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FRANK E. YOUNG, M.D., Ph.D. - Association Of Food And Drug Officials

SPEECH 06/23/1988
REMARKS
BY
FRANK E. YOUNG, M.D., Ph.D.
COMMISSIONER OF FOOD AND DRUGS

Association Of Food And Drug Officials
92ND ANNUAL CONFERENCE

HARTFORD, CONNECTICUT
JUNE 14, 1988

Good morning. It's always a pleasure to speak before a
Group that has been sharing the challenges and accomplishments of
Ensuring the safety of the food and drug supply even longer than
The food and drug administration. I am especially pleased to be
Here in person to greet many of my friends whom i missed last
Year in tulsa.

INTRODUCTION

It's particularly significant that i am speaking before
You today -- for in eleven days we at fda will be celebrating the
Fiftieth anniversary of the 1938 food, drug, and cosmetic act. I
Believe that it is striking to compare how the health and well
Being of americans has since evolved over these five decades.
Since 1938 we have seen unprecedented changes in the way
Americans live. Marvelous medical discoveries have
Revolutionized our understanding of disease; afflictions like
Smallpox and polio that were once a scourge have been eradicated;
Our homes, workplaces, and highways are safer than ever; and
Because of those things we live longer, more productive lives.

Yet no change was more important -- and beneficial --
Than the passage of the legislation that was to ensure that there
Were nationwide laws protecting the public's foods and medicines.

THE 1938 ACT

Let me take a moment to revisit the days before that
Legislation came into being. In the 1930s, milk was still often
Harvested from tubercular cows; arsenic was routinely applied to
Fresh fruits and vegetables; and useless drugs were commonly
Sold with claims of curing all the ills that flesh is heir to.
In fact, one curative hodge podge of the time included potassium
Ferrocyanide, cadmium, lead and silver nitrate, oatmeal, whiskey,
Tobacco, and even tapioca and bay rum -- which sounds like it
Might actually have made some people feel better if it didn't
Kill them first.

Those things weren't just nonsensical; they posed a
Real threat to human health. That's why federal, state, and
Local health officials campaigned vigorously throughout the 1930s
To have legislation enacted to give food and drug officials
Greater authority to control such hazards. But i don't need to
Tell you that the truly precipitating event in the 1938 act's
Passage was the tragedy involving elixir of sulfanilamide.

That poisonous sulfa drug killed 107 people, mostly
Children, before a horrified nation realized the nature and
Extent of the tragedy. In fact, a young graduate student at the
University of chicago helped discover what was destroying those
Lives -- the addition of the solvent diethylene glycol (anti-
Freeze!) To an otherwise useful drug. That young student,
Dr. Frances kelsey, was later to become an fda employee, and to
Be decorated by president kennedy for using the 1938 law to
Prevent another drug -- thalidomide -- from being sold in the
United states.

Most people, though, don't know of the many heroic
Efforts made by fda, state, and local inspectors to track down
Stocks of the elixir before they could kill yet more americans.
One texas state inspector drove 460 miles and called on 45
Druggists in 17 towns within a 24-hour period. An arkansas-based
Fda inspector investigating one lot of the drug spent four days
Tracking down just one purchase, knowing only that it had been
Sold to someone named long. He traveled throughout several small
Towns in arkansas, finally reaching the right long family -- as a
Funeral for their seven-year-old daughter, who had taken the
Drug, got underway.

And a south carolina inspector tracked a bottle to the
Grave of a man who had just died, and found the bottle among his
Personal effects on top of the grave -- a custom in those parts
For disposing of sickroom utensils. Amazingly, the nation's food
And drug inspectional forces were able to mobilize so thoroughly
That they found over 99% of the 700 pints of the poisonous elixir
That had been distributed throughout the nation.

I also don't think most people realize that those
Forces could ensure the recovery of the drug not because it was
Unsafe -- that condition did not warrant using existing seizure
Authority -- but because the elixir was misbranded (to be called
An "elixir" it had to have alcohol, which this didn't contain).

