FDA Advisers To Debate Next Month Whether To Allow Emergency Contraception To Be Sold Without Prescription
[November 25, 2003]
FDA scientific advisers next month are scheduled to debate whether to allow emergency contraception to be sold without a prescription, the AP/Long Island Newsday reports (Neergaard, AP/Long Island Newsday, 11/24). In April, Washington, D.C.-based Women's Capital Corporation, which originally brought Plan B to the market in 1999, applied to the FDA to sell the drug without a prescription. In October, Pomona, N.Y.-based generic drug maker Barr Laboratories acquired the drug from WCC. EC, which can significantly reduce the risk of pregnancy if taken within 72 hours of unprotected sexual intercourse, is thought to work by interrupting ovulation, preventing fertilization of an egg or inhibiting a fertilized egg from implanting in the uterus (Kaiser Daily Reproductive Health Report, 11/11). Although the FDA has said that EC is "very safe to use," the panel is expected to discuss the question of whether women will understand precisely how to use EC without any professional advice, according to AP/Newsday. Dr. John Jenkins, director of the FDA Office of New Drugs, said that the "fundamental thing we'd be looking at is … do the women understand the instructions" and administer the drug properly, according to the AP/Newsday. If the agency decides to allow EC to be sold without a prescription, it will then need to determine whether EC should be available "on any drugstore shelf" or "behind the counter," the AP/Newsday reports. According to a senior FDA official, "all options are open," the AP/Newsday reports (AP/Long Island Newsday, 11/24).
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily Reproductive Health Report, search the archives, and sign up for E-mail delivery at www.kaisernetwork.org/dailyreports/repro. The Kaiser Daily Reproductive Health Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2003 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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