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Plan B Approval is Not Assured
The Chicago Tribune puts the FDA's seeming about-turn on Plan B in (cautionary) context:
FDA approval for over-the-counter sales is not assured. One potential hurdle: the FDA wants the company to ensure that pharmacies won't sell the pill over the counter to girls younger than age 18. But isn't that the pharmacies' responsibility? Some advocates worry that such an onerous requirement could be a loophole that would allow the FDA to deny permission for over-the-counter sales.
Dr. Susan Wood, former director of the FDA's Office of Women's Health, resigned in protest last August after the last Plan B delay. She said she was "somewhat encouraged" by Monday's announcement. But she also warned: "I feel they're making it appear they're moving forward. But until we actually see a decision, we can't count on that." Yes, some skepticism is warranted here. Unfortunately, politics may yet trump science again.
Posted by Julian Brookes on 08/04/06 at 10:57 AM | E-mail | Print | Digg | de.licio.us | Reddit | Newsvine | Yahoo! MyWeb | StumbleUpon | Netscape | Google |
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Andrew von Eschenbach, who has been acting FDA commissioner for nearly a year, was completely silent on the issue until Monday, the day before his Senate confirmation hearing. His predecessor, Lester Crawford, said something similar on the eve of his confirmation as FDA commissioner in 2005:
"The science part is generally done. We're just now down to what the label will look [like]. This is going to be a very unusual sort of approval."
Indeed.
Plan B's maker, Barr Pharmaceuticals, is scheduled to meet with the FDA on Tuesday. Maybe some real action will come of the meeting, but I can't say I'm optimistic.
Posted by: Ann on 08/04/06 at 11:46 AM