Frances Oldham Kelsey, a medical examiner at the U.S. FDA, opposed the approval of thalidomide (Kevadon) due to safety concerns, despite commercial pressure from its manufacturer.
The initial release of thalidomide in Germany led to a tragic epidemic of birth defects, with doctors unaware of the drug's link to these serious medical conditions.
Pharmaceutical companies in Germany experienced rapid growth in the 1950s, nurturing a culture that believed in miracle drugs, which unfortunately contributed to the rise of thalidomide.
Kelsey’s insistence on safety over speed in drug approval was pivotal in averting a potential disaster in the U.S., as early warnings emerged from other countries about thalidomide.
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