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Overview of FDA: How Regulation Came to Be. WHY DO WE HAVE THESE…? 21 CFR* 200’s : How to implement the law for “ Pharmaceuticals ” 21 CFR* 800’s : How to implement the law for “ Medical Devices ” * CFR = Code of Federal Regulations. BECAUSE OF THESE…. Thalidomide Dalkon Shield.
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WHY DO WE HAVE THESE…? 21 CFR* 200’s:How to implement the law for “Pharmaceuticals”21 CFR* 800’s:How to implement the law for “Medical Devices”*CFR = Code of Federal Regulations
BECAUSE OF THESE… Thalidomide Dalkon Shield Elixir Sulfanilamide
Before 1906 There was… NO FDA! No Medical Device Regulation & No Pharmaceuticals Regulation
There was, however… The LAW of UNINTENDED CONSEQUENCES
1901 “A Horse Named Jim”
1902 The Biologics Control Act is passed to ensure purity & safety of serums, vaccines, & similar products used to prevent or treat diseases in humans. Biologics were tested in the Hygienic Laboratory (precursor to the National Institute of Health - NIH)
1902 Congress appropriates $5,000 to the Dept. of Agriculture’s Division of Chemistry,to study the effects of chemical preservatives and colors.Harvey Washington Wiley is Chief Chemist. His “Poison Squad” studies draw widespread attention to the problem of food adulteration. Public support for passage of a federal food and drug law grows very slowly. * Song of the Poison Squad by Lew Dockstader’s Minstrels, Oct 1903 “O, they may get over it but they’ll never look the same, That kind of bill of fare would drive most men insane..*”
Fictional account of contamination in the meat industry. Except it was not fiction. Social activists meet with Wiley, who writes the “Wiley Act” adding concerns of his own. 1906
June 30, 1906 – President Theodore Roosevelt signs the “Federal Food & Drugs Act” AKA “The Wiley Act” or “The Pure Food & Drug Act” Beginning the modern era of FDA. FDA was formally established 1908. Harvey W. Wiley first commissioner (1907-1912) 1906
Harvey W. Wiley 1906 Wiley’s house – West Lafayette Wiley Hall, Purdue
If the label is false, it is misbranded and therefore, adulterated. Unable to transport adulterated food and drug across state lines (Interstate Commerce). Note: The presence and amount of alcohol, heroin, cocaine & 8 other dangerous items had to be listed. Note: No requirement for pre-market approval at this point… not until 32 years later The New FDA
Public outrage again causes Congress to react Massengill markets a new sulfa drug that would appeal to pediatric patients: Elixir Sulfanilamide The solvent for this liquid product was diethylene glycol, a sweet-tasting, highly toxic analogue of antifreeze 107 people, mostly children, are slowly killed over days A simple pre-market animal test would have discovered this danger 1937
June 25, 1938 – Franklin D. Roosevelt signs Food, Drug & Cosmetics Act – ‘The Act’ Mandated pre-market approval of all new drugs and cosmetics requiring demonstration of safety and quality before marketing Subjected Devices to regulation for the first time – but no requirement for pre-market approval Could take action against adulterated or misbranded devices Authorized factory inspections Added court injunctions to the previous penalties of seizures and prosecutions 1938 – Food, Drug & Cosmetics Act
New intrauterine birth control device (IUD) Dalkon Shield A.H. Robbins Despite limited premarket testing: ~2.8 million devices placed Scarred uterine wall Pregnancies Infection & sepsis Birth defects & miscarriage Death ~300,000 lawsuits 1971-1974
Devices classified according to risk Registration of establishments & listing of devices Establish device-specific Good Manufacturing Practices Recall authorities Premarket approval required based on risk class 1976 – Medical Device Amendments
1990 – Safe Medical Devices Act • MAUDE(Manufacture And User facility Device Experience database) Requires medical facilities using devices to “voluntarily” report any incidents that suggest a device probably caused, or contributed to, death, serious illness or serious injury. • Requires post-market surveillance for permanent implants and establishment of methods to trace and locate patients with such devices. • Special Controls for specific device types • Design Controls for Class III, Class II and some Class I devices
New Laws & Regulations: Proactive public policy or Reaction to negative events?
