Thalidomide was never officially available in the US, thanks to FDA-doctor Francis Kelsey who never gave permission for the drug to be sold. Still, the American drug company Richardson-Merrell was allowed to hand out more than 2.5 million Thalidomide pills as samples to doctors across the country. What looked like a clinical trial was in reality a huge marketing campaign to familiarize potential future patients with the drug. At the time clinical trials did not require FDA approval. To this day it is not clear how many people in the US were affected by possible side effects resulting from Thalidomide’s unofficial distribution.
The Thalidomide scandal motivated profound changes within the FDA. In 1962 the Kefauver-Harris Drug Amendments Act was passed significantly extending the powers of the FDA. Drug companies now had to prove the efficacy and safety of new medications and furthermore were asked to disclose all information concerning possible side-effects encountered during testing. These new regulations were also applied to drugs already on the market. Additionally, clinical trials now had to be monitored by the FDA.
Lawyer Michael Magazanik talks about the Thalidomide marketing campaign in the US.