Federal Medication Development Regulation

Excerpt

Before 1906, there were few controls on drug distribution, and products were often inconsistent in strength or poorly labeled. The Federal Drug Administration (FDA) was formed as part of the Pure Food and Drug Act of 1906, which prohibited misleading drug labeling and created consumer protections for drug safety. The Federal Food, Drug, and Cosmetic Act (FDCA) of 1938 would replace the former act and strengthen the FDA's ability to regulate the medication development process. It required manufacturers to provide proof of safety and adequate information on labels.

Numerous amendments were added to the FDCA to modify the regulations and oversight of the FDA. The Durham-Humphrey Amendment was enacted to regulate unsafe medications to be taken without medical supervision, distinguishing between over-the-counter and prescription drugs.

In 1961, thalidomide was shown to cause severe congenital disabilities after being marketed in Europe, prompting increased regulations on medication development. There were also cases of thalidomide-induced congenital disabilities in the US. However, the FDA did not approve the medicine. The passage of the Kefauver-Harris Amendment in 1962 would allow the FDA to require proof that drugs were both safe and effective before approval. This amendment contained provisions for obtaining informed consent for clinical trials and initiated Good Manufacturing Practices (GMP).