NIH Grand Rounds

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

                              Bethesda, Maryland
                                August 7, 1991




Good afternoon.


A number of people have asked me to identify what one accomplishment I would   
like to achieve during my tenure as Commissioner of the FDA.


My answer is simple: I want above all to restore the credibility of the        
agency. 


I am confident that the Agency's fortunes are on the mend.  We have put the    
generic drugs program back on track, and Congress has begun to redress the     
imbalance of resources.  The FDA is moving forward.


We could spend hours talking about the various challenges facing the FDA:      
vaccines, the blood supply, cosmetics, generic drugs.  The need for tougher    
enforcement of our Nation's food and drug laws.  The need for streamlined      
management throughout the agency.


The agency's responsibilities are vast, and public expectations run high.


But today I'd like to focus on some of our recent actions that I hope will     
help restore the credibility of the FDA.  We need to affirm that the agency    
is on the side of the American consumer.


Doing that requires looking at a couple of questions:


What does consumer protection mean in the 1990's?


What do Americans expect from the FDA?


Certainly, the American public wants a reasonable degree of safety for         
products that we regulate.  That should come as no surprise.  Over the years,  
the greatest FDA controversies have involved safety:  saccharin, nitrites,     
the food color additive Red Number Three.  The list goes on.


Whatever else is said about the FDA, its record on product safety is           
extraordinary.  Our decisions sometimes are long in coming, but their quality  
stands the test of time.

It seems to me that consumer protection must go beyond traditional notions of  
safety.


In defining the FDA's goals of consumer protection, there should be no         
question that the agency's fundamental mission of protecting the American      
public remains as  strong as ever.


But let me also remind you that the original Food and Drugs Act of 1906 had    
two goals.  One was to protect and promote the public health; the second was   
to promote honesty and fair dealing in the marketplace.


Today, 85 years later, those two goals continue to be closely linked.  It is   
not enough for the FDA to focus solely on the contents of the vial or ampule   
or package and ensure that the product inside is safe.  The labeling of        
products, the claims made for them, and the way they are promoted, frequently  
have public health as well as economic ramifications.


The decisions that people face day in and day out -- what foods to eat,        
whether to embark on a particular course of therapy -- are difficult enough    
in and of themselves.  They are only compounded by those who would stretch,    
bend, or otherwise distort the truth.


In my undergraduate days, I had the good fortune to be a student of Henry      
Steele Commager.  He was a historian so steeped in this country's traditions   
and institutions that we nicknamed him "Henry Steele America."


Yet Professor Commager observed, and I quote, that
"A society trained to accept the preposterous claims, the deceptions, and the  
vulgarities of American advertising can perhaps be manipulated into accepting  
anything."


As the requirements of consumer protection continue to evolve, we at the FDA   
want American consumers not to be "trained" into accepting anything, but to    
be questioning -- and informed -- consumers.  Then, and only then, can         
consumers make informed and intelligent choices.


Let me tell you what we're doing to that end.


In the realm of food labeling, we took action against orange juice labeled     
"fresh," when it was in fact highly processed.  Next, we acted against         
products labeled "no cholesterol" when they were high in fat.


Then we announced our serious reservations about an increasingly prevalent     
form of food labeling:  the declaration that a product is " 'x' percent        
fat-free."  
We feel that this kind of labeling can be misleading, in much the same way as  
"no cholesterol" is misleading.


Our reasons for moving against these products were simple. The claim of        
freshness on processed food products is false.  The "no cholesterol" label on  
vegetable oil -- 100% fat -- is misleading, pure and simple.  And most         
"percent fat free" claims, as they are currently presented, are nothing more   
than a marketing gimmick.


These actions raise the broader question about whether the words on the food   
label have any meaning.  Words must have meaning, especially when people rely  
on them to make decisions about their health.


And our actions are closely tied to a longer-range goal:  FDA intends to       
foster the availability of useful information about the products we regulate.


The food label can contribute to a healthier America.


From the many letters supporting our actions, it is clear that the FDA has     
struck a chord with the American public.  Even Jay Leno complained on the      
Tonight show that his Bumblebee brand tuna contained no bumblebees!

The Nation's editorial pages have been watching, too.  One editor noted that   
the food descriptors "Contains no nuclear waste" or "no gasoline additives"    
would make as much sense as the words "no cholesterol" on a bottle of corn     
oil. 


The cartoonists have also been at work, as you can see from these examples:

o The first slide [Mighty Mouse] depicts a typical day for the FDA . . .

o Here is the way another cartoonist views supermarket shelves.

Standing in front of vacant shelves, the grocery clerk observes "We decided    
to remove only those products with misleading labels."

o Look at this slice of life from Gary Larson's "Cafe du Anteater."  The       
obviously finicky anteater on the right is asking the waitress, "Are the red   
ants fresh off the hill?"


