HEALTH GAP (Global Access Project)

May 17, 2004
For more information, contact:  Sharonann Lynch +1 646 645 5225 or Asia
Russell +1 267 475 2645

New F.D.A. Program to Approve AIDS Drugs for Poor Countries:
Cover for Shutting Out Generics in U.S. Bilateral Program?

(Washington, DC) 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

Activists caution the FDA process has numerous pitfalls for generic
manufacturers whose products have already been prequalified by the WHO
Prequalification Project. In addition to submitting to redundant plant
inspections, the FDA may require manufacturers to recreate key trials. Most
damaging to future efforts to combat AIDS, the draft FDA guidelines specify
applications for generic versions of newer 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.


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