David A. Kessler, M.D.
Commissioner of Food and Drugs before the
FDA Anti-Viral Drug Products
July 18, 1991
I've asked to appear briefly before you this morning for one simple reason: this advisory committee meeting represents a milestone in drug review.
It is the culmination of much hard work by many people.
Today, less than three-and-a-half months after receiving the new drug application for DDI, we are asking for your advice on that NDA. Our goal for all important new AIDS drugs is to turn protocols around in weeks, and to measure review times in months.
This meeting is a milestone in another respect: the creative and innovative techniques that have contributed to the evaluation of this NDA. These include the development of more sophisticated models designed to quantify CD4 levels in patients, highly productive and cooperative efforts with the Division of AIDS at the NIH, and innovative review procedures.
Moreover, this NDA is the first marketing application for which the U.S. and Canada are co-reviewing clinical data.
In a sense, we are asking for your views not only on the application for DDI -- we are also seeking your opinion on the usefulness of these innovations.
In the jargon of test pilots, this new drug application "pushes the envelope" of drug development and review. Whether these efforts provide evidence of "the right stuff," is for you to evaluate.
I am also here to acknowledge those who have made the NDA, and today's meeting, possible.
First, the FDA's Division of Anti-Viral Drug Products. This division deserves credit regardless of your committee's ultimate recommendations on the issues before you.
I have spent time in the Anti-Viral Division. I have witnessed the energetic and creative approaches of the scientists and physicians there. These people have given generously of themselves -- time and again -- to bring us where we are today.
By their example, they are driving change throughout this agency. They are making things happen.
Dr. Sandy Kweder, Dr. Dianne Murphy, Dr. Rachel Behrman -- and Dr. Jim Bilstad -- have distinguished themselves. And through his enlightened leadership, Dr. Carl Peck is changing the way things are done in the Center.
But the praise goes beyond individuals. And I'm talking about the entire Division of Anti-Viral Drug Products. People working on DDI have received considerable attention, and that is appropriate. I'd simply like to acknowledge the essential work of everyone else there -- those who have tended to the other business of the Division. Their role is every bit as crucial.
Second, let me recognize our colleagues in NIH and other agencies. Representatives of the NIH Division of Acquired Immunodeficiency Syndrome, part of NIAID, have been meeting weekly with people from our own Anti-Viral Division. Their interactions represent scientific collaboration of the highest quality.
I would like specifically to recognize and thank Dr. Dan Hoth, Director of the Division of AIDS, and Dr. Susan Ellenberg, Chief of the Biostatistics Research Branch, for their constructive approach to getting the job done -- and of course my friend, Dr. Tony Fauci.
When FDA reviewers are members of the AIDS Clinical Trials Group "core" committees, as they are now, everyone benefits.
Third, I would like to recognize all parties with a stake in finding new treatments for AIDS. What we have been seeing is unprecedented cooperation -- first from the drug's sponsor, Bristol-Myers.
Let me also say that we have learned much from the AIDS community. We have recognized that FDA is -- that we must be -- accountable for what we do. And I think that, in some ways, the AIDS community has a more complete understanding of the challenges that the FDA must confront.
I appreciate the frank and open dialogue we have had with the AIDS community during the last several months.
The intense and innovative approach to drug development in evidence here today is the paradigm of the future.
The state-of-the-art is constantly evolving. As it does, you have my commitment that the FDA will remain at the forefront of drug development and review.
The work before you is very important, and I don't want to take any more of your time.
But I must add one note: a more human note, and a particularly sad one. This has been a most challenging time for the Division of Anti-Viral Drug Products -- but a subdued time as well.
We are all mourning the loss of Mike Phelin, a young chemist who died suddenly a few weeks ago. Mike's contribution -- and his gentle humanity -- will be missed.
Let me also mention Dr. Bob Schnur, who was instrumental in the review of foscarnate. Bob is extremely ill, and I want him and his family to know that all our thoughts are with him today.
As you begin your work this morning, let me assure you that, regardless of how this meeting turns out, AIDS will remain at the top of FDA's priorities. The intensity of FDA's efforts devoted to all new AIDS drugs will not diminish over time.
We will continue to focus, and focus intently, on AIDS --until this dread disease has been brought under control.
Thank you all for your efforts.