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50th anniversary of the FDA.

Let me take a moment to revisit the days before that 1938 legislation to establish the FDA came into being. In the 1930s, milk was still often harvested front 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 hodgepodge 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; 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 thcts 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 (antifreeze!) to an otherwise useful drug. That young student, Dr. fiances 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 thcts many heroic efforts made by FDA, state, and local inspector to track down stocks of the elixir before they could kill yet more Americans. One Texas state inspector drove 460 miles arid called on 45 druggists in 17 towns within a 2A-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-yearold 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 the man's personal effects on top of the grave--custom in those parts for disposing of sickroom utensils. Amazingly, the nations Food and Drug inspectional forces were able to mobilize so thoroughly that they found over 99 percent 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 vias misbranded (to be called an "elixir" it had to have alcohol, which this didn't contain).

The passage of the Food, Drug, and Cosmetic Act into law in 1938 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. An outpouring of important new drugs began with new antibiotics in the We 1940s and cortisone in 1949. Then, in a kind of creative cascade, came the first tranquilizer in 1952, the first antifungal antibioticts in 1954, the first oral antidiabetic agent in 1955, and in 1963, the first antivital drug. Indeed, those years were so incredibly productive that they have been called "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 1940s 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 practice 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 more than 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 40 percent a century ago to just over 15 percent today.

The Future

The future for those industries is every bit as bright as the past. In fact, many believe that 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 plague 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 target sites;

* Monoclonal antibodies will be developed 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 desired amount of a drug at the right timesand 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 yields 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 nonfood 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 yields, 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 finished foods. The freezedrying 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 containers 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, but also contribute to better health. Better processing techniques will help guard against microbial contamination and help detect such dangerous contaminants as Listeria, and new packaging methods will help prevent spoilage. Perhaps most important, however, many of the new foods will contain fewer 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 the FDA share. It means that we often find ourselves standing between the findings of basic research and the applications of such 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.
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Title Annotation:Food and Drug Administration
Author:Young, Frank
Publication:Saturday Evening Post
Date:Jan 1, 1989
Previous Article:Dr. Frank Young: making a difference.
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