When president franklin roosevelt signed the food,
Drug, and cosmetic act into law on june 25, 1938, he thus
Launched a half-century of scientific progress and regulatory
Protection for americans. The new law placed greater emphasis
Upon preventing public health problems from arising rather than
Punishment, and included several new provisions to ensure the
Safety of cosmetics, medical devices, food ingredients, and
Pesticides. In addition, one of its most important new
Provisions gave the federal government, for the first time, the
Responsibility for approving new drugs as safe before they could
Be marketed.

INNOVATION FOLLOWING THE 1938 ACT

Industry at the time feared the new law, and predicted
That it would stifle research. In fact, the new law encouraged
Innovation, because it required research to prove that products--
Particularly drugs -- were safe. As the act was being signed,
Alexander fleming's discovery that mold spores could kill
Bacteria was leading to the development of penicillin. In a
Little over a decade after that, there was an unprecedented
Outpouring of important new drugs -- beginning with new
Antibiotics in the late 1940s and cortisone in
1949. Then, in a kind of creative cascade, came the first tranquilizer in
1952, the first antifungal antibiotic in 1954, the first oral
Antidiabetic agent in 1955, and, in 1963, the first antiviral
Drug. Indeed, those years were so incredibly productive that
They have been called the "first therapeutic revolution." and
The drug review system that had been established by the 1938 act
Was able to ensure that those drugs were safe. As a result, as
Wave after wave of new drug classes were discovered in the 1941s
And beyond, physicians and their patients developed a degree of
Confidence in their medications that had never before existed.

In the food industry, the heat treatment techniques of
Louis pasteur were improved upon to virtually perfect the art of
Canning perishable foods. New techniques followed -- freezing,
Dehydrating, fermenting, even irradiating foods to make them last
Longer and preserve their nutritional content.

There was a concomitant increase in the ability of
American agriculture to produce ever more bountiful yields of the
Fruits, vegetables, grains, and meats that serve as the basis for
Our food supply -- largely through the development of safe and
Effective new fertilizers and pesticides. That productivity,
Combined with innovations in food processing and packaging, has
Allowed the industry to provide our citizens with a variety of
Food that is the envy of other nations.

Indeed, today's supermarket contains over ten times the
Food items found in a market in 1938, and hundreds more are being
Developed by industry every year. And, as remarkable as that is
By itself, the proportion of their income that americans spend on
Food has actually dropped from about forty percent a century ago
To just over fifteen percent today.

THE FUTURE

The future for those industries is every bit as bright as the past. In
Fact, many believe the drug industry -- and the emergent medical device
Industry -- are now entering a period that some are calling the "second
Therapeutic revolution." here's what the coming years hold in store:

Advances in recombinant dna will provide outstanding
Opportunities to conquer many of the diseases that plagued
Mankind. Already we have seen the advent of cloned insulin,
Growth hormone, tissue plasminogen activator, and a vaccine
For the prevention of hepatitis-b;

Microencapsulation will be perfected to allow drugs to be
Carried through the body until they arrive at targed sites;

The development of monoclonal antibodies for the diagnosis
And treatment of a variety of diseases;

Computerized devices will be developed to augment functions;

New, more effective neuropharmacological compounds will come
Into use to combat senility, mental retardation, and
Schizophrenia;

Tiny electronic pumps will be implanted into the human body
And programmed to deliver the right amount of a drug at the
Right times -- and send information about how they are working
As well as receive instructions to change the dosage;

And animal hormones will be developed that will increase the
Yield of food animals beyond what was once believed possible.

NEW FOODS

A variety of novel foods are just over the horizon as well. For example,
Foods will be derived from unconventional sources, such as fungi, to produce
High protein foods; and from non-food chemicals, to produce food ingredients
That are functional without providing calories. But the most exciting
Developments in food processing are likely to come from genetic
Engineering. Already, geneticists can foresee livestock improvements that
Will include increased milk and egg output, disease resistance, growth rate,
Fertility, and meat quality.

