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Views Mixed on US Shift on Drugs for AIDS
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New York Times
May 18, 2004
Donald G. McNeil Jr. The Bush administration's surprise announcement Sunday that it will buy AIDS drugs that combine three medications in a single pill and that it will consider buying drugs from generics manufacturers for its global AIDS plan is drawing mixed reviews from AIDS activists and doctors in poor countries. While the decision delighted many, others expressed frustration that the White House had set up a new approval process overseen by the Food and Drug Administration when the World Health Organization already has such a process.
"I think it's fabulous," said Dr. Merle Sande, who treats 4,000 AIDS patients in Uganda.
"This is just another roadblock," said William Haddad, a US generic manufacturer who now consults for Indian generic drug-maker Cipla Ltd.
Rep. Henry Waxman (D-Calif.) expressed disappointment that the plan does not involve cooperation with WHO. "We need to see the fine print before we can tell if the new process will actually improve access to these affordable, effective drugs."
Critics charged that even though the administration indicated it would waive the usual $500,000 drug approval fee and let companies submit published data instead of conducting new trials, any new approval process will require paperwork, legal expertise and time. A WHO official, speaking on condition of anonymity, questioned how Health and Human Services Secretary Tommy Thompson could promise to approve new drugs in as little as two to six weeks unless FDA simply accepts all the data submitted to WHO.
Merck, Bristol-Myers Squibb and Gilead Sciences immediately responded to Sunday's announcement by issuing a joint statement saying they will develop a combination pill. GlaxoSmithKline and Boehringer Ingelheim said they were discussing packaging three drugs together. "Obviously, they had inside information. That calls into question the 'honest broker role' of the US government," said Global AIDS Alliance Director Dr. Paul Zeitz.
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