FDA Advisory Committee Review of Daily Oral Truvada as PrEP - An Advocate’s Primer for Public Participation

Sep 27, 2026

Guide explaining how the FDA Antiviral Drugs Advisory Committee evaluates Gilead’s once-daily Truvada as oral PrEP to reduce HIV infection risk. Describes committee membership, conflict-of-interest expectations, and what briefing materials and FDA staff evaluations are shared before the meeting. Details the public’s input routes, including written comments and time-limited oral remarks, plus practical submission deadlines announced through the Federal Register and AVAC materials to maximize comment impact.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages4

Reading Time10 min

AccessFree to download

How the FDA committee review works

Who are the advisory committee members

What the committee receives in advance

Public input opportunities

How to make participation effective

FDA’s Advisory Committee Review of Daily Oral Truvada as Pre:Exposure Prophylaxis (PrEP) to Reduce the Risk of HIV Infection An Advocate’s Primer for Public Participation On February 13, 2012, FDA granted priority review to consider Gilead Sciences, Inc.’s application for approval of onceCdaily emtricitabine/tenofovir disoproxil fumarate (Truvada®) to reduce the risk of HIV infection among uninfected adults (an approach known as oral preCexposure prophylaxis, or PrEP) . Priority review speeds up the process, and the FDA set June 15, 2012 as the target approval decision date for Gilead’s application. Seeking outside expert opinions about the application, FDA will put several issues before members of its Antiviral Drugs Advisory Committee (“Committee”), scheduled to meet in open public session on May 10, 2012 . Expert opinions, public comment, available clinical data and the recommendations of the committee provide FDA with information to make its independent decision whether to approve onceCdaily Truvada as PrEP, balancing benefits and safety risks and considering the degree of seriousness for HIV infection and prevention. FDA is not bound by the recommendations of its committees, but often follows their advice. This primer offers a guide to the workings ofthe committee and ways to participate in its review. Who are members ofthe Advisory Committee? Voting committee membership consists of about a dozen regular and temporary member experts in the field. A consumer or patient representative (a person with the ability to effectively communicate patient concerns) is also a member of the committee. Each member is required to disclose financial or other conflicts of interest and may require that he/she recuse him/herself from voting. What will the committee see in advance and be asked to do? Two or three weeks in advance of the meeting, the FDA will provide committee members with a formal set of briefing materials consisting of: 1) Gilead’s submitted data about safety and effectiveness for onceCdaily Truvada as PrEP, proposed drug labeling (including intended population users and warnings or cautions) and other technical support items, and 2) FDA staff’s own initial evaluation. This full material set may contain some protected private information that the public will not see. The committee will also later receive materials that the public submits. Two days before the meeting, FDA provides the public a web accessible copy of briefing materials that can be publically disclosed. The public will also see a set of specific questions that the FDA will ask the committee to answer by voting or opinion. These questions will most likely address areas of special FDA concern about onceCdaily Truvada as PrEP such as its overall benefit in relation to known risks, the need for other studies or conditions of proper use in different populations, and the best ways for individuals to use it. Public input FDA and PrEP: An Advocate’s Guide 1 AVAC, February 2012 to the committee should address these questions when providing oral comments to have greatest impact. Will the committee accept input before and/or during the day of the meeting? The open meeting will consist mostly of formal and invited presentations by Gilead, other experts and FDA staff to review the specific questions under review. The public has two opportunities for input: 1) Written comments submitted approximately two weeks in advance, and 2) FiveC to tenCminute oral remarks (outlined and mailed to the FDA approximately three weeks in advance, even if they are not in final form,) presented during aoneChour or extended meeting time slot after formal presentations. Permission to deliver oral remarks must be requested, and the FDA may limit public presentations by conducting a lottery among those requesting time. Groups may wish to join together to present combined input. Those who have not registered before the meeting will only be invited to speak at the d

FAQs

Who serves on the FDA Antiviral Drugs Advisory Committee for the PrEP review?

The voting membership includes about a dozen regular and temporary experts in the field. A consumer or patient representative is also included, and each member must disclose conflicts of interest and may recuse from voting if needed.

What briefing materials does the committee review before the meeting?

Two to three weeks before the meeting, FDA provides briefing materials including Gilead’s submitted safety and effectiveness data for once-daily Truvada as PrEP, proposed labeling details, and FDA staff’s initial evaluation.

How can the public provide input, and what are the key deadlines?

Public input is accepted through written comments submitted about two weeks in advance and through five-to-ten-minute oral remarks presented during a one-hour or extended time slot after formal presentations. Deadlines are announced via the Federal Register and include dates for oral presentation requests, written submissions, and when briefing materials and committee questions are posted.

Sep 27, 2026

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