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U.S. Department of Health and Human Services

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MAY 2l, 1990


I appreciate that gracious introduction and the opportunity to be with you
today. I regret I was unable to be here last year, but, I'm glad Dr. Guest
was able to fill in, and that you have invited me back for this historic
meeting that marks your fifty years of commitment to animal health.

I've been Acting Commissioner for six months now, and in the Commissioner's
Office for two years. So, you might say I'm still on the steep side of the
learning curve. And most of the learning is through crises and dealing with
issues like BST and drug residues in milk.

There are lots of important subjects for us to address today as we consider
animal health issues for the 1990's, and our joint responsibilities in
assuring the safety of the nation's food supply.

Food safety is -- and will continue to be -- a main theme for FDA, and our
constant goal.

This is a time of intense activity for FDA. There are lots of regulatory
issues, which is not unusual. There is increased interest in our activities
by the Secretary of Health and Human Services. We have been shocked by the
generic drugs irregularities and have been the subject of considerable
amount of oversight. Secretary Sullivan has recently set up a Blue Ribbon
panel to examine the Agency's strengths and weaknesses, resources and
obligations, performance and priorities. We're going to be scrutinized
under a magnifying glass, which is healthy. We welcome this opportunity for
thorough analysis and stock-taking.

The timing of this meeting is good, because I can give you a fresh report on
the opening session of the advisory panel, which met last Thursday and
Friday. During the meeting, senior FDA staff, including Gerry Guest,
provided an overview of our activities. Many of the topics we discussed
bear directly on animal health issues for the 1990's. Gerry, for instance,
talked about biotechnology products and generics.

In my mind, there are two major FDA themes for the Blue Ribbon group: the
gap between public expectations and what we can deliver, and our
credibility. The level of expectations from FDA keeps going up all the
time. People are more health conscious than ever, and they look to the
Agency to guarantee not only the safety of their food and cosmetics, but
also the safety and efficacy of their drugs, and medical devices.

Our job keeps getting bigger and bigger. We're getting new drug
applications in unprecedented numbers -- twice to three times as many as we
used to get a decade ago. Imports have tripled since 1972. Congress has
passed 23 new laws in the last l7 years whose implementation is wholly or
partly our responsibility. On top of all this, there is a growing pressure
from consumer organizations and the general public for greater scrutiny of
foods for traces of pesticides and other potentially harmful chemicals. We
are expected to handle this ever-growing workload by everyone -- Congress,
industry, the ordinary citizen.

Yet when you look at our budgets over the past ten years, you will see that
after subtracting the special increases for the AIDS epidemic, the amounts
we've received have remained flat. The pressure on our available resources
has become so serious that we have recently initiated a comprehensive needs
assessment that will look at the projected Agency work load until 1997 and
estimate the FDA needs to handle it.

We're looking for the most cost-effective ways of fulfilling our various
regulatory tasks, from sampling imported produce for pesticides to testing
the performance of medical devices and checking the safety and efficacy of
drugs. The bottom line is that we have to align our mission with public
expectations. If we don't, the FDA will lose assets in one area where
depletion cannot be tolerated -- namely, credibility.

Credibility, as I see it, is one of the biggest challenges we're facing now
and will face in the years ahead. In the 1950's and 1960's, it was possible
to submit a food sample to a battery of state-of-the-art tests and proclaim
it free of pesticides and other harmful chemicals. At that time, we could
identify traces of pesticides at the level of one part per l00 million.

By now, scientific measurements have become so refined that we can look for
carcinogens at the level of one part per trillion -- and we find them. They
are there, far below concentrations which pose a risk to human health, but
they exist.

The results make headlines -- about Alar in apples, about traces of
chemicals in milk, about pesticides in imported vegetables stopped by FDA
investigators at the border. Frequent headlines of this sort breed distrust
that you see reflected in the campaign against milk from experimental herds
injected with BST.

What we've also learned in the last few years is that simply pronouncing a
food "safe" is not enough. The public remains skeptical. State
legislatures, food processors, and supermarket chains respond more to public
perceptions than to our scientific evidence.

I am not sure of the solution. One obvious part of the answer to our
credibility gap is that we always have to be very careful to tell the public
the truth. We have to speak openly about the size of the risk, if there is
a risk involved, and we have to do a better job than we have done in the
past of educating the public.

Our public should know what we really mean when we talk about a "negligible"
risk posed by traces of pesticides in our food. It should also have an idea
about the contribution which these pesticides make to our standard of
living. Only then will consumers be in a position to arrive at their own
conclusions about food safety.

A better informed, more sophisticated public perception of food hazards
would enable us at the FDA to use our resources where they would do the most
good, not where they allay the greatest misconceptions and fears.

Now, some steps in this direction have already been taken. Following the
Alar episode a little over a year ago, the White House set up a task force
to look at depth at the problems of food safety. Cooper Evans, the
Agriculture Adviser of President Bush, very knowledgeably took up the issue
of revision of the pesticide legislation, including the Delaney Amendment
which set up the now-unattainable standard of "zero risk" of carcinogens in
food additives. At the same time, the President's plan made realistic food
safety a national priority, as we are the FDA -- and our friends at the
Environmental Protection Agency and the U.S. Department of Agriculture --
have believed it should be.

