FDA Tentatively Approves Generic Drugs for Use by PEPFAR

The New York Times today detailed the FDA's recent tentative approval of a generic 3-in-1 combination anti-retrovival drug made by the Indian manufacturer Aurobindo Pharma. This decision follows on the heels of another approval last week (that one for a generic version of GlaxoSmithKline's Epivir ARV) and opens the door for the purchase and use of the drugs in PEPFAR-supported programs in developing countries.According to Mark Dybul, quoted in the article, it is unclear if the generic drug will significantly cut costs, but by requiring patients to only take one pill two-times a day the combination drug "should facilitate better therapies and better adherence." Equally important, it seems, the ability to use these drugs will bring PEPFAR's policies and procurement closer to those of other donor partners working in the same countries, including the Global Fund, and help reverse the duplicate and often confusing procurement and drug supply systems that have characterized the emergency responses to date in many places.