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  • Title: FDA panel recommends female condom approval; efficacy concerns remain.
    Journal: Wash Memo Alan Guttmacher Inst; 1992 Dec 21; (20):1-2. PubMed ID: 12344700.
    Abstract:
    On December 10, 1982, the Obstetrics and Gynecology Devices Advisory Panel of the US Food and Drug Administration (FDA) reexamined its earlier decision giving conditional approval to the female condom (Reality), because some members were concerned about its efficacy rates. Despite these concerns, the panel agreed again to recommend approval of this female condom to the FDA commissioner. Women's health groups continued to back the female condom since it is the first barrier method empowering women to prevent unplanned pregnancy and transmission of sexually transmitted diseases (STDs) or HIV. In 1988, the panel decided that the female condom would have to be approved on its own, since it was not exactly like the male condom. In 1989, FDA simplified the process for this limited class of devices (female condoms) by requiring only 6 months of effectiveness data and that effectiveness in pregnancy prevention would substitute for effectiveness in preventing STDs. These trials showed a mean pregnancy rate of 14.9% over 6 months (12.2% for US women and 21% for Latin American women) which would probably increase over 12 months. Panel and FDA staff concerns prompted the panel to recommend that public health messages be added to labels which already lists specific instructions for the female condom. For example, one message may be warning that the risk of pregnancy is likely to be 50% greater than the 14.9% reported failure rate. Some panel members expressed the need for more research in new barrier methods, particularly comparison of the various types of barrier methods. The FDA Commissioner agreed and proposed the creation of a high-level task force to set minimum standards of effectiveness for future methods. The task force should include representatives from FDA, the National Institutes of Health, and the Centers for Disease Control.
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