The most recent FDA actions in association with PEPFAR were tentative approvals of the following generic drugs:
- abacavir oral solution (Hetero Labs Ltd. Unit III, July 2, 2012)
- lopinavir and ritonavir oral solution (Cipla Ltd., June 29, 2012)
- efavirenz tablets (Edict Pharmaceuticals Private Ltd., June 25, 2012 and Micro Labs Ltd., June 20, 2012)
Tentative approval means that although FDA has found that a drug product has met all required manufacturing quality, clinical safety, and efficacy requirements, it cannot be approved for marketing in the U.S. at this time because of existing patents and/or marketing exclusivity. However, the product is eligible for purchase outside the U.S. through the PEPFAR program. All FDA reviews of drug applications received in association with PEPFAR are expedited, as are any inspections of the overseas manufacturing facilities.
Established in 2003, the PEPFAR program seeks to prevent, treat, and care for those infected with and affected by HIV/AIDS worldwide. It is a cooperative effort that involves the FDA and other Department of Health and Human Services agencies, the State Department's Office of the U.S. Global AIDS Coordinator, U.S. Department of Defense, other federal agencies, host country governments, and many international partners. PEPFAR represents the largest commitment by any nation to combat a single disease.
"PEPFAR is driven by a shared, global responsibility to save lives affected by HIV and AIDS," said Commissioner Hamburg, M.D. "Thanks to the hard work and commitment of hundreds of FDA staff and our partners, we now have safe and effective antiretroviral drugs that are widely available at low cost and in forms that allow for better adherence. Together, we are changing the course of the AIDS epidemic."
The antiretroviral drug products either fully or tentatively approved by the FDA under PEPFAR include innovative formulations such as fixed-dose combination and co-packaged products that can be used alone as complete regimens or in combination with other antiretroviral drugs. The products also include tablets for adults, as well as tablet formulations that can be dispersed in water for children who are unable to swallow tablets, making it easier for infected individuals to take and adhere to their medications.
The PEPFAR program has supported life-saving antiretroviral treatment for more than 3.9 million men, women, and children worldwide as of Sept. 30, 2011, the most recent figure available. In fiscal 2011, PEPFAR directly supported antiretroviral drug prophylaxis to prevent mother-to-child HIV transmission for more than 660,000 HIV-positive pregnant women, allowing more than 200,000 infants to be born HIV-free.
The FDA approved the first antiretroviral drug in association with the PEPFAR program in 2004.
FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.