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U.S. Department of Health and Human Services

Background

The PHEMCE is an interdepartmental governance structure overseen by HHS for the research, advanced development, procurement, stockpiling, and development of plans for effective use of MCMs needed to respond to infrequent, but high-consequence, public health and medical emergencies. These events may result from intentional, accidental, or natural occurrences. The PHEMCE is led by ASPR and includes multiple HHS divisions. Several interagency partners have been active within the PHEMCE, including the U.S. Department of Defense (DoD), the U.S. Department of Veterans Affairs (VA), the U.S. Department of Homeland Security (DHS), and the U.S. Department of Agriculture (USDA). The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L. 116-22) added the Director of National Intelligence to the membership of PHEMCE.

This report, the FYs 2018–2022 Public Health Emergency Medical Countermeasures Enterprise Multiyear Budget, describes the five-year interagency budget plan for the basic research, advanced research and development, regulatory review, procurement, stockpiling, and replenishment of the U.S. government’s civilian medical countermeasure enterprise.2 The report consolidates PHEMCE budget forecasting into one document providing an update for FYs 2018–2022 of PHEMCE budget priorities across chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and other emerging, or re-emerging, infectious diseases for ASPR (including BARDA and the SNS), FDA, and NIH.


Background on Medical Countermeasure Development

The development of MCMs is a time-intensive, risky, and expensive endeavor, requiring substantial coordination among federal departments and agencies, and the concerted efforts of commercial partners. It is also a critical component of the Nation’s health preparedness and response capability. Prioritizing federal funding across portfolios and the stages of MCM development is fundamental to achieving the PHEMCE’s goals. Successful coordination requires strategic planning that incorporates discrete funding streams into a coherent plan spanning many years.

The PHEMCE's success is demonstrated by the products that evolved across programs, achieved regulatory approval, and were stockpiled in the SNS. Currently, HHS’s advanced research and development pipeline contains more than 200 products. The PHEMCE stockpiled 15 countermeasures in the SNS that are available for use during a public health emergency. Since 2007, the FDA has approved 48 products for CBRN threats and pandemic influenza supported by HHS’s PHEMCE agencies, including BARDA.

This report forecasts that seven MCM candidates will transition from procurement under BARDA’s Project BioShield to stockpiling by the SNS by 2022. Although these MCMs may not have FDA approval at the time of initial delivery to the SNS, they may potentially be used under investigational drug protocols, such as clinical trials or may potentially be used under the FDA provisions for Emergency Use Authorization (EUA), as needed, and authorized under the Federal Food, Drug and Cosmetic (FD&C) Act.3 SNS will be responsible for the replenishment costs of those MCMs procured by BARDA under PBS once these products achieve FDA approval. The SNS also procures commercially available, FDA-approved or licensed materials that meet identified PHEMCE MCM requirements.


Background on the Multiyear Budget

The multiyear budget report (MYB) fulfills the requirement to “develop, and update on an annual basis, a coordinated five-year budget plan based on the medical countermeasure priorities,” in section 2811(b)(7) of the PHS Act. This report provides cost estimates for the three HHS PHEMCE agencies within the scope of this report and involved in MCM development and stockpiling. These cost estimates are based on enacted appropriations in FYs 2018 and 2019, and the FY 2020 President's Budget request. In addition, for FYs 2018, 2019, and 2020, estimated spending also includes the use of funds from pandemic influenza no-year supplemental appropriations balances. For FYs 2021 and 2022, funding estimates are to support MCM-related activities, including research, development, or procurement of MCMs.

Each office and program developed its own methodology for providing estimates for this report. The estimates for procurement costs are point-in-time estimates and could change in future reports to reflect current market prices.

  • NIH assumed an inflationary increase in FYs 2021 and 2022, indexed to the Biomedical Research and Development Price Index.

  • BARDA assumed funding levels to address all DHS-identified threats with Material Threat Determinations and to meet the goals of the HHS 2017 Pandemic Influenza Plan Update.

  • The SNS assumed funding levels necessary to maintain the current inventory, including replenishment of all FDA approved MCMs, including those originally acquired by PBS. Also, SNS includes an estimate of the funding that will be needed in out-years to replenish products originally purchased by PBS that are not yet FDA approved, but which are forecasted to become so and require replacement in those years.

  • FDA assumed a three percent increase for each of FYs 2021 and 2022.

  • The out-year funding levels (FYs 2021 and 2022) for NIH, BARDA, SNS, and FDA, were developed without regard to the competing priorities considered in the annual President’s Budget formulation process. These estimates are subject to change in the future.


2 For purposes of this document, “approval” refers to “FDA approval, licensure, or clearance” under sections 505, 510(k), or 515 of the FD&C Act, or under section 351 of the PHS Act.

3 The Project BioShield Act of 2004, [PL 108-276], amended the Federal Food Drug and Cosmetic Act, which was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 [PL 113-5], to give authority to the Secretary of HHS to declare that circumstances exist that justify the emergency use authorization, and for FDA to grant emergency use authorization, of certain MCMs that are not approved, or for uses for which the MCMs are not approved, in emergencies under certain terms and conditions [21 USCS § 360bbb-3]. An emergency use authorization does not require the declaration of a public health emergency under section 319 of the PHS Act.

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  • This page last reviewed: January 29, 2020