African Countries' Refusals to Accept FDA Approval of Generic AIDS Drugs Delaying Drug Delivery, Officials Say
June 20, 2005
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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