Thalidomide was a sleep medication marketed as “completely safe” including for mother and child, “even during pregnancy,” as its developers “could not find a dose high enough to kill a rat.” Due to lack of testing, the FDA didn’t approve the use of Thalidomide. Europe and other parts of the world were less strict. By 1960, thalidomide was marketed in 46 countries, with sales nearly matching those of aspirin. When it was discovered to relieve morning sickness it saw widespread use by pregnant women.

The result was phocomelia; shortened, absent, or flipper-like limbs in babies that were exposed to thalidomide while developing in utero.

The Kefauver-Harris Amendments of 1962 strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness.

Victim of the Thalidomide tragedy

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.