WASHINGTON - May 17 - In an attempt to deflect mounting criticism of policies against using U.S. money to purchase generic AIDS drugs for use in poor countries hardest hit by HIV/AIDS, the U.S. government announced a FDA program for accelerated review of generic and brand-name AIDS drugs financed by the Bush's aid program, Presidential Emergency Plan for AIDS Relief (PEPFAR). Rather than a good faith effort by the U.S. to support the international consensus that already endorses procurement of quality assured generic products through the WHO prequalification project, activists say this new program is designed to shield the Administration from criticism while creating significant new hurdles for generic producers.

"While the US claims this plan will speed AIDS drug approval for use in the President's Emergency Plan for AIDS Relief, representing an shift in policy, in reality the FDA process will likely toe the administration line and end up a bottomless pit of enhanced approval criteria, aimed at shutting out generics from approval," said Paul Davis of Health GAP. "Brand-name medicines will continue to enjoy a monopoly, not only in U.S. markets, but now throughout the developing world through U.S. aid programs and U.S. trade agreements."

Activists caution the process requires generic manufacturers that have already proven the safety and efficacy of their product through passing WHO prequalification, to recreate key trials and submit to redundant plant inspections. According to draft guidelines, applications for generic versions of new products that have exclusivity as "new chemical entities," would be barred from consideration by the FDA. These include important new AIDS drugs that will be invaluable in treatment scale up efforts.

Generic versions of antiretrovirals are the least expensive option for scale- up of AIDS treatment in poor countries. The Clinton Foundation negotiated a price for generic triple combination medications from generic manufacturers for less than $140 per person per year. Already in use by national governments, UNICEF, World Bank, the Global Fund to Fight AIDS, TB, and Malaria, and private international relief organizations, these generic medicines have been used throughout developing countries to treat tens of thousands of people living with HIV/AIDS. However, US policies that block procurement of these generic AIDS medications threatens to undermine these new advances.

Activists claim the U.S. successfully stalled the PEPFAR program so that brand- name pharmaceutical companies to play "catch up" and announce plans for their own FDC to compete with generic versions of antiretrovirals that are currently the least expensive option for scale-up of AIDS treatment in poor countries. "The US, while appearing to finally find religion on this issue, continues to buy time to lock in countries and recipients into using only patented drugs," said Health GAP's Asia Russell. "This decision will cost money, time and lives."

The new system proposed by HHS will create a parallel process with different requirements, processes, and standards for drug approval than the WHO's project to approve medicines. "If it ain't broke, don't fix it," said Jen Cohn of Health GAP. "Even though the WHO pre-qualification program has the support of the international community, the US government is more interested in pleasing big pharma and stifling the use of generics medicines."

On May 18th AIDS Czar Tobias will give testimony on PEPFAR to the Senate Appropriations Subcommittee on Foreign Operations. Questions regarding the new FDA process and potential barriers to approval of generic drugs are expected, including: postmarking surveillance of products, regulations protecting clinical data of brand-name drug companies used to prove safety and efficacy, requirements to re-do tests for bio-equivalence, cost of submitting drugs for approval, and timeline and requirements for FDA inspections of manufacturing sites.

###