Uganda Bars Imports of FDA-Approved, South African-Made Generic AIDS Drugs Because of Lack of WHO Testing, Approval
Uganda is refusing the importation of FDA-approved, South African-made generic antiretroviral drugs, despite the fact that up to 100,000 of the country's HIV-positive residents are in "dire need" of the medications, AFP/Yahoo! News reports. Ugandan officials insist that the drugs first must be tested and approved by the World Health Organization and the country's National Drug Authority. "For us, we have the duty to protect our citizens from drugs that have not been thoroughly scrutinized," NDA Chair James Makumbi said. He added that the issue could have been resolved if FDA had conferred with WHO about the safety and effectiveness of the South African drugs, AFP/Yahoo! News reports. "The WHO can always endorse the U.S. regulator's review," he said, adding, "The United States is a member of the WHO, if they feel that their tests are sufficient, then they should sort that out with WHO" (AFP/Yahoo! News, 6/23). Uganda is one of four African countries -- including Ethiopia, Nigeria and Tanzania -- that has told South African generic drug maker Aspen Pharmacare that the company's generic drugs require safety and quality approval from WHO despite the company's FDA approvals for its antiretroviral drugs. Aspen also must register its drugs in each country before the governments will approve the drugs' distribution (Kaiser Daily HIV/AIDS Report, 6/20). Up to one million Ugandans are estimated to be HIV-positive, and nearly the same number have died from AIDS-related causes since the the early 1980s (AFP/Yahoo! News, 6/23).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.