Regulering van geneesmiddelen

Drug regulation involves controlling the use of drugs through safety and efficacy evaluations by regulatory bodies.

Unfortunately, several tragic incidents mark the history of drug regulation.

In the Elixir Sulfanilamide tragedy, toxic diethyl glycol used in a sweet-tasting medication resulted in numerous deaths. This tragedy led to the passage of the Food, Drug, and Cosmetic Act in 1938.

Under this act, drug companies were required to demonstrate the safety of their products through toxicity studies and accurate labeling. However, proof of efficacy was not mandatory.

The thalidomide disaster led to the passage of the Kefauver-Harris Amendments in 1962.

This required manufacturers to provide evidence of a drug's efficacy and safety through the risk-to-benefit ratio. Research on animals was also made mandatory before running human trials.

The resulting data were submitted to the FDA as an application for an IND.

To expedite the drug approval process, the FDA took measures such as accelerating the review of drugs used for fatal illnesses and getting more actively involved in drug development.