“Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of an attack or threat, whether it's one we know about today or a new one. 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 to public health threats.” (HHS Secretary Kathleen Sebelius)
Emerging infectious diseases, pandemics, and bioterrorism carry the potential for catastrophic impact, and the U.S. government has faced chronic challenges in producing medical countermeasures against such threats, as exemplified during the recent 2009-H1N1 pandemic. The President called out the renewed need for a national capability to respond to these threats in the State of the Union, and the Secretary of HHS stepped forward to address this need. The vision to combat such threats is simple: our nation must have the nimble, flexible capability to produce medical countermeasures rapidly in the face of any attack or threat, whether known or unknown, novel or reemerging, natural or intentional.
The business model of the current medical countermeasure development enterprise requires new, innovative approaches to meet this vision. The new strategy envisions a capabilities-based approach and a much more active role by the U.S. government in forging partnerships, attacking constraints, modernizing regulatory oversight, and supporting transformative technologies. It also addresses federal leadership and management practices needed to produce an integrated and successful program.