The Nation's Medical Countermeasure Stockpile Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary (2016) / Chapter Skim
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2 The Strategic National Stockpile: Origin, Policy Foundations, and Federal Context
2 The Strategic National Stockpile: Origin, Policy Foundations, and Federal Context
Pages 9-30
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From page 9... ...
Burel explained that the first real deployments were during the events of September 11, 2001, and the Anthrax incident in 2001. Both deployments consisted of 12-hour push packages with appropriate equipment and medical countermeasures (MCMs)
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From page 10... ...
They were the first people to show us capability that we can't match up with on that front end." was expanded from 8 different types to 12 and the managed inventory of products expanded, currently sitting at more than $7 billion.2 The Division of Strategic National Stockpile's (DSNS's) role in the development of federal medical stations and the Cities Readiness Initiative (see Box 2-1)
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From page 11... ...
Observations on the Current State of the SNS Based on his experiences, Burel observed that none of the historic SNS responses have yet matched pre-event planning or expectations, but planning has built in the flexibility to address the unexpected and has allowed for the most effective use of available resources, material, and commercial marketplace capabilities. Coordination with other federal buyers allows agencies to work together with a coordinated government approach to obtain items that are needed without disrupting the entire supply chain.
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From page 12... ...
Sherman explained that the way the statute is written provides broad discretion to HHS and the Secretary; public health officials are the ones who decide what is needed, what constitutes a public health emergency, and how to protect the emergency health security of the 3 Strategic National Stockpile, Public Health Service (PHS)
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From page 13... ...
The VA coordination provision was removed, and provisions for deployment authorities were added: as required by the Secretary of Homeland Security to respond to an actual or potential emergency; and at the discretion of the Secretary to respond to an actual or potential public health emergency or other situation in which deployment is necessary to protect the public health or safety. She pointed out a common misconception that the Secretary of HHS must declare a formal health emergency to deploy the stockpile; however, this is not actually required.
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From page 14... ...
Another clause requires stockpile contents to be determined consistent with ASPR authority, with an explicit provision for an annual report to Congress, and another provision addressing the depletion and replacement of the current contents. It further enhances CBRN procurement and advanced research and development authorities, and reuthorizes the Special Reserve Fund.
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From page 15... ...
Additional reporting requirements written into the statute to improve transparency include integration with annual PHEMCE SIPs as well as the 5-year coordinated biodefense budget. More recently, Congress requested additional reports on certain supplies within the stockpile, and for future budgets to include additional information about planning for replacement and acquisition of new MCMs, for example.
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From page 16... ...
and nonfederal partners, although there are ongoing concerns about the process and whether the outreach has been sufficient. In 2015, Gottron reported that Congress called for CDC to update guidance to state and local public health officials regarding new acquisitions to the SNS and how they would be used.
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From page 17... ...
ASPR and CDC have coordinated and integrated with respect to state and local grantees, as well as public 10 FDA Regulatory Science Initiatives, the BARDA Centers for Innovation in Advanced Deveopment & Manufacturing, National Institute of Allergy and Infectious Diseases' Concept l Acceleration Program; the HHS Five Year Budget Overlook for the Medical Countermeasures Program; the annual review of the National Stockpile, and the National and International Portfolio Tracking Tool for CBRN and MCM products.
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From page 18... ...
18 THE NATION'S MEDICAL COUNTERMEASURE STOCKPILE FIGURE 2-2 PHEMCE agencies, partnerships, and mission components. NOTE: ASPR = Office of the Assistant Secretary for Preparedness and Response; BARDA = Biomedical Advanced Research and Development Authority; CDC = Centers for Disease Control and Prevention; DHS = Department of Homeland Security; DoD = Department of Defense; FDA = Food and Drug Administration; HHS = Department of Health and Human Services; NIH = National Institutes of Health; PHEMCE = Public Health Emergency Medical Countermeasures Enterprise; USDA = U.S.
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From page 19... ...
