Susan F. Wood was the director of the FDA’s Office of Women’s Health until she resigned at the end of last August in protest over the department's handling of Plan B. That was her discussion topic for the lecture- everything that was flat-out wrong with the administration's decision. Among the problems were that absolutely nobody up to the Director saw any problem with making Plan B (the emergency contraceptive) OTC; all recommendations were "approve", and the Director sent a "non-approvable" letter to the company. ("Non-approvable" is only the second-worst they can get; "Not Approved" is the FDA's way of telling a company to fuck off. Non-approvable means that the problems can at least be potentially fixed; "approvable" means the problems are trivial, and "approved" is obvious.) So the petition was re-submitted as per the director's suggestion: make it OTC for those 16 and over, but by prescription only for those younger.
The Commissioner stalled it. It was supposed to have been approved last January; it's still stalled and now "open for public comment, pending rulemaking". It's about as much of a non-appealable "no" as you can get, because you can't appeal indecision. It's being administratively stalled for no valid reason. A large part of the discussion was about the complete lack of valid scientific reasons to not have this drug be OTC...
There's a lot more I want to say about this, but I'm not very coherent- I'll have to go through the large quantity of notes I took. (Two pages, printed in Tahoma 10.) I'll leave you with two quotes from the lecture:
"The FDA is not someone's mother." --Dr. Susan F. Wood
"I Quit My Job!!!" --Dr. Susan F. Wood's screensaver, much to the amusement of the audience. Dr. Wood's daughter was blamed.
Of course, it's Experimental Psych that I did skip, but it's Computer Architecture that I should have. Dr. Bayazit is back, and class isn't any better now than it was.
If I (and a friend- we can work on teams of 2) can implement the Commodore 64 on a Field-Programmable Gate Array and demonstrate that it works by running a game on it, it's worth the Instant A- a guaranteed A in the class, with no expectation of taking exams or quizzes, and no expectation of attending class. It is very tempting to go all-or-nothing for it right now...