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David A. Kessler, M.D. - FDA Chapter of Sigma Xi

The Role of Scientific Research in the FDA

by

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

Joint Spring Banquet Meeting
FDA Chapter of Sigma Xi
and the
Society for Experimental Biology and Medicine,
D.C. Section

Bethesda, Maryland
May 6, 1991

Good evening. I am honored to participate in your annual banquet and awards
celebration. As an undergraduate I was elected an Associate Member of Sigma
Xi, and it means a great deal to me to see scientists -- of all ages --
recognized for their work.

I am also very comfortable here with you tonight. Many speeches and public
appearances I do because they come with the Commissioner's turf. This one
I'm doing because I want to.

But I have to admit I was somewhat startled when I saw the menu: especially
the part about "fresh" vegetables. After a brief inspection of the
Marriott's kitchen, however, I was able to verify that the vegetables were
not frozen, or treated with heat, or otherwise processed.

My message for you this evening is a simple one. I am here to say that
research in the Food and Drug Administration is a precious commodity -- one
that requires careful nurturing and constant attention.

It also requires clear goals and judicious management.

This evening, I'd like to focus on the role of scientific research in the
FDA. Most of you are FDA scientists, and you deserve to know how science
fits into the structure I envision for the Agency.

To do justice to the topic, it's important for you to understand how I view
the broad mission of the Agency -- where FDA has been, and where it is going.

I began my time as Commissioner with a deep appreciation for the rich
history and tradition of the FDA. Few institutions have such continuity of
mission. Few agencies can boast of the special spirit that pervades FDA.

FDA is without a doubt, without reservation, the most important consumer
protection agency in the world. Over the years, its employees have
demonstrated a unique commitment to protect and enhance the health of the
American public.

That mission has not changed during this century. And the Agency's success
in carrying it out has derived in large measure from the cadre of expert and
dedicated scientists that have been the FDA's strong suit.

My goal as Commissioner is to build upon the tradition of excellence and to
reaffirm the fundamental mission of the Agency. I fully recognize that such
a reaffirmation is particularly crucial after a difficult period.

It's clear that recent years have not been easy for the FDA. The erosion of
resources that has occurred for more than a decade -- and the consequences
of that erosion -- is a story that must be told. It's a simple point to
make: FDA must have the resources to do its job.

People have always been -- and will always be -- the FDA's most significant
resource. That's why the Agency must renew its commitment to retaining its
excellent scientists -- as well as doing everything we can to recruit fresh
scientific talent.

The Agency's science base has served the nation well in the past, but some
observers -- both in FDA and outside -- have suggested that changes are in
order for science in the FDA.

Consider the following points:

o The scientific resources at FDA's disposal have simply not allowed the
Agency to keep pace with developments in the industries it regulates.

o The desirability of internal FDA research has been questioned. The
Edwards Committee -- which is studying the structure, mission, and resources
of the FDA -- has heard several strong presentations challenging the need
for the FDA to do its own science.

o Furthermore, some have argued that the National Center for Toxicological
Research should be removed from the FDA. Although I have not accepted their
argument, it does raise questions about the relationship between NCTR and
the FDA. Let me get back to this subject shortly.

o One last factor is of my own making. I have emphasized the importance of
enforcement. Some may have interpretedthis emphasis on enforcing the law as
a signal that I do not value strong science or appropriate research.

I mean no such thing. I am absolutely committed to strong science within
the FDA. But I am also convinced that the FDA must regain some of its lost
credibility before it can get on with other unfinished business. Enforcing
the law firmly and fairly is simply the best way I know to restore the
Agency's credibility as a strong protector of public health.

Some of you might have seen the story on enforcement that appeared on the
Federal Page of today's Washington Post. The story got it right: the FDA
under this Commissioner is very serious about the integrity of the food
label.

But the recent actions against labels claiming their foods are "fresh"
transcend claims on the food label. These actions are really "about" the
FDA's willingness to enforce the law.

It is a willingness I am prepared to demonstrate in all areas of FDA's
regulatory responsibility. I recognize that enforcement is only a tool, but
I believe that it is the most important tool FDA has.

And let me emphasize that I am not interested in running up the enforcement
numbers for the sake of keeping score.

