[Ip-health] Health GAP Statement on Aspen's FDA Approval

[Mike Palmedo]

 From the Health GAP list...
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Health GAP (Global Access Project)
PRESS STATEMENT
For more information:
Sharonann Lynch +1 646 645 5225,
Asia Russell +1 267 475 2645

For Immediate Release: January 26 2005

Aspen's FDA Approval Weak Evidence of the Effectiveness of the FDA
Expedited Approval Process

(New York) The announcement that Aspen Pharmacare of South Africa has
received approval for co-packaged Lamivudine/Zidovudine and Nevirapine
through the FDA fast-track marketing approval process represents a
glimmer of progress in what still remains an unnecessary, duplicative,
costly, delayed, and ultimately flawed U.S. review process.

Dr. Mark Dybul, second in charge at the U.S. Office of the Global AIDS
Coordinator hopes that this one approval will "silence critics" and that
they will now rally behind a unilateralist effort by the U.S. to be the
final arbiter of quality, safety, and efficacy of medicines used to
battle AIDS. For activists, however, this is yet another example of too
little, too late, and too imperial.

The primary criticism of the FDA Expedited Approval Process is that it
is unnecessarily duplicative. The WHO already had a prequalification
project for listing AIDS medicines of proven safety, efficacy, and
quality and listed qualifying generic medicines as early as December
2003 - fourteen months before the first U.S. approval of an on-patent
ARV. Before listing a prequalified medicine, the WHO required
manufacturers to prove Good Manufacturing Practices at the particular
plant where the medicines was produced and it also required rigorous,
world-class proof of the bio-equivalence of the generic medicines to its
brand name counterpart. (Proving bioequivalence means that the active
ingredient is available in the body at the same rate and in the same
quantity and quality for the two products.)

Admittedly, the WHO went through a rough-patch of adverse publicity
orchestrated by the U.S. pharmaceutical industry and its chorus of
right-wing ideologues and publicists at the Hudson Institute, American
Enterprise Institute, and the AIDS Responsibility (sic) Project, when
several Indian manufacturers including Cipla, Ranbaxy, and Hetero were
required to delist some antiretroviral products because of poor record
keeping practices of the independent contract research organizations
(CROs) that conducted their bioequivalence studies. Contrary to
pro-PhRMA claims, however, the WHO and the Indian generic producers
acted promptly to delist their products and to undertake new
bioequivalence studies. Cipla's products have already been relisted at
the WHO, but of course dishonest PhRMA shills have neglected to retract
their slanders against generic producers and/or the WHO.

The U.S. went the unilateralist and duplicative route for one reason
only - to reassert the hegemony of its pharmaceutical industry of its
captive agency, the Food and Drug Administration. What is particularly
galling in the present circumstances is that the U.S. could oppose
"giving Africans medicines that haven't been approved for Americans"
when in fact the FDA was not even set up to give such approval until May
of last year. And the FDA's approval process and watchdog status for
safeguarding consumer's interests is hardly squeaky clean in the
aftermath of the Vioxx scandal and its belated black-box warning about
suicide risks for youthful consumers of anti-depressants.

In addition to being duplicative, the FDA tentative process is unduly
expensive. The U.S. likes to brag that it has been willing to waive the
normal $500,000 filing fee, but foreign generic companies are frequently
required to conduct new and costly bioequivalence studies using U.S.
registered medicines as the reference product instead of identical
European products which they had previously used to gain WHO
prequalification.

U.S. drug companies could allow generic companies to short cut these
duplicative studies if they would give so-called "reference rights" to
the generic producers, confirming the equivalence of the European and
U.S. products, but so far they have frequently refused to do so.
Moreover, putting together the registration application file is
inordinately complex under picayune FDA regulations and requires not
only reams of paper but an army of specialized lawyers.

Moreover, it's deeply ironic to call the FDA process "fast-track" when
"slow-track" would be a better designation. The U.S. announced it
expedited procedures in May of 2004 and it has taken generic producers
over eight months to amass the necessary paperwork. Mark Dybul is
bragging that the approval process only took two weeks after Aspen
submitted its final dossier, but he neglects to mention the months and
months of consultations and redocumentation that were required to put
together an application file that could finally cut through the red-tape
and Byzantine rules at the FDA. We know for a fact that other generic
producers, including Indian giants like Ranbaxy, have been working since
last summer to dot every "i" and cross every "t" but that they still
have not succeeded in getting a U.S. stamp of approval. It's hard to
call this process fast when you're a person living with AIDS whose CD-4
cell count is plummeting every day.

However, the most deeply troubling aspect of the FDA tentative approval
process is that it is incomplete - that it cannot yet grant even
tentative approvals for the newest AIDS medicines. Because of
data-protection rules in U.S. law, rules that prohibit the FDA for five
years from confirming the safety and efficacy of bioequivalent generic
products by even indirect reference against marketing-approval dossiers
submitted by originator companies, the U.S. Fast Track process grinds to
a halt for the newest medicines like tenofovir.

It's fine that a PhRMA-favored generic company in South Africa has
finally gotten approval for some of the first-line generic medicines
needed for lower cost ARV therapy (Aspen has announced that it will sell
at approximately $200 per year versus nearly $600 for the mostly heavily
discounted brand name equivalents). It is even better that activists in
South African forced GlaxoSmithKline and Boehringer-Ingelheim to grant
broader and cheaper licenses that will permit Aspen to sell its ARVs
regionally throughout Southern Africa. However, Aspen has no plans yet
to market easier-to-use triple-fixed-dose product like those
manufactured by Cipla and Ranbaxy.