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David A. Kessler, M.D. - NIH Grand Rounds

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.