Public Health Emergency Medical Countermeasures Enterprise .
U.S. Department of Health and Human ServicesPublic Health EmergencyMedical CountermeasuresEnterpriseMultiyear BudgetFiscal Years 2018-2022December 2019Saving Lives. Protecting Americans.
U.S. Department of Health and Human ServicesyPublic Health Emergency MedicalCountermeasures EnterpriseMultiyear BudgetFiscal Years 2018–2022Table of ContentsExecutive Summary.2Background.5PHEMCE-Wide Findings.7Conclusion.12Appendix A – Spend Plan.13Appendix B – Agency or Office Figures and Tables.21
Executive SummaryFor the five-year period of fiscal years (FYs) 2018–2022,this report provides estimates for HHS total spendingwhich 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 totalaggregates MCM-related spending estimates for NIH,BARDA, SNS, and FDA (Table 1).Section 2811(b)(7) of the Public Health Service (PHS) Actrequires the Assistant Secretary for Preparedness andResponse (ASPR) to lead the development of a coordinatedfive-year budget plan for medical countermeasure(MCM) development and to update the plan annually.This Public Health Emergency Medical CountermeasuresEnterprise (PHEMCE) Multiyear Budget Report (MYB) isThis year’s report updates the previous report andprovides an amended analysis. The report maintainsTable 1. Estimated Total PHEMCE Spending by HHS Division and Fiscal Year (dollars in millions)DivisionFY 2018FY 2019FY 2020FY 2021FY 2022TotalChange OverFYs 20172021NIH 2,170 2,329 2,011 2,065 2,121 10,695 392ASPR BARDA 1,514 1,653 1,698 4,217 3,671 12,753 2,778ASPR SNS 610 610 620 1,081 1,657 4,578 803FDA 142 141 154 173 178 787 12Total 4,436 4,733 4,483 7,535 7,626 28,813 3,985the methodology from last year’s report by including anestimate of funding needed to replenish products held inthe SNS that were originally purchased by Project BioShield(PBS) but are anticipated to be approved or licensed bythe FDA prior to FY 2022. This report includes estimatesof the replenishment costs that would be incurred by theSNS beginning in FY 2020 through FY 2022 and this amounttotals 1.1 billion. Replenishment costs arise from productspurchased previously by BARDA or SNS that expire andneed to be restocked.the fifth submission in response to that requirement. Thisreport includes the multiyear budgets for the followingDepartment of Health and Human Services (HHS) entitiesinvolved in MCM development and stockpiling: theNational Institutes of Health (NIH), ASPR’s BiomedicalAdvanced Research and Development Authority (BARDA)and Strategic National Stockpile (SNS), and the Food andDrug Administration (FDA)1 for fiscal years (FY) 2018–2022.This report revises and updates the estimated funding datain the FY 2017–2021 PHEMCE Multiyear Report submittedto Congress in February 2019. The House AppropriationsCommittee stated in its FY 2020 Labor-HHS-Educationappropriations committee report:This report developed the spending estimates in the reportas follows: for FYs 2018 and 2019, the report includesthe enacted annual appropriation levels; for FY 2020, thereport includes the FY 2020 President’s Budget request. Inaddition, for FYs 2018, 2019, and 2020, estimated spendingalso includes the use of funds from pandemic influenzano-year supplemental appropriations balances. The outyear funding levels (FYs 2021 and 2022) were developedwithout regard to the competing priorities consideredin the annual budget formulation process. As theAdministration formulates Congressional budget requestsfor FYs 2021 and 2022, these estimates may be subject tochange.“The Committee appreciates the release of thePublic Health Emergency Medical CountermeasuresEnterprise multiyear budget in February 2019. TheCommittee 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 FYs2019–2023 in March 2020.Section 2811-1 of the PHS Act (as amended by P.L. 116-22) establishes themembers of the PHEMCE to include the following HHS members or theirdesignees: the ASPR, the Director of the Centers for Disease Control andPrevention (CDC), the Director of the NIH, and the Commissioner of FDA.Representatives from other federal agencies may also be part of PHEMCE asdetermined appropriate by the Secretary, including: the Director of BARDA,the Director of the SNS, the Director of the National Institute of Allergy andInfectious Diseases (NIAID), and the Director of the Office of Public HealthPreparedness and Response.1The following summary describes estimated spending bythreat for the cumulative five-year period and the changerelative to the last year’s report for FYs 2017–2021:2
