just by gender, 
but by race, ethnicity and age. As we move into an era in which 
medications can be tailored increasingly to the individual 
characteristics of patients, I believe that developing such tools is 
important for FDA to fulfill its responsibilities effectively. I also 
understand that FDA's OWH, in partnership with the National Library of 
Medicine, is initiating activities related to electronic labeling. I 
look forward to working on these and other important women's health 
issues while at FDA
    In terms of improved maternal and neonatal health, FDA has proposed 
a new pregnancy labeling rule for improved communication about medicine 
used during pregnancy and lactation. I will work to implement and build 
on this effort to provide more useful information about medication 
risks during pregnancy.
    Question 44. In our new focus on homeland security and 
bioterrorism, FDA will play a key role in approving new vaccines or 
treatments. In an effort to expedite this process, FDA may use a lower 
safety standard for approval. While I support the need to review and
    approve new treatments or vaccines to prepare against a deadly 
bioterrorism attack, I am concerned about special or vulnerable 
populations like children and pregnant women.
    What safety standards will you implement at FDA to ensure that new 
treatments or vaccines to fight a bioterrorism attack are safe or as 
safe for children and pregnant women. We know that Cipro, the only 
antibiotic approved specifically to treat Anthrax, has never been 
approved for use by children or pregnant women. How do we protect 
vulnerable, special populations in the event of the unthinkable?
    As a general matter, FDA cannot license or approve ``new vaccines 
or treatments'' using a ``lower safety standard for approval.'' FDA 
must follow the statutory standards for safety which are set out in the 
Federal Food, Drug, and Cosmetic Act and the Public Health Service Act 
and which are described in FDA's implementing regulations. Second, if a 
sponsor seeks FDA's approval of a product for use in bioterrorism 
preparedness by an expedited approval mechanism, such as accelerated 
approval or the Animal Efficacy rule, FDA will apply all appropriate 
safety standards.
    Finally, in terms of special or vulnerable populations, my 
understanding is that FDA has done the following: the Agency published 
a final rule in May of 2002, effective June 2002, entitled ``Evidence 
Needed to Demonstrate Effectiveness of New drugs When Human Efficacy 
Studies are Not Ethical or Feasible'', and also known as the Animal 
Efficacy Rule. This rule provides explicit conditions under which 
studying the effectiveness of products used to reduce or prevent the 
toxicity of chemical, biological, radiological or nuclear substances 
can be performed in animals when studies in human are not ethical or 
feasible. These conditions includes a well-understood mechanism of 
toxicity of the threatening substance, an animal model known to be 
predictive for human response, and sufficient information on the way 
the product is metabolized to allow for the selection of an effective 
dose. These studies can include non-adult animals to provide 
effectiveness and dose selection data for children, as well as studies 
on the reproductive toxicity of these products. The Agency published 
guidance in August 2000 that provides advice on how to design 
reproductive toxicity studies in animals for preventive vaccines for 
infectious disease indications. If confirmed, I will obviously pay 
close attention to the effectiveness of this guidance.
                 Response to Questions of Senator Reed
    Question 45. One of the recommendations made in a recent GAO report 
to help increase the pipeline of new vaccines would be to have FDA 
review vaccines under its ``fast track'' or ``priority review'' 
authorities. Is this something you would consider as Commissioner?
    FDA has reviewed, and will continue to review, license applications 
for vaccines in the most expeditious manner possible. Often, shortages 
are temporary and are over before even the most expeditious review can 
be completed. In such cases, the formal designation for the review 
process has little impact on the shortage. Thus, as a practical matter, 
it will be infrequent that a new vaccine will become licensed expressly 
and in time to alleviate a shortage. However, FDA will consider fast 
track and priority reviews designations whenever it appears that FDA 
can facilitate increased supply of vaccine through such actions. I also 
intend to examine the factors responsible for vaccine shortages to 
determine if further steps may be possible to prevent shortages in the 
first place.
    Question 46. In light of the focus on bioterrorism since September 
11, 2001, do you believe that FDA's relationships with other HHS and 
government agencies and with industry are sufficient to allow FDA to 
deal adequately with the drug- and device-related efforts necessary to 
America's safety? If not, have you considered what other partnerships 
FDA might need to establish or what other resources it needs?
    Effective coordination with other agencies, hopefully including the 
new Department of Homeland Security, is a critical task given the 
terrorist threats that we now face. It is my understanding that FDA has 
strong relationships within the HHS, and government agencies and with 
industry which are necessary to deal with bioterrroism issues. Even 
before September 11, 2001 FDA worked closely with its sister agencies 
within HHS - for example Center for Disease Control and Prevention on 
the anthrax attacks and many food illness outbreaks as well as with 
other agencies on bioterrorism-related issues. I am encouraged by work 
that CDC Director Gerberding is undertaking to improve our monitoring 
capabilities; these efforts may have spillover benefits for other FDA 
activities in monitoring food and drug safety.
    FDA also has worked with many local and state health agencies on 
food issues and has had long-standing and well-developed relationships 
with various law enforcement agencies, particularly important in 
tracking counterfeit drugs. There has been extensive work with industry 
to respond to the need for new vaccines and to expedite development of 
needed countermeasures. But terrorist threats are a new and evolving 
priority for all government agencies, and so effective coordination 
will demand ongoing attention. If confirmed, I will work with Congress 
and outside groups, as well as government agencies, to ensure that we 
identify and respond to new opportunities to work together to protect 
against bioterrorism.
    Question 47. There has been growing public concern about dietary 
supplements. Do you think that the regulation of dietary supplements 
should be revisited or is the current framework sufficient?
    While my examination of issues relating to dietary supplements has 
allowed me to appreciate the challenges the Agency faces under the 
Dietary Supplement Health and Education Act of 1994, at this time I do 
not have specific statutory changes to recommend. As Commissioner, I 
will work with the Department and with Congress to implement the Act in 
accordance with Congressional intent.
    Question 48. Currently both the FDA and the USDA lack the legal 
authority to recall contaminated food. But food recalls conducted 
voluntarily by companies don't always work. For example, an August 2000 
General Accounting Office report identified several instances in which 
the FDA believes that food companies delayed initiating a recall of 
their products. Do you support mandatory recall authority for the FDA? 
If not, how will you deal with instances where companies refuse to 
recall an adulterated or misbranded product or to provide distribution 
information?
    My understanding is that FDA, through its authority under the 
Federal Food, Drug, and Cosmetic Act, can remove a violative product 
from the market by using its seizure authority. It is also important to 
note that the new Bioterrorism law signed by the President this year 
(P.L. 107-188) grants substantial new powers to FDA to administratively 
detain foods for which there is credible evidence or information that 
the food presents a serious adverse health consequence or death to 
humans or animals. This authority is coupled with additional authority 
to detain imported foods at ports of entry for a period of time 
sufficient to enable their inspection. FDA is currently working on 
regulations to implement these new authorities. It will be important to 
assess the potential need for mandatory recall authority in the context 
of these new and expanded food safety authorities once they are 
implemented.
    Question 49. Federal food safety responsibilities are divided among 
twelve different agencies and governed by 35 different statutes. 
President Bush, Health and Human Services Secretary Tommy Thompson, and 
Homeland Security Director Tom Ridge all have publicly discussed 
combining federal food safety responsibilities into a single agency. 
Would you support efforts to establish a single, independent food 
safety agency? If so, but you do not believe that an independent agency 
needs to be established, where would you suggest housing a single food 
agency within the current government framework?
    There has been much discussion about consolidating all food safety, 
inspection, and labeling functions into one Agency to increase the 
effectiveness of the food safety system. My view is that what matters 
most are food safety results, not organizational changes.
    Last year, the White House established a Policy Coordinating 
Committee (PCC) led by the Domestic Policy Council and the National 
Economic Council to work on this issue. This group did not support the 
development of legislation to create a single food agency. In my view, 
the more important and urgent question is whether coordination amongst 
various Federal agencies with food safety authorities is working 
effectively, and whether and any new steps are necessary to improve 
that effort in order to advance food safety. To accomplish this goal, 
the PCC is continuing to explore ideas to better enhance our nation's 
food safety systems. As Commissioner, I would continue to enhance the 
close cooperation FDA has with its food safety partners.
    Question 50. It was recently disclosed that the FDA failed to make 
public industry-submitted findings about the adverse effects of 
Celebrex compared to alternatives drugs. This and other cases have 
given rise to concern that FDA's protection of industry trade secrets 
makes it easy for companies to conceal safety concerns from the public 
and mislead the public with overly-optimistic public statements about a 
drug's prospects.
    How would you propose to address this concern about trade secrets? 
What is your view on the relative priority of disclosure and protection 
of trade secrets? What, in your view, is the best process for 
determining what constitutes a trade secret?
