Here is a succinct summary by Jim Edwards on why the FDA cannot be relied upon to police big pharma. Be sure to follow the link at the end because it has links to the GAO (Government Accounting Office) detailed reports on each of the points.
FDA's Most Embarrassing Moments
August 1, 2008
You can read them in detail here.
But here's a summary:
1. After rule-change that allowed consumer drug advertising, didn't hire enough staff to police consumer drug advertising.
2. Post-marketing monitoring no good. Why? FDA doesn't know how to do post-market monitoring.
3. Took 11 months to successfully execute an off-label violation warning letter.
4. Supposed to be inspecting foreign drug manufacturers, but, uh, can't speak foreign languages.
5. Decided that emergency contraceptive should not be available to under-age rape victims.
6. Although elderly people take most drugs, forgot to ask companies whether they had tested their drugs on the elderly.
This entry was posted on August 1, 2008 at 3:05 pm and is filed under Uncategorized.
http://jimedwardsnrx.wordpress.com/2008/08/01/fdas-most-embarrassing-moments/
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