PEPFAR Paying More Than Twice as Much for Many AIDS Drugs as Other Aid Organizations, Draft GAO Report Says

The U.S. government is paying more than twice as much for many antiretroviral drugs for its global HIV/AIDS program as other international aid organizations are, a draft Government Accountability Office report says, the Wall Street Journal reports. The report, which is based on a survey of antiretroviral drug companies, shows that because the Bush administration will not purchase generic forms of many antiretroviral drugs from India for the President's Emergency Plan for AIDS Relief, it is paying higher prices than other international HIV/AIDS programs, including programs funded by the Global Fund to Fight AIDS, Tuberculosis and Malaria and the World Bank, according to the Journal (Lueck, Wall Street Journal, 10/29). PEPFAR is a five-year, $15 billion program that directs funding to 15 focus countries, including the African nations of Botswana, Ethiopia, Cote d'Ivoire, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda and Zambia; Haiti and Guyana in the Caribbean; and Vietnam in Asia (Kaiser Daily HIV/AIDS Report, 10/14). The data from the draft report was provided to the media by Senate Democrats, who have criticized the Bush administration for not purchasing Indian-made generic drugs. Public release of the report is expected after the Bush administration submits formal comments to GAO, the Journal reports.

Cost of Therapy
The lowest available price to the United States for a common antiretroviral drug regimen that combines stavudine, lamivudine and nevirapine is $562 per person annually, whereas a similar drug combination is available to other international HIV/AIDS groups in one pill for $215 per person annually. The U.S. government pays nearly $450 per patient annually for Boehringer Ingelheim's nevirapine, but generic versions of the drug are available for $120 to $170 per patient annually, and GlaxoSmithKline's zidovudine costs the United States about $200 per patient annually, compared with $125 to $175 for generic versions, according to the draft report. However, the U.S. government pays the same amount as other organizations for some antiretroviral drugs, such as Bristol-Myers Squibb's stavudine and GSK's lamivudine, the draft report says, according to the Journal.

Reaction
Mark Dybul, chief medical officer for the Office of the U.S. Global AIDS
Coordinator, said that prices for Indian-made pills, which violate U.S. patent laws, are less expensive than the drugs the United States is buying. However, he said that medications are a "relatively small" part of what the United States spends for PEPFAR when compared with the costs of staff training, salaries, lab tests and infrastructure, the Journal reports. According to a survey conducted by the U.S. AIDS Coordinator Office, Indian antiretroviral drugs are about $200 cheaper per patient annually than the drugs the United States is purchasing. Administration officials have said they plan to buy the less expensive drugs when FDA approves their safety, but HIV/AIDS advocates say that FDA review of the drugs is "unnecessary" and that the administration should "treat the epidemic as an emergency," according to the Journal. However, Mark Grayson, spokesperson for the Pharmaceutical Research and Manufacturers of America, said, "We need to make sure drugs taken by people around the world are safe." GSK spokesperson Nancy Pekarek said that the company is not "fighting" the use of generic antiretroviral drugs "as long as they're limited to the developing world," the Journal reports. Chuck Caprariello, spokesperson for the Indian-based generic antiretroviral drug manufacturer Ranbaxy Laboratories, said that the company applied last week for FDA approval of one medication and plans to early next year submit applications for 12 other products, including a three-in-one combination drug. South African-based generic drug maker Aspen Pharmacare also has said it plans to apply to FDA for approval of its generic drugs. However, Bill Haddad, an adviser for the Indian-based generic drug firm Cipla, said that the FDA process has been "cumbersome" for the company, and they are "still debating" whether it is "worthwhile" to apply, according to the Journal (Wall Street Journal, 10/29).