FDA History-Alyssa Deguzman

Events

FDA's Division of Chemistry

1862

evaluate applications for new drugs for use in humans or animals, food and color additives, medical devices, and infant formulas

Pure Food and Drug Act

1906

First passage of major legislation passed by Wiley. Made new changes in authority. Name changed to Food, Drug, Insecticide Administration

Harvey Wiley

Approx. 1906

Changed direction of division, established scientific authority by researching effects of chemical preservatives used in production of foods and drugs, exposed potential hazards in products, focused on consumer safety

Supreme Court Case that undermined the Wiley Act

1912

Supreme Court determined that the law enforcing regulation of drugs did not apply to false therapeutic claims

Franklin D. Roosevelt

1933 - 1945

New presidential administration changed the authority of the FDA to include both quality and identify standards for food and drugs, prohibition of false therapeutic class for drugs

Post Office Department and Federal Trade Commission

1938

in charge of ensuring safety of cosmetics and medical devices

Federal Food, Drug, Cosmetic Act

1938

Required manufacturers to prove to the FDA that a drug was safe before marketing it. Manufacturers had to provide directions on drug's label. Mandated standards for foods. set tolerances for certain poisonous substances and authorized factory inspections

FDA has more Responsibility

1939

FDA became in charge of ensuring the safety of cosmetics and medical devices

Kefauver-Harris Amendment

1962

Revolutionary in scope for ensuring safety and effectiveness of medications in US market

Drug Abuse Control Amendments

1965

Gives FDA control over barbiturates and addictive agents

Medical Devices Amendments

1976

Allowed FDA to regulate and approve devices to recall ineffective and dangerous devices

Orphan Drug Act

1983

Targeted rare diseases and influenced expanded research and availability of new treatments for acquired immunodeficiency syndrome, cancer and genetic diseases