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FDA Delays Decision on Over-the-Counter Status for EC

The Food and Drug Administration (FDA) late Friday announced it would delay its decision on over-the-counter status for the emergency contraceptive Plan B for women ages 16 and older. This decision prompted an immediate outcry among women’s rights and health groups, which have been working to win over-the-counter status for emergency contraception (EC).

“The FDA is playing a dangerous game in allowing right-wing politics to trump science,” said Eleanor Smeal, president of the Feminist Majority Foundation. “These stall tactics are just hurting women, especially young women.”

The FDA previously gave a not-approvable letter to Barr Laboratories in response to its request to make Plan B available over-the-counter (OTC). To comply with the conditions under which the FDA would approve EC OTC, Barr resubmitted its application with age limitations on OTC status – women 16 and older would be able to access Plan B over-the-counter, and girls aged 15 and younger would still only be able to obtain Plan B with a prescription. The FDA missed its January 21, 2005 deadline to make a decision. According to Barr Laboratories, the FDA intends to make a decision in the “near future.”

“The science is clear, the need is great, and yet with this disastrous decision, the FDA continues to play politics with women’s lives, placing women at needless risk and in harm’s way,” said Beth Jordan, MD, the medical director for the Feminist Majority Foundation.

The Center for Reproductive Rights (CRR) on Friday filed suit against the FDA in federal court for failing to approve Plan B for over-the-counter status and for “to follow its own procedures and statutory and regulatory mandates,” which violated the Administrative Procedures Act and the US Constitution. CRR represents the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, and individuals from the MAP (Morning After Pill) Conspiracy.

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Sources:

Feminist Majority Foundation; Barr Laboratories 1/22/05; CRR 1/21/05