Crohn's Disease: The Complete Guide to Medical Management

Gary R. Lichtenstein, MD, FACP, FACG, AGAF

Chapter 3: The Role of the FDA in Drug Development in Inflammatory Bowel Disease (continued)

Alan C. Moss, MD; Adam Cheifetz, MD

The FDA has the broad oversight responsibility for all medical products in the United States.4 Its legislative basis originated in the Federal Food, Drug and Cosmetic Act of 1938, which required that new drugs be tested for safety before they could be marketed and the results submitted to the FDA. This act arose out of the sulfanilamide elixir disaster of 1937, when more than 100 people died from poisoning by diethylene glycol contained in the elixir. The FDA’s role was further expanded with the Kefauver-Harris Amendments in 1962, after the harmful effects of thalidomide on the fetus…