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David A. Kessler, M.D. - FDA Anti-Viral Drug Products

Remarks

by

David A. Kessler, M.D.
Commissioner of Food and Drugs

before the
FDA Anti-Viral Drug Products
Advisory Committee

Bethesda, Maryland
July 18, 1991

Good Morning.

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.