    At the core of FDA's public health mission is its responsibility to 
assure the safety and effectiveness of medical products. At the same 
time, the Agency is required by statute and its own regulations to 
safeguard trade secret and confidential commercial information 
submitted to it by sponsors of premarket approval applications, which 
in turn helps encourage the development of new treatments to improve 
the health of the public. I believe that FDA takes both 
responsibilities seriously, and that it should be possible to both 
protect trade secrets and take rapid action where there is clear 
evidence of significant adverse effects. FDA should respond to sponsor 
concealment of safety information using the full extent of its legal 
authority. If the concealment were uncovered following approval, for 
example, FDA could take a variety of actions, ranging from issuance of 
a public health advisory, to requiring labeling changes, to withdrawal 
of approval.
    For products under review that have not yet been approved, FDA is 
not charged with policing the marketplace for false or misleading 
statements or omissions from the standpoint of protecting individual 
investors from financial losses. Instead, Congress has assigned this 
responsibility to the Securities and Exchange Commission (SEC), which 
is entitled to initiate enforcement action against a firm for making 
false or misleading statements or for failing to disclose material 
information in connection with a securities transaction. Depending on 
the circumstances, this could include concealment of material safety 
information about an investigational new drug. My understanding is that 
FDA refers cases of suspected false or misleading statements concerning 
investigational products to the SEC for prosecution and assists SEC in 
investigating such cases. If confirmed, I will work to make sure that 
FDA provides such information in a timely and appropriate fashion.
                Response to Questions of Senator Clinton
    Question 51. FDA is currently undertaking a regulatory review of 
the pediatric rule. Can you assure the Committee that you will not take 
any action to weaken the protections in the pediatric rule or weaken 
enforcement so that pediatric studies for drugs are delayed, if 
completed at all?
    I know FDA is committed to make sure all drugs for pediatric 
patients are properly studied. I share this goal and will work to make 
certain that children's medications are safe and properly studied. With 
the Best Pharmaceuticals for Children Act, Congress provided the 
government with a very important tool to address specific pediatric 
needs. In an advance notice of proposed rulemaking (ANPR) published on 
April 24, 2002, FDA sought public comment on how best to implement the 
BPCA and what additional steps, if any, need to be taken to ensure that 
drugs in children are adequately studied. I certainly support these 
efforts.
    Question 52. FDA is defending its current authority against legal 
challenge to the pediatric rule. Is it also your view that FDA has 
authority to carry out the pediatric rule, and do you intend to 
exercise and defend that authority?
    On April 19, 2002, the Department strongly reiterated that it is 
committed to further ensuring the safety and effectiveness of drugs 
used to treat children and will continue to enforce FDA's rule 
requiring companies to take steps to ensure drugs are properly labeled 
for pediatric use based on scientific studies. I share this commitment 
to ensuring that FDA is using all of its statutory authorities as 
effectively as possible to improve our understanding of the appropriate 
use of pharmaceuticals in children.
    Question 53. Different representatives of this Administration have 
made differing statements with regard to the official position on the 
drug, mifepristone. It has now been safely used by more than a million 
women, but anti-choice organizations that opposed its approval in the 
first place have now called for the FDA to reverse its position and 
pull the drug from the market. What is your view on the safety and 
efficacy of this drug? Do you believe it is appropriate for FDA to add 
any new criteria in its evaluation of drugs and devices now on the 
market?
    Please see above.
    Question 54. FDA's capacity to enforce regulation of prescription 
drug promotion has not kept pace with the increased volume of 
prescription drug advertising. One study has found that more than half 
of direct-to-consumer advertisements contain misrepresentations, 
another that 38 percent of advertisements directed at doctors violated 
five or more FDA regulations. Examples of repeat offenders, who 
continue to run false and misleading ads despite multiple enforcement 
letters also raise serious concerns about the adequacy of FDA's 
enforcement of existing regulations on prescription drug promotion. 
Claritin for example was asked to change its advertising at least 10 
times since 1997, and Celebrex was cited 3 times.
    A) What actions would you take or recommend to assure compliance 
with existing laws and regulations governing prescription drug 
promotion?
    B) The benefits of prescription drug advertising are enhanced if 
patients are directed the most therapeutically appropriate medicine, 
rather than a therapy that involves no advantage, or may even be 
therapeutically inferior to its alternatives. What action will you take 
to assure that comparative information for drugs and non-drug therapies 
for the same indication(s) is disseminated, rather than obscured?
    A: One of the FDA's important responsibilities is to ensure that 
the public receives truthful and nonmisleading health information on 
drugs. The Division of Drug Marketing, Advertising, and Communications 
(DDMAC), in the Center for Drug Evaluation and Research (CDER), FDA, is 
responsible for regulating prescription drug promotion. DDMAC's mission 
is to protect the public health by insuring that prescription drug 
information is truthful, balanced, and accurately communicated. This is 
accomplished through a comprehensive surveillance, enforcement, and 
education program, and by fostering optimal communication of labeling 
and promotional information to both health care professionals and 
consumers. Section 522 of the Bioterrorism Bill will provide additional 
resources for DDMAC beginning in FY-03. If Congress passes 
appropriations for DDMAC as specified in Section 522 of the 
Bioterrorism Bill, the additional resources will be especially useful 
for regulation of direct-to-consumer advertising. Thus, if confirmed, I 
believe I will have an enhanced ability to help ensure that consumers 
receive accurate information on drugs.
    B: Advertising needs to be truthful, balanced, and not misleading. 
Presentation of a discussion of alternatives to the treatment being 
promoted may be especially important in achieving this goal in cases 
where the product is harmful to people who can't use or have failed to 
benefit from an alternative therapy. In that case, my understanding is 
that FDA's regulations currently require that the promotion should 
recognize that limitation of use.
    Question 55. It was recently disclosed that the FDA failed to make 
public industry-submitted findings about the adverse effects of 
Celebrex compared to alternatives drugs. This and other cases have 
given rise to concern that FDA's protection of industry trade secrets 
makes it easy for companies to conceal safety concerns from the public 
and mislead the public with overly-optimistic public statements about a 
drug's prospects.
    How would you propose to address this concern about trade secrets? 
What is your view on the relative priority of disclosure and protection 
of trade secrets? What, in your view, is the best process for 
determining what constitutes a trade secret?
    At the core of FDA's public health mission is its responsibility to 
assure the safety and effectiveness of medical products. At the same 
time, the Agency is required by statute and its own regulations to 
safeguard trade secret and confidential commercial information 
submitted to it by sponsors of premarket approval applications, which 
in turn helps encourage the development of new treatments to improve 
the health of the public. I believe that FDA takes both 
responsibilities seriously, and that it should be possible to both 
protect trade secrets and take rapid action where there is clear 
evidence of significant adverse effects. FDA should respond to sponsor 
concealment of safety information using the full extent of its legal 
authority. If the concealment were uncovered following approval, for 
example, FDA could take a variety of actions, ranging from issuance of 
a public health advisory to requiring labeling changes to withdrawal of 
approval.
    For products under review that have not yet been approved, FDA is 
not charged with policing the marketplace for false or misleading 
statements or omissions from the standpoint of protecting individual 
investors from financial losses. Instead, Congress has assigned this 
responsibility to the Securities and Exchange Commission (SEC), which 
is entitled to initiate enforcement action against a firm for making 
false or misleading statements or for failing to disclose material 
information in connection with a securities transaction. Depending on 
the circumstances, this could include concealment of material safety 
information about an investigational new drug. My understanding is that 
FDA refers cases of suspected false or misleading statements concerning 
investigational products to the SEC for prosecution and assists SEC in 
investigating such cases. If confirmed, I will work to make sure that 
FDA provides such information in a timely and appropriate fashion.
    Question 56. The Best Pharmaceuticals for Children Act, passed by 
Congress last year, provided explicit authority and support for the 
work conducted by the Pediatric Subcommittee of the Oncologic Drugs 
Advisory Committee including work to help evaluate and prioritize new 
and emerging therapies for treating pediatric cancer so that pediatric 
cancer patients have timely access to the most promising new cancer 
therapies. Because the population of pediatric cancer patients is 
relatively small in number, limiting the number of therapies that can 
be studied for that population, and because the studies have very high 
stakes, the decisions about which therapies to study are important and 
should be deliberate and scientifically sound. Do you support these 
functions of the Pediatric Oncologic Drug Advisory Committee and how 
would you assure the facilitation of these functions?
    I support the Pediatric Subcommittee of the Oncologic Drugs 
Advisory Committee and its ability to carry out its important 
functions. Related to this important area of oncology, FDA recently co-
sponsored a workshop on pediatric oncology drug development with 
representatives from the American Academy of Pediatrics, the National 
Cancer Institute, and pediatric oncology organizations listed in the 
Best Pharmaceuticals for Children Act. The workshop provided 
perspective from advocacy groups, interested health care providers, 
academia, and industry organizations on various aspects of drug 
development in pediatric oncology, including prioritization of new and 
emerging agents, clinical trial design, and access to new therapies. 
The input received from this workshop has been used in developing 
topics for discussion at future meetings of the Pediatric Subcommittee 
of the Oncologic Drugs Advisory Committee. If confirmed, I look forward 
to receiving further input through the subcommittee.