Pandemic and Seasonal Influenza: 5.7 billion, anincrease of 1.4 billion ( 33 percent), to fully supportnecessary efforts to address identified gaps in pandemicinfluenza preparedness and response capabilities, developa universal influenza vaccine, and maintain currentcapabilities. BARDA would begin a robust developmentprogram for more effective, non-egg based vaccines thatcan be domestically manufactured, delivered faster, andlast on shelves longer. Development of novel influenzaantivirals and therapeutics, including repurposing ofcurrently approved products, would start. Efforts to pushdiagnostics to home use to allow more rapid detection andtreatment would be increased. Currently existing domesticmanufacturing facility capacity, critical to the Nation’sresponse capabilities, will be maintained. A portion of thisincrease also supports replenishment of expiring materialin the SNS.supporting advanced development of MCMs againstother emerging infectious disease threats. The fundingestimate reflects the multitude of infectious diseases thathave emerged over the last decades and pose a seriousthreat to health security, the need to have licensed MCMsavailable to detect, treat, and prevent these diseases,and the numerous countermeasures that have completedearly development and are situated for advanced productdevelopment. Funding will also support development andtesting of platform technologies to streamline vaccinediscovery and development and facilitate a rapid responseto emerging infectious diseases. Specifically, developmentof MCMs against the Zika virus are captured in thisportfolio as well. Part of the estimated increase reflectssuccessful advancement of the current vaccine candidatestoward licensure, and a need for BARDA to fund pivotalclinical trials and manufacturing work in order to achieveFDA approval.Broad Spectrum Antimicrobials: 3.7 billion, an increaseof 193 million ( 6 percent), for the development andapproval of one current and one new product to addressgaps for threats caused by Gram-negative bacteria (broadspectrum antimicrobials). This includes the transition oftwo products from advanced research and development(ARD) to PBS. These investments are consistent withobjectives in the National Strategy for CombatingAntibiotic-Resistant Bacteria (2015–2020).Anthrax: 2.3 billion, an increase of 302 million ( 15percent).This portfolio supports the development,procurement, and support for preparation of anapplication for licensure of the next-generation anthraxvaccine, AV7909, as well as anthrax therapeutics.The increase in estimated spending supports thereplenishment of anthrax therapeutics in the SNS.Radiological and Nuclear Threats: 2.0 billion, an increaseof 191 million ( 10 percent) for basic and advanced clinicalresearch and development of products to address acuteradiation syndrome (ARS) and the delayed effects of acuteradiation exposure (DEARE), and procurements of antineutropenic cytokines, biodosimetry devices, and multiplecandidate products for the treatment of thermal burns.Cross-Cutting Science Portfolio: 2.9 billion, a decreaseof 90 million (-3 percent), for NIAID and BARDA researchactivities that cannot be assigned to a specific threat,but augment preparedness and response as overarchingcapabilities. These investments support such necessaryareas as animal model development, diagnostics,sequencing facilities, reagent manufacturing, clinicaltraining programs, epitope mapping, biosafety lab support,and computational biology. Investments in this area alsosupport the development of vaccine platform technologiesthat could be used to generate candidate vaccines againstmultiple different established or emerging pathogens.These platforms include gene-based vaccinationsystems such as viral vectors, plasmid DNA, and mRNA,and stabilization technologies (e.g., dry versus liquidformulations).Filoviruses (including the Ebola virus): 1.9 billion, anincrease of 282 million ( 18 percent), to support a varietyof activities related to the development of Ebola vaccinesand therapeutics, including: 1) manufacturing of clinicalinvestigational lots, 2) conducting clinical trials in the U.S.and West Africa that are essential to assess whether theproducts are safe and effective, 3) attaining the abilityto manufacture these MCMs at commercial scale, and4) ultimately procuring vaccine and therapeutic MCMs.The funding estimate would support the transition of oneSudan ebolavirus therapeutic from ARD to PBS.Other Threats Portfolio: 2.8 billion, an increase of 186million ( 7 percent), for investments to support activitiesagainst threats such as arboviruses (including Zika virus),MERS-CoV, waterborne and foodborne pathogens,tuberculosis, adjuvant discovery/development, andactivities investigating fundamental aspects of the humanimmune system. This portfolio includes investmentsSmallpox: 1.8 billion, an increase of 563 million ( 47percent), for the procurement of a next-generation vaccineagainst smallpox, potentially providing a longer shelf-lifeand, therefore, lower replenishment costs. This increase inestimated spending also includes replenishment of currentvaccinia and immune globulin stockpiles in the SNS.3
