Posted on 08/31/2005 3:07:58 PM PDT by truthandlife
A senior women's health official at the Food and Drug Administration resigned on Wednesday to protest the agency's failure to approve over-the-counter sales of a "morning-after" contraceptive despite favorable recommendations from staff scientists.
The FDA said Friday it was indefinitely postponing a decision on Barr Pharamceuticals Inc.'s (BRL.N: Quote, Profile, Research) bid to sell the Plan B contraceptive without a prescription.
A decision that "continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions is contrary to my core commitment to improving and advancing women's health," said Susan Wood, the FDA's assistant commissioner for women's health and director of its office of women's health.
"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overuled. I therefore have submitted my resignation effective today," Wood said in an e-mail to colleagues.
Wood was a career scientist who worked at the FDA for nearly five years. She holds a doctorate in biology and has worked on women's health issues for about 15 years.
The FDA praised Wood's work at the agency, saying in a statement that her leadership led to "significant strides" in women's health that "undoubtedly helped thousands of consumers."
"Her decision to leave is unfortunate as we work toward solving the complex policy and regulatory issues related to Plan B," the statement said.
Plan B is a set of pills that may prevent pregnancy if taken within 72 hours of sexual intercourse. The product is available now with a doctor's prescription.
Supporters say easier access is needed to make sure women get the pills in time. Opponents, including some conservative lawmakers and groups, say wider availability could increase promiscuity and sexually transmitted diseases.
Some Democrats and women's groups have charged the FDA with letting politics interfere with science in the Plan B review.
Wood, in an interview, said she did not know if politics played a role because "it was a very closed decision" made by FDA Commissioner Lester Crawford rather than the head of the FDA's drug center.
"I know a lot of professional staff at FDA are deeply concerned about a loss of credibility for the agency" on Plan B and other issues, Wood said.
Crawford announced on Friday that officials were unable to decide whether to approve Barr's bid to sell Plan B over the counter to females age 16 and older.
Agency scientists agreed Plan B could be used safely without a prescription by girls and women 17 and older, but other questions including how to enforce an age limit were unresolved, Crawford said. The agency is taking public comment for 60 days.
The application to sell Plan B over the counter was first submitted in April 2003. A panel of outside advisers voted 23-4 in December 2003 to urge the FDA to reclassify Plan B from a prescription to over-the-counter drug.
It just breaks my heart to think about all those babies that can't be easily aborted... I MEAN FETUSES! FETUSES!!!
Owl_Eagle(If what I just wrote makes you sad or angry,
They won't do what I told them to do so I quit.....what a stupid, insiped little woman to take such an attitude. Hope the door doesn't hit her in the ass on the way out, and tell her to write when she finds work somewhere!! Bye-bye & boohoo!!
Good riddance to bad rubbish!
A PhD level biologist should KNOW that showing a drug's safety for occasional use does NOT establish its safety for frequent use. If it's sold OTC, there will be women who think it's safe for daily use, when that's not what it was developed for. Dr. Wood obviously values a political agenda above women's health.
The FDA is a complete and utter joke. THey are currently sitting on approval of a compound called MEXORYL that is approved everywhere else in the world except here. It's the best UVA blocking compound found to date that is used in sunscreen. One can buy sunscreen with it via Canadian pharmacies but why the hell is the FDA dragging it's feet on it's approval? With other evidence of how the FDA is incompetent, it's time to either over haul it or get rid of it.
I didn't know that an openly acknowledged abortifacient is now considered a contraceptive.
If you're a Christian, please don't succumb to the temptation to use a government agency to force people to accept your moral views. Moral suasion is what pulpits are for.
OK, since you're evidently NOT a Christian, please don't succumb to the temptation to peddle abortion drugs to our kids. We voted for Bush so that kind of thing wouldn't happen. Who did you vote for?
Does anyone not think that the availability of a 'morning after' pill would lead to an increase in the number of 'nights before'?
"A decision that "continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions is contrary to my core commitment to improving and advancing women's health," said Susan Wood, the FDA's assistant commissioner for women's health and director of its office of women's health."
I cannot wait for the anti-Bush book to come out.
Wonder if she will use the same puiblisher Dick Clarke used.
Actually Bush, although I'm one of those awful Libertarians. I freely admit that our candidates sucked that year.
All I'm saying is that using a government agency to enforce moral codes puts that agency in charge of that code. Is that a good thing? It's like putting the FCC, which is an agency chartered to keep broadcasters within specified frequency bands and geographic areas, in charge of pornography.
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