[Film leader] [Frank Reynolds:] There wasan announcement today by the Food andDrug Administration. Patina Gregory has the story. [Patina Gregory:] Today, theFood and Drug Administration approved what it calls the firstsignificant drug to stop women from going into labor too soon. It's called ritodrinehydrochloride, but it's knowngenerically as ritodrine. [Tom Jarriel:] A warningtoday to pregnant women about the possible dangersin coffee, tea, and colas. [Teletype machine tapping] The Food and DrugAdministration says the caffeine in those drinkshas caused birth defects in laboratory animals andthat until human testing is more conclusive,expectant mothers should try to avoidbeverages with caffeine. [Lea Thompson:] Anotherhealth related matter-- the FDA todaytook its first step in putting into action theInfant Formula Act of 1980. [Paul Berry:] The Food andDrug Administration today-- often in the news and backaround the turn of the century, unsafe foods and drugswere also in the news. And that's how FDA came to be. I'm Paul Berry withthe FDA's story-- a chronicle of scienceand law working together to protect the Foodand Drug supply of the American consumer. [Upbeat music playing] [FDA 75, 1906-1981] [Pioneers in Consumer Protection] [Inspirational orchestration] [Montage depicting the rangeof FDA activities] The range of FDA activitiestoday, the scale and complexity of its responsibilities,contrasts sharply with FDA's meager beginningat the turn of the century. Resources were limited,staff few in number, authority almost nonexistent. But the Food and DrugAdministration back then had an invaluable asset-- a truly remarkable man whohelped shape its destiny-- Dr. Harvey Washington Wiley. [Robert Roe:] I met Dr. Wileyat an AOAC meeting in 1928. It was quite a thrillto me as a young chemist to have seen and heard Dr.Wiley, the father of the Food and Drugs Act of 1906. Dr. Wiley came to theBureau of Chemistry from Purdue University,where he had been professor of chemistry. He also had served the stateof Indiana as a chemist during that same period intheir agricultural department. He was a native ofthe state of Indiana, I believe, and hadsome farm experience, and certainly wasinterested in agriculture, and at the Bureau of Chemistry,engaged in research projects involving agriculture. He was a physician. He had a medical degree. I do not know whether hehad practiced medicine. Most of his work had been inchemistry at the university and in the state,and of course, later, in the federal government. [Paul Berry:] In the 20 years thatDr. Wiley and his supporters fought for federal regulationof foods and drugs, they exposed conditionsthat, in some respects, were so horrendous they seemalmost unbelievable today. Foods were commonly mixedwith harmful fillers and preservatives. The lack ofsanitation caused milk to become a common carrierof communicable diseases. Medications containingnarcotics were sold freely, addicting the unwary andcausing numerous deaths. Quackery flourished. Worthless medications weresold on the promise they'd cure virtually every disease. Dr. Wiley calledfor legislation that would curb theseharmful practices, and he urged influentialgroups to join in his campaign. Strong support came fromfood industry leaders who were facing both dishonestcompetition and intolerable variations in state laws. In 1903, Dr. Wiley capturedthe attention of the nation when he established avolunteer squad of young men who agreed to eat foodtreated with suspect chemical preservatives [James H. Young:] Wileydecided to set up what he called a hygienic tablein the basement of the Bureau of Chemistry building, and toselect a group of young men-- 12, he chose-- mostlyfrom the workers in the Department of Agricultureand his Bureau of Chemistry, some from outside, and have themeat food only at that table. Wiley himself, I mightsay, ate most of his meals with these young men. Wiley studied theirhealth as they went through a dietthat had added to it one of these preservatives. But newspaper reporterslearned about it. And it was a WashingtonPost reporter who coined thephrase "Poison Squad" and gave rather too muchsensational publicity, as Wiley thought, to the whole affair. [Colliers National Weekly] [Paul Berry:]Crusading journalists joined in the campaign,helping to arouse public ire by publishingcartoons, articles, and editorials. [The Jungle, Upton Sinclair] Public opinionreached a fever pitch when a chapter in UptonSinclair's novel, "The Jungle", exposed the terrible conditionsin the Chicago stockyards. [Tense music playing] [Excerpts from the novel on screen] The crescendo ofpublic concern prompted Congress to pass both a meatinspection law and the Food and Drugs Act. Both bills were signed into lawby President Theodore Roosevelt on the last day of June, 1906. The Food and Drug Actprohibited interstate commerce in adulterated andmisbranded foods and drugs. Products that violated the lawcould