The requirement for the demonstration of safe and effective medications came about as a result of the Thalidomide debacle in Europe. FDA's Frances Kelsey refused to approve Thalidomide for marketing in the US, and the tragedy was avioded in the US. Experts estimate that thalidomide led to the death of approximately 2,000 children and serious birth defects in more than 10,000 children, about 5,000 of them in West Germany. Frances Kelsey received the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy, 1962.

The Kefauver Amendments (1962) to the US Food Drug and Cosmetic Act today requires 2 well-controlled clinical trials demonstrating safety and effeciveness of new drugs seeking approval for marketing.

Sadly today's FDA is a far cry from Kelsey's - even as it has chosen to ignore demonstrated safety concerns for CV-19 jabs