AFRICAN STATES REFUSE US ARV SHIPMENTS

According to reports in the US media, a number of African states have rejected consignments of antiretroviral (ARV) drugs supplied under the PEPFAR initiative for HIV/AIDS pandemic areas.

Ethiopia, Nigeria, Tanzania and Uganda have reportedly rejected South African generics maker Aspen Pharmacare's triple combination therapy, which was tentatively approved by the US FDA under PEPFAR's accelerated review process.

The countries' governments argue that Aspen's product, a co-packaged fixed-dose combination of lamivudine/zidovudine and nevirapine, has not been cleared by the WHO. As such, it has no standing within their regulatory systems, and further safety and efficacy studies are required.

US anti-AIDS coordinators are now reported to have contacted their counterparts at the WHO to request immediate approval of any drugs cleared by the US FDA under PEPFAR. Notably, competitive unauthorised generics makers already operate in many pandemic countries such as Uganda, Nigeria and Tanzania.