Chapter 1: General Pharmacological Principles

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1.5:

Drug Regulation

JoVE Core
Pharmacology

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JoVE Core Pharmacology

Drug Regulation

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1.2: Preclinical Development: Overview

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1.6: Drug Classes and Categories

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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.

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.