Chemical Threats: 1.6 billion, an increase of 448 million( 39 percent), to support the development of safer andmore effective therapeutics to treat exposure to nerveagents, vesicating chemicals, pulmonary agents, and toxicindustrial chemicals. This amount includes a substantialinvestment in countermeasures against pharmaceuticalbased agents, such as fentanyl.Botulinum: 132 million, a decrease of 250 million (-65percent), for continued support for the hBAT (botulinumantitoxin, heptavalent) program that includes processingadditional hyperimmune plasma into finished product. Thisdecrease reflects the removal of a placeholder expense forregenerating the hyperimmune horse herd that providesthe antibodies for the hBAT product. The existing supplyand production capacity for the hBAT product is sufficientto meet the current PHEMCE requirement for the next 10years.Centers for Innovation in Advanced Development andManufacturing (CIADM): 125 million, an increase of 125million, for maintaining and increasing the capabilitiesof the CIADMs. This increase reflects the transition toa capability-based approach, which takes advantage ofprevious investments to address existing public healththreats by having access to rapid domestic manufacturingcapabilities for a broad array of countermeasures.Other Portfolios: The remaining funds ( 3.5 billion) for thefive-year period are allocated to: SNS Non-ProcurementCosts and federal medical stations, FDA Regulatory Science,NIH’s Multiplex Diagnostics, BARDA’s Managementand Administration, BARDA’s Medical CountermeasureInnovator Program, MCM for plague and tularemia, MCMfor glanders and melioidosis, ancillary products, andbiodiagnostics.This FYs 2018–2022 PHEMCE MYB highlights the PHEMCEpipeline from bench research to FDA approval andprocurement. This pipeline has resulted in more than200 products in advanced research and development, 15countermeasures that are, or have been, stockpiled in theSNS that are available during a public health emergency,and 48 products achieving FDA approval since 2007.4
BackgroundThe PHEMCE’s success is demonstrated by the productsthat evolved across programs, achieved regulatoryapproval, and were stockpiled in the SNS. Currently, HHS’sadvanced research and development pipeline containsmore than 200 products. The PHEMCE stockpiled 15countermeasures in the SNS that are available for useduring a public health emergency. Since 2007, the FDAhas approved 48 products for CBRN threats and pandemicinfluenza supported by HHS’s PHEMCE agencies, includingBARDA.The PHEMCE is an interdepartmental governance structureoverseen by HHS for the research, advanced development,procurement, stockpiling, and development of plans foreffective use of MCMs needed to respond to infrequent,but high-consequence, public health and medicalemergencies. These events may result from intentional,accidental, or natural occurrences. The PHEMCE is ledby ASPR and includes multiple HHS divisions. Severalinteragency 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. Departmentof Homeland Security (DHS), and the U.S. Departmentof Agriculture (USDA). The Pandemic and All-HazardsPreparedness and Advancing Innovation Act of 2019 (P.L.116-22) added the Director of National Intelligence to themembership of PHEMCE.This report forecasts that seven MCM candidates willtransition from procurement under BARDA’s ProjectBioShield to stockpiling by the SNS by 2022. Althoughthese MCMs may not have FDA approval at the time ofinitial delivery to the SNS, they may potentially be usedunder investigational drug protocols, such as clinical trialsor may potentially be used under the FDA provisionsfor Emergency Use Authorization (EUA), as needed, andauthorized under the Federal Food, Drug and Cosmetic(FD&C) Act.3 SNS will be responsible for the replenishmentcosts of those MCMs procured by BARDA under PBSonce these products achieve FDA approval. The SNSalso procures commercially available, FDA-approved orlicensed materials that meet identified PHEMCE MCMrequirements.This report, the FYs 2018–2022 Public Health EmergencyMedical Countermeasures Enterprise Multiyear Budget,describes the five-year interagency budget plan for thebasic research, advanced research and development,regulatory review, procurement, stockpiling, andreplenishment of the U.S. government’s civilian medicalcountermeasure enterprise.2 The report consolidatesPHEMCE budget forecasting into one document providingan update for FYs 2018–2022 of PHEMCE budget prioritiesacross