2/22/91

Mr. Secretary, Dr. Mason, friends and honored guests,


Allow me to start my remarks by saluting the men and women who are engaged in  
the Persian Gulf. I know that some of your sons and daughters, friends and     
colleagues, are there. They are very much on our minds as we proceed with      
this ceremony.


I want to thank all of you for coming.  Your presence means a lot to me.       
It's great to have my wife, my parents, and my children here today.


This ceremony marks an exceptional event in my life.  First of all, I want to  
say that in leaving New York I left a hospital that I loved -- and many        
wonderful people -- and that was not easy for me.


I am well aware of the challenges I am about to face.  I know they are many.   
But I am willing, I am eager, to get on with the job.  If the issues are       
complex, my own motives are not.  I simply want to be part of our response to  
these challenges.


This afternoon, I want to spell out some of the challenges we face.

If we are to succeed, we must make them shared challenges.  Everyone who has   
a stake in the nation's health has a role in our work.

What are some of the challenges that we must face together?


Certainly, we must carry out the tasks that have traditionally been FDA's      
"bread and butter."   We must restore full confidence in the integrity of the  
data upon which we base our work.  We must increase domestic and import        
inspections; reduce review times for product applications and streamline       
enforcement procedures by paying more attention to our field activities. We    
must recognize that we have become an information agency and we must manage    
accordingly.


But that is only part of the story.  The environment in which we operate has   
produced an entirely new set of challenges.   We must think about how to       
apply traditional principles to non-traditional problems.


Over the past decade, these new challenges have tested our mettle -- and they  
will continue to do so.

o The AIDS epidemic.

Who could have predicted, even 10 short years ago, the effect of this          
modern-day scourge?  Since 1981, we have lost 100,000 Americans to this        
epidemic -- a quarter of them in 1990 alone.

o The changing medical model.


Patients are demanding more choice, more information, and a greater say in     
their health care.  This is as it should be. But easier access, earlier        
access, may change the risk/benefit calculus.


Patients must understand that greater risk may be involved when they choose    
to use products earlier in the development and review process. But in no       
event should fraudulent products see the light of day.

o The global marketplace.

The United States now imports a variety of foods from all over the world.      
The U.S. is also a major exporter of foods, drugs, and medical devices.  We    
must maintain our role as world leaders even as we come to grips with a host   
of international issues. It is a more competitive world.

o Changing patterns of food production and consumption.

There has been a virtual revolution in the way Americans grow, buy and         
consume food.

o A new generation of therapies.

The number of Investigational Drug, Biologic, and Device applications is       
beginning to increase exponentially, and these newer products tend to be more  
complex.


Reviewing their safety and efficacy will require greater expertise in          
traditional disciplines and a thorough understanding of new technologies.


To me as a physician, though, there's an exciting and invigorating aspect to   
this landslide of applications.  Itmeans that a new medical armamentarium --   
with its new promise for patients -- is on the horizon.


Each of these challenges will test FDA's own creativity and resolve.

If we -- collectively -- are to succeed, if we are to meet these challenges    
-- we must defend and uphold certain principles.


Above all, we must stand for the principles that breathe life into the Food,   
Drug and Cosmetic Act.  In the broadest sense, I see two such principles.


Our society has judged that it is the purveyor of goods that must be           
responsible for ensuring that they are safe, effective, and properly           
labeled.  Over the years, Congress has shown remarkable consistency in         
upholding this principle -- largely, I believe, because its members            
recognized that the FDA can never be a ubiquitous policeman.



Bu the FDA is a policeman.  Congress has given FDA the authority to deal with  
those who would shirk their statutory responsibilities. And I promise you,     
the FDA will not be a "paper tiger."


The other fundamental principle that gives life to our statute is the FDA's    
positive duty to promote and protect the public health.  This principle        
requires the agency to act promptly and efficiently in everything we do.


All of us must care deeply about keeping unsafe products off the market.  But  
the corollary is that we should also care as deeply about making important     
new therapies and technologies available, as promptly as we can, to those who  
need them. Every decision the agency makes is a decision involving balance.    
There can be no perfect decisions. Our decisions are based on current          
scientific knowledge. As that knowledge is updated or revised we must remain   
open to change as well.


Finally, and most importantly, we must stand for -- and insist upon --         
honesty in everything that we do.  Nothing is more important. We must be true  
to the fundamental principle of science -- a scrupulous commitment to          
honesty.  The past two or three years have taught all of us painful lessons    
about what can happen when integrity takes a back seat to expedience.


These are the things we must stand for:  fealty to the Food, Drug and          
Cosmetic Act, a willingness to enforce the statute, a commitment to strong     
management, and integrity in everything we do.

Only in this way can we respond to the challenges, and the opportunities,      
that we -- the community of those who care about health -- now face.


Let me close by speaking directly to FDA employees. I know that you joined     
the agency because you wanted to protect the American consumer.  And that is   
exactly what you are going to do.

Do not let current or past problems outweigh the pride you can rightfully      
take, day in and day out, in a job well done. Always remember that you are     
working for the most important, the most respected, consumer protection        
agency in the world.


There will be problems; there will be setbacks.  But they should never get in  
the way of the satisfaction you can take in the knowledge that every day you   
make a difference.


The times demand a lot, but they demand no more than the FDA is capable of     
delivering.  Time and again you have proven your dedication, you have          
demonstrated your ability to stick to your work until it is done.


This is one of the traits I most admire in you.  It is an honor to join your   
ranks today.  I am proud to call myself a "Food and Drugger."


As the custodians of a proud heritage, we must always be willing to make the   
tough decisions that are required of us. Regulators do not win popularity      
contests -- and they should never try.  But they should take great pains       
never to be arrogant or overbearing.

Thirteen years ago Don Kennedy said the FDA was a large, slow-moving object    
that bleeds profusely when hit. I suppose that says something about            
bureaucratic inertia and about the FDA's vulnerability to attack from the      
outside and from within. But large, slow-moving objects have momentum, too,    
and when they are well-aimed they get where they are going, no matter what.

The story of the Food and Drug Administration is a series of proud chapters    
in American history, written not by Commissioners, but by the men and women    
of the FDA.


Their collective imprint on this agency -- and on the public health -- is      
their greatest achievement, their enduring legacy. We must never lose sight    
of the fact that the agency's record in assuring safety is unparalleled.


I pledge my every effort to drive appropriate change, to bring out this        
agency's great resolve, vigor, and intellect.  But change does not come from   
the Commissioner alone.


True change comes from those who actually do the hands-on, day-to-day work.    
And in our quest for change, in our desire to fix things, we must preserve     
all that is good in this agency.


The Food and Drug Administration, Mr. Secretary, has the will and the talent   
to serve this nation well.  It has the most vital resource, the dedication of  
its people.


Today we are here to celebrate not one person's new job, but the resurgence    
of community, of tradition, of respect, of values that come alive only when    
they are shared.


FDA is a great agency, and I am honored to become its Commissioner.

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