Just as improvements in plant genetics have already begun the "green
Revolution" that has helped so much of the world's population feed itself,
Refinements in that technology will continue to increase crop yield, disease
And herbicide resistance, fertilizer efficiency, and nutritional quality.

The processing of the foods we know today will continue to evolve as well.
The food processing plant of the future will be fully automated and
Computerized, with only a handful of employees needed to ensure that raw
Materials entering the production line come out as a finished food. The
Freeze-drying techniques we have seen for years in coffee and tea will be
Used in a wider variety of foods, such as fruit juices and alcoholic
Beverages. And the movement in food packaging away from glass and metal
Contains will continue -- toward the new flexible "pouches" that are both
Lighter and less expensive than bottles and cans.

These changes in food production will not only increase the variety and
Appearance of foods, they will also contribute to better health. Better
Processing techniques will help ensure against microbial contamination and
Help detect dangerous contaminants such as listeria; and new packaging
Methods will help prevent spoilage. Perhaps most importantly, however, many
Of the new foods will contain less or no fats, which evidence suggests will
Contribute to americans' fight against two of the most serious modern
Afflictions -- cancer and heart disease.

The responsibility to regulate such an amalgamation of food, medicines,
Animal drugs, medical devices, and high technology is an enormous one that
We at fda share with those of you in the states. It means that we often
Find ourselves standing between the findings of basic research, and the
Applications of that research that allow industry to realize profits and
Sponsor yet more research. We must ensure that we act as a bridge between
Basic and applied research, not as a barrier.

BIOTECHNOLOGY

A good example of how we at fda had addressed such questions is in our
Regulation of the fruits of biotechnology -- what someone has described as
The "last great technical innovation of the 20th centure." clearly,
Biotechnology has a tremendous potential for improving our foods and drugs
-- indeed, our lives. Yet some fear that genetic engineering will unleash
Dangerous new organisms that will plague both nature and mankind. I reject
That belief, for nearly fifteen years of research and commercial experience
In recombinant dna technology have yet to demonstrate inherent danger in
Using these newest methods to modify genetic structure.

But realization that there are not such dangers is not the only thing we
Need to ensure that the tremendous potential of biotechnology is reached.
We need continued research, an informed public, a science-based regulatory
Framework, and well-prepared support.

To accomplish those goals, the federal government must begin with high
Quality scientists, who are up-to-date in their understanding of new
Technologies. Their excellence will determine the accuracy and timeliness
Of agency judgments -- whether it be fda's, or epa's, or the department of
Agriculture's. We also need state-of-the-art laboratories and equipment
Second to none to guarantee the high quality product evaluations the public
Expects and deserves.

We must also address the unjustified fear and lack of public confidence that
Exists relative to biotechnology. To do so, we need a broadly educated,
Knowledgeable public capable of making informed decisions on such important
Scientific issues.

The last part of the recipe is the regulatory framework -- one that
Understands the complexities and promises of biotechnology, and can work
With the many new -- and some old -- biotechnology firms that are doing the
Groundbreaking research to develop new products. At the fda, we committed
Ourselves to setting a regulatory approach that could assure the swift
Development of safe and effective biotechnology drugs, devices, and other
Fda-regulated products. That approach has been carried out in two basic
Ways.

First, we at fda review new human and animal drugs, foods, vaccines, and
Medical devices derived from biotechnology using the same criteria used to
Review other products -- under the premarket approval authority embodied in
The 1938 act and its later amendments. No more, no less.

Second, we try to foster innovation by working directly with biotechnology
Firms to guide them through the various regulatory steps. For the small
Medical device firms that have been such innovators in developing new
Rdna-derived diagnostic products, we designed a "small business" approach
Which recognizes that such firms are inexperienced in dealing with fda
Requirements and lack large government relations staffs to guide them. This
Approach includes the provision of technical assistance to firms, frequent
"consultations" on research and testing protocols, and guidance through all
Phases of the application process.

