1.5 : Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under this legislation, pharmaceutical companies were obligated to establish the safety of their products via toxicity studies and accurate labeling. However, demonstrating efficacy was not a requirement. The thalidomide catastrophe subsequently led to the adoption of the Kefauver-Harris Amendments in 1962. These amendments mandated manufacturers to present evidence supporting a drug's efficacy and safety by evaluating the risk-to-benefit ratio. Furthermore, animal research was made compulsory before initiating human trials. The resulting data would be submitted to the FDA as an application for an investigational new drug (IND). In order to speed up the drug approval process, the FDA implemented measures such as hastening the review of drugs intended for life-threatening diseases and taking a more proactive role in drug development.