Principles of Proposed Agreement on FDC Antiretrovirals Would Not Impede Drug Access, Joint Statement Says

A draft proposal on guidelines to consider when developing, evaluating and/or considering fixed-dose combination antiretrovirals is "not intended to and would not impede access to safe, efficacious and quality" drugs, according to a joint statement released on Thursday by HHS, the World Health Organization, UNAIDS and the Southern African Development Community. The statement is the result of talks held March 29 through March 31 in Gabarone, Botswana, among government officials, representatives of drug regulatory agencies, public health workers, health care providers, advocacy groups, researchers and members of nongovernmental organizations (HHS/WHO/UNAIDS/SADC release, 4/8). Officials at the two-day meeting that was cosponsored by the four organizations discussed a draft agreement over scientific and technical standards for generic antiretroviral drugs for use in developing countries. The medications in question are fixed-dose combination, or FDC, antiretroviral drugs, including Cipla's Triomune and Ranbaxy Laboratories' Triviro, which combine stavudine, lamivudine and nevirapine into one pill that is taken twice a day and costs as little as $140 per person per year. A regimen of the same three drugs purchased separately from patent holders GlaxoSmithKline, Bristol-Myers Squibb and Boehringer-Ingelheim requires six pills a day and costs about $562 per patient per year (Kaiser Daily HIV/AIDS Report, 4/1). U.S. officials want to ensure that the drugs will not contribute to the development of drug-resistant HIV strains through widespread or improper distribution and use. Critics of the U.S. position have said that setting up another review system could delay attempts to roll out antiretroviral drug programs in African countries, and some groups have accused the U.S. government of seeking to protect the patents of large pharmaceutical companies, a charge that U.S. officials deny (Kaiser Daily HIV/AIDS Report, 3/31).

Principles Process
An expert panel of drug regulators and other representatives of the sponsor organizations in February met in Cape Town, South Africa, to develop the draft document of shared principles for evaluating FDCs. The draft then was posted on the Internet for comment. The participants at the Gaborone meeting agreed to work to develop a final principles document through the further refinement of the proposed draft. They plan to incorporate comments from the conference, as well as feedback offered during the public comment period. The revised draft document will be posted at globalhealth.gov/fdc.shtml for a two-week comment period by mid-April, after which an expert panel will meet to write the final document for use by mid-May, according to the release (HHS/WHO/UNAIDS/SADC release, 4/8).

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