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Science 25 June 2004:
Vol. 304. no. 5679, pp. 1911 - 1912
DOI: 10.1126/science.1100441
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Policy Forum

PUBLIC HEALTH:
Regulatory Challenges in Microbicide Development

Paul M. Coplan,* Mark Mitchnick, Zeda F. Rosenberg

Topical vaginal microbicides to prevent HIV infection are urgently needed. Recent scientific progress has identified potential new molecular targets for microbicides, and six older candidates are starting phase III trials. However, regulatory hurdles to licensure risk delaying future availability in developing countries unless these obstacles are pro-actively addressed. Although clear safety and efficacy data for microbicides are essential, risk-benefit profiles differ enormously between developed countries, which by default dominate global regulatory decisions, and developing regions where microbicides are needed most. This Policy Forum suggests actions to avoid regulatory logjams in making safe and efficacious microbicides available to women in resource-poor, HIV-prevalent settings.

The authors are with the International Partnership for Microbicides, Silver Spring, MD 20910, USA.

*Author for correspondence. E-mail: PCoplan{at}ipm-microbicides.org

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