3 ms·
You can't attribute thalidomide being blocked in the US to "the FDA". Frances Oldham Kelsey was practically solely responsible for stalling the drug until suffi
by cdr 12y ago
You can't attribute thalidomide being blocked in the US to "the FDA". Frances Oldham Kelsey was practically solely responsible for stalling the drug until sufficient evidence of birth defects emerged to reject it. She was under intense pressure from within the FDA to approve it. In addition, the US benefited from being the last major market to receive the drug - if it had been developed in the US, the US would have almost certainly been hit just as badly as Europe.
The scandal did lead to FDA drug testing reforms, but that was after the fact.
(Also, there were US victims of thalidomide birth defects. There were human clinical trials and the American distributor aggressively distributed "free samples" to employees.)
- refurb 12y agoI guess we'll have to disagree as to what constitutes "the FDA". Frances Kelsey was a physician working for the FDA, so although there were internal disagreements on whether or not to approve, the point is, "the FDA" didn't approve it. My argument is that that situation bred a lot of cautiousness at the FDA after the fact.
- cdr 12y ago"The FDA" would be taken to mean some quality of the organization - a regulation, a standard process. It was not. It was a single stubborn person, working off little more than a gut feeling, and going against standard practices of the organization.