AIDS Healthcare Foundation (AHF), today noted that the current "FDA fiasco" involving the agency's initial approval and subsequent recall of Merck's troubled arthritis drug, Vioxx, raises serious questions about the FDA's ongoing parallel role in the approval of generic AIDS drugs for widespread use in Africa and the developing world.
At present, the President's Emergency Plan for AIDS Relief (PEPFAR) which pays for, or provides AIDS drug treatments for patients in developing world countries stipulates that if cheaper generic drugs are to be used, they must be approved for 'bio-equivalency' to their branded drug counterpart by the FDA.
"This latest FDA fiasco underscores the need for a better method for drug approval to ensure the health and welfare of all patients-be they in Alabama or Africa, India or Indiana," said Michael Weinstein, AIDS Healthcare Foundation president. "Drug industry spin usually slants heavily toward the notion that 'branded equals safe,' yet this Vioxx recall and the removal of Rezulin from the market in 1997, remind us that any drug could have problems. Just as there are some dangerous branded drugs, there are also some excellent generics drugs. The issue is really one of developing a competent and respected testing and approval process that the public can truly trust."
The drug safety issue rose in Washington yesterday in testimony before a United States Senate Committee by Dr. David Graham, the FDA official who first blew the whistle on the approval and subsequent recall of Merck's Vioxx. The arthritis drug has been implicated in as many as 160,000 heart attacks and strokes in patients and has been removed from the marketplace. According to the Guardian newspaper, "Dr. Graham (also) identified GlaxoSmithKline's asthma drug, Serevent, AstraZeneca's cholesterol fighter Crestor, Pfizer's arthritis treatment Bextra, Roche's acne treatment Accutane and Abbott Laboratories weight-loss drug Meridia, as carrying possible risks."