be seized and destroyed. Dr. Wiley resigned in 1912. His successor wasDr. Carl Ellsberg. Continuing under Ellsbergas chief inspector and succeeding him was a manwho would influence the agency's history for four decades-- Walter G. Campbell. In the early 1930s,Campbell pressed for revisions in the1906 law to correct some serious shortcomings. Campbell showedCongress a series of posters depicting hazardousproducts that were sold freely under the existing law. There were pictures ofa woman whose eyeballs had been corroded by an anilineeyelash dye, a man who'd died from a radium waterproduct, quack devices, risky reducing products,and a stack of death notices testifying to the failure of ahorse liniment sold to people as a cure for tuberculosis. The posters were put togetherwith products and devices in a dramatic exhibit thatbecame known as the American Chamber of Horrors. But it took a nationwidetragedy to change the law. The crisis emerged in the formof a product that started out as a boon for many people. It was called sulfanilamide. And its infection-fightingproperties made headlines whensulfanilamide pills saved the life of FDR's son. But later, a smallpharmaceutical firm rushed a liquid form ofthe drug to the market without testing it for safety. The liquid form contained thesolvent diethylene glycol, which is now used in brakefluid and antifreeze. Disaster struck. Headlines the countryover broke the news of a mounting death tollcaused by the solvent in elixir sulfanilamide. The tragedies pointed tothe need for a new law ensuring the safety ofdrugs before marketing. In 1938, Congress passedthe Federal Food, Drug, and Cosmetic Act. President Roosevelt signedthe new law on June 25, 1938. [William W. Goodrich:] Icame to the agency in 1939, just about the time the1938 act was taking effect. What it did was makeimprovements in all areas-- drugs, foods, cosmetics,devices, and so forth. New drugs were requiredto be proven safe before they could be marketed. Avoidable and unnecessarypoisons were banned from food. And those that were unavoidableor necessary in production required to be controlledunder safe tolerances. Food sanitation, foodand drug labeling were improved extensively. Economic concerns were addressedthrough standards of identity. Quality and fill of containerfor foods, cosmetics, and medical devices werebrought under control for the first time. And enforcement wasimproved by authority for factory inspectionby grant of jurisdiction for court injunctions byincreased criminal penalties and extension of theseizure authority. All of this made formuch better public law. [Explosions, Naval Station Pearl Harbor] [Gentle music] [Paul Berry:] Pearl Harborcatapulted our nation into World War II. The FDA staff that wasstretched thin before the war had to take on amassive drug testing job created by the new law. Enforcement of the law went on,and some important victories were tallied. An anti-obesityproduct called Marmola, which consisted of ground-upanimal thyroid glands, was finally taken off the marketafter 30 years of litigation. Quack diabetesremedies were removed from the market, theirpromoters fined and jailed after vigorous prosecution. War was also waged by FDA withvarying degrees of success against quack cancer cures andclinics that delivered nothing except transient hope. The discovery andwidespread use of penicillin on the battlefieldsof World War II brought more newlegislation requiring certification of the safetyand efficacy of every batch. Later, Congress extended thisrequirement to all antibiotics. New responsibilitieswere legislated to FDA after the war, as foodtechnology made great advances with the use of chemicals. In 1954, FDA was given authorityto enforce tolerance levels for pesticide residues ofpossible harmful substances remaining in foodafter harvesting. In 1958, the agencywas given authority to requiremanufacturers to prove the safety of food additives. In late 1959, SenatorKefauver of Tennessee began investigatingdrug pricing. In testimony, it becameclear that other problems needed consideration as well. For one thing, therewere inadequate controls over the distribution anduse of drugs for testing. Legislation was draftedto correct these flaws, but it might never havebeen enacted had it not been for another disaster. [Frances O. Kelsey:] Theapplication for thalidomide was submitted to FDAin September 1960. I was a medical officerassigned to review it, and it was also reviewed by apharmacologist and a chemist. We felt the data wasinsufficient to support safety, and requestedfurther information. While this wasbeing assembled, we learned that peripheralneuritis was associated with the prolonged useof the drug in countries where it had beenapproved for marketing. We asked for furtherdata, both regarding this and possiblesafety in pregnancy. We asked thisbecause at that time, there was a developinginterest in awareness that the fetus andembryo