NOT late-breaking news. Just a reminder of why all those people who commute to regulatory agencies are there.
Physician to be honored for historic decision on thalidomideBy Lyndsey Layton
Washington Post Staff Writer
Monday, September 13, 2010; 9:17 PM
It was a straightforward assignment for a newcomer to the Food and Drug Administration, such a simple task that Frances Oldham Kelsey was given a cubbyhole of an office and the bare basics to get it done: review an application from a drug company to market a new sedative called Kevadon.
The drug was already widely used in Britain, Germany and about 20 other countries and it was a lucrative success for its manufacturer, the William S. Merrell Co., which was eager to get it into medicine cabinets in the United States.
At the time, in 1960, Americans were dazzled by vaccines, antibiotics and the vast array of new discoveries defining modern life.
But Kelsey, a physician and a pharmacologist, questioned the safety of Kevadon, the brand name for thalidomide, and refused approval. "It just came with so many extravagant claims that I didn't believe," Kelsey, now 96, said Monday in an interview at her Bethesda home.
The drug company pushed back and started an intense campaign, repeatedly calling and meeting with Kelsey and her superiors, including the FDA commissioner.
Kelsey was steadfast, and her resistance became the stuff of legend when it turned out that thalidomide caused severe birth defects in thousands of babies born in Europe and elsewhere. The drug had been prescribed for women to help them sleep or manage morning sickness. The babies often had malformed arms or legs or extra appendages.