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.