Rather, I see judicious enforcement as the means to rebuilding the Agency's
credibility -- for making certain that the FDA does not relinquish its
status as the foremost scientific regulatory agency in the world.

With that as background, I'd like to provide my views on where research fits
in the structure I envision for the FDA.

I have assured anyone who has asked that I will not make organizational
changes lightly or without good reason. But I have also made it clear that
I do intend to drive some changes in the way the FDA goes about its
business. Since those changes will involve science, they are relevant for
us this evening.

The current product-oriented structure -- with five FDA Centers responsible
for various types of products -- impresses me as entirely satisfactory.

When it comes to the overall structure of the Agency, however, there is room
for improvement.

In my view, there are five important functions:

o First, policy

o Second, external affairs

o Third, management systems

o Fourth, operations

o And fifth, science.

I'd like to say a word about each of the first four, and then concentrate on
science.

Concerning policy, if I were to ask each of you who in the FDA has the
overall responsibility for coordinating the process by which the Agency
issues regulations, I'm willing to bet there would be many answers. If I
were asked, I would answer in two words: "No one."

This situation must be remedied. The FDA must be able to issue regulations
in a reasonable amount of time. I told Congressman Waxman in March that I
want one focus for regulations
-- and I'm optimistic that soon that location will be established in the FDA.

Please don't misunderstand my intentions. The individual Centers have
always done the bulk of the work on regulations, and I don't expect that to
change. But there are times when the Centers need guidance on a proposed
rule -- just as there are times when the review of a regulation has moved
beyond the control of an individual Center.

On the external affairs front, it is essential that the FDA have a means to
coordinate the way we deal with matters involving various constituencies --
the appropriations committees, to name only one example.

Concerning management systems, I am committed to helping the Agency find
better ways to do its work. The FDA needs more efficient systems, better
management structures, if it is to cope successfully with its current
responsibilities.

I'm not simply talking about computer systems. I'm talking about the way we
do work, about our internal processes. I'm talking about "Systems" with a
capital "S."

Operations comprise the fourth overall function. There should be someone in
a very senior position whose job it is to workclosely, day-in and day-out,
with the five Center directors -- not to interfere or micro-manage the
Centers, but to support their efforts and to provide consistency throughout
the Agency.

That leaves science. I am convinced that "Science" must have a considerably
higher profile on the fourteenth floor of the Parklawn Building. In plain
English, when we discuss significant scientific and regulatory matters, it
is important to bring a scientist to the table. I know that I need someone
to keep up with science around the Agency, someone who can analyze the
issues and evaluate the arguments -- all of this with a scientist's
particular point of view.

Let me repeat the five basic functions: policy, external affairs,
management systems, operations, and science. Don't be surprised if, in the
months ahead, you begin to see some of the way we do business organized
around these five functions.

The focus this evening, of course, is on science. As I mentioned earlier,
science in the FDA must be nurtured. To this end, I hope to recruit a
senior scientist to serve as a resource to me and to the various FDA Centers.

I am not interested in building a new science organization in the
Commissioner's Office, any more than I am interested in establishing an
extraneous hoop through which new products and new policies must jump.

The responsibility for making decisions based on science will remain where
it belongs -- in the FDA Centers. But there are times when individual
Centers simply get too close to an issue, times when they could use an
expert, independent set of eyes and ears.

I know there are occasions when I will need scientific advice -- because
I've needed it already. It is abundantly clear that I cannot review all the
relevant science on a given issue. I need the expertise of a trusted
advisor, the wisdom of a senior statesperson.

The bottom line is that the FDA must have a management and organizational
structure that fosters decision making. Focusing on the five functions --
policy, external affairs, management systems, operations, and science --
should help the FDA do just that.

All of this brings me to this evening's major topic, the broader role of
research in the Food and Drug Administration. My views should hold no
surprises for you. Essentially, I believethat research in the FDA should
support the Agency's consumer protection and public health mission -- as
this mission is expressed both in terms of enforcement and product review.

As I see it, research in the FDA should have several characteristics.

First of all, it should be relevant to the work of the Agency. Although
research needs do vary from Center to Center, the general rule is that
scientific research in the FDA should concern questions the Agency is called
upon to answer.

