FDA Panel to Consider EC Over-the-Counter Status

A Food and Drug Administration (FDA) panel will meet next month to consider over-the-counter sales status for the emergency contraceptive (EC) Plan B. New York-based Barr Laboratories, Inc. – which recently acquired Women’s Capital Corporation, the manufacturer of Plan B – will speak with FDA panelists on December 16. “The idea of over-the-counter (sales) is to increase education and increase access,” Barr spokeswoman Carol Cox told Bloomberg News.

EC, a concentrated dose of birth control hormones, is up to 95 percent effective at preventing pregnancy if taken within 72 hours of unprotected intercourse, contraception failure, or rape. The Feminist Majority Foundation joins a host of other reproductive health and rights groups, including the American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association, in advocating FDA approval for over-the-counter status. Women’s Capital Corporation submitted a request to the FDA last April for over-the-counter status of EC.

The New York state Comptroller’s office released a report last week estimating that increased access to EC could save the state $452 million annually in health care costs, according to Kaisernetwork.org. Using actual Medicaid and representative private health insurance data, state Comptroller Alan Hevesi found nearly 60 percent of pregnancies in New York in 2000 were unintended, with the majority resulting in abortion. “Easy access to emergency contraception is a win for everyone. Women avoid pregnancies and abortions they don’t want. And rapidly rising Medicaid costs will be cut by $254 million a year, saving money for the State and local governments. In addition, private insurers would save nearly $200 million,” Hevesi said, according to his office’s press release. Still, only 54 percent of pharmacies statewide carry EC. Among the report’s recommendations are: permission for pharmacists to dispense EC under advance and/or phone prescriptions; support for FDA approval of over-the-counter EC status, and $10 million a year for five years to expand public education and awareness of EC.

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Kaisernetwork.org 11/10/03; Bloomberg News 11/8/03; Newsday 11/10/03; Feminist Daily News Wire

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