chemical, biological, radiological, and nuclear(CBRN) threats, pandemic influenza, and other emerging,or re-emerging, infectious diseases for ASPR (includingBARDA and the SNS), FDA, and NIH.Background on the Multiyear BudgetThe multiyear budget report (MYB) fulfills therequirement to “develop, and update on an annual basis,a coordinated five-year budget plan based on the medicalcountermeasure priorities,” in section 2811(b)(7) of thePHS Act. This report provides cost estimates for the threeHHS PHEMCE agencies within the scope of this report andinvolved in MCM development and stockpiling. These costestimates are based on enacted appropriations in FYs 2018and 2019, and the FY 2020 President’s Budget request. Inaddition, for FYs 2018, 2019, and 2020, estimated spendingalso includes the use of funds from pandemic influenzano-year supplemental appropriations balances. For FYs2021 and 2022, funding estimates are to support MCMrelated activities, including research, development, orprocurement of MCMs.Background on Medical CountermeasureDevelopmentThe development of MCMs is a time-intensive, risky, andexpensive endeavor, requiring substantial coordinationamong federal departments and agencies, and theconcerted efforts of commercial partners. It is also acritical component of the Nation’s health preparednessand response capability. Prioritizing federal fundingacross portfolios and the stages of MCM development isfundamental to achieving the PHEMCE’s goals. Successfulcoordination requires strategic planning that incorporatesdiscrete funding streams into a coherent plan spanningmany years.The Project BioShield Act of 2004, [PL 108-276], amended the Federal Food Drugand Cosmetic Act, which was further amended by the Pandemic and All-HazardsPreparedness Reauthorization Act of 2013 [PL 113-5], to give authority to theSecretary of HHS to declare that circumstances exist that justify the emergencyuse authorization, and for FDA to grant emergency use authorization, of certainMCMs 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]. Anemergency use authorization does not require the declaration of a public healthemergency under section 319 of the PHS Act.3For purposes of this document, “approval” refers to “FDA approval, licensure, orclearance” under sections 505, 510(k), or 515 of the FD&C Act, or under section351 of the PHS Act.25
Each office and program developed its own methodologyfor providing estimates for this report. The estimates forprocurement costs are point-in-time estimates and couldchange in future reports to reflect current market prices. NIH assumed an inflationary increase in FYs 2021and 2022, indexed to the Biomedical Research andDevelopment Price Index.BARDA assumed funding levels to address allDHS-identified threats with Material ThreatDeterminations and to meet the goals of the HHS2017 Pandemic Influenza Plan Update. The SNS assumed funding levels necessaryto maintain the current inventory, includingreplenishment of all FDA approved MCMs,including those originally acquired by PBS. Also,SNS includes an estimate of the funding that willbe needed in out-years to replenish productsoriginally purchased by PBS that are not yet FDAapproved, but which are forecasted to become soand require replacement in those years. FDA assumed a three percent increase for each ofFYs 2021 and 2022. The out-year funding levels (FYs 2021 and 2022)for NIH, BARDA, SNS, and FDA, were developedwithout regard to the competing prioritiesconsidered in the annual President’s Budgetformulation process. These estimates are subjectto change in the future.6
PHEMCE-Wide Findingsthe five-year period, which represents an increase of 1.4billion ( 33 percent). This increase is critical to supportpandemic preparedness objectives as outlined in the 2017Pandemic Influenza Plan Update. This update includesHHS’s establishment of one of its key actions to “supportinnovation in influenza vaccine production for improvedefficiencies to enable the production and distribution offinal presentation vaccines for pandemic response within12 weeks from the declaration of an influenza pandemic.”4Other requirements objectives include the need forimprovements in diagnostics and treatment options. Theincreased spending estimate supports BARDA to begin arobust development program for more effective vaccinesthat can be made and delivered faster than currentlyavailable vaccines. NIH would continue to supportdiscovery of innovative new pandemic influenza vaccineprototypes, while advancing the clinical development ofcurrent universal influenza vaccine candidates. Effortsto push diagnostics to home use to allow more rapiddetection and tre
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
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