-Here's one view of "fat free" labeling.  It depicts the salesman's claim      
that, since his company is charging only for other ingredients, the fat in     
his product is free.

o Continuing in the car dealer motif, this cartoon shows one car salesman      
explaining to his colleague that, even though the "no cholesterol" claim for   
their automobiles may be true, the FDA just might find it misleading.

o This is one of my favorites.  The modern American supermarket, with the      
aisles organized not by food category, but by the veracity of food label       
claims.

o And just to show that the FDA's concern about truthful claims extends        
beyond food, here is one final slide showing two scientists discussing their   
latest drug.  "No problem," one says to his colleague, who has just sprouted   
lower fangs and shoulder-length hair.

 "We just change our advertising slogan:  cures baldness and builds strong     
teeth."


In my view, when it comes to labeling and promotion, a fundamental             
repositioning needs to take place throughout industry. 

I would urge certain segments of the industry to shift their thinking on       
labeling.  Unfortunately, it's as if some firms are asking themselves, "How    
long can I get away with misleading information on my label?"


A more appropriate question, in my view, is this:  "How can I use accurate     
information, clearly presented, as a competitive advantage?"


All we ask is for the information to tell the whole story. Recent experience   
shows that the kernel of truth in a half truth is sometimes the worst half.


Put yourself for a moment in the shoes of the average consumer, slogging       
their way through the swamp of conflicting claims in any American              
supermarket.  Often, they don't know what -- or whom -- to believe anymore.


We have reached the point where the American people have had it with attempts  
to mislead them.  The status quo must change.


What it comes down to is this:  we are simply trying to achieve a fundamental  
tenet of the FDA's mandate.  We want to achieve honesty in the marketplace.


If we can do that, then it's safe to say that we are on the side of consumers.


The importance I attach to accurate information has obvious ramifications for  
the advertising and promotion of prescription drug products and medical        
devices as well.  FDA must take a closer look at the various promotional       
activities of the pharmaceutical and medical device industries.  We want to    
make sure that promotional activities are appropriate, that they provide       
clear and accurate information.


The sheer volume of prescription drug promotional activities concerns me.


Over the past two decades, for example, resources devoted to                   
industry-sponsored symposia have increased exponentially. According to the     
Congressional Research Service, sixteen companies sponsored 34 thousand        
symposia during 1988 -- at a cost exceeding 85 million dollars.


Comparable figures for 1974 showed that the same firms had sponsored seven     
thousand symposia, spending some six million in 1988 dollars.


In 1988, these 16 firms spent more than 13 times what they spent  -- in        
constant dollars -- 14 years earlier.


Perhaps even more significant, conventional methods of drug promotion --       
print advertising and written materials -- are being supplemented by           
non-traditional promotional techniques that rely heavily on researchers and    
medical experts.


I might add that, for pharmaceutical promotions, it's not enough for words to  
have meaning.  These promotions must also occur in the appropriate context.    
Things must actually be what they seem to be.


I'm not thinking of theoretical examples.


When a former star athlete appears on national television and discusses his    
arthritic knees, that is his business.  However, when the same former star,    
under sponsorship of a pharmaceutical firm, extols the virtues of a            
particular drug, his endorsements fall within the jurisdiction of the FDA.


When the drug is not unique, but one of many in its class, it is misleading    
to suggest that the product is a uniquely effective wonder drug.


It is even more misleading not to disclose the financial ties.  There may be   
nothing inherently wrong with the new techniques, such as special supplements  
to professional journals and satellite symposia.  But the FDA is seeing        
several drawbacks in their "real world" application.


First, the new promotional techniques are beginning to blur the distinction    
between promotion and legitimate scientific exchange.  If left unchecked,      
this trend could eventually dilute the quality of scientific discourse.


Second, these practices can mislead the medical community and, ultimately,     
the public.


Third, the inappropriate use of promotional tactics can give the unscrupulous  
an unfair market advantage.


How can physician-investigators be assured that they will not run afoul of     
the FDA?


FDA is establishing a few fundamental criteria that will help ensure that      
scientific exchange doesn't end up being promotional. 

The first criterion is independence.  It requires that the sponsor of an       
activity, the drug firm, have neither express nor implied control over the     
scientific content of the program.


Second is objectivity, which should ensure that the treatment of a drug or     
class of drug is not promotional.  It suggests that sponsors should fund       
educational activities through organizations known for their objectivity.


Balance is the third quality.  It requires the activity to include a range of  
views about the drug, class of drug, or disease under discussion.  The goal    
should be a free exchange of ideas --not a pre-ordained conclusion.


Finally, scientific rigor -- the fourth criterion -- suggests that the data    
presented should be reliable.


 Careful adherence to these four criteria -- independence, objectivity,        
balance, and scientific rigor -- will minimize the risk that a                 
industry-sponsored event or activity will cross the line and become            
promotional.


Let me move on to yet another example of the need to provide complete and      
accurate information about a product under our purview.  Last week, the FDA    
initiated a seizure action against one brand of breast implant.



