Presidential Emergency Plan for AIDS Relief (PEPFAR)

The Liaison for all FDA activities under the President’s Emergency Plan for Aids Relief (PEPFAR) also resides within the FDA Office of International Program’s Asia and Africa Office. The PEPFAR Liaison serves as the FDA point of contact with all outside entities in coordinating Agency activities dealing with PEPFAR, including those associated with drug firms seeking to participate in the expedited review process for antiretroviral (ARV) therapies for use in the PEPFAR focus countries. The Liaison is also the point of contact with the World Health Organization’s (WHO) Prequalification Unit to facilitate the sharing of confidential information to leverage review of antiretroviral products and facilitate posting of FDA tentatively approved and approved ARVs listed on the WHO website. Programs that have developed as a result of the PEPFAR initiative such as the White House Private Public Partnership for Pediatric Therapies, is also coordinated under this umbrella.

• AIDS Drugs under President’s Emergency Plan for AIDS Relief (Table)
  (Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan)