FDA is Proud to Have Helped PEPFAR Reach its Latest Milestone: More than 150 Drugs Now Available Worldwide to Help Treat HIV/AIDS

By: Jeffrey S. Murray, M.D.

While Americans today are all too familiar with the acronyms “HIV” and “AIDS,” many of us are not familiar with the strange-sounding acronym, “PEPFAR.”  Despite being less well-known than these other acronyms, PEPFAR, which stands for the President’s Emergency Plan for AIDS Relief, has saved about 1.2 million lives in its global efforts to battle the HIV/AIDS epidemic.  This month marks a historic milestone: As of July, 2012, PEPFAR has now made available more than 150 drugs to help treat people worldwide infected with HIV.

Access to life-saving HIV/AIDS therapy is one of many goals of the PEPFAR program, the U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world.  Since PEPFAR’s establishment in 2003, the HIV/AIDS drug program has supported life-saving treatment for more than 3.9 million adults and children worldwide.

FDA is proud to play a role in contributing to PEPFAR’s success.  As part of PEPFAR’s program, FDA conducts an expedited review of antiretroviral drugs produced by manufacturers all over the world and ensures that these products are rapidly reviewed, their quality assessed, and that they are acceptable for purchase with PEPFAR-supported funds.

In 2004, to help increase the availability of safe and effective HIV/AIDS drugs for use under PEPFAR, FDA began an expedited review process for generic HIV/AIDS drugs.  This process respects the patent and exclusivity rights of brand name HIV/AIDS therapies in the U.S., but helps ensure that safe and effective lower-cost generic versions of these therapies can be purchased under PEPFAR for use in other countries.  The PEPFAR program reaches 15 of the hardest hit countries in Africa, Asia, and the Caribbean.  By the end of 2007 more than 90 percent of HIV/AIDS drug products provided in eleven of these countries were generic.

As a result of this expanded use of generic products under PEPFAR, the overall cost of providing treatment has been substantially reduced.  For instance, in one PEPFAR-assisted country it once cost $10,000 per person each year for a typical treatment regimen.  That cost is now less than $200 a year.  Such cost savings have likely helped millions more people receive HIV/AIDS therapy who otherwise would not have access to this treatment.

The goal of PEPFAR is to work with host nations to support treatment of at least 3 million people, prevention of 12 million new infections, and to provide care for more than 12 million HIV-infected and affected people by 2013. In addition, PEPFAR will support training of at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.

With PEPFAR reaching its historic milestone of making more than 150 drugs available to help fight HIV/AIDS, FDA applauds the program’s efforts, its dedicated workers, and all of PEPFAR’s international partners for their life-saving work.

Jeffrey S. Murray, M.D, is Deputy Director in the Division of Antiviral Products at FDA’s Center for Drug Evaluation and Research

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