    Question 57. Prescription drug use for children under nineteen grew 
twenty-eight percent last year. Prescriptions of Ritalin grew 122 
percent over the past four years, and a recent House Government Reform 
Committee hearing raised continued concerns about over prescription of 
this drug, especially because it is easier to write prescriptions than 
to use behavioral therapies that may be as effective, if not more.
    As much as 70% of funding for studies psychostimulant medications 
come from pharmaceutical companies. Investigators who have been funded 
have raised concerns about undue influence on trial design and 
reporting of results. This has prompted the Journal of the American 
Medical Association to stop publishing studies without full disclosure 
of pharmaceutical companies' role in the study design. This 
intervention has helped, but researchers continue to face legal 
intimidation and other difficulties because of dependence on 
pharmaceutical financing. How do you plan to ensure that the role of 
other effective non-drug treatments to be addressed adequately in ADHD 
drug studies that lead to FDA approval?
    Pharmaceutical companies are targeting ADHD drugs directly to 
consumers, and some suggest that the consumer marketing promotes these 
drugs to patients who may not meet ADHD criteria, and de-emphasizes the 
role of non-pharmacologic interventions for ADHD. What, in your 
opinion, is the FDA's role in ensuring fair marketing of drugs to 
consumers, especially for ADHD drugs?
    The Office of the Surgeon General, together with the National 
Institute of Mental Health (NIMH) and FDA, coordinated a Conference on 
Children's Mental Health: Developing a National Action Agenda that was 
held on September 18-19, 2000. Pharmaceutical manufacturers, academic 
and other investigators, advocacy groups and Pediatric Pharmacology 
Research Units participated in this conference. In preparation, FDA had 
a meeting in April 2000 with the NIMH to discuss issues that were 
brought to the conference. In addition, at the Pediatric Advisory 
Subcommittee meeting September 11 and 12, 2000, a session was held to 
update the Committee on issues being developed for the conference.
    Many topics, including the use of Ritalin (methylphenidate) to 
treat ADHD, were examined and discussed at the conference. The 
information generated from this meeting will help answer questions 
about appropriate trial designs and the needed research in this area. 
If confirmed, I will work to make sure that FDA continues to 
collaborate with sponsors to ensure the appropriate labeling of these 
products.
    Question 58. Currently both the FDA and the USDA lack the legal 
authority to recall contaminated food. But food recalls conducted 
voluntarily by companies don't always work. For example, an August 2000 
General Accounting Office report identified several instances in which 
the FDA believes that food companies delayed initiating a recall of 
their products. Do you support mandatory recall authority for the FDA? 
If not, how will you deal with instances where companies refuse to 
recall an adulterated or misbranded product or to provide distribution 
information?
    My understanding is that FDA, through its authority under the 
Federal Food, Drug, and Cosmetic Act, can remove a violative product 
from the market by using its seizure authority. It is also important to 
note that the new Bioterrorism law signed by the President this year 
(P.L. 107-188) grants substantial new powers to FDA to administratively 
detain foods for which there is credible evidence or information that 
the food presents a serious adverse health consequence or death to 
humans or animals. This authority is coupled with additional authority 
to detain imported foods at ports of entry for a period of time 
sufficient to enable their inspection. FDA is currently working on 
regulations to implement these new authorities. It will be important to 
assess the potential need for mandatory recall authority in the context 
of these new and expanded food safety authorities once they are 
implemented.
    Question 59. As a result of heightened concerns about food 
bioterrorism, the FDA received funding to hire more than 600 new food-
inspection personnel. But even with this funding, the Agency can only 
inspect around two percent of the millions of food shipments imported 
to the U.S. each year.
    With much of FDA's funding prioritized for drug approval, or other 
important FDA missions, FDA's food inspection capacity has struggled 
even to remain steady relative to inflation, much less keep pace with 
the growth in imported foods, and when there are occasional increases 
in funding, FDA has frequently been unable to capitalize on these 
increases by building those increases into the baseline for the 
following year. Do you support increased resources for FDA food 
inspection, incorporated into the baseline, and will you be an 
aggressive advocate for this funding?
    What other plans do you have for improving the safety of imported 
foods? Do you believe that the FDA should have the authority to go to 
foreign countries to inspect the plants that are shipping foods to the 
U.S.?
    I consider the safety of imported food a very high priority and 
will work to ensure that food safety activities are funded at the 
appropriate level. As you note, the bioterrorism bill has provided 
valuable new resources for food safety activities. As you know, 
minimizing food risks is a complex undertaking that involves many 
issues besides inspections. The Agency staff reports that due to 
constantly changing environments of operation, for example, counter-
terrorism and BSE, FDA's domestic inspection and import strategy cannot 
be defined in terms of a percentage of coverage through inspections, 
physical examinations, and sample analyses. It needs to be a flexible 
blend of the use of people, technology, information, and partnerships 
to protect Americans from unsafe imported products.
    An important part of the long-term solution to a higher level of 
confidence in the security and safety of food products lies in 
information technology that will merge information on products, 
producers, and intelligence on anticipated risks to target the products 
for physical and laboratory examination. This solution relies on data 
integrity activities that reduce the opportunity for products to be 
incorrectly identified at ports. It also relies on cooperation from 
producers so that FDA can identify sources that are unlikely to need 
physical testing. Foreign inspections are an important aspect of FDA's 
approach. If confirmed, I will work to implement these improvements in 
food safety activities.
    Even with such targeting of products to be more closely examined, 
improvements are limited by the available methodologies for assessing 
threat agents and the Agency's ability to predict which tests ought to 
be used. I understand that the Agency is also using funds to work to 
further improve targeting and using force multipliers such as 
information technology.
    Question 60. Following a General Accounting Office report that was 
highly critical of the FDA's efforts to regulate feed mills, the Agency 
in 1997 inspected all U.S. feed mills to ensure feed segregation. Since 
then, the FDA has promised annual inspections of feed mills that handle 
mammalian materials. Did the Agency meet its inspection goal for 
FY2002? How many firms remained out of compliance with the Agency's 
feed ban? What enforcement actions, if any, were taken against non-
compliant firms?
    The European Union has banned animal protein in both ruminant and 
non-ruminant feed, while FDA allows mammalian protein in non-ruminant 
feed. However, because feed is a high-volume, rather than precision 
product, studies have shown that large numbers of feed mills lack 
systems to prevent commingling of ruminant and non-ruminant feed. What 
actions would you take to protect the American public an/d the American 
farmer against the fatal and economically devastating outbreaks of BSE 
that can result from inappropriate contamination of animal feed by 
mammalian protein?
    FDA's Center for Veterinary Medicine and Office of Regulatory 
Affairs advise me that as of October 2, 2002, FDA and its state 
counterparts have completed over 15,000 inspections of approximately 
11,000 firms. FDA's FY 02 goal of inspecting all renderers and feed 
mills handling prohibited material should be met. Currently 85% of the 
inspections have been completed and entered into the FACTS data system 
with the remaining inspection information expected by the end of 
October. According to FDA, less than 1% of the renderers and feed mills 
handling prohibited material are out of compliance and appropriate 
enforcement action will be taken. To date FDA has issued over 50 
Warning Letters and classified 31 recalls of more than 240 products.
    FDA and its state counterparts conducted initial inspections of all 
renderers, protein blenders, and feed mills, as well as a 
representative number of distributors and ruminant feeders starting in 
late 1997. In FY 02, FDA focused its inspection effort on renderers and 
feed mills handling prohibited material. Any firm found to be out of 
compliance in its last inspection was placed in first priority to be 
re-inspected. In addition, FDA prioritized its inspectional coverage to 
include for-cause inspections (e.g., as a result of a sampling 
assignment). During FY 2002 FDA developed a comprehensive Compliance 
Program to provide clear instructions to the field staff for conducting 
inspections and appropriate enforcement. In addition, the Agency 
conducted numerous training sessions for Federal and State 
investigators in order to enhance the conduct, quality, timeliness and 
accuracy of inspection findings and reporting; and provide updates on 
the science of BSE and animal protein detection methods. This included 
2 major national meetings with 300 participants. These meetings 
included participants from USDA and Canada.
    BSE is a very important issue for FDA and I will continue to devote 
time and attention to this as Commissioner.
    Question 61. The Food and Drug Administration is charged with 
insuring the safety and efficacy of drugs. The same quality standards 
to generic drugs as to brand-name drugs. All available evidence 
demonstrates that generic drugs are medically equivalent to their brand 
counterparts. One analysis has suggested that a 1% increase in generic 
substitution rates could result in more than $1 billion in additional 
savings annually for consumers. Yet, the brand-name companies sometimes 
wrongly suggest that generic drugs are inferior. Do you agree that 
there is no basis for that charge? When false claims are made about the 
equivalence of generic drugs, are you, as Commissioner, prepared to 
work to set the record straight?
