FDA Approves 100th Antiretroviral For PEPFAR

HHS recently announced the FDA’s 100th approval of an antiretroviral drug for PEPFAR, PharmTech.com reports. Seventy-one of the more than 100 drugs reviewed by FDA for PEPFAR were generic products.  HHS Secretary Kathleen Sebelius said in a statement, “This milestone exemplifies the dedication, caring, and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS” (10/15).

According to the Business Standard, “Indian drug companies have cornered an overwhelming majority of drug approvals” under PEPFAR. The newspaper writes, “Aurobindo leads the list with 34 approvals, followed by Cipla and U.S.-based Mylan Laboratories’ Indian arm Matrix Laboratories with about 15 approvals each. Companies such as Strides, Emcure and Hetero also would supply about 5-15 drugs each under the programme” (Jayakumar, 10/16).

FDA Commissioner Margaret Hamburg said around the release of the approval data, “[I] t is estimated that FDA’s actions are allowing PEPFAR to spend $150 million more each year on patient access to care. I look forward to developing and expanding FDA’s international collaborations.” U.S. Global AIDS Coordinator Eric Goosby said, “PEPFAR is committed to supporting partner countries to build and maintain sustainable procurement and supply chain systems” (FDA release, 10/6).