On Friday, Dr. Frances Kelsey passed away at the age of 101. She was the Food and Drug Administration official who changed the way drugs were tested and marketed to the general public when she began asking questions about the safety of thalidomide.
Developed in the 1950s, Kevadon was a sedative administered to pregnant women to alleviate symptoms of morning sickness, and came before Kelsey in September 1960 for approval. She had noticed that there was some questionable data when it came to the safety of the drug, and asked for more information from its maker, the William S. Merrell Company.
Thus began a fateful test of wills. Merrell responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey’s bosses, calling her a petty bureaucrat. She persisted. On it went. But by late 1961, the terrible evidence was pouring in. The drug — better known by its generic name, thalidomide — was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects.
It’s hard to understate the importance of what Kelsey did: she helped create the regulatory framework that created a buffer between the efforts of pharmaceutical companies to market and sell their products, and the general public using their products.
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