    FDA approves generic drugs that are therapeutic equivalent to 
brand-name drugs. The quality, strength, and purity standards for 
approval of drugs sold in the United States are uniform, whether they 
are for generic or brand-name drugs. Generic drugs contain the same 
active ingredients as the brand-name drug and are just as safe and 
effective.
          Response to Questions of Senators Graham and Nelson
    Question 62. Most food inspections in the country are done through 
state food regulatory programs at both Departments of Agriculture and 
Departments of Health. It is important that such partnerships remain 
strong and continue to grow. What are your suggestions for ways to 
strengthen partnerships with the states? (Barnes/Oliver)
    I agree that such partnerships are critical and should be 
strengthened. FDA works with the States through a combination of 
partnerships and contracts and since the passage of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 will 
also be utilizing cooperative agreements and grants. I look forward to 
working with you on this issue if confirmed.
    Question 63. In today's world of biotechnology and genetic 
engineering, the position for which you have been nominated is that of 
the top administrator in the nation setting standards and approval 
processes for new drugs and bioengineered foods. How will you approach 
the development of safety standards and the approval of new products?
    I believe that the safety standards for all of the products FDA 
regulates must be based on sound science. This is true for foods and 
for medical products, and for products developed through bioengineering 
or by other technologies. The Federal Food, Drug, and Cosmetic Act, and 
the Public Health Service Act lay out the safety standards that foods 
and drugs, including biological products, have to meet, and I believe 
that FDA has done a good job in ensuring that they do.
    Drugs and biological products manufactured using biotechnology must 
meet the safety and efficacy standards set forth in the statues and 
implementing regulations. I believe that it is important for patients 
to have access to safe and effective therapies as expeditiously as 
possible through an efficient review process. I plan to work with CBER 
and CDER to ensure that new drug and biologics applications receive the 
highest quality review for both safety and effectiveness, and that 
these reviews are performed as efficiently as possible.
    Regarding bioengineered foods, FDA currently has in place a 
science-based process to evaluate information concerning the safety of 
these foods. This process permits FDA scientists to evaluate safety 
tests conducted by developers to ensure that relevant safety, 
nutritional, or other regulatory issues are resolved prior to 
marketing. My understanding is that this process has been successful, 
and the bioengineered foods that have entered the U.S. market have been 
evaluated by FDA and found to be as safe as other foods. I also 
understand that the Agency is taking steps to keep pace with the latest 
scientific advances. FDA has established a new advisory committee for 
food biotechnology, and the Agency is developing new guidance to assist 
industry in the early stages of product development. FDA believes that 
these and other initiatives will ensure that the Agency is ready for 
new developments and will enhance consumer confidence and enhance the 
safety of the food supply.
    Question 64. How do you propose to establish close liaisons to 
coordinate on food security and food safety with the proposed new 
Department of Homeland Security?
    FDA has close ties with the law enforcement and intelligence 
communities through its Office of Criminal Investigations. Those 
interactions have been strengthened since the events of September 11, 
2001. FDA has already established or participates in a number of 
interagency committees to coordinate food safety and security 
activities. These interactions are anticipated to continue and expand 
when the Department of Homeland Security is established.
    Question 65. Most states have enacted the Model Food, Drug, and 
Cosmetic Act and work closely with FDA to ensure uniformity and 
consistency. There have been past attempts to enact a more stringent 
federal preemption statute that some fear could thwart state programs 
for food safety. Many state legislature are questioning whether to fund 
state programs if these are preempted by federal law. What is your 
position on federal preemption?
    State programs play an important role in promoting food safety, and 
as Commissioner I intend to build on efforts to work with states 
cooperatively to ensure uniformity and consistency. As I learn more 
about this issue, I will work with the Administration and other 
interested parties on developing a position on the issue of whether 
federal preemption is appropriate in certain circumstances.
    Question 66. There has been numerous reports of adverse reactions 
associated with herbal supplements on the market. In light of these 
reports, what are your thoughts on how best to address adverse 
reactions occurring with herbals and dietary supplements?
    Dietary supplement safety is one of FDA's key responsibilities. As 
part of FDA's Dietary Supplement Strategic Plan, the Agency is 
developing and will soon implement the CFSAN Adverse Event Reports 
System (CAERS). This comprehensive system will track and analyze 
adverse event reports involving cosmetics and foods, including dietary 
supplements. CAERS will replace the patchwork of existing adverse event 
systems that are currently maintained by individual offices within 
CFSAN.
    Publishing regulations on good manufacturing practices (GMPs) for 
dietary supplements is also an important initiative related to the 
safety of dietary supplements. FDA has forwarded draft proposed GMP 
regulations to the Department of Health and Human Services. On October 
4, 2002 the Department submitted this proposal to the Office of 
Management and Budget for 90-day review. If confirmed, I intend to work 
to implement GMP regulations as quickly as possible.
    Question 67. The FDA has long endeavored to get mercury out of 
other health products and devices, yet in docket # 01-N-0067 and 01-D-
0064 declares that mercury dental fillings are safe. The Dental Devices 
section failed to have a current scientific advisory panel examine the 
proposal, nor has it held public hearings on the proposal, which has 
drawn overwhelmingly negative responses during the public comment. The 
regulation would preempt state consumer protection laws, a move out of 
step with the general position of this administration. Dr. McClellan, 
will you ensure that any actions taken by FDA with respect to mercury 
in regulated products comport with the position of the White House Task 
Force on Mercury, the general FDA policies against mercury in health 
products and devices, and FDA policies on up-to-date scientific review 
of its proposed regulation?
    I will work to make sure that actions FDA takes on mercury in 
regulated products are guided by the recommendations of the White House 
Task Force on Mercury, the general FDA concerns about health problems 
associated with mercury, and FDA's reliance on up-to-date scientific 
information for decision making. The comment period on this proposed 
rule has just recently closed. The Agency will carefully review all 
comments to the proposed rule and, if confirmed, I look forward to 
acting based on these comments.
                 Response to Questions of Senator Gregg
    Question 68. Do you share the view that FDA and CMS have distinct 
regulatory missions and that any harmonization of their 
responsibilities should be approached carefully? Given your background, 
how are the missions of these agencies similar and distinct? How can 
FDA and CMS work together to speed access of safe and effective medical 
technologies for Medicare beneficiaries without delaying access to 
those same technologies by the rest of the American public? Can you 
assure me that you would oppose efforts to involve FDA in collecting 
data related to cost, cost effectiveness, value, and other 
reimbursement considerations in an effort to address concerns with the 
CMS coverage process, which responsibility is outside the current scope 
of FDA review, and which responsibility would inevitably only result in 
delaying public access to medical technology?
    Certainly, FDA and CMS have distinct roles. As you know, FDA does 
not make coverage decisions. Rather, it approves items like devices and 
drugs based on their safety and efficacy. CMS must make determinations 
for coverage. These are different standards and may require different 
analyses. From the perspective of CMS' authority, just because an item 
is safe for marketing, it is not necessarily the most medically 
appropriate item for a beneficiary, or a good use of taxpayer funds.
    That said, I think increased interaction and cooperation among 
Federal agencies is wise. I understand that CMS currently works 
collaboratively with FDA when gathering and considering evidence to 
make national coverage decisions. In addition, the staffs collaborate 
through interagency agreements, workgroups and task forces, and in 
consultative roles with respect to setting and enforcing quality 
standards, quality improvement and measurement activities, and 
coverage. I have worked closely with CMS Director Scully over the last 
18 months, and if confirmed, I will work with him to explore areas 
where these two agencies can further improve their working relationship 
for the benefit of the American public.
    The activities that you identify relating to cost and reimbursement 
are not primarily within FDA's mandate under the Food, Drug and 
Cosmetic Act.
    Question 69. User Fees. Dr. McClellan, the Senate now has before it 
legislation to reduce delays in FDA review of innovative medical 
technologies by giving it user fee resources. The user fee agreement 
recognizes that CDRH's base has been substantially eroded over the 
years. In order for the public to obtain the full benefit of the 
performance goals outlined in the user fee deal, the CDRH needs both 
the fee revenue from manufacturers and an additional $15 million in 
appropriations added to its base in 2003 and carried forward in each of 
the subsequent four years. Do you support adding the $15 million to the 
device centers' budget in FY'03? Will you work to ensure that the 
President's budget for FY '04 and subsequent years includes this $15 
million?
    The user fee program that has been negotiated over the last five 
months is a $50M program by year five. The goals that FDA agreed to 
meet are contingent on the Agency receiving $50M by year five. The 
industry agreed to fund up to $35M in user fees by year 5 and the 
remaining $15M is to come from appropriated dollars. I strongly support 
enactment of this new user fee program in this Congress. If Congress 
passes the law that creates this user fee program for medical devices, 
I plan to work to ensure that the device program receives the funds it 
needs to adequately implement the program and meet the goals that are 
laid out in the draft goals letter.