For example, not too long ago the best test for detecting Listeria required
two weeks to confirm or rule out the presence of the bacteria. A delay of
this magnitude was unacceptable if the FDA was going to deal effectively
with outbreaks of Listeria contamination of dairy products.

What did researchers at FDA's Center for Food Safety and Applied Nutrition
do? They developed a rapid DNA probe for the organism -- a test that takes
one day, not two weeks.

A second requisite for FDA science is that it must be first rate.
Otherwise, it will have no impact, it will be worthless. To borrow another
example from foods, the recent work on the migration of packaging materials
from heat susceptors in microwave foods had to be good. It was good work,
it was credible science, and it had an impact on industry.

Third, research in the FDA must be focused so that it contributes to the
Agency's role as a repository of credible knowledge. The FDA must carry out
research that other organizations will not -- or cannot -- perform. When a
medical device malfunctions or a vaccine is contaminated or a food is making
people sick -- and a phone call comes in the middle of the night -- the
telephone rings at the FDA.

And we must not only be there to respond -- we must also have the right
answers.

Let me provide a "for instance." It involves the recent product tamperings
in Washington State. You may recall that someone removed decongestant
capsules from their packages and added cyanide to the medicine. Two deaths
and one serious illness have been attributed to this outbreak of tampering.

As it turns out, there was brief speculation that the tamperings were not
limited to capsules of the product. One victim died after apparently
ingesting cyanide from a tablet of thedecongestant.

Had this occurred, it would have represented a major escalation of the
tampering episode. The manufacturer of the product was faced with the
decision of whether to recall its tablet formulations of the product as well.

The company needed answers fast -- and it turned to FDA.

Traces of cyanide had been found in the vomitus of the victim who had died
after ingesting a tablet. When that cyanide had been tested by FDA's
laboratories in Cincinnati, however, it was found to contain traces of gold
as well.

No gold had been found in the cyanide that had been placed in the capsules.
But on further investigation, cyanide was found at the work place of the
"tablet" victim.

That lot of cyanide did contain traces of gold -- conclusive evidence that
the death was not caused by a tablet tampering, but by a successful suicide.

Most of the examples I have cited so far involve enforcement. But FDA's
research extends to product review as well -- the fourth characteristic of
FDA science.

Consider an example from the world of medical devices. Diagnostic ultrasound
has become an increasingly important tool in the detection of fetal
abnormalities. It has great merit, and is much in demand. As a result,
FDA's Center for Devices and Radiological Health has been receiving more and
more submissions for devices that use this technology.

One basic question about diagnostic ultrasound has remained largely
unanswered: the long-term effects of this technology on the fetus. In
response to this need, scientists at CDRH have developed techniques for
analyzing and measuring the dose of ultrasound received -- and of keeping
that dose to the absolute minimum.

This is a task that the Agency could have turned over to the various
sponsors of devices using ultrasound -- in essence, requiring them to
develop the necessary analytical tools. Instead, we anticipated a need,
developed innovative techniques, and almost certainly shortened review time.

Speaking to a meeting of food industry executives two weeks ago, I announced
the seizure of orange juice because of its false and misleading label.
Although that action made the news, my primary goal in the speech was to
describe the mission of theCenter for Food Safety and Applied Nutrition.

In that speech, I made the case for internal FDA research in food safety and
nutrition. But because the point about internal research can be generalized
to FDA as a whole, it is worth repeating here. The point is simply that, if
the FDA is familiar with a given technology or the science on which it is
based, the Agency is much more likely to know how to evaluate it.

If we haven't "been there" scientifically, it will be all too easy simply to
say "no" when a new product is submitted for review.

There's a fifth and final observation about research in the FDA. It is
that, when all is said and done, science drives policy. The objectivity
conferred by good science -- along with the safeguards of peer review -- are
ultimately what give FDA policy its credibility. These attributes,
fundamental to research, make FDA's policy judgments much more than simply
one person's opinion against another's.

Frankly, I was not pleased some two weeks ago when the first notice I
received about the latest problem with prosthetic silicone breast implants
came from my morning New York Times.

