Health Policy 05.10.2012

FDA to review PrEP application today

Today, the U.S. Food and Drug Administration (FDA) is reviewing a supplemental new drug application for emtricitabine/tenofovir disoproxil fumarate (FTC-TDF) to reduce the risk of acquiring HIV in men and women by pre-exposure prophylaxis (PrEP), offered as part of a comprehensive HIV-prevention package including risk reduction counseling.

FTC-TDF pills
FTC-TDF is an anti-HIV medication being reviewed by the FDA for use in preventing HIV infection.

PrEP has the potential to be a game-changer in the effort to curb HIV infection worldwide.  Fenway Health called on the FDA to approve PrEP use in at-risk populations in written comments filed on April 26.

“We believe that if the FDA looks closely at the science, it will see the merit of allowing PrEP to be added to our tool kit to prevent HIV infections,” said Kenneth Mayer, M.D., Medical Research Director and Co-Chair of The Fenway Institute at Fenway Health and a leading researcher in the field of biomedical HIV prevention. “We must deploy new tools to prevent new infections, which are affecting 50,000 Americans each year and more than 2 million people worldwide, most in Africa,” Mayer continued. “PrEP combined with sustained behavioral interventions and medical care to maintain adherence could help us finally begin to turn the tide with this virus.”

Earlier this year, The Fenway Institute issued a Policy Focus summarizing the state of PrEP and microbicides research as of January 2012, looking at willingness to use PrEP among various populations, addressing concerns about PrEP that could present obstacles to implementation, offering strategies for effective implementation, and examining policy issues related to cost and how to make PrEP accessible to those most vulnerable to HIV.

“PrEP has the potential to dramatically reduce HIV incidence among gay men, heterosexual women and men, and other populations,” said Sean Cahill, Director of Health Policy Research at The Fenway Institute and author of the report. “We look forward to action by the U.S. Food and Drug Administration and the World Health Organization this year to make PrEP available to those most vulnerable to HIV. PrEP could prove an invaluable new tool in the fight against HIV.”

Cahill has also authored a couple of op-ed pieces arguing for the approval of PrEP as an HIV prevention tool, first on March 26 on The Boston Globe’s Podium online opinion blog and then yesterday, May 9, on The Huffington Post.

We’ll be closely watching today’s hearing and will keep you posted about the FDA’s decision.

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