    Question 70. It is an unavoidable fact that FDA cannot keep pace 
with rapid advances in medical technology without more help from 
outside experts. This is not a criticism of the hardworking reviewers 
at FDA. Even with its limited resources, it would never be practical 
for FDA to have the expertise on staff to properly assess the most 
recent innovations from the frontiers of medical technology. In 1997, 
Congress gave FDA explicit authority to use outside experts to help 
with all or portions of a product review. To date, FDA has seldom, if 
ever, used this authority. Needless delays in product reviews could be 
avoided if FDA brought in an outside expert to help reviewers 
understand the scientific issues behind a product application. In 
addition, legislation now under consideration would authorize the 
Agency to make use of independent outside experts in the facility 
inspection process. It is important to stress that what FDA needs in 
these situations is not more resources but more expertise. Dr. 
McClelland, what are your thoughts on how FDA can make greater use of 
independent outside experts to augment FDA's in-house review and 
inspection programs?
    I believe that appropriate reliance on outside experts can augment 
and strengthen FDA's internal capabilities. I understand that FDA is 
making greater use of independent outside experts, and the activity at 
the Center for Devices and Radiological Health (CDRH) is a good example 
of this. CDRH is working to enhance scientific decision-making and 
expand the Center's capacity to evaluate and ensure the safety and 
effectiveness of medical devices. The Center is engaging outside 
experts to assist with pre- and post-market product review. Clinicians, 
surgeons, engineers and scientists from academia, other government 
agencies, and the military are providing needed medical and scientific 
expertise on a wide range of increasingly complex medical devices. As 
Commissioner, I look forward to having the opportunity to further 
evaluate this matter and to support collaborations with outside experts 
where appropriate.
    Question 71. We have seen recent reports raising concern about a 
drop-off in the number of warning letters that FDA field offices are 
issuing on drug advertising and other issues. Yet FDA leaders highlight 
the need to bring greater consistency and predictability to the process 
of issuing warning letters for violating FDA rules, which in the past 
has varied widely from district to district. As Commissioner, how do 
you plan to ensure appropriate, yet consistent, enforcement of FDA 
rules?
    I believe in credible, risk-based enforcement. I also believe FDA 
should speak with one voice and be as consistent as possible, to help 
make sure that the threat of an FDA enforcement action is taken very 
seriously. It is my understanding that this was why, in November of 
2001, Deputy Secretary Claude Allen directed that the Office of Chief 
Counsel review all enforcement correspondence. Before this directive, 
there was no central repository of such letters, no tracking system, 
and little coordination. Letters were often issued long after the 
deadlines set in the Regulatory Procedures Manual. (RPM).
    It is my understanding that there had been complaints that, in some 
cases, different districts were taking varying positions on the same 
issue. There had also been complaints that FDA would not follow up on 
many of the letters. Moreover, there were assertions that some of the 
letters were not legally sufficient, and some did not reach the 
threshold of regulatory significance.
    I intend to examine this issue more closely if I am confirmed, and 
thanks to recent FDA actions, I will have better and more timely data 
to do so. FDA now tracks such letters, and has recommitted to the 
deadlines in the RPM. Between February 27 and September 5, OCC reviewed 
and disposed of 699 letters. It refused to concur in only 6 percent. 
The vast majority was concurred in subject to various changes meant to 
strengthen and improve the letters.
    In fact, my understanding is that, on occasion, OCC has urged that 
the district or center consider bringing an enforcement action instead 
of sending a letter. OCC has even refused to concur on the grounds that 
an actual enforcement action, rather than a letter, was the appropriate 
response.
    FDA's mission in protecting the public health is so critical that 
its enforcement capabilities must be taken extremely seriously. When 
the Agency takes a position, companies must believe that FDA can and 
will back it up by going to court if necessary. I believe that the OCC 
review policy is consistent with this goal, and I intend to make sure 
that it works to increase FDA's consistency and credibility. I would 
like to state very clearly that, if I am confirmed, I will work to 
ensure that FDA takes action when companies fail to comply with 
warnings.
    Question 72. A challenge facing every head of a science-based 
regulatory agency is how to effectively communicate to the American 
public about the risk and benefits of regulatory decisions. The vast 
majorities of new medical technologies perform as intended and deliver 
life saving and life improving benefits to patients. Yet medical 
technologies can be inherently dangerous and on rare occasions, a 
serious problem arises. Dr. McClellan, how do you propose to balance 
the occasional need to alert the public to real and potential product-
related threats without undermining the public's well placed confidence 
in the medicines and foods they use on a daily basis?
    Communicating effectively with the public about risks and benefits 
is one of FDA's most important and challenging tasks. FDA already has a 
well developed system to alert and advise the American public about the 
risks that may come to light with FDA regulated products. The Agency 
uses different modes of communication in an effort to achieve a 
rational, balanced presentation of the facts. The Agency makes 
extensive use of the Internet, issue talk papers and press releases 
regularly distributed to the media as well as a system to alert 
healthcare professionals and industry as necessary.
    As good as any system for communicating risk may be, there is 
always room for improvement and, as risks and available methods of 
communication change, good reasons to take a fresh look at the issue of 
effective risk communication. As Commissioner, I will work with the FDA 
Centers to explore such innovative approaches. Where appropriate, I 
will examine ways to improve communication approaches across the 
Centers. I look forward to discussing any additional recommendations 
from you and other members of Congress in this important area.
    Question 73. An increasing number of breakthrough medical 
technologies are based on tissue-engineered technology. I believe that, 
based on the primary mode of action of these technologies, they must 
remain under the purview of FDA's device center, and that there is no 
public health reason to move these products to another center. I am 
concerned doing so would introduce needless delays in the review 
process. Would you agree that tissue-engineered medical products should 
continue to be regulated as medical devices?
    You have highlighted an important example of how FDA's regulatory 
capabilities need to adapt to new kinds of biomedical innovation. FDA's 
device center has clearly developed unique expertise that will be 
relevant to many new tissue-engineered technologies. In my oral remarks 
I urged that Congress adopt the Medical Device Amendments of 2001, H.R. 
3580, during the current session. As reported by the House Committee on 
Energy and Commerce, section 203 of the bill would establish an Office 
of Combination Products in a manner that is consistent with recent 
Agency actions to promote combination product reviews. As Commissioner 
I will work with Congress and others to evaluate the most appropriate 
approaches for addressing tissue-engineered medical products, and I 
will ensure that the expertise developed by FDA's device center is used 
to ensure timely and consistent review of such products. Obviously, 
enactment of H.R. 3580 would be a great help in achieving this goal.
    Question 74. The U.S. is the world leader in developing new medical 
device, drug, and biotechnology products. These products contribute 
$7.2 billion annually to our balance of trade. The market for these 
products is truly a global one and the regulatory systems our 
manufacturers face can be quite varied. Patients around the world, and 
our own US based companies will be better off with greater convergence 
among the regulatory models around the world. Achieving mutual 
recognition agreements with trading partners is one important step FDA 
can take in this regard. As Commissioner, will you work to implement 
existing MRAs quickly and reaching additional agreements with our major 
trading partners?
    As you note, there are enormous benefits for American workers and 
our national economy from a greater ability to export our world-leading 
medical products. Mutual recognition agreements are important for the 
Agency because of the leveraging it provides for FDA's inspectional 
resources and assisting the Agency in its public health mission. If I 
am confirmed as Commissioner, I will certainly investigate expediting 
implementation of current MRA's and working on additional agreements.
                 Response to Questions of Senator Frist
    Question 75. The Administration is, reportedly, developing a plan 
to allow individuals to choose to receive smallpox vaccinations in 
advance of any potential smallpox attack by a bioterrorist. The 
Administration already has asked states and localities to develop plans 
to vaccinate individuals in the event of a smallpox outbreak. What role 
do you expect and believe the FDA should play in supporting the 
Administration's plans to protect the American people from a potential 
smallpox attack?
    FDA will play an important role in providing guidance, technical 
assistance, and product review for the smallpox vaccine and other 
bioterrorism-related products. The Agency has embarked on an expanded 
program of regulatory and scientific assistance to industry and to 
state and Federal public health agencies. I have also been advised that 
FDA is expediting its review of new products, new uses of approved 
products, including products to address a smallpox attack, and new 
manufacturing sites for counter-terrorism products.
    Finally the Agency is working with the Department of Defense to 
develop test methods for investigational products suitable for large 
scale military and civilian health emergencies. I believe that these 
are appropriate actions to respond to such threats.
    If confirmed, I will work expeditiously on these and other steps to 
develop safe and effective bioterrorism countermeasures.
    Question 76. Currently, we do not have vaccines for a number of the 
deadly potential agents that may be used in a bioterrorist attack 
against Americans. What responsibility do you believe the FDA has to 
ensure that additional vaccines, assays, and other bioterrorism 
countermeasures are rapidly developed? Are there any legal changes that 
you believe are necessary in this area to ensure that we are able to 
develop necessary countermeasures to protect the American people?
