U.S. AIDS Drug Assistance Plan Needs Better Procurement Practices, GAO Says
This article was originally published in The Pink Sheet Daily
Executive Summary
A report on the President’s Emergency Plan for AIDS Relief notes that USAID and the HHS-sponsored Global Fund have different policies on purchase of generic drugs that are not FDA-approved. Restrictions on purchasing generics may conflict with PEPFAR goals, GAO says.
You may also be interested in...
U.S. Patents Could Limit President's AIDS Drug Assistance Plan, GAO Says
The U.S. Global AIDS Coordinator's Office suggests it will use its authority to purchase an FDA-approved generic antiretroviral product for which permission could not be obtained from the patent holder. FDA grants tentative approval to a South African firm for a generic co-packaged version of Combivir and Viramune.
U.S. Patents Could Limit President's AIDS Drug Assistance Plan, GAO Says
The U.S. Global AIDS Coordinator's Office suggests it will use its authority to purchase an FDA-approved generic antiretroviral product for which permission could not be obtained from the patent holder. FDA grants tentative approval to a South African firm for a generic co-packaged version of Combivir and Viramune.
GSK, Boehringer Ingelheim Discussing Co-Packaged Combivir/Viramune
The companies have signed a “letter of intent” and are talking to FDA about NDA submission requirements. The agreement may test how quickly the agency can approve co-packaged HIV therapies, and how easy it is for manufacturers to negotiate deals.