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.


                                     ###