and the newborn did not always respond todrugs as did the adult. [Paul Berry:] The answer cameswiftly and conclusively. Headlines all over the worldreported thousands of cases in Western Europe of malformedbabies born to women who had taken the drug thalidomide. The drug company withdrew itsnew drug application from FDA, but the thalidomide disaster,though avoided in this country, stirred strong public reactionand moved Congress to act. The 1962 amendments to theFood, Drug, and Cosmetic Act added the requirement thatdrugs had to be effective before they could beapproved, and also added other requirements tostrengthen the drug law. The amendment added a newrealm of responsibility for the agency. During the decadeof the '70s, there was tremendousgrowth in the agency. It no longer regulated justfoods drugs, cosmetics, and devices. In 1971, the agency wasassigned the responsibility for setting and regulatingsafety standards for products and equipmentthat emit radiation. In 1972, theDivision of Biologics was transferred to FDA from theNational Institutes of Health, the authority for assuring thesafety, effectiveness, purity, and proper labeling of biologicssuch as serums and vaccines, and for overseeingblood bank operations. With the advances ofhealthcare technology that employed medical devicessuch as heart pacemakers and artificial limbs, newmedical device legislation became necessary. It was provided in 1976 whenCongress gave FDA the authority to regulate medical devicesand ensure their safety and effectiveness. As a result, life-supportingand implanted devices must be tested beforethey can be sold. The responsibilitiesCongress placed on FDA in the '70s brought FDAstaff to 7,500 employees. Even with the dramaticgrowth in staff and budget, enforcement of the increasingstatutory responsibilities has been an awesome task. [Music] In the food area alone, thereare 79,000 establishments under FDA's jurisdiction. [Music] Investigators inspect anaverage of 30,000 establishments annually. [Music] [Food plant conveyor belt] [Machine noise] [Investigator:] We have 47investigators in the Baltimore District. And there are 6,000establishments under our jurisdiction. [Paul Berry:] FDAscientists analyze approximately 27,000 domestic,and 17,000 foreign products each year. [Large laboratory] [Lab worker:] Here in theBaltimore District Laboratory, we have 28 scientists whoanalyze product samples, develop methods ofanalysis, and do research. [Paul Berry:] The routinework is taxing enough, but when an emergencydevelops, sheer dedication gets the job done. When the nuclear incident atThree Mile Island occurred, FDA people worked around theclock advising local officials, collecting and analyzingsamples of food for possible radiationcontamination, and providingpharmaceutical antidotes. When dangeroussubstances, such as PCBs, get into the food supply, thelights burn all night at FDA. A PCB spill from oneelectric transformers sent FDA investigators to1,400 firms in 19 states. They were there to seethat none of thousands of contaminatedchickens and turkeys ever reached the marketplace. How well FDA does its job istested in that marketplace. Americans can shop with ahigh degree of confidence, because our country's foods,drugs, medical devices, biologics, animaldrugs and feeds, and radiological productsare the safest in the world. But conditions change. New challenges arise. More than 3/4 of a century ago,when the first Food and Drug Law was put into effect, themain public health concern was about the harmful substancesthat were deliberately packed into foods and medicines. Today, the concern ismore likely for substances that end up intoproducts by chance that have to be detected in partsper billion that remain in the body for years, waitingto upset cellular mechanisms and cause cancer. [Mark Novitch:] Well,we've literally had a revolution in thiscountry in the past 75 years in our ability to promotehealthcare through better nutrition and better care. And in my judgment,there's every reason to believe that the futureholds even more dramatic gains in every field over whichFDA has responsibility. I think there're goingto be enormous challenges in everything we do. The challenge to make sure thatthe benefits of technology, which is going to beadvancing all the time, outweighs the risks. The challenge tonurture innovation without jeopardizing the publichealth-- and most important, the challenge to give the peopleof this country confidence in the products that they useand in the ability of the FDA to make sure thoseproducts are reliable. The work has beendifficult in the past. It's going to be even moredifficult in the years ahead. But that's what makes ourwork so vital, so challenging, and to me, very, very exciting. [Paul Berry:] The Food andDrug Administration-- 3/4 of a century old,but still full of youth. This has been the FDA's story. [Music] [Upbeat music] [Credits] [Fade to black] [Color bars]