WASHINGTON - If U.S. President George W. Bush is expecting bouquets from AIDS activists for his proposal to expedite approvals for life-saving anti-retroviral drugs by the Food and Drug Administration (FDA), he is in for a disappointment.

Africa and AIDS activists are assailing the proposal not only as a new attempt to delay the delivery of desperately needed, low-cost generic drugs to needy AIDS victims in Africa and the Caribbean, but also as an effort to undermine the World Health Organization's (WHO) own expedited approval process which has already authorized the use of generics by the World Bank, the UN Children's Fund (UNICEF), and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

"WHO was asked by its member states to establish an international standard called the pre-qualification process so that it could play the role of honest broker for both the global North and the global South (in certifying medications for use), said Paul Zeitz, director of the Global AIDS Alliance. "Now the U.S. is undermining the credibility of that international program."

Critics also charged that the administration's new FDA program appeared designed to give U.S. and western pharmaceutical companies a leg up on their competitors in developing countries whose generic drugs generally cost far less than their brand-name equivalents manufactured by "Big Pharma."

At stake is hundreds of millions of dollars that are being allocated by the administration under its five-year, US$15-billion President's Emergency Plan for AIDS Relief (PEPFAR) to procure life-preserving anti-AIDS drugs for 14 African and Caribbean nations that are among the worst-affected by the global AIDS epidemic. AIDS is currently killing about three million people a year, or 8,000 - of whom about 6,000 are Africans - each day.

Public-health agencies and activists argue that the fastest, cheapest, and most efficient way to provide these drugs is buying fixed-dose combination (FDC) drugs, which combine drugs from multiple sources into single pills that are taken twice daily, produced by generic manufacturers in India, Brazil, and other developing countries, and which currently cost as little as $140 per person per year, or about one-fifth the cost of the same combination of drugs, which currently must be taken in the form of six pills a day, that is manufactured by brand-name companies.

Geneva-based WHO, which has its own review process to determine the safety and effectiveness of medicines, has already approved a number of FDCs produced by generic manufacturers, and activists say that assessment should be good enough for the U.S. government.

Until Sunday, however, the Bush administration claimed that the FDCs had not been tested sufficiently and that they should be submitted to the FDA's own approval process, which normally takes some four years, before U.S. aid money should be spent on their procurement.

But Health and Human Services (HHS) Secretary Tommy Thompson, who is in Geneva for a major WHO meeting this week, announced Sunday that the administration would expedite FDA's approval process for FDCs so that licenses could be approved in as little as two to six weeks from the date that the paperwork was submitted.

Zeitz praised Thompson's recognition of the importance of using FDCs as a key strategy for AIDS treatment in poor countries, but he and other activists expressed exasperation that Washington is still insisting on a separate and independent review by the FDA and warned that it risked further delays in delivering the drugs to needy people.

"The concern we have about the 'fast-track' FDA approval is that there already is a recognized process which includes many of the exact same steps that the FDA uses," he told OneWorld. "Instead of reinforcing the (WHO's) pre-qualification process, they are slowing things down by creating a redundant and parallel U.S.-led review process."

Africa Action, a Washington-based grassroots network, denounced Thompson's announcement as "an elaborate ruse to stall the use of low-cost generic drugs" and "a callous manipulation of the truth."

"Thompson says that the administration is expediting the approval process for generic and combination anti-retroviral drugs when in reality the U.S. government is telling African and Caribbean nations that they cannot use U.S. funds to buy cheaper and easier-to-use FDCs of anti-AIDS drugs that have already been approved by the WHO and accepted by governments throughout Africa and the Caribbean," Booker said.

The activists said Sunday's announcement appeared to be aimed at deflecting mounting criticism both in the U.S. and abroad of the administration's delays. A march in Washington that is likely to include civil disobedience is planned for Thursday this week.

But they also charged that Bush appears determined to protect Big Pharma from competition by the generic manufacturers and they pointed to announcements shortly after Thompson's by major U.S. and western drug companies that they intended to introduce FDCs as well as evidence that the administration is doing the companies' bidding.

Three big U.S. pharmaceutical companies - Bristol-Myers Squibb Co., Gilead Sciences Inc. and Merck & Co, Inc. - announced Sunday night that they are jointly pursuing development of their own one-dose-a-day anti-AIDS drug, while British-based GlaxoSmithKline and Germany's Boehringer Ingelheim Corp. said they were also considering a co-packaging deal for FSCs.

Activists said they believe the administration stalled the PEPFAR program so the brand-name pharmaceutical companies could play "catch up" to the generic manufacturers in developing their own FDCs. "The U.S., while appearing to finally find religion on this issue," said Health Global Access Project's (HealthGAP) Asia Russell, "continues to buy time to lock in countries and recipients into using only patented drugs. This decision will cost money, time, and lives," she added.

"The U.S. pharmaceutical industry is behind the game on FDCS, and the White House is stepping in to help them catch up with the more innovative generic producers who have pioneered FDCS," said Bill Fletcher, Jr., president of TransAfrica Forum in Washington. He and Booker called for Congress, which has generally shown much greater urgency in dealing with the AIDS crisis, to pass legislation to compel the administration to buy generic FDCs.

The administration has strongly denied the FDA process is designed to give the brand-name countries a leg-up, although guidelines on the new plan released Monday by HHS appears to give patent-holders some advantages. "There is a significant amount of skepticism that the generic manufacturers will get a fair review," said Zeitz who also stressed that the FDA's role should be confined to approving drugs for use in the United States and not assume that of a "global, supra-national health authority."

"If it ain't broke, don't fix it," said Jen Cohn of Health Global Access Project (HealthGAP). "Even though the WHO pre-qualification program has the support of the international community, the U.S. government is more interested in pleasing big Pharma and stifling the use of generics."

© Copyright 2004 OneWorld.net

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