New contraceptive method, female-worn condom, approved by FDA panel
Washington memo 1992(4): 3-4
1992
ISSN/ISBN: 0739-4179 PMID: 12284786 Document Number: 317067
An expedited review of the Reality intravaginal pouch--the so-called "female condom"--led the Food and Drug Administration (FDA) to recommend conditional approval for the new contraceptive device on January 31. Developed by the Wisconsin Pharmacal Company, Reality consists of a lubricated polyurethane sheath that is the same length but wider than a male condom, and contains flexible rings at both ends. The closed end is inserted similarly to the diaphragm, covering the cervix. The open end remains outside the vagina in order to prevent skin contact, thereby preventing pregnancy and protecting against STD. Nonetheless, questions linger as to the efficacy of the device. In 1988, an FDA expert panel determined that female condoms were not "substantially equivalent" to male condoms. Soon after, however, the FDA issued new guidelines which streamlined the approach for bringing to market female barrier contraceptives which offer protection against STDs. The FDA's January meeting was marked by a debate between those supporting the expedited process, who viewed approval of the product as a moral imperative for protecting women, and those questioning the efficacy of the product, who said that not enough information is available. The latter group noted that one study found a 15.1% pregnancy rate among a group of women using the device. The FDA decided to grant conditional approval; pending further company data on the use-effectiveness of the device. Noting that expedited decision reflects the relatively slow pace and lack of federal support for contraceptive research, the article goes on to discuss a legislative attempt to give permanent authorization for five contraceptive and infertility research centers, a move that is not supported by the Bush administration.