The network of partnerships also allows interagency partners to come together on major emerging issues when convened for other purposes. Philips outlined some of the challenges faced by PHEMCE, including dealing with competing demands as to what the SNS is and what it should be, as well as the constantly evolving issues that are intrinsic to the entire MCM enterprise (pandemics, new EIDs, CBRN threats, and its BioShield underpinnings)
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From page 20... ...
The ASPR leads and coordinates departmental policy development and implementation on SNS-related policy, ensures documentation of plans and procedures that include SNS assets, and oversees the Enterprise Senior Council (ESC) , with participation of the CDC director, to advise the HHS Secretary regarding strategic priorities for the SNS.
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From page 21... ...
The second phase is a deep dive into the threat-specific areas to see if there are any "game changers" in threats or technologies. The third phase is cross-threat prioritization, looking within and across the Integrated Program Teams (IPTs)
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From page 22... ...
All of these goals are informed by the SNS, tracked, and aligned to create the best stockpile with the best product to mitigate threats. The Biomedical Advanced Research and Development Authority Gary Disbrow, director, CBRN Division, ASPR/BARDA, explained that the mission of BARDA is to support advanced development and availability of countermeasures for CBRN threats, pandemic influenza, and EIDs through product development, innovation, acquisition, stockpiling, building manufacturing infrastructure, and core service assistance.
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From page 23... ...
NOTE: ADS = Analytical Decision Support; BARDA = Biomedical Advanced Research and Development Authority; CIADM = Center for Innovation in Advanced Development & Manufacturing; Mfg. = Manufacturing.
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From page 24... ...
The Nonclinical Development Network was used to evaluate other EVD therapeutics; the CIADMs were actually leveraged to manufacture monoclonal antibodies that could address the EVD outbreak through a partnership with Genentech Inc. Disbrow noted that as the value of the SNS formulary has increased over the past several years, the range of products supported under Project BioShield that have been (or will soon be)
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From page 25... ...
BARDA must brief both the Enterprise Executive Committee and the Enterprise Senior Council before making acquisitions for Project BioShield, meaning that all PHEMCE partners are informed. Integrated program teams are PHEMCE-wide teams of subject-matter experts that make decisions on requirements for different types of products.
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From page 26... ...
The Food and Drug Administration and the Federal Medical Countermeasures Enterprise The role of FDA in the federal MCM enterprise was described by Brad Leissa, deputy director and emergency coordinator, Counter- errorism and T Emergency Coordination Staff, Center for Drug Evaluation and Research. He explained that FDA's overarching MCM objective is to facilitate the development of and access to safe and effective MCMs (i.e., drugs, biologics, and devices, including diagnostics and PPE to counter high-priority CBRN and EID threats)
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From page 27... ...
A summary of EUAs issued between 2005 and 2015 is listed in Table 2-1. Emergency-use legal mechanisms allow expanded access to investigational drugs and devices; Leissa explained that in certain circumstances, clinical trials under an IND/IDE may be the most ethical and fairest means to provide access, given limited supplies and need to assess products.24 EUA25 was established by the Project BioShield Act (2004)
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From page 28... ...
2005 Anthrax Vaccine Adsorbed (AVA) DoD Terminated 2008 (reissued in Doxycycline hyclate 100 mg oral HHS (ASPR/ Current 2009, 2010, and tablets (in National Postal Model BARDA)
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From page 29... ...
NOTE: ASPR = Office of the Assistant Secretary of Preparedness and Response; BARDA = Biomedical Advanced Research and Development Authority; CDC = Centers for Disease Control and Preparedness; DoD = Department of Defense; EUA = Emergency Use Authorization; HHS = Department of Health and Human Services; IVD = in vitro diagnostics; PCR = polymerase chain reaction; rRT-PCR = real-time reverse transcription polymerase chain eaction; RT-PCR = r reverse transcription polymerase chain reaction. SOURCE: Leissa presentation, February 4, 2016.
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From page 30... ...
in anticipation of FDA approval, clearance, or licensure or EUA issuance. These authorities preserve otherwise applicable liability protections (e.g., PREP Act)
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