A History of the FDA & Drug Regulation in the U.S.

Year	Act	Purpose
1906	Food and Drug Act	Outlaws states from buying and selling food,drinks, and drugs that have been mislabeled and tainted.
1912	Sherley Amendment	Outlaws labeling drugs with fake medical claims meant to trick the buyer.
1930	FDA	Food and Drug Administration is named.
1938	Federal Food, Drug, and Cosmetic (FDC) Act of 1938	Requires new drugs to be proven safe prior to marketing; starts a new system of drug regulations; requires safe limits for unavoidable poisonous substances; and allows for factory inspections.
1951	Durha-Humphrey Amendment	Defines the type of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals.
1962	Kefauver-Harris Drug Amendments	Requires manufacturers to prove that their drug are effective prior to marketing.
1972	Over-the-Counter Drug Review	Nonprescription medications must be safe, effective and appropriately labeled.
1982	Tamper-Resistant Packaging Regulations	Makes it a crime to tamper with packaged products and requires tamper-proof packaging.
1984	Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)	Allowed FDA to approve generic versions of brand-name drugs without repeating research to prove safety and efficacy; allowed brand-name drugs to apply for up to 5 years of additional patent protection for new drugs make up for time lost while their products were going through the FDA approval process
1988	Prescription Drug Marketing Act	Designed to eliminate diversion of products from legitimate channels of distribution and requires wholesalers to be licensed.
1997	Food and Drug Administration Modernization Act	Expands scope of agency activities and moves agency to the Department of Health and Human Services (DHHS)
2003	Medicare Prescription Drug Improvement and Modernization Act of 2003	Includes Medicare Part D which increases access to medications through private insurers.

 
Adapted from U.S. Food and Drug Administration, Center for Drug Evaluation and Research