Laws governing new drugs had been on the books for decades but were not always rigorously enforced, and F.D.A. approval was often routine. But Dr. Kelsey, working with a chemist and a pharmacologist, found the evidence for Merrell’s claims about Kevadon [the brand name for thalidomide] to be insufficient. She withheld approval and asked Merrell for more data on toxicity, strength and purity.
Merrell stood to make millions and was anxious to get moving. It had tons of Kevadon in warehouses, ready for marketing, and 1,000 American doctors had already been given samples for “investigational” research. The company supplied more data, but also mounted a campaign to pressure Dr. Kelsey. Letters, calls and visits from Merrell executives ensued. She was called a fussy, stubborn, unreasonable bureaucrat.
Ultimately she stalled drug approval long enough for damning evidence from abroad to accumulate. The drug was never approved in the United States. In all, just seventeen American babies are known to have been born with birth defects originating from thalidomide—their mothers having been given doctors’ samples of the unapproved drug. Thousands of children were likely spared deformity and death by her scientific rigor and tenacity. She went on to have a long career at FDA, remaining at the agency until the age of 90. On August 7, she died at the age of 101.
Dr. Kelsey’s story serves as an inspiring reminder of the wide-ranging impacts individuals can have, even in a bureaucracy as seemingly monolithic and faceless as the federal government. By refusing to abandon her public duty, even in the face of enormous industry pressure, her story holds important lessons for modern civil servants faced with industry’s ever-increasing influence over its regulators. We can only hope that when the FDA is faced with the next thalidomide, there will be someone as courageous as Dr. Kelsey protecting public health.
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.