Regulatory Challenges in Microbicide Development

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Abstract
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.