The US Department of Health and Human Services (HHS) has called for more investment, more support for innovation and better regulation of medical countermeasures including medications, vaccines, and medical equipment.
The plea for a change in US Food and Drug Administration (FDA) processes was made following the publication of results from an examination of government methods of producing medical countermeasures – a process that collected much criticism after last year’s H1N1 influenza pandemic.
Health Secretary Kathleen Sebelius said that the US needs a system that is flexible enough to produce medical countermeasures quickly in the face of any attack or threat.
“By moving towards a 21st century countermeasures enterprise with a strong base of discovery, a clear regulatory pathway and agile manufacturing, we will be able to respond faster and more effectively,” Sebelius said.
The review identified a need to upgrade science and regulatory capacity, and as a result the HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to new discoveries.
The HHS will also release a draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing to develop manufacturing processes that can be used for multiple medications or vaccines.
The review found that some of the most promising research and development on countermeasures is done by small, emerging biotech companies with little experience in large-scale manufacturing.
It also states that the federal government must do a better job of nurturing discoveries in the early stages and has recommended new teams be installed at the National Institutes of Health to identify and promote promising research.
