African Countries' Refusals to Accept FDA Approval of Generic AIDS Drugs Delaying Drug Delivery, Officials Say

African countries are not accepting FDA approval of generic antiretroviral drugs, postponing the delivery of the less-expensive medications to HIV-positive people, according to U.S., U.N., African and pharmaceutical company representatives, the Boston Globe reports (Donnelly, Boston Globe, 6/20). HHS in May 2004 announced plans for a new FDA fast-track review program to speed the delivery of low-cost antiretroviral drugs -- including fixed-dose combination drugs -- to nations covered under the President's Emergency Plan for AIDS Relief. The expedited process is meant to encourage drug makers to produce generic medications to improve access to drugs in remote areas of severely affected countries and ensure the drugs' safety (Kaiser Daily HIV/AIDS Report, 6/17). However, officials from Ethiopia, Nigeria, Tanzania and Uganda have told South African generic drug maker Aspen Pharmacare that they require generic drugs to receive safety and quality approval from the World Health Organization despite the company's FDA approvals for its antiretroviral drugs. Aspen also must register its drugs in each country before they will approve distribution, a process that could take nine months to a year, according to Stavros Nicolaou, Aspen's senior executive in charge of strategic trade development. However, Nigerian and Ugandan officials said registration could be completed in one to four months, the Globe reports. U.S. Ambassador Randall Tobias, head of the State Department's Office of the U.S. Global AIDS Coordinator, has called WHO Director General Jong-Wook Lee to ask that the agency immediately approve any FDA-approved drugs. WHO officials and FDA scientists are discussing ways to accelerate the exchange of information on any FDA-approved drugs, according to the Globe.

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Nigerian and Ugandan officials defended their reliance on WHO's approval, the Globe reports. "This is how we've been doing things for time immemorial," James Makumbi, chair of Uganda's National Drug Authority, said, adding, "We don't ask for FDA approval. I think this is basically a problem with the FDA interacting with the WHO because the WHO can always endorse" the FDA's review. Deputy U.S. Global AIDS Coordinator Mark Dybul said in an interview, "It is ironic. We've been blamed by quite a few people about delaying procurement of drugs by going through a stringent regulator before we make the drugs available. And now we have the premier stringent regulatory agency in the world -- or one of them -- find that the drugs meet all the requirements, and then we have the inability to use the drugs." Paul Zeitz, executive director of the Global AIDS Alliance, said the United States started the controversy because if U.S. officials had "started a regulatory system that everyone could have agreed to more than a year ago, we would have been much farther along" (Boston Globe, 6/20).

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