    FDA's role in the development of medical countermeasures to combat 
terrorism is a proactive stance in the provision of regulatory guidance 
to see that vaccines, drugs, and medical products developed for these 
purposes are safe, effective, and available to the public when they are 
needed. Activities include regulatory guidance for products under 
development, communication with manufacturers to address shortages and 
inventory concerns, and regulatory guidance for the deployment of 
products for which outcomes data collection is a legal requirement. FDA 
has many important responsibilities, but the development of 
bioterrorism countermeasures must be given a very high priority. I 
assure you that I will devote significant attention to this task while 
at FDA.
    Question 77. The bioterrorism legislation was completed in record 
time. Do you have any recommendations about how we could improve upon 
that bill. Are there actions you believe the FDA Commissioner can take 
administratively to further improve our bioterrorism preparedness or 
response capabilities?
    This is landmark legislation that gave the Food and Drug 
Administration new responsibility and authority with respect to 
ensuring the safety of the food supply and rapidly approving vaccines 
and other countermeasures. FDA is currently involved in a number of 
rulemakings with respect to this new authority. I am not aware of the 
need for any major amendments. If I learn of the need for changes, I 
will work with the Administration to notify Congress. As for 
administrative changes, preventing bioterrorism and protecting the food 
and drug supply will certainly be a major focus of my tenure at FDA. As 
the Agency identifies administrative actions to improve our 
bioterrorism preparedness, I will work to implement them and work with 
Congress to ensure they are consistent with our specified statutory 
authorities. I appreciate the committee's leadership in enacting this 
important legislation, and look forward to working with you to achieve 
our shared goal of protecting the nation from new bioterrorist threats.
    Question 78. Are there actions the FDA could take to alleviate 
existing shortages of childhood vaccines and prevent future shortages?
    Beginning in 2001, there was an unanticipated shortage of some of 
the recommended vaccines in the United States. Through concerted 
efforts by suppliers, FDA, and other HHS agencies, my understanding is 
that this situation has eased considerably. Supplies of these vaccines 
returned to normal by the summer of 2002, with the exception of the 
Pneumoccal Conjugate Vaccine. Because of manufacturing challenges as 
well as the large demand, this vaccine is still in short supply.
    An ample supply of influenza vaccine is currently available for the 
2002-2003 influenza season, and there are no delays at this time.
    In the future, as in the past, FDA will work with manufacturers to 
anticipate shortages, to encourage increased production of needed 
vaccines when shortages are anticipated, and to expedite FDA review of 
any pending applications or submissions for vaccines in short supply. 
If confirmed, I intend to work with you to explore new ways to prevent 
vaccine shortages in the future.
    Question 79. Broadly thinking, what changes in FDA regulation and 
policy are necessary to ensure an adequate, stable supply of needed 
vaccines?
    We must look first to the causes of past shortages. These have been 
addressed recently in detail by the GAO and by the National Vaccine 
Advisory Committee; the causes are complex. Shortages caused by such 
events could be mitigated, in part, by maintaining stockpiles of 
essential vaccines, and by improving incentives for adequate 
participation and production in the vaccine industry.
    Currently, there is no mechanism for FDA to get reliable reports 
from vaccine manufacturers, even sole manufacturers, of projected 
shortfalls in production or a decision to stop manufacturing or 
distributing a vaccine. Advance notification to FDA by vaccine 
manufacturers would facilitate timely and effective agency actions. For 
now, FDA must rely on information voluntarily provided by vaccine 
manufacturers to help mitigate any shortages.
    Question 80. In addition to prioritizing the review and approval of 
emerging technologies, what action can the FDA take to further ensure 
the safety of blood, tissue and organ supplies?
    Blood, tissue, and organ safety is an important FDA responsibility, 
and I intend to build on some recent programs implemented by FDA to 
improve safety in these areas. FDA has created a new office that 
oversees tissues as well as cellular and gene therapies. Close 
coordination with the Office of Blood Research and Review within the 
Center for Biologics Evaluation and Research (CBER) will help ensure 
that consistent donor testing is performed on potential blood and 
tissue donors. For example, development of West Nile Virus screening 
tests will be used not only for blood donors, but also for human tissue 
donors. Human organ transplantation is regulated by the Health 
Resources and Services Administration, with which CBER has close 
coordination. FDA continues to increase its capacity to inspect human 
tissue banks to bring inspections on par with blood bank inspections.
    Additionally, FDA continues to work with the tissue industry and 
the Centers for Disease Control and Prevention to provide guidance on 
procedures to minimize the chance for cross-contamination of tissues 
with pathogenic organisms during processing. The Agency intends to work 
with the medical community to enhance the sharing of information 
concerning potentially contaminated tissues and to provide guidance on 
the submission of INDs for new cellular and tissue-based products.
    Question 81. FDA plays a critical role in protecting individuals 
participating in clinical trials. What actions do you believe FDA can 
take to strengthen protections today, and what legislative steps do you 
believe are necessary in the future?
    My examination of the issues relating to Human Subject Protection 
has allowed me to appreciate the importance of these issues, which are 
vital to the integrity and validity of clinical research. As 
Commissioner I will work with you and others in Congress to assess the 
need for potential changes to the law or regulations in order to better 
protect those who participate in clinical trials.
                Response to Questions of Senator Collins
    Question 82. Dr. McClellan, over five years ago, the Food and Drug 
Administration (FDA) examined the health issues that tissue 
transplantation could pose to the public and concluded that the 
existing regulatory framework was insufficient. Subsequently, FDA 
notified the industry that it intended to impose regulatory changes to 
strengthen oversight of tissue banks and processors, through the 
``Proposed Approach to the Regulation of Cellular and Tissue-Based 
Products.'' Yet, five years later, the majority of the regulatory 
changes are not final, and the Agency cannot even state when the 
remaining regulations will be implemented.
    In August 2002, Secretary Thompson advised me that while the 
department is giving publication of the final rules high priority, they 
are not able to forecast a specific date. When do you anticipate the 
regulations will be finalized?
    I agree with you that improving the safety of tissue banks and 
processing is an urgent priority. FDA is giving publication of the 
final rules high priority as indicated by the current listing in the 
Unified Agenda (67 FR 33072) and expects to complete its rulemaking 
process within the next 12 months. I will work to expedite this 
process, and will continue to work closely with you and others to help 
ensure that all tissue banks and production processes meet the new FDA 
standards.
    Question 83. Dr. McClellan, in May 2001, as Chair of the Permanent 
Subcommittee on Investigations, I held a hearing that examined the 
efficacy of the current regulatory framework. During the hearing, Dr. 
Kathryn Zoon, Director of FDA's Center for Biologics Evaluation and 
Research, testified that FDA is committed to establishing a regulatory 
framework that will ensure the safe use of human tissue for 
transplantation. Dr. Zoon estimated that the Agency would dedicate 
$4.35 million in resources in fiscal year 2002 to the regulation of 
human tissue. She also testified that cost estimates of the 
implementation of the tissue regulation would be developed as part of 
the fiscal year 2003 budget. No estimates have yet been provided by FDA 
or the Department of Health and Human Services (HHS). Furthermore, in 
January 2001, my colleague Senator Durbin sent a letter to FDA 
requesting a breakdown of costs for implementation of the proposed 
regulations, and has never received a response.
    It is impossible for Congress to provide the necessary resources 
unless the figures are identified. Would you please provide an estimate 
of the costs associated with implementing the regulations?
    Thank you for your efforts to promote safe tissue transplantation 
policy. If confirmed, I look forward to working with you to ensuring 
that all tissue banks and processors provide safe tissue products.
    Question 84. Dr. McClellan, in my bill, S. 2531, The Tissue 
Transplant Safety Act of 2002, I included a provision that would 
require the Commissioner of FDA and the Director of the Centers for 
Disease Control and Prevention (CDC) to jointly develop a single 
reporting mechanism for use in reporting adverse reactions of tissue. I 
believe there is a need for a centralize reporting system because the 
CDC does not currently have access to the same information as FDA. In 
fact, CDC must now rely on information it solicits from FDA ans state 
health departments. A central repository of adverse reaction 
information would be very useful in order for CDC to perform timely 
investigations of public health threats.
    When FDA was asked to comment on my bill, the Agency did not take a 
position on the requirement other than to suggest that it might be a 
cumbersome process. What is your position on a central reporting 
requirement?
    My understanding is that FDA currently receives voluntary reports 
of adverse events related to tissue through FDA's Medwatch System. 
FDA's proposed Good Tissue Practice rule would require tissue 
establishments to report adverse reactions and product deviations to 
the Agency. FDA also recognizes the importance of sharing and 
coordinating this information with CDC and is committed to working 
closely with CDC on this issue. If confirmed, I will work with you to 
ensure that this important goal is achieved.
    Question 85. Dr. McClellan, included in my bill, S. 2531, The 
Tissue Transplant Safety Act of 2002, is a provision that would require 
tissue establishments to submit a registration request to the 
Commissioner of FDA that would identify the principals of the 
establishment and the scope of its operation. Upon approval, a covered 
entity could then engage in activities related to human cell, tissue, 
or tissue-based products. An entity's registration could however, be 
suspended or revoked if found not to be in compliance with tissue 
regulations.
