Public Health Emergency - Leading a Nation Prepared
Section 2811(b)(7) of the Public Health Service (PHS) Act requires the Assistant Secretary for Preparedness and Response (ASPR) to lead the development of a coordinated five-year budget plan for medical countermeasure (MCM) development and to update the plan annually. This Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Multiyear Budget Report (MYB) is the fifth submission in response to that requirement. This report includes the multiyear budgets for the following Department of Health and Human Services (HHS) entities involved in MCM development and stockpiling: the National Institutes of Health (NIH), ASPR’s Biomedical Advanced Research and Development Authority (BARDA) and Strategic National Stockpile (SNS), and the Food and Drug Administration (FDA)
1 for fiscal years (FY) 2018–2022.
This report revises and updates the estimated funding data in the FY 2017–2021 PHEMCE Multiyear Report submitted to Congress in February 2019. The House Appropriations Committee stated in its FY 2020 Labor-HHS-Education appropriations committee report:
“The Committee appreciates the release of the Public Health Emergency Medical Countermeasures Enterprise multiyear budget in February 2019. The Committee expects more timely future submissions, as the updates are due annually.”
This abbreviated report seeks to meet this expectation. The Department anticipates submitting a full report for FYs 2019–2023 in March 2020.
For the five-year period of fiscal years (FYs) 2018–2022, this report provides estimates for HHS total spending which would be $28.8 billion, a $4.0 billion, or 14 percent, increase compared with the projection for FYs 2017–2021, which was $24.8 billion. The five-year funding total aggregates MCM-related spending estimates for NIH, BARDA, SNS, and FDA (Table 1).
Estimated Total PHEMCE Spending by HHS Division and Fiscal Year (dollars in millions)
This year’s report updates the previous report and provides an amended analysis. The report maintains the methodology from last year’s report by including an estimate of funding needed to replenish products held in the SNS that were originally purchased by Project BioShield (PBS) but are anticipated to be approved or licensed by the FDA prior to FY 2022. This report includes estimates of the replenishment costs that would be incurred by the SNS beginning in FY 2020 through FY 2022 and this amount totals $1.1 billion. Replenishment costs arise from products purchased previously by BARDA or SNS that expire and need to be restocked.
This report developed the spending estimates in the report as follows: for FYs 2018 and 2019, the report includes the enacted annual appropriation levels; for FY 2020, the report includes 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. The out-year funding levels (FYs 2021 and 2022) were developed without regard to the competing priorities considered in the annual budget formulation process. As the Administration formulates Congressional budget requests for FYs 2021 and 2022, these estimates may be subject to change.
The following summary describes estimated spending by threat for the cumulative five-year period and the change relative to the last year’s report for FYs 2017–2021:
Pandemic and Seasonal Influenza: $5.7 billion, an increase of $1.4 billion (+33 percent), to fully support necessary efforts to address identified gaps in pandemic influenza preparedness and response capabilities, develop a universal influenza vaccine, and maintain current capabilities. BARDA would begin a robust development program for more effective, non-egg based vaccines that can be domestically manufactured, delivered faster, and last on shelves longer. Development of novel influenza antivirals and therapeutics, including repurposing of currently approved products, would start. Efforts to push diagnostics to home use to allow more rapid detection and treatment would be increased. Currently existing domestic manufacturing facility capacity, critical to the Nation’s response capabilities, will be maintained. A portion of this increase also supports replenishment of expiring material in the SNS.
Broad Spectrum Antimicrobials: $3.7 billion, an increase of $193 million (+6 percent), for the development and approval of one current and one new product to address gaps for threats caused by Gram-negative bacteria (broad-spectrum antimicrobials). This includes the transition of two products from advanced research and development (ARD) to PBS. These investments are consistent with objectives in the
National Strategy for Combating Antibiotic-Resistant Bacteria (2015–2020).
Cross-Cutting Science Portfolio: $2.9 billion, a decrease of $90 million (-3 percent), for NIAID and BARDA research activities that cannot be assigned to a specific threat, but augment preparedness and response as overarching capabilities. These investments support such necessary areas as animal model development, diagnostics, sequencing facilities, reagent manufacturing, clinical training programs, epitope mapping, biosafety lab support, and computational biology. Investments in this area also support the development of vaccine platform technologies that could be used to generate candidate vaccines against multiple different established or emerging pathogens. These platforms include gene-based vaccination systems such as viral vectors, plasmid DNA, and mRNA, and stabilization technologies (e.g., dry versus liquid formulations).
