HHS’s ASPR leads PHEMCE and the federal medical and public  health response to public health emergencies, including strategic  planning and support for developing and securing medical  countermeasures. As part of these activities, HHS develops priorities  for which medical countermeasures are needed. Within ASPR, BARDA—established by the Pandemic and All-Hazards  Preparedness Act of 2006—coordinates and supports advanced  research and development, manufacturing, and initial procurement  of medical countermeasures for CBRN threats, pandemic influenza,  and emerging infectious diseases into the Strategic National  Stockpile—the national repository for medications, medical supplies,  and equipment for use in a public health emergency. HHS Awarded $440 Million in Fiscal Years 2012 and 2013 in Contracts for Activities to Support Flexible Manufacturing for Medical Countermeasures

In fiscal years 2012 and 2013, HHS’s BARDA awarded nearly   $440 million to establish its CIADMs and a network of facilities to provide  packaging support to ready the product for distribution, known as the Fill  Finish Manufacturing Network. The CIADMs and the Fill Finish Manufacturing Network Are Intended to Provide Three Activities to Support Flexible Manufacturing

BARDA’s CIADMs are intended to provide three activities—surge  capacity for manufacturing pandemic influenza vaccine, core services for  the development of CBRN medical countermeasures, and workforce  training—to support HHS’s flexible manufacturing activities. According to  HHS, the primary goal of the CIADMs is to provide core service  assistance to CBRN medical countermeasure developers, their ability to  provide some core services depends on the retrofitting of existing, or  building of new, facilities that are also needed to provide surge capacity. These facilities are to include a biologics development and  manufacturing facility that is intended to provide core services for  CBRN medical countermeasures, with the added capability of  developing and manufacturing live virus vaccine candidates; a current  Good Manufacturing Practices vaccine bulk manufacturing facility  dedicated to large-scale surge manufacturing of pandemic influenza  vaccines; a laboratory and office building to support process  development and technology transfer of CBRN medical  countermeasures into the CIADM; and a facility to support the fill and  finish requirements for medical countermeasures. Each of the  three CIADMs are to be able and, in the event of an influenza pandemic,  be required to produce 50 million doses of vaccine within four months of  receipt of the influenza virus strain, with the first doses for the public  available to HHS within 12 weeks. BARDA anticipates placing task orders for  pandemic influenza vaccine, if needed, during the annual contract option  periods available to extend the contracts at the end of the respective base  periods. Core Services

For the core services activity, the CIADMs are to provide services for the  development and production of CBRN medical countermeasures, such as  assisting CBRN medical countermeasure developers in manufacturing  small amounts of products that can be used in clinical trials. BARDA officials told us that during the contract  base period, the CIADMs are required to develop their workforce training  programs, and that the agency may begin to request workforce training  activities through task orders in fiscal year 2014. HHS’s Flexible Manufacturing Activities Are Designed to Support the Development and Production of CBRN Medical Countermeasures, but It Is Too Early to Determine Their Effectiveness

HHS established the CIADMs to provide needed core services to support  the development and production through flexible manufacturing of certain  CBRN medical countermeasures that were identified as priorities by  PHEMCE. However, it is too early to tell how effective this approach will be because  HHS has not begun to issue task orders to CIADMs for core services. As Core Services Have Not Yet Been Provided, It Is Too Early to Tell How Helpful They Will Be to Countermeasure Developers

BARDA has not issued any task orders for core services to date, as the  CIADMs are still completing activities associated with the contract base  periods. The steering committee is to then  While it is too early to tell how effective HHS’s approach to providing core  services to CBRN medical countermeasure developers through the  CIADMs will be, some industry stakeholders we interviewed expressed  concerns about demand, availability of funding, and communication with  BARDA. BARDA officials told us that  they expect to have sufficient funding for task orders in fiscal years 2014  and 2015. We are sending copies of this report to the Secretary of Health and  Human Services. Public Health Preparedness: Developing and Acquiring Medical  Countermeasures Against Chemical, Biological, Radiological, and  Nuclear Agents.
Why GAO Did This Study

Public health emergencies, such as the 2001 anthrax attacks and the 2009 H1N1 influenza pandemic, raise concerns about the nation's vulnerability to threats from CBRN agents and new or reemerging infectious diseases, such as pandemic influenza. HHS is the federal agency primarily responsible for identifying medical countermeasures needed to address the potential health effects from exposure to CBRN agents and emerging infectious diseases. HHS conducted a review to assess how to better address these concerns. Its August 2010 review concluded that the advanced development and manufacture of CBRN medical countermeasures needed greater support. The review recommended that HHS develop centers to provide such support, in part by using flexible manufacturing technologies, such as disposable equipment, to aid in the development and rapid manufacture of products.
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 requires GAO to examine HHS's flexible manufacturing initiatives and the activities these initiatives will support. This report addresses (1) how much funding HHS has awarded for flexible manufacturing activities for medical countermeasures, and (2) the extent to which these activities will support the development and production of CBRN medical countermeasures. To address these objectives, GAO examined HHS documents and interviewed HHS officials, contractors, and stakeholders. In comments on a draft of the report, HHS agreed with its findings and provided additional information.

What GAO Found

In fiscal years 2012 and 2013, the Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) awarded nearly $440 million in contracts to establish three Centers for Innovation in Advanced Development and Manufacturing (CIADM) and a network of facilities to provide packaging support for medical countermeasure distribution, known as the Fill Finish Manufacturing Network (FFMN). The contracts require the CIADMs to develop three activities to support flexible manufacturing for medical countermeasure development and production: the manufacture of pandemic influenza vaccines during an emergency; core services to support the development and production of chemical, biological, radiological, and nuclear (CBRN) medical countermeasures; and workforce training. During the contract base periods, each CIADM is to retrofit existing or build new facilities able to produce 50 million doses of pandemic influenza vaccine within 4 months of receipt of the influenza virus strain and to establish the capacity to provide core services, such as assisting countermeasure developers by manufacturing products to be used for clinical trials. The CIADMs are also required to develop workforce training programs, which are intended to increase expertise in CBRN medical countermeasure development. The CIADM base contracts are intended to retrofit or build facilities to stand ready to provide these three activities and maintain this readiness through annual contract option periods. Once the facilities are prepared to provide these activities, BARDA may place task orders for provision of CIADM vaccine surge capacity, core services, or training, and BARDA, through the task orders, would provide additional payments to obtain these services. The FFMN is to supplement CIADMs' pandemic influenza surge capacity, packaging up to 117 million doses of pandemic influenza vaccine in 12 weeks, if needed, and can also provide core services as CIADM subcontractors.
HHS's CIADM core services activities are designed to support the development and production of certain CBRN medical countermeasures, but it is too early to tell how effective this approach will be. BARDA's establishment of the CIADMs implements a recommendation from HHS's review of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)—a federal interagency body that advises HHS on medical countermeasure priorities. The CIADMs are to support the development of biologics-based countermeasures only, which are products like vaccines that are derived from living sources such as cells, because BARDA considers these countermeasures to need the greatest support. BARDA has identified some of its current biologics-based countermeasure development contracts that could use core services' support and are priorities for PHEMCE. However, the CIADMs are still completing activities associated with their contract base period. Thus, BARDA has not issued any task orders for core services to date, but has created a CIADM steering committee and completed guidance to govern the task order process once the CIADMs are operational. Until the CIADM core services are used, it will be unclear how effectively they will support the development and production of CBRN medical countermeasures. Stakeholders we interviewed were uncertain about the demand for and availability of funding for core services. BARDA officials said that they anticipate having sufficient demand for the services and funding for task orders in fiscal years 2014 and 2015.