GAO issues report on MCM study

The Government Accountability Office recently released a report on its study into flexible manufacturing initiatives funded by the Department of Health and Human Services to develop medical countermeasures.

The GAO conducted the study because the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 requires an examination of HHS flexible manufacturing initiatives. The study determined how much funding HHS awarded for MCM manufacturing activities and the extent to which the activities will support the development of chemical, biological, radiological and nuclear MCMs.

In fiscal years 2012 and 2013, the Biomedical Advanced Research and Development Authority awarded approximately $440 million in contracts to establish three Centers for Innovation in Advanced Development and Manufacturing and a network of facilities to provide packaging support for MCM distribution. The CIADMs must also provide workforce training and core services to support the development of CBRN MCMs.

During the contract base period, each CIADM must build or retrofit facilities that can produce 50 million doses of pandemic influenza vaccine within four months of receiving the virus strain. The Fill Finish Manufacturing Network is able to package up to 117 million doses of pandemic influenza vaccine in 12 weeks.

While the CIADM core services activities are meant to support the development and production of certain CBRN MCMs, the GAO said it was too early to tell how effective the approach will be. As the CIADMs are still completing activities connected with their contract base period, BARDA has yet to issue any task orders for core services to date.

"Until the CIADM core services are used, it will be unclear how effectively they will support the development and production of CBRN medical countermeasures," the GAO said. "Stakeholders we interviewed were uncertain about the demand for and availability of funding for core services."

BARDA officials anticipate having sufficient demand for core services and funding for task orders during fiscal years 2014 and 2015.