PEPFAR ARV Formulation Priorities

PEPFAR ARV Formulation Prioritization - November 2018


Since the inception of the President’s Emergency Plan for AIDS Relief (PEPFAR), the United States Government (USG) has committed to purchasing safe, effective, quality-assured, and low-cost antiretrovirals (ARVs) in compliance with international trade law. These ARVs may be manufactured by brand (innovator) and generic (non-innovator) companies.

To help meet this commitment, the U.S. Food and Drug Administration (USFDA) utilized existing review and inspection processes for reviewing new drug applications (NDA) and abbreviated new drug applications (ANDA) for PEPFAR use. As part of global efforts to optimize treatment from multiple international stakeholders, PEPFAR actively monitors the research pipeline and determines ideal characteristics of treatment formulations in a public health context. Currently PEPFAR is partially reimbursing USFDA to review NDAs for ARVs. The USFDA reviews NDAs according to the Prescription Drug User Fee Act (PDUFA) and ANDAs according to the Generic Drug User Fee Amendments (GDUFA) in the order in which ANDAs are received.

The PEPFAR Interagency ARV Prioritization Committee has sought to create a systematic and proactive process for prioritizing reviews of ARVs by the USFDA, in order to ensure access to critical ARVs for PEPFAR-supported countries, including (1) maintaining reliable access to currently recommended ARVs and (2) expediting access to new, high-priority ARVs . Because generic manufacturers require FDA approval (ANDA) when there are production process changes (eg, new facility) to existing products, including current first-line ARVs, these products appear on the prioritization list to highlight the importance of their timely review in order to minimize supply disruptions. For anticipated new first-line ARVs, this process is of particular importance as additional safety and efficacy data become available and the Consolidated World Health Organization (WHO) HIV Guidelines evolve.iv A number of new pharmaceuticals, new combinations of ARVs, and new formulations could offer improvement over existing ARVS to meet the needs of patients in a clinical and public health context. As new medications with improved safety and efficacy profiles become available, it is imperative to recommend prioritization of these medications over previously recommended first- and second-line regimens. Ideally, manufacturers are submitting dossiers for formulations that will be used in the field but FDA cannot require the submission of applications for specific products.

The work of this Committee represents the interests of all of the implementing agencies across PEPFAR. It assists all USG partners in communicating a unified message of PEPFAR’s ARV priorities to external stakeholders. For example, this report could be used to communicate a message to assist pharmaceutical manufacturers in strategically targeting investments towards formulations that will be in high demand from PEPFAR-supported countries. Similarly, this report could be used in countries during discussions to determine modifications of national HIV treatment guidelines.