Open Letter to FDA Urging PrEP Review

January 25, 2012

This is an open letter to the Food and Drug Administration, urging the priority review of the drug Truvada for use in PrEP (pre-exposure prophylaxis). The AIDS Foundation of Chicago and 25 other organizations signed this letter to counter the AIDS Healthcare Foundation's protest of the FDA regarding this review. To read the PDF of the letter, with footnotes, click here.

January 25, 2012

Margaret A. Hamburg, M.D.
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852

Re: Request for Priority Review – Supplemental NDA submission by Gilead Sciences, Inc.
requesting approval of a labeling change to include HIV prevention indication use for
emtricitabine; tenofovir disoproxil fumarate fixed dose combination

Dear Commissioner Hamburg:

We write as a coalition of 25 leading HIV/AIDS and health organizations to request that
FDA grant priority review of a supplemental New Drug Application1 (sNDA) for the
approval of emtricitabine/tenofovir disoproxil fumarate (Truvada®) fixed dose combination
for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection among adults as part
of a comprehensive prevention package including risk reduction counseling and condoms.
The rigorous priority review process applicable to efficacy supplements is the best means to
promote public health by recognizing the potential of PrEP to offer a major advance in HIV
prevention and deserving this priority “where no adequate alternate therapy exists or as a
significant improvement compared to marketed products … including nondrug products or


Our organizations understand that granting priority review is not tantamount to a final
approval. Nevertheless, we are hopeful that the full dossier of data on
emtricitabine/tenofovir disoproxil fumarate fixed dose combination of PrEP from multiple
clinical trials in different populations can lead to a responsible regulatory and marketing plan
that allows safe use in the populations that may benefit from this innovative development.

The need for significantly improved safe and effective HIV prevention tools is clear. Despite
many years of efforts to reduce HIV incidence using available counseling methods, some
50,000 new infections occur annually. Disparities persist so that incidence continues to
concentrate among African Americans and Latinos, men who have sex with men (including
transgender individuals), and the poor. These grim and stubborn facts led to the creation of
the White House-directed National HIV/AIDS Strategy for the United States (NHAS), which
lists enhanced prevention efforts as a primary objective. If emtricitabine/tenofovir
disoproxil fumarate for PrEP satisfies FDA approval criteria, health programs and individuals
will have improved choices to address a domestic priority and save lives.

The PrEP sNDA for Truvada® meets criteria set out in FDA’s Manual of Policies and
Procedures for priority review. As organizations committed to ending the AIDS epidemic,
we appreciate how the history of FDA’s regulatory tools for fast track approval or for
accelerated and priority review4 introduced the current suite of HIV therapeutic drugs to treat
active infection. In the present case, there is a clear unmet need for new effective methods
for preventing HIV infection, a need that is as urgent today as was the need for HIV
therapeutics over the past two and more decades.

HIV advocacy organizations made it possible to launch such regulatory procedures for the
benefit of all patient disease groups when those tools were not yet available. We are not
aware of any legitimate reason to thwart the faster introduction of medicines FDA determines
to be safe and effective to stop HIV, nor should anyone turn back the pages of history and act
against the interests of patients to do so now. Unfortunately, recent actions by the AIDS
Healthcare Foundation regarding PrEP would introduce unwarranted roadblocks in the FDA
process of making responsible decisions about potentially useful medicines and public health.
Those actions also foster misunderstandings of the careful balancing of risk and benefits that
informs a mature marketing permission based on all available data. Those actions would also
set an unhelpful precedent as PrEP research evolves in the future and the FDA is asked to
review non-tenofovir-based regimens (e.g. maraviroc), microbicide gels, and intermittent
PrEP. We urge that FDA continue its public health promotion goals now in the service of the
critical need to prevent, as well as treat, HIV and grant this priority review.

We would be happy to discuss the priority review process as applied to HIV prevention
further at your convenience. Mitchell Warren, Executive Director of AVAC, acts as the
contact person for the organizations signing this letter and can be contacted at 1-212-796-
6423 and

Yours sincerely,

AIDS Foundation of Chicago

AIDS Legal Referral Panel

AIDS Resource Center Ohio

AIDS Research Consortium of Atlanta

AIDS United

amfAR, The Foundation for AIDS

Asian & Pacific Islander Wellness Center

AVAC: Global Advocacy for HIV Prevention

Black AIDS Institute

Caracole, Inc.

Chicago Black Gay Men’s Caucus

Fenway Health

HIV Prevention Justice Alliance

International Rectal Microbicide Advocates

Justice Resource Institute

LA Gay and Lesbian Center

Multicultural AIDS Coalition

National Alliance of State and Territorial
AIDS Directors

National Black Gay Men's Advocacy

National Latino AIDS Action Network

National Minority AIDS Council

Ohio AIDS Coalition

Project Inform

San Francisco AIDS Foundation

SisterLove, Inc.

Ursuline Sisters of Youngstown

HIV/AIDS Ministry

Us Helping Us

Categorized under Prevention.

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