The medical countermeasure review found that we needed to do more to promote regulatory innovation and invest more in regulatory science and provide private sector partners with more access to regulators and greater clarity about the pathways to product approval.
In March of 2011, the U.S. Food and Drug Administration sought input from the Institute of Medicine, which in turn convened a workshop to gather input, recommendations, and ideas to help inform the medical countermeasure regulatory science program.
The FDA launched the first two “Public Health and Security Action Teams” for medications and diagnostic tests for acute radiation syndrome. These action teams are helping to identify and resolve challenges that companies face in getting medical countermeasures licensed. These teams work with industry and federal partners throughout the regulatory process as these products move through advanced development toward FDA approval. The outcome will be that less time is needed to develop and approve new medical countermeasures so more of these critical products are available faster to protect the nation. FDA plans to establish more action teams in the coming months.
A lot of scientific knowledge is needed to approve or license a medical product for use in the United States, and FDA has a special group of scientists who focus on products that would be used in disasters. To make sure these scientists are focused first on the products that matter most to our nation’s security, FDA asked federal partners to form a steering committee and do a peer review of FDA’s regulatory program.
To improve even more, FDA is collaborating with the Dept. of Defense to leverage each agency’s scientific expertise in the process of approving products. By bringing in scientific knowledge from federal expertise in addition to FDA, the agency will have the information needed to approve products faster.