Other Threats Portfolio: $2.8 billion, an increase of $186 million (+7 percent), for investments to support activities against threats such as arboviruses (including Zika virus), MERS-CoV, waterborne and foodborne pathogens, tuberculosis, adjuvant discovery/development, and activities investigating fundamental aspects of the human immune system. This portfolio includes investments supporting advanced development of MCMs against other emerging infectious disease threats. The funding estimate reflects the multitude of infectious diseases that have emerged over the last decades and pose a serious threat to health security, the need to have licensed MCMs available to detect, treat, and prevent these diseases, and the numerous countermeasures that have completed early development and are situated for advanced product development. Funding will also support development and testing of platform technologies to streamline vaccine discovery and development and facilitate a rapid response to emerging infectious diseases. Specifically, development of MCMs against the Zika virus are captured in this portfolio as well. Part of the estimated increase reflects successful advancement of the current vaccine candidates toward licensure, and a need for BARDA to fund pivotal clinical trials and manufacturing work in order to achieve FDA approval.
Anthrax: $2.3 billion, an increase of $302 million (+15 percent). This portfolio supports the development, procurement, and support for preparation of an application for licensure of the next-generation anthrax vaccine, AV7909, as well as anthrax therapeutics. The increase in estimated spending supports the replenishment of anthrax therapeutics in the SNS.
Radiological and Nuclear Threats: $2.0 billion, an increase of $191 million (+10 percent) for basic and advanced clinical research and development of products to address acute radiation syndrome (ARS) and the delayed effects of acute radiation exposure (DEARE), and procurements of anti-neutropenic cytokines, biodosimetry devices, and multiple candidate products for the treatment of thermal burns.
Filoviruses (including the Ebola virus): $1.9 billion, an increase of $282 million (+18 percent), to support a variety of activities related to the development of Ebola vaccines and therapeutics, including: 1) manufacturing of clinical investigational lots, 2) conducting clinical trials in the U.S. and West Africa that are essential to assess whether the products are safe and effective, 3) attaining the ability to manufacture these MCMs at commercial scale, and 4) ultimately procuring vaccine and therapeutic MCMs. The funding estimate would support the transition of one Sudan ebolavirus therapeutic from ARD to PBS.
Smallpox: $1.8 billion, an increase of $563 million (+47 percent), for the procurement of a next-generation vaccine against smallpox, potentially providing a longer shelf-life and, therefore, lower replenishment costs. This increase in estimated spending also includes replenishment of current vaccinia and immune globulin stockpiles in the SNS.
Chemical Threats: $1.6 billion, an increase of $448 million (+39 percent), to support the development of safer and more effective therapeutics to treat exposure to nerve agents, vesicating chemicals, pulmonary agents, and toxic industrial chemicals. This amount includes a substantial investment in countermeasures against pharmaceutical-based agents, such as fentanyl.
Botulinum: $132 million, a decrease of $250 million (-65 percent), for continued support for the hBAT (botulinum antitoxin, heptavalent) program that includes processing additional hyperimmune plasma into finished product. This decrease reflects the removal of a placeholder expense for regenerating the hyperimmune horse herd that provides the antibodies for the hBAT product. The existing supply and production capacity for the hBAT product is sufficient to meet the current PHEMCE requirement for the next 10 years.
Centers for Innovation in Advanced Development and Manufacturing (CIADM): $125 million, an increase of $125 million, for maintaining and increasing the capabilities of the CIADMs. This increase reflects the transition to a capability-based approach, which takes advantage of previous investments to address existing public health threats by having access to rapid domestic manufacturing capabilities for a broad array of countermeasures.
Other Portfolios: The remaining funds ($3.5 billion) for the five-year period are allocated to: SNS Non-Procurement Costs and federal medical stations, FDA Regulatory Science, NIH’s Multiplex Diagnostics, BARDA’s Management and Administration, BARDA’s Medical Countermeasure Innovator Program, MCM for plague and tularemia, MCM for glanders and melioidosis, ancillary products, and biodiagnostics.
This FYs 2018–2022 PHEMCE MYB highlights the PHEMCE pipeline from bench research to FDA approval and procurement. This pipeline has resulted in more than 200 products in advanced research and development, 15 countermeasures that are, or have been, stockpiled in the SNS that are available during a public health emergency, and 48 products achieving FDA approval since 2007.
1 Section 2811-1 of the PHS Act (as amended by P.L. 116-22) establishes the members of the PHEMCE to include the following HHS members or their designees: the ASPR, the Director of the Centers for Disease Control and Prevention (CDC), the Director of the NIH, and the Commissioner of FDA. Representatives from other federal agencies may also be part of PHEMCE as determined appropriate by the Secretary, including: the Director of BARDA, the Director of the SNS, the Director of the National Institute of Allergy and Infectious Diseases (NIAID), and the Director of the Office of Public Health Preparedness and Response.
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