The Assistant Secretary for Preparedness and Response (ASPR), Dr. Nicole Lurie, requested that the NBSB take a leadership role in the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) review currently underway at ASPR. The NBSB's Medical Countermeasures Research and Development Working Group, as well as the Medical Countermeasures Markets and Sustainability Working Group have been developing background on these issues since early 2008. Specifically, the Board was asked to take on two activities:

  • First, convene a workshop to examine the strategic management, leadership and accountability structure of the PHEMCE. This workshop took place on February 10, 2010.
  • Second, generate a written report for the Secretary of Health and Human Services (HHS) synthesizing the issues and challenges facing the PHEMCE and suggesting policy options to optimize it. This report was the focus of today's meeting.

On March 26, 2010, the NBSB presented the goals as outlined in the written report which will be submitted to HHS. Overall, NBSB's assessment was that the government is lacking synchronization. They strongly recommend that all government entities work from a common set of goals and metrics for accountability in order to balance development and acquisition priorities.

The specific recommendations from the NBSB are outlined below:

  1. Establish government coordination across all cabinet departments;
  2. Establish a coordinated national strategy;
  3. HHS should identify top 3 priorities for medical countermeasure (MCM) development with targeted development timeline (one of top three should be related to radiation);
  4. HHS should coordinate with the Department of Defense (DOD) and the Department of Homeland Security (DHS) to develop list of ALL threats to guide MCM development efforts;
  5. HHS should empower ASPR as operation leader and provide oversight authority;
  6. ASPR should refine acquisition structure and metrics (look to DOD type models and flexibility in acquisition structure);
  7. Biomedical Advanced Research and Development Authority (BARDA) should be designated as portfolio director;
  8. HHS should develop a common set of research goals, product requirements and dispending goals;
  9. HHS/DHS should develop a plan to overcome distribution/administration obstacles for individuals in need and children;
  10. HHS should develop a coordinated budget requirements for all departments within HHS and DOD, request improvement to President's budget and pay special attention to the Food and Drug Administration FDA (FY 2011);
  11. HHS should develop a coordinated budget request for all agencies within HHS and DOD (FY2012 & beyond);
  12. HHS should seek multi-year funding authority similar to those exercised by DOD (look beyond two year active budget to provide congressional leaders and administration strategic planning for long-term spending);
  13. HHS should develop legislative plan for reauthorization of BioShield Special Reserve Fund before expiration in 2013;
  14. ASPR should provide a plan for "some" centralized advanced development and manufacturing plan through a public private partnership (vaccines would especially benefit from such a partnership);
  15. FDA should provide plan to Secretary for determining high priority review products and outline appropriate criteria for safety and efficacy of MCM products;
  16. FDA should develop new input and workshop to review/revise draft FDA Guidance on Animal Rule;
  17. CDC/BARDA/NIAID develop plan for establishing and implementing screening and diagnostics in "clinical setting";
  18. HHS/DOD/DHS should identify: (a) need for pediatric products; (b) dosages; (c) create pre-Emergency Use Authorization (EUA) option for MCM; (d) plan for integrated response plans from alert to MCM dispensing; and (e) evaluate state level MCM distribution plans;
  19. The National Institutes of Health (NIH)/National Institute for Allergy and Infectious Diseases (NIAID) should develop explicit plan for NIH funds matched to prioritized list to research goals to meet threats based on priorities;
  20. HHS/DOD should develop a plan to allocate limited animal resources and facilities to optimize use for priority MCM;
  21. HHS should allocate Public Readiness and Emergency Preparedness (PREP) Act funds for all products under EUA, not just pandemic influenza;
  22. ASPR should provide a plan for distribution of more information on biodefense threats to the public; and
  23. ASPR should develop a plan to make information available and accessible about MCM to the public during an event.

Dr. Lurie was very appreciative of the NBSB's recommendations. She indicated that the goal of the PHEMCE review is to restructure and reform in a bold and transformative, but not interfere with that which is already working well. Dr. Lurie plans to have the first report regarding PHEMCE review/reforms prepared and presented to the Secretary of HHS by mid April. The report will also be presented to Congress and the NBSB.

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