This coming Thursday, May 10, the United States Food and Drug Administration (FDA) will convene its Antiviral Drugs Advisory Committee at a public session in Washington D.C. to review data and public input related to the potential use of the antiretroviral drug Truvada for HIV prevention. The Committee will vote on whether or not daily oral intake of Truvada is safe and effective when used to prevent HIV infection, an approach known as pre-exposure prophylaxis (PrEP).
Relevant background materials for the session became available today, which include the FDA’s initial evaluation of research data related to Truvada’s safety and efficacy in the context of PrEP. Using the Committee’s recommendations and its own evaluation, the FDA is expected to make a final decision on approval by June 15, 2012.
If approved, PrEP will become part of the existing suite of evidence-based HIV prevention tools. Although many questions remain regarding high costs, operational challenges, accessibility and additional implications of PrEP both within and outside the United States, the FDA’s Committee will limit their assessment to Truvada’s safety and efficacy.
You can submit data, information or views concerning this meeting to the FDA Advisory Committee in written or electronic format until May 17, 2012. Click this link to learn how to make a submission. Additional links to key documents are provided below to help advocates better understand PrEP and the FDA review process.
Additional Resources:
- MSMGF Report: Access to HIV Prevention Services and Attitudes About Emerging Strategies (PDF)
- MSMGF Statement on FDA Review of PrEP (March 21, 2011)
- AVAC’s Primer for Public Participation in the FDA Review of PrEP
- Recent Statement by US civil society groups on PrEP
- AVAC’s PrEP Watch Website