The FDA Should Approve Drugs Based on Evidence, Not Emotions image

Slate, December 13, 2016
Alan Levinovitz, quoting Rachel E. Sachs (Academic Fellow Alumna)

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From the article:

Unlike many other countries, the United States managed to avoid the thalidomide crisis, thanks to a heroic FDA regulator named Frances Oldham Kelsey. Despite intense pressure from the drug’s manufacturer, Oldham demanded further testing, pointing to inconclusive results about thalidomide’s efficacy in humans and initial evidence that the drug caused nervous system side effects. Six applications for approval were denied, and the subsequent birth of countless deformed babies like Medus vindicated the wisdom of Kelsey’s tenacity. For her efforts, she received the President’s Award for Distinguished Federal Civilian Service from John F. Kennedy in 1962. That same year Congress unanimously passed the landmark Kefauver Harris Amendment, which raised the evidentiary bar for new drug approval.

“It’s well-known scandals and crises like thalidomide that led to the FDA having the power it has today,” says Rachel Sachs, a law professor at Washington University who specializes in health law, innovation, and patient access. “Perhaps the existence of the FDA is a slight barrier to innovation. But in my view, it’s far more important to prevent unsafe, ineffective drugs from coming to market.”

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fda health law policy pharmaceuticals rachel sachs regulation