U.S. Women Need the Dapivirine Ring, Too: FDA as Structural Barrier to HIV Prevention for Women.

Abstract

The dapivirine monthly vaginal ring-a discreet, anti-HIV microbicide created specifically for women-has received a positive scientific opinion by the European Medicines Agency and is included in the WHO HIV prevention guidelines. It has received regulatory approvals in several countries in southern and eastern Africa. During the review of the New Drug Application that was submitted in December 2020, FDA advised the developer, International Partnership for Microbicides, that it was unlikely to be approved in the United States; the application has since been withdrawn. This commentary will present the case for FDA approval for the dapivirine ring. Advocacy is urgently needed to protect U.S. women's access to user-controlled HIV prevention technologies, consistent with both global regulatory decisions to date and with a reproductive justice framework. Women continue to need the fullest range of HIV prevention methods to integrate into their lives in the most practical and effective way possible.