The U.S. Food and Drug Agency (FDA) gave, for the first time, approval for a non U.S.-based generic antiretroviral drug; South African Aspen Pharmacare’s regimen of a generic version of GSK’s fixed-dose combination Combivir® packaged along with Boehringer Ingelheim’s Viramune® (nevirapine).

Though it would be hard to deny the obvious benefits this ruling gives, there are some other facts that make this first-time approval less than groundbreaking.

Interestingly enough this FDA’s approval has no effect on U.S. consumers but instead concerns those without treatment in South Africa. For reasons of patent rights these types of generic medicines are not cleared for use within the United States. In 2003 George W. Bush announced the President’s Emergency Plan for AIDS Relief (PEPFAR), which is aimed at the 15 hardest hit countries by the epidemic. PEPFAR will give 15 billion dollars over the next 5 years but the only drugs that can be sent are those approved by the FDA. This therefore excludes many effective-proven and approved drugs, by international standards, from the list of possible treatments.

There has been much said from within the U.S. program that this decision will help to stem criticisms on how drugs are approved for U.S. humanitarian use. But outside this community it seems that others are not so hopeful. While the administration patted their own back for the ”fast-track“ approach that was used to approve the drug and waving of application fees, activists still focused on the fact that the FDA approval is truly unnecessary in deciding which drugs are safe for international use. This being because most feel that the WHO’s pre-qualification project of AIDS products is more than sufficient to test safety of generic ARVs and that the FDA’s process is only repetitive.

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 that prohibit the FDA for five years from confirming the safety and efficacy of bio-equivalent generic products by even indirect reference against marketing-approval dossiers submitted by originator companies, the U.S. Fast Track process grinds to a halt help to stem criticisms on how drugs are for the newest medicines like tenofovir. So in the end although this looks like a step in the right direction it is still far from the type of commitment needed from a country like the United States to curve the damages caused by the epidemic in the developing world.

EATN - European AIDS Treatment News, Volume 13, I – Spring 2005