A Disaster Averted Thalidomide

A Disaster Averted
Thalidomide

Sedative sold over-the-counter in Europe
- Treated morning sickness during pregnancy
- Produced birth defects in European babies
FDA received application for marketing in the US
- Reviewer Frances Kelsey had concerns
- Delay in approval prevented its being sold in US

Decorative Image: Dr. Francis Kelsey, an FDA medical officer is shown here with President Kennedy awarding her the Civilian Medal of Honor, the highest civilian award in the government.

As with the 1938 act, a therapeutic disaster compelled passage of the new law; in this case the disaster was narrowly averted. Thalidomide, a sedative that was never approved in this country, produced thousands of grossly deformed newborns in Western Europe. Dr. Francis Kelsey, an FDA medical officer, is credited with keeping the drug off the U.S. market, and increasing public support for stronger drug regulation. She is shown here with President Kennedy awarding her the Civilian Medal of Honor, the highest civilian award in the government.

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