    When FDA was asked to comment on the bill, the Agency responded 
that the provision conflicts with FDA's current registration 
requirement, which is a simple notification to FDA that allows the 
Agency to communicate with and inspect establishments that engage in 
tissue activities.
    Unfortunately, a major gap in the current oversight regulatory 
scheme has been the haphazard inspection cycle with which FDA has 
examined tissue establishments. The ability to suspend or revoke 
registration would be a powerful means by which FDA could use to ensure 
greater compliance with safety standards and tissue regulations.
    What is your opinion with respect to strengthening the registration 
requirement?
    I agree that inspections and strong enforcement tools are important 
to help protect the public from unsafe tissues. FDA's recent 
Establishment Registration and Listing Final Rule requires tissue 
establishments to register with FDA and list their products and will 
increase the effectiveness of our inspection program. The Good Tissue 
Practice Proposed Rule includes inspection and enforcement provisions 
to ensure compliance. These provisions would allow FDA to order, as 
needed, the retention, recall, and destruction of products that present 
a communicable disease threat to the public. The proposed enforcement 
provisions would also permit FDA to order the cessation of one or more 
steps in the manufacture of tissue products, as needed, to protect the 
public health. These are powerful enforcement tools. FDA has 
successfully ensured compliance with other regulations using similar 
tools, without linking registration with the right to conduct business. 
If confirmed, I will examine whether these compliance tools are working 
effectively to achieve our important goal of tissue safety, and whether 
additional measures are necessary.
              Response to Questions of Senator Hutchinson
    Question 86. Recognizing the potential for prescription to 
nonprescription drug switch to further develop consumer empowerment and 
lower the costs of health care, would you describe the level of 
emphasis that you would place on Rx-to-OTC switch and the approval of 
new OTC drugs?
    Over-the-counter (OTC) drugs play an increasingly vital role in 
America's health care system. As Commissioner my goal is to be 
proactive in identifying Rx-to-OTC switches of drug products that will 
provide consumers an enhanced role in their health care decisions.
    Question 87. Nonprescription or over-the-counter (OTC) medicines 
serve important benefits for consumers, empowering them to treat 
certain conditions that can be self-diagnosed without the intervention 
of a physician. Do you agree that OTC medicines provide value for the 
public health delivery system, and if so, do you support giving greater 
emphasis to programs that focus on OTC medicines and consumer self-care 
issues?
    Over-the-counter (OTC) drugs play an increasingly vital role in 
America's health care system. As Commissioner my goal is to be 
proactive in identifying Rx-to-OTC switches of drug products that will 
provide consumers an enhanced role in their health care decisions.
    Question 88. Based on recent actions by FDA relating to dietary 
supplements, such as the development of a more rigorous adverse event 
surveillance system and several enforcement actions relating to safety 
and claims, do you agree that the Dietary Supplement Health and 
Education Act (DSHEA) provides FDA with adequate legal authority to 
regulate dietary supplement products?
    While my examination of issues relating to dietary supplements has 
allowed me to appreciate the challenges the Agency faces under the 
Dietary Supplement Health and Education Act of 1994, at this time I do 
not have specific statutory changes to recommend. As Commissioner, I 
will work with the Department and with Congress to implement the Act in 
accordance with Congressional intent.
                 Response to Questions of Senator Frist
    Question 89. Background: On September 28, 2000, the FDA approved 
RU-486, mifepristone (Mifeprex), for termination of early pregnancy (49 
days or less).
    The drug is distributed by Danco Laboratories, and manufactured in 
China for distribution in the United States by Hua Lain Pharmaceutical 
Company. FDA contends that the manufacturing site was inspected by the 
FDA to make sure it met FDA's requirements under Section 510 of the 
Federal Food, Drug and Cosmetic Act.
    Many question the safety of RU-486 to the health of the mother. 
According to the FDA medication guide that is required to accompany 
each physician's distributing of RU-486, patients should visit their 
provider three times throughout this treatment and that 5-8% of women 
will need surgery to end the pregnancy or stop chronic bleeding.
    The drug must be supplied directly by qualified physicians, and 
will not be available through pharmacies or the Internet. Physicians 
administering the drug must be qualified to provide any necessary 
surgery, or have made arrangements for any necessary surgery.
    Recent Events: April 19, 2002, Danco Laboratories, working with the 
FDA, issued a letter to health care providers regarding postmarketing 
adverse events of ectopic pregnancy (including one case of ectopic 
pregnancy resulting in death), sepsis, and a single case of heart 
attack. The letter reminded providers of the approved regimen for 
Mifeprex and of the need to report any serious adverse events 
associated with Mifeprex.
    On September 13, 2002, Governor Davis of California signed into law 
a bill that would allow nurses to prescribe abortion pills, such as 
Mifeprex, as long as they are under the supervision of a physician. 
However, the law does not require the physician be present, and may be 
read to conflict with the approval guidelines laid down by FDA.
    On September 25, 2002, Danco Laboratories stated that more than 
100,000 abortions had been completed in the U.S. since approval of the 
Mifeprex in 2000, that sales have increased significantly this year and 
that they have begun to see the drug used in private physicians' 
offices, as well as abortion and family planning clinics.
    Questions. What do you believe are appropriate circumstances under 
which to withdraw a drug from the market?
    Along with Senator Jeffords, I introduced legislation to improve 
patient safety. The House has passed two similar bills, and Senator 
Kennedy has even introduced such a bill. A common provision in all the 
bills would create a voluntary reporting system to track patient errors 
and adverse events. As you know, FDA already has such system for 
reporting adverse reactions to medications. What else do you think 
should be done to improve patient safety?
    a. As you know, the circumstances under which the Commissioner of 
Food and Drugs has the power to withdraw the approval of a drug are 
specified by section 505(e) of the FD&C Act. These circumstances 
include: 1) new evidence shows that the drug is unsafe for use as 
approved by the Agency, 2) new evidence that either was not considered 
or was not available at the time of approval demonstrates that the drug 
is not shown to be safe for use as approved by the Agency, 3) new 
evidence indicates that there is a lack of substantial evidence that 
the drug will have the intended effect under the conditions of use in 
the labeling, 4) the sponsor fails to file patent information required 
under the Act, or 5) the application contains an untrue statement of 
material fact.
    Additionally, mifepristone was approved for marketing under 21 CFR 
Part 314, Subpart H. Under Subpart H, FDA may withdraw approval of an 
application approved under that Subpart if: 1) a post-marketing 
clinical study fails to demonstrate clinical benefit, 2) the sponsor 
does not perform a required postmarketing study with due diligence, 3) 
post-approval use of the product demonstrates that post-marketing 
restrictions are inadequate to assure safe use of the drug, 4) the 
sponsor does not follow agreed-upon postmarketing restrictions, 5) the 
promotional materials are false or misleading, or 6) other evidence 
demonstrates that the drug is not shown to be safe or effective as 
approved.
    b. As you know, I appreciate your leadership and Senator Jeffords' 
leadership on the important problem of patient safety. Indeed, I 
believe that a major step that this Congress could take before 
adjournment to reduce errors is to enact your bipartisan bill, or the 
very similar bipartisan legislation that has been reported out of the 
Ways and Means and Energy and Commerce Committees in the House.
    If confirmed, I look forward to working with you and other members 
of Congress to building on this legislation with further administrative 
actions to help improve patient safety and eliminate avoidable 
complications of drugs and devices. More complete information on 
adverse events will help achieve this goal. As you know, FDA's 
voluntary system focuses on adverse events, which may or may not be the 
result of medical errors. FDA has undertaken efforts to encourage 
increased reporting of adverse events and medical errors.
    FDA currently is working on several additional patient safety 
initiatives, such as a proposed rule to require bar-coding of 
prescription drug products. I will look for more opportunities for FDA 
to take action to improve patient safety.
               Response to Questions of Senator Wellstone
    Question 90. FDA officials have been working hard to improve the 
speed of the review process for drugs and biologics, and if there is 
new medical device legislation that provides FDA's Device Center more 
resources, those reviews are also likely to be faster in the coming 
years. Speed of approval must be balanced ,of course, with patient 
safety. Many patient and consumer groups are worried that FDA has 
become more focused on responding to industry's concerns rather than 
rigorously assuring patient safety. In order to assure patient safety, 
what will you do to improve resources needed to monitor adverse 
reaction reports, Phase IV trials, and other safeguards that protect 
patients from potentially dangerous products?
    The enactment of PDUFA III allows resources from user fees to be 
used for enhanced risk management resources for the human drug and 
biologics programs. These additional user fee resources should enable 
the Agency to add additional staffing to the Agency's risk management 
efforts, including those efforts that occur up to three years after a 
new drug is approved. These additional PDUFA resources will enable the 
Agency to add about 100 additional staff years to drug and biologic 
risk management efforts by 2007. The PDUFA resources are clearly 
designed to enhance patient safety.
