Drugs that shaped the FDA: From elixir sulfanilamide to thalidomide

Epstein, Jessica

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https://hdl.handle.net/2142/127987 Copy

Description

Title

Drugs that shaped the FDA: From elixir sulfanilamide to thalidomide

Author(s)

Epstein, Jessica

Issue Date

2018-09-15

Keyword(s)

• History
• Chemistry

Date of Ingest

2025-04-30T11:27:21-05:00

Abstract

The United States Food and Drug Administration (FDA) currently regulates pharmaceuticals, medical devices and food products. Since the inception of the FDA in 1906, two key pieces of legislation have shaped the FDA into the organization that we recognize today: The Federal Food, Drug and Cosmetic Act (FD&C Act) of 1938 and the Kefauver-Harris amendment in 1962. The FD&C Act of 1938 gave the FDA authority to oversee the safety of food, drugs and cosmetics. The law authorized the FDA to require evidence of safety for new drugs, issue standards for food, and conduct factory inspections. The Kefauver-Harris amendment to the FD&C Act in 1962 required each new drug application (NDA) contain evidence from "adequate and well-controlled studies" demonstrating that a new drug was effective for its intended use and that the established benefits of the drug outweighed its known risks. Companies were required to present animal studies to the FDA before obtaining approval to test on humans. Furthermore, clinical studies on humans required informed consent from participants. Each of these pieces of legislation dramatically shaped the FDA and the pharmaceutical industry in the United States (US). They were the product of mounting consumer activism and political pressure, and they were ultimately pushed to passage by high-profile medical disasters: elixir sulfanilamide in 1937 and thalidomide in 1962.

Publisher

Division of the History of Chemistry

ISSN

1053-4385

Type of Resource

text

Genre of Resource

article

Language

eng

Permalink

https://hdl.handle.net/2142/127987

DOI

https://doi.org/10.70359/bhc2018v043p102

Copyright and License Information

Copyright 2018 Division of the History of Chemistry

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