The Alliance for a Stronger FDA has issued a statement praising the newly released FDA Science Board Report titled, “Mission Possible: How FDA Can Move at the Speed of Science”, asserting that the report reinforces the need for additional resources. This report follows up on the 2007 report, “FDA Science and Mission at Risk,” which brought attention to several deficiencies within the agency. The new subcommittee was tasked with assessing the progress of FDA since 2007, and noted several positive changes at the report’s outset:

• The creation of the Office of the Chief Scientist and other offices to support regulatory science, health informatics, the professional development of scientists, scientific integrity, minority health and a group devoted specifically to countermeasures for acts of terrorism and emerging threats
• New authority from Congress and increased funding, from both appropriations and user fees, enabling FDA to improve its ability to tackle public health problems
• Initiatives that deal with new and emerging technologies, including stem cells, 3D printing, predictive toxicology, genome sequencing, and computer simulation
• The Precision Medicine Initiative, in collaboration with the National Institutes of Health (NIH)
• Advances in regulatory science that promote the lifecycle approach to regulation for drugs, devices and biologics
• Increased focus on active post-market surveillance, primarily related to the new Sentinel active surveillance system

Looking ahead, the report addresses several ongoing concerns including regulatory burdens and lack of funding noting, “Several resource deficits exist that the Subcommittee believes threaten FDA’s ability to advance in the future.”

Access the complete report here.

Last updated: September 29, 2015