Jane E. Henney, M.D.

As prepared for delivery.

Mr. Vice President, Madame Secretary, Distinguished Members of Congress, Friends - AI stand before you as a tangible example of the breadth and depth of FDA=s recall authority.@

I am most grateful for the honor bestowed on me by the President, with his nomination, and the Senate, with their confirmation, to become the 18th Commissioner of Food and Drugs. Vice President Gore, I want to personally thank you for your support and for your tireless efforts on behalf of the Agency.

The opportunity to share this ceremony with those of you in the room is something I have looked forward to for a long time. Many of you played a direct role in supporting my nomination for this position. Although they weren=t able to be in attendance, I want to particularly acknowledge Senators Domenici and Bingaman for their early and enduring support. Chairman Jeffords could not be here today, but Senators Hatch and Coats are in attendance and their interest in the FDA - and concern that the Agency have a Commissioner - was extremely and extraordinarily important in the final days of the confirmation process. And Senator Kennedy, I thank you for your words of endorsement and encouragement throughout the entire process.

I would also like to recognize my friend, Dr. Michael Friedman, who has served as the Agency=s Acting Head. Having myself been AActing Dean@ of a medical school for a year and a half, I know the unique challenges that face an individual with full responsibility but uncertain tenure.

I also want to thank Secretary Shalala. Her guidance and tenacious support was evident and much appreciated. There are also countless others here who have provided me with both their support and opportunity in my past times of federal service. And some of you have been kind enough to play a role in both episodes. I am grateful for the friendship, support, and trust that all of you have shown in me.

Before making a few comments, I would also like to introduce you to the members of my family. My parents, Harry and Jeanette from Woodburn, Indiana -- their love and loyalty is a constant and unconditional source of support for me and the other members of my family. My sister, Anne Hansen, from Lansing, Michigan, my brother, Floyd Henney and his spouse, Geri from Ft. Wayne; and my brother, Dr. Fred Henney and his spouse, Kathy from Monticello, Indiana. I would also like you to meet my sister-in-law, Cheri Jones from Seattle and, in abstinentia, my father-in-law, Jim Graham, who couldn=t join us for health reasons, but is here in spirit. And my spouse, closest friend, adviser and confidant, Dr. Bob Graham, who, 16 years ago this month, was sworn in by Secretary Schweiker as the first Administrator of the Health Resources and Services Administration. Knowing how much Bob enjoyed that experience as an agency head was very much a factor in my considering this return to Washington.

I would like to acknowledge a special guest, Emerson Niswander, Professor Emeritis from Manchester College, North Manchester, Indiana. When queried by me about whether or not I could possibly consider a career in medicine, Doc said simply and succinctly Awhy not?@.

One of the particular reasons that assuming the Commissioner=s role was of interest to me, was that it provided me with an opportunity to return to Federal service in a role of public leadership. Every period of history for a federal agency has its own special requirements for effective leadership, and it has been my view that the challenges facing the Agency put a premium on finding a Commissioner who had a fundamental understanding and background of the workings of multiple communities - science, academia, the Congress and Administration, and the public. It is my hope that my past professional experiences measure up well to these criteria.

I recognize that I am but a single individual joining an Agency with a rich history of accomplishment and service in the public=s interest. One of my main tasks will be to ensure that our multiple constituencies view the FDA as championing three important principles: to be fair, to be firm, and to be effective.

The FDA stands at the critical juncture between scientific discovery and clinical application. The laws which we carry out mandate that we make decisions related to the safety and effectiveness of drugs, devices, and foods in such a way that the public=s health is both protected and promoted. Controversy will always surround this interface, and the dictates of good science will often be in dispute between the opposing views of people of good intent.

In the words of St. Thomas Aquinas, AWe must love them both - those whose opinions we share and those whose opinions we reject. For both have labored in the search for truth, and both have helped us in the finding of it.@

We will be committed to making and applying our judgements with both fairness and firmness ... open to all legitimate opinions and information, but knowing that the final responsibility for making each judgement must rest with us.

Carrying out our tasks with a heightened degree of effectiveness will also be a key objective of mine as I know it has been of the Vice President. In complex systems - and certainly government today meets that definition - what you can accomplish is often defined by how you seek to accomplish it. I am committed to the management principle that the best organizations find ways to constantly improve themselves. They continuously re-examine their processes, tasks, and goals, and use their daily experiences to refine their efforts in approaching the next task.

I am committed to assuring that the FDA is a science-based, public service organization, which will never miss an opportunity to evolve itself to better meet its multiple tasks.

Let me close these remarks with an observation attributed to the late President Kennedy:

AMy experience in government is that when things are noncontroversial,

beautifully coordinated, and all the rest, it must be that there is not

much going on.@

By his criteria, I=m sure that there will always seem to be a lot going on at the FDA. I look forward to this opportunity to follow my many distinguished predecessors as Commissioner, and I thank all of you again for taking the time today to share this moment of beginning with me and my family.