Wiley expanded the Bureau of Chemistry's food adulteration studies. Considered the father of the Pure Food and Drugs Act.
Pure Food and Drug Act passed
Drugs had to meet the standards of strength, quality, and purity established by the United States Pharmacopoeia and the National Formulary
Supreme Court Case: U.S. v. Johnson
The FDA suffered a setback when the Supreme Court determine that the 1906 Pure Food and Drug Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of the drug.
ACT For preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes
Harrison Narcotic Act
Requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.
Pure Food and Drug Act Renamed FDA
The FDA regulated new applications for drugs, devices, etc. The FDA was moved to the U.S department of Health and Human Services.
Federal Food, Drug, and Cosmetic Act
A set of laws passed by Congress that gave authority to the FDA to oversee the safety of food, drugs, and cosmetics.
Gave clarification of what constituted a prescription drug and what constituted an over the counter drug.
Before marketing a drug firms have to provide substantial evidence of effectiveness for the product's intended use.
Drug Abuse Control Amendments
Gave the FDA more control over addictive agents by allowing the Federal Food, Drug, and Cosmetic Act to establish special controls for depressant and stimulant drugs and counterfeit drugs.
Medical Device Amendments
Allowed the FDA to regulate and approve of cosmetic and medical devices.
Orphan Drug Act
Law passed to facilitate development of orphan drugs — drugs for rare diseases such as Huntington's Disease, ALS, Tourettes, etc.