History of Federal History of Food and Drug Laws Regulations FDA - PDF document

Regulatory Issues in Laboratory Thursday, January 17th, 2008 Management History of Federal History of Food and Drug Laws Regulations FDA has grown from a single chemist in the US Food and Drug Department of Agriculture in 1862 to a staff of 9,100 Administration employees in 2001…. • FDA left the Department of Agriculture in 1940 and joined the Federal Security Agency and joined the Department of Health and Human Services in 1980. • Today comprising chemists, pharmacologists, physicians, microbiologist, veterinarians, MM Marshall QAO pharmacists, lawyers and many others. History of Food and Drug Laws History of Food and Drug Laws In 1902 …. Volunteers “poison squad” of young men agreed to eat only foods treated with measured amounts of chemical, with the object of demonstrating whether these ingredients were injurious to health. Harvey Washington Wiley • Offered the position of Chief Chemist in the US Dept of Agriculture in 1882 • Earned the title “Father of the Pure Food and Drug Act” History This initiated many news articles in • Nauseating story of the plight of the 1902-1906 years… workers in the food processing • Packers blamed with shipping “embalmed industry around Chicago beef” that sickened troops in the Spanish- American War. • Public was horrified by the food processing, not the workers • Upton Sinclair published the “The Jungle” describing the filthy conditions in Chicago’s • Need for regulation at the Federal meat packing plants in 1906. level, as each state had its own laws Marilyn Marshall 1

Regulatory Issues in Laboratory Thursday, January 17th, 2008 Management • However, support came from the vote less Strenuous opposition….from: but militant club women of the country who rallied to the pure food cause and….. Whiskey distillers and patent medicine firms, who were the largest advertisers in President Theodore Roosevelt the country. who used his weigh decisively to ensure that this time Congress It was argued, the Federal Government had would not adjourn, as so often no business policing what people ate, before until the food bill was drank, or used for medicine. passed. • 1906 Food and Drugs Act became law … to • control adulterated and misbranded drugs and food in interstate commerce. • However assurances of safety issues were not mandated • Still unclear as to new drugs…. And… • Continuing problems with dangerous Provisions lacking in the 1906 law were History drugs that fell outside the parameters corrected in 1938…President Franklin D. of the Pure Food and Drugs Act, finally Roosevelt signed the Federal Food, Drug, received national attention with the Elixir Sulfanilamide disaster in 1937. and Cosmetic Act. • Massengill distributed this preparation without testing for safety (which was not required by law). � therapeutic devices and cosmetics become • It contained diethylene glycol as a subject to regulation vehicle, a chemical analogue of � standards of identity and quality be instituted antifreeze, for foods • Over 100 people died, many of whom � formalized FDA’s ability to conduct factory were children. inspections. Marilyn Marshall 2

Regulatory Issues in Laboratory Thursday, January 17th, 2008 Management Durham-Humphrey Amendment This remains the basic law we have today …with numerous amendments and other (1951) clarified the vague line acts which broaden FDA’s responsibilities between prescription and considerably. nonprescription drugs The goal for FDA is above all else to The Amendment specifically stated: safeguard the health and well being of the “dangerous drugs, defined by several American people parameters, could not be dispensed without a prescription, witnessed by the prescription legend: "Caution: Federal law prohibits dispensing without prescription." Interesting development in 1960 . . . • During this time a single report in a British journal, indicated that some long term users of this drug developed nerve damage A Pharmaceutical company applied to FDA in their hands and feet. for permission to market a drug [very popular sleeping pill in Europe] in the US. • Dr. Kelsey asked the company to conduct studies to show that drug could safely be • Application was assigned to “new” staff taken by pregnant women without harming member Frances O. Kelsey… the fetus. asked for more data……concerned that drug acted differently in animals than it did • Company officials were appalled that this in humans (it wasn’t a sedative in “stubborn bureaucrat”…… animals). Frances Kelsy • Long before the Company could received the Distinguished complete its tests . . . news broke of a Federal Civilian Service terrible deformity in babies born with Award from President John tiny flipper-like stumps instead of arms F. Kennedy August 1962. and hands. • All the baby’s mothers • 17 American babies were born with the had taken the drug deformity because [at the time] the company was permitted to provide free thalidomide in the first 20- samples to physicians as soon as the 40 days of pregnancy company applied for FDA licensing permission . Marilyn Marshall 3

Regulatory Issues in Laboratory Thursday, January 17th, 2008 Management However….. • Congress responded to thalidomide tragedy by passing the Kefauver-Harris In the 70’s FDA’s investigation into drug law in 1962 “sloppy and fraudulent” research • This law, for the first time, gave FDA .. resulted in the Senate investigaiton- Kenndy Hearings and the conclusion to the power to require specific the hearings stated that…. procedures for testing new drugs for safety and effectiveness. “Lack of understanding appears to Findings of the Senate Committee on review stem from ……… of documents of the Drug company found [1] insufficient appreciation by that personnel did not…. managers of the need for instruction � assure the accuracy of data which are and indoctrination of personnel in laboratory methods transcribed from original documents to final reports [2] An absence of established, written � make accurate observations of the laboratory procedures and appropriate parameters and to document [3] A general lack of attention … to their observations promptly, and accurately, routine quality assurance procedures and to sign and date records of such and correction of deficiencies” observations Regulations are for all to follow…. So ………. 1992 FDA officials marched into the office of Chapter 1, Title 21 Regulatory Sections of the University of Minnesota President to the Code of Federal Regulations announce that the agency had imposed a [CFR] 58 hold on a Clinical Study 21 CFR 58 The investigator, was world renown for transplant surgery. 1978: Original Regulation ……Grand jury indictment 1987;1997 Amendments Marilyn Marshall 4

Regulatory Issues in Laboratory Thursday, January 17th, 2008 Management There were many factors ….. But several crucial GLP deviations.. Paper work didn’t get done…. “ PI saw himself, says a former colleague as a pacesetter who was moving the field of Federal regulations are government transplant surgery forward, someone who documents describing the rules! couldn’t be bothered with the details of the rules because he was changing the rules” Code of Federal Regulations (CFR) � is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government History Code of Federal Regulations (CFR) which establishes the laws under which some 50 different government agencies operate and exert their influence. – 21 CFR is the FDA [Food and Drug Administration] – 45 CFR is the DHHS [Department of Human Health and Safety] – 40 CFR is EPA [Environmental Protection Agency] – 12 CFR is Banking – 6 CFR is Homeland Security Marilyn Marshall 5