Mr. Chairman, Senator Kennedy, distinguished members of the Committee, I
thank each of you for the invitation to be here today and for the courtesies you have
already extended to me in the confirmation process. I also want to express my
gratitude to Senators Domenici and Bingaman for their friendship and support for my
It is an honor to appear before the Committee that has shown so much
leadership on health care issues, particularly through the enactment of the Food and
Drug Administration Modernization Act of 1997. I appreciate this opportunity to discuss
my qualifications and commitment to lead the Agency's effort to implement the Act, and
to promote the public's access to safe and effective medical products.
I am also grateful to President Clinton for nominating me and for his continued
confidence in my abilities to serve as the next Commissioner of Food and Drugs. I
have been fortunate to serve in the Administrations of Presidents Ford, Carter, Reagan,
Bush and Clinton. My goal has always been to promote the public health, and I am
here again because of this opportunity to serve the public.
As a medical oncologist with two decades of experience managing change in
public health care institutions, I am eager to meet the challenges that lie ahead for one
of our nation's pre-eminent public health agencies. The Food and Drug Administration
touches each American's life every day. And industries that the Agency regulates --
food, cosmetic, pharmaceutical, biotechnology, blood, medical device, and veterinary
medicine -- are respected worldwide for their ingenuity, success, and, perhaps most
importantly, for the quality of their products.
American industries produce the finest medical therapies because of this nation's
substantial investment in basic research and because FDA ensures that new medical
products meet the American public's expectation that the treatments they use will be
safe and effective. By ensuring the high quality of the products it regulates, FDA plays
a critical role in promoting and protecting the public health.
Mr. Chairman, if I am confirmed, my priorities will be very clear. First and
foremost will be implementing the FDA Modernization Act, both the letter and the spirit
of the law. My desire to return to federal service is in large part driven by the content
and substance of the Act and the new philosophy that it embodies. I intend to build on
this collaborative, constructive model by working closely with Congress, the regulated
industries, patients, consumers, and health care professionals. I am deeply committed
to building bridges of communication and breaking down the barriers that have kept the
Agency from being as effective and productive as it should be.
One key element of the new collaborative spirit embodied in the FDA
Modernization Act is the reauthorization of the Prescription Drug User Fee Act. This
Act was the prototype legislation that I am proud to have helped develop during my
previous tenure at FDA. It increased the Agency's resources and dramatically
improved the Agency's performance, speeding safe, effective drugs and biologics to
those in need. This Act also demonstrated the benefits that come when the Congress,
FDA, industry and consumers work together to achieve a common goal that benefits
the public health. The FDA Modernization Act takes this philosophy further through
innovative procedures, such as third-party reviews for devices that will expedite review
times without compromising the public's health. In addition, the Act will provide
companies an expedited process for making certain health claims.
I also intend to focus on other key responsibilities of FDA. In particular, I share
the commitment of members of this Committee to make our nation's food supply as
safe as it can be. The safety of our blood supply and preventing the harm that can
come to our country's youth from tobacco use also are of great concern. I know that we
can, and must, work together to assure the American public that we, as a government,
are doing all we can, and should do, in these critical areas.
Finally, if I am confirmed as Commissioner, it will be a high priority of mine to
strengthen the science base of the Agency. Recruiting and retaining the best scientists
is key to FDA's success. A firm scientific foundation is critical to assure the accuracy
and timeliness of our regulatory activities. It should concern us all that, at the very time
the public and private research enterprise in this country is flourishing, one of our
essential regulatory agencies may have difficulty recruiting and retaining strong
scientists. Certainly not all scientists need to be engaged in active bench research, and
there may be many opportunities to develop alliances with other public agencies, but
together we must find ways and means to keep the science base of the Agency from
I am confident that these difficult and often complex issues can be managed
efficiently and effectively. But you also need to know why I am confident, and why I am
qualified to lead this important public agency.
I am a physician and cancer specialist who has demonstrated strong
management and leadership skills in a variety of large and complex health
organizations. FDA is an agency that I know well. For two years, I managed its daily activities and recruited most of the extremely capable center directors who now lead the Agency. I know its strengths; I know its limitations.
Leading a science-based organization is not a new experience for me. The first
nine years of my career were spent in federal service at the National Cancer Institute,
where from 1980 to 1985 I served as Deputy Director. I have been privileged to hold
leadership positions in large academic health centers, first at the University of Kansas
and now as Vice President for Health Sciences of the University of New Mexico. As
Vice President, I have led the organization by implementing significant change, both in
the way health care is delivered and in how the next generation of health care
professionals learn. One of the keys to success in our work has been the meaningful
involvement of legislators, other policy makers, health care providers and payers,
professionals, and patients. These voices from the community have been critical in
assuring that we are meeting our state's needs.
In carrying out my responsibilities at both the University of Kansas and the
University of New Mexico, I have fostered an environment and recruited leaders that
resulted in tremendous growth in our research efforts.
In addition to my responsibilities in an academic health science center, my
current service on the Director's Advisory Committee of the National Institutes of Health
and as President of the United States Pharmacopeia continues to give me an
appreciation and perspective of the strengths and needs of science -- and of the
patients who benefit from its results.
I also have had "hands-on" participation in the scientific enterprise. During my
early years at the National Cancer Institute, I was responsible for drug development
activities as a drug monitor for investigational drug studies. Later, at the University of
Kansas, I became a principal investigator on investigational studies for the treatment of
As you know, I now live and work in New Mexico, but much of what has shaped
my career is rooted in the small community of Woodburn, Indiana, a town of just 512
people when I was a child. A woman who I admired in Woodburn was stricken with
breast cancer, a disease that was only mentioned in a hushed voice in those days. She
shared some of her struggle with me. As her cancer advanced, she opened herself to
the possibility -- and risk-- of what research could offer. It was her belief that if the
experimental therapy did not benefit her, then her experience would at least help
others. This experience and her altruism influenced my choice of a career in medicine
at a time when women often were not welcomed.
There were many other lessons to be learned in Woodburn. In our small
community, resources were finite in terms of people and finances. Both were valued
and used wisely.
Some of you know first-hand the privilege of learning to live in a community
where everyone -- literally -- knows your name and almost everything about you. In
small towns, there are few places to hide; responsibility and accountability become
second nature. Consequently, I have never shied away from tough or uncomfortable
decisions. I also learned first-hand that if decisions are to last, they need to be reached
by consensus and collaboration. This is not to say everyone in our town thought alike,
for as Walter Lippman once said, "if we all think alike, someone's not thinking."
Expressing oneself clearly, and, more importantly, listening were placed at a high
premium in our community.
In Woodburn, people who knew and respected one another were able to build
strength out of differing points of view and make wise and long-lasting decisions. It was
in this community that I learned many fundamental lessons of leadership and
management, lessons that I have applied over and over again in even the most
complex organizations. The result is, I believe, an approach of being open, fair,
forthright, and honest. It is my intention to bring this same discipline and integrity to the
role I would assume as Commissioner.
I have been fortunate to enjoy a challenging career that, I believe, well prepares
me for the task at hand. I look forward to our discussion today and to our working
together in the future. Thank you.