M E D I C I N E O F F T H E M I D WAY
The Power of No FDA heroine Frances Kelsey, PhD ’38, MD ’50, is lauded by President Barack Obama half a century after one of the most fateful decisions in U.S. pharmaceutical history By Stephen Phillips
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he auditorium at the Food and Drug Administration’s headquarters was buzzing. For the massed ranks of FDA officials, it was an opportunity to mark a defining moment in the agency’s history. Half a century almost to the day, the central figure in a case that changed the face of drug regulation was returning to the FDA. As the car carrying her pulled up, Frances Oldham Kelsey, PhD ’38, MD ’50, now 96, marveled at the FDA’s manicured new campus set in the rolling Maryland countryside. It was a far cry from the World War II-era prefab in downtown Washington, D.C., she had occupied as a new recruit. Frail and hard of hearing now, “Lobbying at the FDA could be Kelsey was chaperoned by her done, but this took it up a notch.” two daughters for the occasion. She beamed as FDA leaders hon— John Swann ored her in speeches before presenting her with the Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting the Public Health. “It was pretty moving,” recalled FDA historian John Swann. As much as any other single person perhaps, Kelsey, during a storied 42-year career in drug regulation, is credited with making the agency what it is today. The personal tribute read aloud from President Barack Obama testified to Kelsey’s impact in the wider world: From September 1960 through November 1961, Kelsey and a handful of FDA colleagues were all that stood between the nation and the ABOVE In
1962, President John F. Kennedy presented Frances Kelsey, PhD ’38, MD ’50, with one of the pens he used to sign the Drug Amendments of 1962, which gave important new regulatory powers to the FDA in the aftermath of the thalidomide case. Photo courtesy of the FDA History Office
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Frances Kelsey’s fame following the thalidomide case prompted the Federal Civil Service to make her its poster child in this 1963 commemoration of its 80th anniversary.