Just how widespread is the concern about safe food and drugs is reflected in
the unprecedented number of bills that have been dropped into the hopper
during the current session of Congress. So far, we have counted:

* l0 seafood safety bills
* 8 garbage backhauling bills
* 4 pesticide bills
* l ban on BST
* l ban on L-tryptophan

plus 8 states considering their own legislation on some of these issues.

I should add that despite their variety, most of the proposals agree in one
important aspect: they set the standard of negligible risk at about one in
a million over a lifetime exposure.

Our scientists tell us this is an attainable ratio and a standard which can
be enforced, as well as a very high assurance of safety.

But legislative action alone will not get the job done. I feel that we must
do much more than simply pass a pesticide bill.

We must act to reassure, as well as to assure the public that the food
supply is safe. We at the FDA will continue working with the Department of
Agriculture to monitor food for pesticide residues. The problem of
Salmonella enteritidis in eggs must be addressed. The danger of foodborne
diseases has to be dealt with more adequately.

Last but not least, we'll have to continue cooperating with the European
Community, Canada, and our other trading partners to harmonize our
regulations and improve the safety of food in international commerce. This
is one of our major issues.

Let me turn to some specifics. There are many important issues concerning
animal health and food safety of concern to all of us. I want to talk about
three: drug residues in milk, BST, and generic animal drugs.

Let me begin with drug residues in milk.

In public perception, milk is right up there with motherhood and apple pie.
People, above all, want a safe milk supply. We, along with you, must assure
that! We can accomplish this with the cooperation of the milk producers,
the veterinary community, and AHI.

As you know, our probe into residues in milk which we conducted earlier this
year caused some controversy.

What happened was that when we finished the first phase of the testing, we
said that we had found no sulfamethazine but that we would continue looking
for it. We then found 2-3 parts per billion of sulfamethazine -- amounts
well below the established level of concern of l0 parts per billion.

The criticism that followed our second announcement was an important
lesson. It showed that facts need to be clearly presented -- and clearly
understood -- the first time.

We believe that the trace amounts of residues in milk found to date pose no
health concern. But we need to be more careful in our communications; if
we're not, we pay a penalty in a highly valuable area, which is our

Milk, perhaps more than any other food, must remain safe and pure. We all
have a role to play in this regard. An excellent example of how producers
and veterinarians can cooperate in safeguarding milk is the quality
assurance guidelines for drugs used on dairy farms which were prepared by
the American Veterinarian Medical Association and the National Milk
Producers Federation. This program is expected to begin in the fall. We
need more joint ventures of this kind. It is the type of industry
responsibility that Senator Kennedy is pushing for in his pesticide bill.

Now, allow me to proceed to another issue that has challenged our
communications stills and raised questions about our credibility: BST.

As I mentioned before, BST is an excellent example of a credibility issue.
What happened was that we handled the review of BST entirely in the
scientific framework, just like any other drug application. What did not
get enough attention was the fact that the use of BST has economic and
social implications for dairy farming, and that the future of small dairy
farms is of considerable concern to a segment of the public, both here and
in Europe. As a result, our position on BST was widely criticized, and many
consumers ended up not trusting FDA.

We believe that BST is safe. To prove our point, we have taken such
unprecedented steps as submitting an article about the drug to Science
magazine where it should appear this summer, and asking the National
Institute of Health to evaluate the human safety data on milk produced by
cows injected with BST.

All this to establish our credibility, an attribute that's easy to
undermine, but hard to build.

And now on to my final topic -- generics.

The law covering generic animal drugs becomes effective January l, 199l.
We've done a lot to get ready for the new task: we've increased our
resources, tried to establish a policy and procedures, and communicated with
the industry and others.

Hopefully we've learned something from problems of the human generics

Among other things, we will set up a new data tracking system that enables
us to track a document down to the individual reviewer and to establish
whether the application is being reviewed according to the priority of its

We also have hired ten of the l6 additional reviewers we'll need to handle
the new generics workload, and we're looking for more manpower to enforce
compliance with our regulations. You have to expect us to be tougher in the
field, although we still want to cooperate. However, we also believe that
industry must establish its own ethics. We can't do it all.

In closing, let me return to our two main themes for the future:
expectations and credibility.

I'm optimistic about the future of FDA. The Roper Polls show that in spite
of our communications problems we still enjoy the consumer support rate of
74% -- the best among American regulatory agencies.

Another good news is an improvement in our budgetary climate. Our resources
are on the upswing.

We have learned our lesson about the importance of communication, and we are
going to make the FDA and its works better known and more easily understood.

But I must emphasize that we're in this together. Risk communications
present a problem for you no less than for us, and it is your interest to
help us deal with it.

Thank you for your attention.