The Obama administration has struck out in a bold, new direction by announcing an overhaul of the production of countermeasures to bioterrorism and pandemic disease, observers say, adding that the plan’s more prosaic recommendations might be as important as its eye-catching items.
The administration’s new plan, released Thursday, calls for reinvesting $1.9 billion in funding left over from last year’s response to the H1N1 “swine flu” pandemic. While some of that money would go toward attention-getting proposals — such as creating a new strategic investment agency to promote innovative but struggling companies — experts also praised less catchy recommendations, such as managerial changes to the countermeasure development effort and a proposal to give the Food and Drug Administration (FDA) $170 million to revamp the way it approves new drugs and vaccines.
The FDA money would go toward improving its scientific expertise and assessment tools and creating special teams to work on high-priority medical countermeasures. Those teams would work from across the FDA to identify problems and resolve them early in the regulatory process. The review also recommended that the Department of Health and Human Services (HHS) create “early development teams” to provide guidance to its public health agencies, academic researchers and biotech companies working on promising drug candidates.