Advisory Board Subcommittee To Look At FDA Regulatory Science Needs
This article was originally published in The Tan Sheet
Executive Summary
FDA's Science Board will create a subcommittee to provide guidance on regulatory science needs in a “rapidly changing future,” according to FDA Chief Scientist Jesse Goodman.
FDA’s Science Board will create a subcommittee to provide input on opportunities for strengthening regulatory science, including setting priorities for the agency’s resources in the area.
The subcommittee is expected to consider three areas: priorities and emerging needs in FDA's strategic plan for regulatory science; regulatory science collaboration; and scientific excellence. The topics stem from recommendations made in the board’s 2007 report, "FDA Science and Mission at Risk" (Also see "Advisors Say FDA Funding Fails Science, Senators Pan Food Safety Plan" - Pink Sheet, 17 Dec, 2007.).
FDA Chief Scientist Jesse Goodman said now, five years since the report came out, is a good time to take stock of progress made in response to the report's blunt conclusion that FDA was scientifically unprepared to meet its responsibilities. But the main charge for the subcommittee, he said, will be to provide guidance on a “rapidly changing future” and “new leveraging opportunities.”
“Really I see this more as a look forward than a look back,” Goodman said at the Science Board’s Oct. 3 meeting in Silver Spring, Md.
“We need to think about how we redirect our efforts and resources going forward.”
While FDA did not ask the Science Board to vote and formally create the subcommittee, members stated they would follow the agency’s suggestion and several volunteered to serve on the panel.
“We had remarkable enthusiasm for joining the committee, so we’ll just make that official,” said member Russ Altman, professor and chair of bioengineering at Stanford University.
Board member Alan J. Russell, a regenerative medicine expert at Carnegie Mellon University, suggested FDA invite the medical school deans to reach a consensus on the curriculum for their schools’ graduate and doctorate programs to better train the future regulatory science workforce.
Regulatory Science Progress
Calling the 2007 report "transformational," Goodman said FDA took the recommendations to heart and has done much to strengthen the agency's scientific capacities.
Most of the changes have occurred by “strategically focusing existing resources to define and support regulatory science as an agency priority," he said during his presentation. A new Office of the Chief Scientist was created, and FDA developed its first strategic plan for regulatory science. Meanwhile, internal and external collaborations to address emerging science and technology have been enhanced, Goodman said (Also see "FDA’s Regulatory Science Next Steps Include Food Safety Enforcement" - Pink Sheet, 29 Aug, 2011.).
“We need to think about how we redirect our efforts and resources going forward.”
– FDA Chief Scientist Jesse Goodman
In addition, FDA in 2009 sought and received its first appropriation specifically intended to support regulatory science.
FDA proposes to seek input on three major areas of regulatory science relevant to the 2007 report. For each area, the agency will provide the new subcommittee with a progress report and a set of specific questions and issues for input, Goodman explained, underscoring that ideas for the subcommittee's charge are still in the proposal stage and could be tweaked.
Goodman said FDA between March and July next year plans to provide a report to the subcommittee on its major activities in support of the Strategic Plan for Regulatory Science. It then will request input on the strategic framework and priorities, including progress and gaps in addressing emerging technologies since 2007; needs and opportunities in considering emerging science with a 10-20 year future horizon; and how best to capture these needs in strategic planning and scientific activities to ensure the agency is prepared going forward.
Between August and November, the subcommittee will be asked to provide feedback on FDA’s collaborative activities by suggesting opportunities and approaches, both within the agency and externally.
Additionally, between November 2013 and February 2014 FDA will seek input from the subcommittee on how to prepare the agency’s workforce for emerging scientific challenges and collaboration, and how to support efforts to train, recruit and retain a talented scientific workforce.
"We want to assure continued attention to the challenges and opportunities in regulatory science, and to the importance of science at FDA in protecting and promoting the health of our nation," Goodman said.