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.

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