Thursday, September 01, 2005

Plan B and Your Ob/Gyn

ACOG comments on the FDA's "decision" on availability of Plan B OTC:

The American College of Obstetricians and Gynecologists (ACOG), the nation's leading organization of physicians specializing in women's health care, reiterates its support for making emergency contraception (EC) available without a physician's prescription to all women of reproductive age.

The medical evidence regarding the safety and effectiveness of emergency contraceptive pills (ECPs) is scientifically sound. Not only does the medical community advocate wider access to Plan B, but the US Food and Drug Administration's (FDA) advisory committees on non-prescription and reproductive-health drugs and the agency's own medical-review staff support the switch to over-the-counter.

In May 2004 the FDA rejected the application from Barr Pharmaceuticals, Inc. to make Plan BTM available without a prescription on the basis of insufficient data related to safety. Though now acknowledging that women age 17 and older can safely use Plan BTM as an over-the-counter drug, the FDA nonetheless has introduced new excuses as reasons to continue its delay in making a decision.

"What this amounts to is a quintessential shell game, in which women are the losers. Unplanned pregnancy remains a major public health issue in the US. Emergency contraception offers a safe and effective way to prevent unplanned pregnancy and reduce the number of abortions in this country," says ACOG President Michael T. Mennuti, MD.

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