FDA panels probe efficacy of barrier contraceptives
Turnbull, W.
Washington Memo 10: 3-4
1996
ISSN/ISBN: 0739-4179 PMID: 12291983 Document Number: 302994
Two recent US Food and Drug Administration (FDA) hearings have focused on barrier contraceptive methods. In the first action, FDA's Obstetrics and Gynecology Devices Panel voted 7 to 1 against approval of Lea's Shield, a device similar to the cervical cap that does not require custom fitting, on the grounds that adequate clinical research on effectiveness was lacking. Only 1 clinical trial, involving 55 women over a 6-month period, was conducted. The panel urged that additional research on effectiveness also investigate whether the device confers protection against sexually transmitted diseases. During another hearing, FDA advisory committees voted 18 to 1 that spermicidal gels and foams containing nonoxynol-9 appear to provide women with some protection against gonorrhea and chlamydia. At the same time, the committees urged FDA to relabel existing spermicides to inform consumers that their effectiveness in preventing pregnancy has not been established. In addition, panelists voted 11 to 8 that spermicides have been proven safe, although concerns were expressed about spermicide-associated vaginal irritation, which may enhance women's susceptibility to human immunodeficiency virus (HIV) infection.