FDA Approves Generic Antiretroviral Drug Combination, Allowing PEPFAR To Purchase Drugs for Use in Developing CountriesFDA on Tuesday announced that it has approved a generic version of a "widely used" co-packaged antiretroviral drug regimen, a move that is "expected to expand AIDS treatment in the developing world" by allowing the President's Emergency Plan for AIDS Relief to purchase the drugs, the AP/Yahoo! News reports. The approval of the regimen, which is made by South Africa's Aspen Pharmacare, is the first time FDA has approved a generic HIV/AIDS drug manufactured by a foreign pharmaceutical company. The regimen includes a generic version of GlaxoSmithKline's fixed-dose combination Combivir, which contains the antiretroviral drugs lamivudine and zidovudine, and a version of Boehringer Ingelheim's Viramune, known generically as nevirapine, which Aspen packages together. Although FDA in December 2004 approved a generic antiretroviral made by Woodcliff, N.J.-based Barr Laboratories, its approval of Aspen's generics is seen as a "major advancement" because the combination is "so widely used as a first-line therapy," according to the AP/Yahoo! News (Agovino, AP/Yahoo! News, 1/26). Aspen completed its marketing application on Jan. 13, and FDA completed its expedited review within two weeks because the co-packaged regimen has "great public health significance," according to FDA Acting Commissioner Lester Crawford (FDA release, 1/25). The Bush administration also waived the $500,000 application fee under its new FDA fast-track review program announced in May 2004 (McNeil, New York Times, 1/26). According to Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation, the estimated cost of the regimen could be between $20 and $30 per person per month. He added that the foundation currently pays $55 per person per month for the brand-name drugs included in the regimen.
The Bush administration previously has been criticized by HIV/AIDS advocates for "refusing" to purchase drugs for PEPFAR that had not been approved by FDA, according to the AP/Yahoo! News (AP/Yahoo! News, 1/26). PEPFAR is a five-year, $15 billion program that directs funding for HIV/AIDS, tuberculosis and malaria to 15 focus countries, including Botswana, Ethiopia, Cote d'Ivoire, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Zambia, Haiti, Guyana and Vietnam (Kaiser Daily HIV/AIDS Report, 1/24). Some advocates alleged that the administration policy was an attempt to boost the profits of U.S. pharmaceutical companies "at the expense" of HIV-positive people in developing countries, the AP/Yahoo! News reports (AP/Yahoo! News, 1/26). Although Tuesday's approval brings PEPFAR "more into line" with international initiatives that have "long advocated the use of cheaper generics," the co-packaged regimen will not be sold in the United States because it would violate U.S. patents, the Washington Post reports.
Although the pharmaceutical industry previously has raised concerns about the safety of generic antiretrovirals, FDA's approval of Aspen's co-packaged regimen "set concerns ... to rest" about generic drugs, according to Mark Grayson, spokesperson for the Pharmaceutical Research and Manufacturers of America, the Post reports. Grayson also "rejected the notion" that the pharmaceutical industry has "voiced safety concerns as a way to keep less-expensive drugs from being purchased with U.S. money," according to the Post. "It wasn't a way to keep the drugs off the market," he said, adding, "It was a way to make sure people got the appropriate medicines. ... People in Africa deserve safe and effective medicines." According to Murray Lumpkin, acting deputy commissioner for FDA international and special programs, the FDA approval process also involved inspections of Aspen's facility in South Africa. Lumpkin said that the facility met "all of our safety, efficacy and manufacturing standards" (Vedantam, Washington Post, 1/26).
FDA's approval "partly answered criticism" from some HIV/AIDS groups who have advocated for the purchase of generic drugs under PEPFAR, according to the Wall Street Journal. The approval "opens the door -- as promised by" U.S. Ambassador Randall Tobias, head of the State Department's Office of the Global AIDS Coordinator, and former HHS Secretary Tommy Thompson -- that PEPFAR "would be able to buy these drugs, and more people can benefit from treatment," UNAIDS Executive Director Peter Piot said (Lueck, Wall Street Journal, 1/26). Jamie Drummond, executive director of DATA, said, "This is obviously a positive and much anticipated step forward in the global battle against AIDS. America's contribution to the fight against AIDS now has the potential to go farther, treat more people with safe and effective drugs and keep more people alive by making it easier for patients to take medicine" (DATA release, 1/25).
However, the "praise for the FDA action was not unanimous," according to the Post. Medecins Sans Frontieres "questioned the need" for FDA approval because the regimen already has been "widely endorsed" by some international health groups, the Post reports. "It sends a strange signal that the FDA should be the arbiter of drug safety for African governments," Rachel Cohen, U.S. director of MSF's Campaign for Access to Essential Medicines, said, adding that the United States should support the World Health Organization's certification program. "We should not have to go down this road to begin with. It is a curious time for FDA to be boasting about its ability to monitor drug safety given recent scandals around Vioxx and other products," Cohen said (Washington Post, 1/26). "Confusion has been sown and precious resources wasted as the administration unnecessarily insisted on brand-name drugs," Paul Zeitz, executive director of the Global AIDS Alliance, said. "This approval, a full two years after the president's declaration of a global AIDS emergency, is a positive development. But, the product that was approved is not a fixed-dose combination, and, as a result, is not as easy to take. Also, the company would not have gotten its drug approved without cozy relationships with several brand-name companies, something not all producers of essential, generic medications enjoy. As a result, this might not be replicated any time soon" (GAA release, 1/26).