2023-2027 PHEMCE Multiyear Budget
The Public Health Emergency Medical Countermeasures Enterprise Multiyear Budget for Fiscal Years 2023 – 2027 (PHEMCE Multiyear Budget) forecasts the funding required to conduct basic research, advanced research and development, regulatory review, procurement, stockpiling, and replenishment of the U.S. government’s civilian medical countermeasure products for FY 2023-2027. ASPR is required to submit an annual multiyear budget for the PHEMCE to Congress.
The 2023-2027 PHEMCE MYB projects an estimated overall funding need of $71.1 billion over the five-year period, an increase of $7.1 billion over the 2022 report. The report estimates a gap of $37.9 billion between the FY 2023 flat-level scenario and the projected five-year total need.
While the figures are generally consistent with those provided in the 2022-2026 report, there are notable differences to highlight. Beyond the enacted FY 2023 levels, PHEMCE agencies identified the following activities to address existing preparedness gaps:
National Institutes of Health (NIH) will support activities to advance a robust pipeline of candidate medical countermeasures for the development of safe and effective products. For NIH, one of the largest spending estimates is for new products to address gaps in the broad-spectrum antimicrobial portfolio, including the advancement of a small molecule antibiotic product, epetraborole (EBO), for the treatment of acute melioidosis as the first indication sought, and then potentially later indications of other biothreat agents (e.g., Plague, Anthrax, and Tularemia). To fund these activities, NIH estimates a $442 million need above enacted levels in FY 2023.
- ASPR's Center for the Biomedical Advanced Research and Development Authority (BARDA) will support the advanced development of medical countermeasures, including improvements to threat-agnostic technologies, pandemic influenza vaccines, and novel therapeutics. To fund these activities, BARDA estimates a $28.8 billion need above enacted levels in FY 2023.
- ASPR's Center for the Strategic National Stockpile (SNS) will support the development and transition of 13 MCM candidates from BARDA's Project BioShield to stockpiling by the SNS by FY 2027. Increased funding needs, beginning in FY 2025, are driven by an Ebola therapeutic, a therapeutic in the radiation/nuclear portfolio, and a smallpox antiviral; the planned transition of an Ebola therapeutic in FY 2027 makes up over half of the delta between the flat level and the projected need. The smallpox expenditures are in order to backfill the SNS for the MCMs distributed during the mpox response. To support these activities, SNS estimates a $6.7 billion increase above the enacted levels in FY 2023. BARDA's successes in supporting the advanced development of a robust portfolio of products that received FDA approval, licensure, clearance, or authorization have not been commensurate with the SNS budget for products to transition to the stockpile successfully. In the absence of a transition path, products without sustainable commercial pathways are likely to be lost, costing USG not only the investments along the way but also the critical ability to build PHEMCE's preparedness posture against future threats.
In addition to the transition of products from development to procurement, the SNS is tasked with maintaining its current preparedness posture. This means the replenishment of existing supplies, including antimicrobials necessary for post-exposure prophylaxis as part of the anthrax portfolio and the sustainment of SNS's current level of preparedness and the procurement of additional smallpox vaccine and therapeutics in order to replace MCMs used during the mpox outbreak. - Food and Drug Administration (FDA) will sustain its ability to foster the establishment of clear, scientifically supported regulatory pathways for MCMs as well as to fill critical scientific gaps that inform regulatory decision-making and support efforts to establish regulatory policies and mechanisms to facilitate the efficient use of available MCMs. To support these activities, FDA estimates a $769 million increase above enacted levels in FY 2023.
- Centers for Disease Control and Prevention (CDC), while newly added to this year's report, represents both new and ongoing programs related to research and development activities and provides critical support functions that ensure access during emergencies.
Download the 2023-2027 PHEMCE Multiyear Budget