    As I indicated in my oral remarks, I believe that Congress should 
adopt the Medical Device Amendments of 2001, H.R. 3580, during the 
current session. H.R. 3580 defines the process for the review of 
medical devices, upon which device application fee revenues may be 
spent, to include both the evaluation of postmarket studies required as 
a condition of approval and compiling, developing, and reviewing 
information to identify safety and effectiveness issues. If this 
legislation is enacted, it will permit FDA to use some of the resources 
to enhance patient safety.
    Question 91. The FDA usually follows the recommendations of their 
advisory committees when decisions are made about approving new drugs, 
biologics, or medical devices. However, sometimes FDA approves products 
that the advisory panels do not recommend. For example, in a recent 
case involving a type of jaw implant (TMJ Implants Inc. Fossa Eminence 
implant), FDA approved the device even though the advisory committee 
unanimously opposed approval and the FDA's scientists pointed out the 
deficiencies of the safety research. The FDA stated that the patient 
and surgeon should share the risk of this device, instead of the FDA 
deciding for them whether the device is safe. Patient groups point out 
that the company heavily lobbied FDA to get their product approved. 
What will you do to ensure that decisions about the approval of new 
drugs, biologics, or devices are made on the basis of scientific 
evidence, not political pressure?
    FDA is a scientific regulating agency that makes decisions on the 
basis of science. The Agency's review and approval of medical products 
must adhere to its legal mandate and mission as a science based public 
health regulatory agency. Open discourse and information gathering 
within FDA about the best available evidence on the safety and efficacy 
of products under the Agency's regulatory authority is essential to 
creating the appropriate decision-making atmosphere to fulfill this 
mandate. I will work to maintain an open atmosphere within FDA for 
dialogue about products under FDA review. At the same time, I will also 
work to promote predictability and transparency about FDA decision 
making processes.
    Question 92. In the last few months, several investigative articles 
have criticized the lack of safeguards in FDA's regulation of implanted 
medical devices. There have been examples of implants being withdrawn 
from the market after patients died or were seriously harmed by 
implants. Some of these implants were approved through the 510K 
process, which is supposed to be limited to products that are 
``substantially equivalent'' to other products on the market. However, 
the FDA determined that some implants were ``substantially equivalent'' 
even if they were made out of a different material,or used in a 
different part of the body.What will you do to make sure that implants 
reviewed through the 510k process really are substantially equivalent?
    Substantial equivalence determinations are intended to be 
sufficiently flexible to allow product change and improvement, so long 
as the new product is at least as safe and effective as a product 
already on the market. In accordance with the statute and its 
regulations, FDA does require the submission of a new 510(k) for 
changes or modifications to an existing device, where the modifications 
could significantly affect the safety or effectiveness of the device. 
Changes in materials may be handled under the 510(k) process. However, 
I understand that the Agency has the discretion to require clinical 
data to support the use of new material in that implant in order to 
establish that the new product remains as safe and effective as the 
``predicate'' product. Obviously, if confirmed, I will work to make 
sure that the Agency continues to collect such information when 
appropriate.
    Question 93. A new GAO report recently concluded that post-market 
surveillance has suffered as a result of the Prescription Drug User Fee 
Act (PDUFA). Post-market surveillance is needed to make sure that drugs 
and other medical products are safe when available to the general 
population, and not just in premarket clinical trials. It is also 
important since so many drugs are taken for many, many years to treat 
chronic conditions. And of course, patients with implanted heart 
valves, knees, and other body parts may lives for decades. What is your 
view of requiring registries for implanted medical devices, and long-
term safety studies for implants and drugs used for chronic diseases? 
How long-term should those long-term studies be?
    I understand that FDA has some experience utilizing registries for 
issues related to medical devices. I also understand that when Congress 
required the Agency to use a pacemaker registry in the mid-1980s, the 
Agency encountered reluctance on the part of health professionals and 
patients. However, I will continue to be open to explore the use of 
registries, as well as other tools to develop more accurate and timely 
information on the safety of drugs and devices in practice. As you 
know, recent changes in the law (Section 522 of the Federal Food, Drug 
and Cosmetic Act) permit the Agency to request postmarket studies for 
up to three years. The Agency considers the use of registries to be a 
postmarket study tool. While the current law establishes three years as 
the ordinary limit on postmarket studies, the Agency may require longer 
studies if the manufacturer consents or the issue is resolved by a 
scientific dispute resolution panel. Finally, as part of the FDA drug 
approval process, the Agency may also obtain a commitment from the drug 
sponsor to perform Phase IV clinical trials, including long-term 
studies. These studies occur after a drug is approved. Finally, other 
electronic data sources may provide useful sources of information on 
long-term safety.
    It is my understanding that some manufacturers of drugs for which 
long-term use has been proposed have committed to follow several 
hundred patients for at least one to two years. How long the studies 
should be would depend on the particular drug and patient population to 
be followed.
    Question 94. Biologics can involve live cells that need nutrients 
such as bovine serum to survive. What safeguards does CBER use to make 
sure that those live cells and serums do not harbor dangerous 
infections such as Mad Cow Disease? Now that CDER will take over some 
responsibilities from CBER, what will you do to make sure that these 
safeguards are still in place?
    FDA's vigilance and procedures will not be changed after the 
transfer of the review of certain biological products from CBER to 
CDER. I understand that, through issuance of several letters and 
guidance documents, FDA continues to recommend that manufacturers of 
all vaccines and other biological products eliminate the use of bovine-
derived materials obtained from high-risk bovine spongiform 
encephalopathy sources.
    Since 1989, and most recently in January 2002, FDA also has issued 
numerous Guidance documents recommending that human blood and blood 
products and other biologic products containing or prepared using human 
blood derivatives not be obtained from donors at increased risk of 
transmissible spongiform encephalopathies, including variant 
Creutzfeldt-Jakob Disease. If confirmed, I intend to continue and, 
where necessary, enhance such steps to ensure the integrity and safety 
of biologics.
    Question 95. When the Prescription Drug User Fee Act (PDUFA) was 
coming up for re-authorization in the past year, FDA officials met with 
industry representatives in a series of meetings, where the outlines of 
the user fee agreement was hammered out. Consumer groups were invited 
to a few meetings with the FDA officials, but were not part of the 
meetings where decisions were made. A similar scenario took place when 
FDA negotiated with device manufacturers to develop user fees for 
medical devices.
    In your view, what is the appropriate role of patient and consumer 
organizations when policies affecting consumers are being developed?
    FDA values the input of all interested stakeholders as the Agency 
carries out its mission to promote and protect the public health. If 
confirmed, I intend to explore ways to enhance opportunities for such 
external input; it is valuable in making sure that FDA's decisions are 
as well informed as possible.
    This approach is consistent with the FDA's governing statute. 
Section 505 of Public Law 107-188 requires the Secretary of Health and 
Human Services to consult with a broad spectrum of stakeholders, in 
developing proposals for reauthorization of the Prescription Drug User 
Fee Act (PDUFA). This section further provides that recommendations for 
reauthorization of this Act be published in the Federal Register. 
Finally section 505 provides that following discussions on the proposal 
with the regulated industry, the recommendations be presented to 
Congressional committees, that a public meeting be held, and that 
comments be accepted on the proposal. I think this is an appropriate 
structure for consulting with all stakeholders during PDUFA 
reauthorizations. However, I welcome suggestions for improving the 
input process from patient and consumer groups.
                                 ______
                                 
          Consumer Healthcare Products Association,
                                       Washington, DC 20036
                                                   October 4, 2002.
Senator Edward Kennedy,
U.S. Senate,
Washington, DC 20510.

    Dear Senator Kennedy: On behalf of the Consumer Healthcare Products 
Association (CHPA), I am writing in support of the nomination of Dr. 
Mark McClellan as Commissioner of the U.S. Food and Drug Administration 
(FDA). Dr. McClellan's distinguished career in public service and his 
knowledge of healthcare issues make him an excellent candidate for the 
position.
    Founded in 1881, CHPA is the national trade association 
representing U.S. manufacturers and distributors of nonprescription or 
over-the-counter (OTC) medicines and dietary supplements. CHPA today 
represents over 200 companies involved in the manufacture, 
distribution, advertising, and research of consumer healthcare 
products. Our industry is heavily regulated by FDA, and the Association 
has a lengthy history of working cooperatively with the Agency to 
assure that consumers have safe and effective products.
    In supporting the nomination of Dr. McClellan as FDA Commissioner, 
we particularly would like to note his active knowledge and involvement 
in issues that are important to us, such as the Prescription Drug User 
Fee Act and bioterrorism preparedness. We also appreciate his 
understanding of the important role of nonprescription medicines in the 
healthcare delivery system, and his commitment to the Administration's 
development of a proposed rule on Good Manufacturing Practices for 
dietary supplements.
    Based on his academic background, knowledge of healthcare policy 
issues, and his commitment to public health and public service, we 
support the nomination of Dr. Mark McClellan as Commissioner of FDA.
            Sincerely,
                                           Linda A. Suydam,
                                                         President.

    [Whereupon, at 2:45 p.m., the committee was adjourned.]

                                    

      
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