In September 1960, a new drug application landed on the desk of Dr. Frances Kelsey. It was one of her first assignments as a new medical officer at the FDA. The drug was thalidomide, a sedative the manufacturer Richardson-Merrell planned to sell as Kevadon. It was already a popular sleeping pill in Europe, and her supervisors expected a simple, routine review. But under the law at the time, the FDA had only 60 days to find a problem with an application. If the clock ran out, the drug was automatically approved for sale in the United States. For Kelsey, that 60-day clock had just started ticking. The company was confident, already preparing for a quick launch before the Christmas season.
Frances Kelsey and Thalidomide
The FDA reviewer who refused to approve thalidomide in 1960, preventing a U.S. tragedy and changing drug laws forever.
Chapter 1
A Routine Application
0:48
Part of
Frequently Asked Questions
What was thalidomide supposed to be used for?
Thalidomide was developed as a sedative and sleeping pill. In Europe, it was marketed as a 'wonder drug' for insomnia and was claimed to be so safe it had no lethal dose.
Why did Dr. Frances Kelsey block thalidomide in the U.S.?
She found the manufacturer's safety data to be scientifically inadequate. She also learned of reports from Europe linking the drug to nerve damage, a fact the company had not disclosed in its application.
What law was passed because of the thalidomide crisis?
President Kennedy signed the Kefauver-Harris Amendment in 1962. This landmark law required drug manufacturers for the first time to prove to the FDA that their products were both safe and effective before they could be sold.
Learn more
To continue the story, download the Chunks Microlearning app
Or get it straight away:
Download on iOS
Download on Android