In 1957, a new and unique sleeping pill was released onto the market in Germany. Thalidomide was a "wonder drug" which soon gained approval in Canada as well as 45 other countries in Europe, Africa, South America.
The application for approval in the US was submitted to the FDA in 1960. FDA concerns about side effects that had not been fully investigated resulted in ongoing prolongation of the application, and in 1962, thalidomide was connected with the birth defect phocomelia, which caused approximately 10,000 children worldwide to be born with hands and feet attached directly to shoulders and hips.
Americans felt pride in having our FDA, which had steered us clear of a disaster which had affected the rest of the world.