The united states is currently the world leader in biotechnology research
And development. But several of the world's nations are pouring their
Resources into this field to challenge that lead. Government and industry
Must cooperate to the fullest extent possible to ensure that we maintain
That preeminence.

AIDS

Biotech will perhaps have its greatest impact on the scourge of aids that
Has so afflicted mankind in recent years, and that threatens to keep
Expanding if not successfully fought by the world's scientists.

Let me remind you for a moment of the magnitude of the problem we face. A
Study just released by the institute of medicine concludes that at least
150,000 persons worldwide now have the disease, and that perhaps 5-10
Million people are infected with the human immunodeficiency virus.

In the united states, 65,000 cases have been reported as of last week.
Although the disease was initially found most often in certain large cities,
Such as san francisco and new york, it now appears to be spreading out much
Further, and is growing among different segments of society. Clearly, we
Need to bring to bear on this problem the combined efforts of government,
The medical profession, the states, and the many other authorities needed to
Combat so serious an affliction.

On a more positive note, the enormous public and private research that has
Been targeted at aids over the past few years is beginning to bear fruit.
Fda's receipts of requests for human testing of new aids drugs, vaccines,
And diagnostics have doubled every two years. We have given those
Applications the highest possible priority, and have approved most requests
For testing within days. Today, over a hundred such products are now
Undergoing clinical trials. The first application for marketing approval
For an aids drug -- azt -- was given such expedited treatment that we had
Almost 75 people working on the application in some fashion, and we approved
The application in record time -- 107 days.

We at fda have no higher priority today than doing our part in the war
Against aids. We have reorganized parts of fda to better concentrate on
That fight, we are expediting the review of aids products, we have hired new
Specialists in viral diseases and are seeking more, we have stepped up our
Aids research, and i have personally committed large portions of my time to
Addressing the many problems posed by this terrible affliction.

OTHER FDA ACTIVITIES

Because your program this week includes a number of other topics of interest
To both afdo and fda officials, i would like to take a moment to address
Some of those as well.

PROPOSITION 65

Tom warriner of the california health and welfare agency and peter barton
Hutt gave the state and industry perspectives on proposition 65 yesterday,
And i'd like to add mine today. As you know, proposition 65 requires
Companies to label most consumer products sold in california with a warning
Statement if those products contain harmful levels of carcinogens or
Reproductive toxicants.

Last december, i testified before the state's science advisory board on
Fda's position on proposition 65. I explained that i viewed the current
Regulatory requirements for foods, drugs, cosmetics, and other such consumer
Goods to be satisfactory in assuring americans that such products were
Safe. I also pointed out the disruptive effects on interstate commerce from
Such a single-state warning requirement, as well as the public confusion
Likely to be engendered by such warnings.

I was glad to learn that the state has provisionally accepted my arguments,
And in their interim regulations provided that virtually all fda-regulated
Products comply with the requirements of proposition 65. We hope that
Policy is carried through into their final regulations, which should be
Completed later this year. Also, california's acceptance of the existing
Regulatory framework as appropriate for protecting our health should
Influence other states that are considering similar legislation to accept
That framework as well.

HEALTH MESSAGES

There is an issue we're dealing with now that reminds me that the food,
Drug, and cosmetic act is a "living" law, capable of adaptation to the
Advances in science and medicine. When the act was passed in 1938, we knew
Little about the specific effects of diet and nutrition on health. Today,
We have accumulated evidence that certain foods appear to have benefits in
Preventing or treating disease. For example, calcium intake is one of the
Factors that influence the occurrence and progression of osteoporosis.
There is a body of evidence that suggests that increased calcium intake --
Either through calcium supplements or consumption of high calcium foods --
Can have a beneficial effect in preventing the onset or progression of this
Disease.

