Ethical and Clinical Considerations for Topical Drug Products (Including Surgical Scrubs)

Abstract

The Food and Drug Administration has the responsibility of evaluating drugs to ensure that they are safe, effective, and properly labeled prior to marketing. This authority is derived from the Federal Food, Drug, and Cosmetic Act. The parent law was passed in 1906, and major revisions were made in 1938 and 1962. These congressional acts have followed notorious events. The 1906 act was influenced by Upton Sinclair’s book The Jungle, which drew public attention to the unsanitary conditions in the meat packing industry. The 1938 amendment followed a national tragedy in which over 100 persons died after ingesting a sulfanilamide elixir that contained diethylene glycol, a solvent used without any preliminary toxicological studies. The 1962 amendment, commonly known as the Kefauver-Harris Amendment, was triggered by the thalidomide incident, which caused a number of malformed babies and established that thalidomide was a fetotoxic agent.

This chapter is based on a presentation at the meeting of the American Association of Pharmaceutical Scientists, Washington, D.C., May 8, 1989.