It is not that I oppose open discussion or free scientific exchange -- far
from it. It is simply that there are better ways for Agency scientists to
communicate with the Commissioner than through the press.

Let me assure you that, whenever the Agency has sound scientific data, I
will take action. Where consumer protection is concerned, the American
public deserves prompt decisions. If any scientists in the Agency should
feel that their voices are not being heard, I urge them to come to me
personally.

I cannot promise that I will agree, but I can promise that we will make
decisions based on science. After all, we're all trying to achieve the same
result: sound consumer protection.

It's one thing to assert the importance of good science in the FDA, and
quite another to find the wherewithal to support it. Supporting the kind of
science needs I've been discussing has significant resource implications.

"O.K., Kessler," you might be tempted to ask. "You've persuaded me that you
sincerely mean it when you assert that research is important to the FDA.
Now, what are you doing about it?"

It is a reasonable question. If I were asked it, here's what I would say.

I would first of all say that I am working to improve our management systems
so that FDA maximizes the benefits it receives from the resources it
currently has. I have been impressed by the quality and the scope of
research at the FDA.

But I am not certain that the FDA's research agenda is as well thought out
and managed as it should be. That is why I am asking each Center Director
to establish clear research priorities. I am asking further that these
priorities be communicated and monitored.

The FDA has to know what kind of research it is doing, and it must be able
to articulate why that research is important. We must always be sure that
every research dollar we spend is a dollar well spent.

Second, I would point to the National Center for Toxicological Research. As
you know, NCTR is a major FDA research facility in Jefferson, Arkansas.

I have asked NCTR and the other FDA Centers to begin integrating the
scientific agenda of NCTR with the rest of the Agency. The research agenda
at NCTR must be closely aligned with the needs of FDA.

I have no quarrel with the quality of research at NCTR. All I am saying is
that, since FDA pays the bills, FDA should reap much of scientific benefit.
I am very determined to integrate NCTR into the mainstream of the Agency.

CFSAN critically needs better methods of assessing human health risks from
animal studies.

Whether the adverse effect is cancer, neurotoxicity, or developmental
toxicity, current methods for evaluating risks or determining no effect
levels are being challenged. NCTR and CFSAN must work together and assist
each other in developing new methods.

One historical impediment to this desired integration has been the lack of
funds for travel from the various FDA Centers to NCTR. To remove this
impediment, I have directed that additional travel funds be made available
-- so that FDA scientists will be able to collaborate more closely with
their colleagues in Arkansas.

I know FDA scientists are willing to move beyond whateverimpediments may
have existed in the past -- so that FDA and the American public can reap the
full scientific benefits of NCTR's talent and expertise.

The bottom line on resources is that FDA cannot make a credible case for
increased research funding unless we can honestly say we are making the best
use possible of current dollars.

Nevertheless, there is a third part to my answer about what we're doing for
research at the FDA. I am working for increased funding.

After a decade of eroding resources, the FDA budget numbers have turned
around and are now heading in the right direction. There is still plenty of
catching up to do, but we are once again on the right track.

Further, I am pushing just as hard as I can for an integrated FDA facility.
The Congress a made great step toward this goal last year when it passed the
FDA Revitalization Act.

The integrated facility I envision will be nothing fancy. But it must be a
sufficient improvement over current facilities, so that prospective FDA
scientists will not reject employment offers because of our deplorable
laboratories.

The new facility will be precisely what we need to end the sense of
fragmentation that pervades the FDA. It will foster a new collegiality and
renewed team spirit.

That is the long-term objective. For the shorter term, we must do what we
can to improve current laboratories. Fortunately, some relief is on the way.

In the next month or two, FDA will dedicate and move into its new research
facility in Beltsville, Maryland. The Beltsville labs will restore some
badly needed research capability. And later this month, I will be in
Chicago to help inaugurate the National Center for Food Safety and
Technology.

This new FDA facility, born of a unique relationship among private industry,
the academic community, and the FDA, shows what can be accomplished through
creative thinking and hard work.

Scientists in general -- and FDA scientists in particular -- are seldom
reluctant to ask questions or exchange views. You deserve the chance to do
just that.

With that, I'd be pleased to entertain questions. I'd ask only one favor:
no jokes about orange juice, freshly-seized orotherwise!