Because such benefits exist, we have concluded that food manufacturers
Should be permitted to place the most current information about such
Benefits directly on the food label. Accordingly, we are now completing a
Regulation that will permit health messages on food labeling that tie
Particular foods to specific health benefits, if those benefits are accepted
By knowledgeable scientists.

Of course, we recognize that adequate scientific evidence of such benefits
Exists at this time for only a small number of food components. But we
Believe better consumer access to information about those food components is
Helpful, particularly if they contribute to the fight against such deadly
Disorders as cancer and heart disease. In fact, i will soon be forming a
Committee of public health service experts that will identify such
Relationships, and thus aid fda in determining when health messages on food
Labels are appropriate.

HEALTH FRAUD

Of course, permitting such "health messages" will not affect our continued
Diligence against fraudulent products. Some 46 million americans are
Thought to be victim each year of a purveyor of quack or bogus health
Products. The food, drug, and cosmetic act gave fda substantial new powers
In 1938 to combat health fraud, which decreased as a result. But it has
Hardly disappeared from the american landscape.

Because health fraud is so widespread, we have devised a priority system of
Regulatory action based on three categories of problems. In the first,
Highest-priority category are health fraud products that present a direct
Health hazard. Fda uses all available sanctions to ensure that such
Products are removed from the market, and we see that such actions receive
Much publicity.

Products that are indirect health hazards fall in the second category. This
Includes products that do not pose health hazards in themselves, but may
Adversely affect a patient's health when their use causes delay or denial of
Proper medical treatment, or when they are wrongly used. For example,
Sobriety aids that were marketed a few years back were harmless in
Themselves, but they prompted inebriated drivers to rely on their alleged
Benefits while driving drunk. Products in the third category, economic
Frauds, pose no health threat to the user, only to his wallet. These
Products include most baldness remedies and weight reduction gimmicks.

Because fda's manpower is limited, we cannot begin to attack every
Fraudulent product. But we believe the coordinated efforts of federal,
State, and local agencies has ensured the maximum efficiency of our combined
Efforts, and has also ensured that the truly hazardous examples of health
Fraud are promptly removed from the market whenever they appear. Indeed,
Recent vigorous enforcement actions by a number of states are making a
Sizeable dent in this problem. I applaud all of you for your efforts in
This continuing battle.

One of the most egregious forms of health fraud takes advantage of the
Public fear and concern about aids. I'm sure many of you have seen such
Fraudulent aids treatments as blue-green algae, injections of hydrogen
Peroxide, the food preservative bht, and herbal capsules that contain
Poisonous metals. For uninfected consumers, there are such products as the
"saniform," a piece of plastic to cover telephone mouthpieces that was
Promoted to protect against infection from public phones. That, of course,
Not only took people's money, but also spread lies about the methods of aids
Transmission.

We are stepping up our work with representatives of aids patients, and with
The physicians who specialize in treating the disease, so that we can share
Information about aids treatments -- both those that are promising and those
That may actually make the illness worse. We want people with aids to know
That we don't intend to persecute them for seeking alternative aids
Therapies, but that we would like them to know what we know about the
Dangers or inadequacies of many so-called aids "treatments."

Closing

Americans now have a food and drug supply that cannot be rivaled for its
Cleanilness, variety, availability, safety, and wholesomeness. There are
Two major reasons for that. The first is the wisdom incorporated into the
Food, drug, and cosmetic act and complementary state laws over the past five
Decades. The second is the dedication and skill of the food and drug
Officials that you here today represent.

As society has changed through the years, both the law and the people
Implementing it have evolved and adapted to the changing needs of modern
Life, just as the food and drug industry has created ever new ways of
Developing and producing foods and drugs to improve our lives.

We will be challenged in the coming years to further adapt ourselves to the
Changes being wrought by technology and innovation. I believe teddy
Roosevelt once said that some one who is too old to learn was probably
Always too old to learn. I think we can avoid that trap -- by continuing
The cooperation we began so long ago, and that has helped the american food
And drug supply reach a level of safety and abundance that has become the
Standard of excellence for the entire world.

Thank you.