A study in the May 1 edition of the journal Clinical Infectious Disease shows that generic antiretroviral drugs distributed in four developing countries meet United States Pharmacopeia standards, undermining the reasoning offered for the Bush administration's reluctance to buy the drugs. USP, a nongovernmental agency made up of representatives from the pharmaceutical industry, consumer organizations, and the federal government, as well as pharmacy, medical, and other health care professions, works closely with the Food and Drug Administration to ensure the quality of medicines for human and veterinary use.
Bush administration officials oppose using funds from the five-year, $15 billion international AIDS initiative for generic antiretroviral drugs because they say the drugs have not been evaluated to ensure that they meet U.S. safety and efficacy standards. The World Health Organization has already approved the use of the drugs.
The new study, conducted by researchers at the National Institutes of Health and the University of Alabama, evaluated six different types of anti-HIV drugs using the Uniformity of Dosage Units test. All of the drugs, which were obtained from doctors in Lithuania, South Africa, Jamaica, and Zambia, fell within the USP-approved efficacy range when stored according to manufacturer specifications. Researchers next plan to study the drugs for bioequivalency, which tests how much of the drugs are absorbed into the bloodstream.