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President's Emergency Plan for AIDS Relief (PEPFAR)

Explore the PEPFAR Interactive Database

Search for information about tentatively approved and approved antiretroviral drugs that are eligible for procurement under the President’s Emergency Plan for AIDS Relief (PEPFAR) Program.

PEPFAR Database

As of January 29, 2020, with support from the U.S. Global AIDS Coordinator and Special Representative for Global Health Diplomacy, Ambassador Deborah L. Birx, FDA launched a new interactive PEPFAR database that provides information to the public about antiretroviral (ARV) drugs tentatively approved or approved that are eligible for procurement under PEPFAR. The new database is managed by the Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM), Division of Drug Information (DDI) and provides information on a mobile-friendly platform through interactive dashboards and in downloadable and searchable formats.

For the first time, providers, patients, and procurers can easily access FDA-reviewed product labeling and package labels for each drug product as well as updates on manufacturing sites, shelf-life, and other information. The product labeling includes information about dosage and administration, warnings and precautions, contraindications, adverse events, pediatric use, and more. The additional information is provided with authorization from each company that sponsored the application.

These enhancements will allow stakeholders to more efficiently gather, organize, and provide information related to FDA ARV drugs tentatively approved or approved under PEPFAR. Ultimately, FDA expects that this interactive database will improve the ability for providers, patients, procurers, and global stakeholders to address the global HIV/AIDS epidemic.

PEPFAR Liaison

The Liaison, known as the PEPFAR Coordinator, for all FDA activities under PEPFAR resides within FDA’s Office of Global Policy and Strategy. 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.

FDA Marks More than 200 HIV/AIDS Drugs Authorized for Purchase Under PEPFAR

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Additional Resources from FDA

FDA's PEPFAR Database of Antiretroviral Drugs

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