The U.S. attorney in Minneapolis filed a seizure action against these breast   
implants on behalf of the FDA because the manufacturer was marketing an        
unapproved breast implant, and because of unsubstantiated claims about that    
product.


This product was being promoted directly to women with claims such as, "Now,   
a breast implant that can give you peace of mind."


Unsubstantiated claims such as this one are simply inappropriate.  The FDA,    
and the medical community, cannot tolerate them.  The many issues involving    
breast implants are uncertain enough, and misleading claims only add to the    
confusion.


Moreover, unsubstantiated claims also lead women to underestimate the risks    
involved with breast implants.


I believe that people are willing to take risks, but claims such as these      
deny them the ability they need to make a fully informed decision.


This situation has been brought home to me by our meetings with women's        
support groups and the many calls we have received from women who simply have  
not realized that there could be adverse effects with breast implants.  Many   
of the telephone calls we are getting come from women who feel that they were  
lulled into believing that these devices are risk free.


When women feel that they have been lulled into believing that breast          
implants are risk free, something is wrong.


Whether the risks were unexplained, played down, not heard, or simply not      
known at the time, the fact remains that we must do a better job of            
communicating the risks and unanswered questions associated with breast        
implants and other products.


Naturally, this need for more information extends to drug products as well.    
We are hearing the message, and we are hearing it loud and clear, that some    
patients with life-threatening diseases want greater control of their care --  
of decisions that affect their lives.


This push for more information is entirely consistent with the FDA's efforts   
to speed the drug development and review process.


It is equally clear to me that some segments of the American public are        
willing to take greater risks with treatments for life-threatening diseases    
for which there is no alternative therapy. The risk-benefit calculus is        
simply different in these situations.


In my view, the FDA must be prepared to respond appropriately. This means      
doing everything in our power to expedite the development and review of new    
therapies -- while maintaining our standards.


The FDA is the gatekeeper that protects the public against unsafe and          
ineffective products, and that role will not diminish. 

When patients are desperately ill, we must not subject them to other           
toxicities unless there is reason to believe a drug will improve their         
overall health.


In the context of today's discussion, responding appropriately also means      
communicating in the clearest possible terms the increased risks that may be   
associated with those therapies we accelerate.


Less than three weeks ago, FDA convened an advisory committee for its advice   
on a new drug application for DDI to treat AIDS.  In the jargon of test        
pilots, this new drug application "pushed the envelope" of drug development    
and review.


Essentially, it only contained Phase 1 trials, and for the most part relied    
on historical controls.


But, the advisory committee apparently thought that FDA's analysis of the      
data had demonstrated "the right stuff," because it was willing to recommend   
approval of DDI.


If the FDA follows this recommendation, it will be crucial for patients to     
understand the greater risk of taking a drug that has been less thoroughly     
tested than most.


There will be second-guessers:  there always are.  But if the FDA adopts a     
"flexible standard" for a small universe of special drugs, it will represent   
a step away from paternalism and a step toward patient autonomy.


But it will be a step worth taking only if the FDA, the NIH, the medical       
community, and the pharmaceutical industry work to ensure that decisions to    
embark on a course of therapy are fully informed decisions.


That note brings me to my final point.  Many people worked long and hard to    
make that advisory committee meeting happen. People from the NIH have been     
meeting constantly with staff members of our Division of Anti-Viral Drug       
Products.


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 Dr. Tony Fauci.

The anti-viral advisory committee was indeed setting important precedents.


Its meeting was a triumph for those so desperately in need of new therapies.   
But it was a triumph of perhaps even greater magnitude:  a triumph of          
collaboration between FDA and NIH.


This invigorated collaboration extends well beyond work on drugs to treat      
AIDS.  FDA and the National Cancer Institute are working fervently on new      
therapies for cancer, and that relationship has never been better.  Dr. Sam    
Broder, Dr. Greg Burke, and Dr. Carl Peck deserve the credit  -- and our       
gratitude. 

In fact, I fully hope and expect  -- and I know Dr. Healy does too -- to see   
the collaboration between the NIH and the FDA stepped up even further.


I look forward to a time of even greater collaboration, of increased fluidity  
of interaction, between the two agencies.  I hope scientists and clinicians    
will be able to move between our organizations with relative ease.  In my      
view, the challenges are too big for any one institution to handle.


So, today, I pledge the FDA's increased support for an even closer working     
relationship with the NIH.  And I ask you to join with the FDA, whenever it    
is appropriate, to speed the review and development of new therapies.


The FDA has a proud history, and so does the NIH.  Yet even though we are      
headquartered in neighboring cities   -- and are literally neighbors here on   
the NIH campus -- we have never fully capitalized on our collective potential  
for advancing medical science.


Let us continue today, to take advantage of the closeness of geography and     
similarity of mission that we share.  The American people will all be better   
off for our efforts.


Thank you.

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