Case File 04 — Thalidomide: The Drug That Changed Regulation Forever

In the late 1950s, thalidomide was marketed as a gentle, “safe” sedative—even for pregnant women—before it caused one of the most devastating drug tragedies in modern history. This episode explores how a lack of testing led to thousands of birth defects worldwide, why one FDA reviewer’s insistence on stronger evidence changed the course of U.S. medicine, and how thalidomide ultimately reshaped global drug regulation.For the full written case file, visit thepharmafiles.substack.com. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit thepharmafiles.substack.com