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.
April 15, 2009 at 8:57 am
The style of writing is quite familiar . Did you write guest posts for other bloggers?