In September 1960, Frances Oldham Kelsey, a medical reviewer at the FDA, faced immense pressure to approve thalidomide, a drug already available in Europe, but she had concerns.
Kelsey’s insistence on thorough evaluations over rushing to approve drugs set a precedent in regulatory practices, marking her as a pioneering figure in pharmaceutical safety.
Sherri Chessen, a television host pregnant with her fifth child, faced severe morning sickness and was looking for relief when she discovered thalidomide's promotion.
Amid public and corporate pressure, Kelsey’s scrutiny highlighted the importance of regulatory integrity, ultimately saving countless lives by preventing the approval of thalidomide in the U.S.
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