Named after Frances Kelsey.
The name comes from the FDA medical officer who asked what the evidence showed.
Frances Oldham Kelsey
Frances Oldham Kelsey joined the FDA as a medical officer in 1960. One of her first assignments was the application for thalidomide. The drug was sold elsewhere, and the US application proposed to market it as Kevadon, through Richardson-Merrell.
She found the safety evidence insufficient. She repeatedly asked the company for more data, despite pressure. The application was never approved, and thalidomide stayed off the US market. (It was approved decades later, in 1998, for a different use under strict controls.)
In 1962 President Kennedy gave her the President’s Award for Distinguished Federal Civilian Service. The same year Congress passed the Kefauver-Harris Amendments, which strengthened the drug approval process.
She worked at the FDA until 2005. She died in 2015 at 101.
Her question is the one at the center of every drug case: what did the evidence show, and when?
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