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September 02, 2005
Cross Your Legs

US FDA Official Quits Over Contraceptive Delay

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 Pharmaceuticals Inc.'s 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

Forget the "regulatory" problems. Restricting access to products for underage people isn't exactly a new concept in this country. The real "nub" is the "policy issues" referred to.

Bottom line: More ways to protect from unwanted pregnancy will only encourage those uppity wimmin to act like they're entitled to control over their own bodies.

Posted by AnneZook at 08:23 AM