FDA Science Looking Forward: Background and Initial Charge to the Subcommittee
It has been over five years since the release of "FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology." In that seminal report, the subcommittee (SC) of the Science Board noted: "The demands on the FDA have soared ... and the resources have not increased in proportion to the demands." The SC called for strategic leadership and support, including new resources; for strengthening science at FDA, with particular attention to emerging technologies; and for strengthening professional development.
The 2007 SC was a call to action and much has been done since that transformational report was issued. The Agency, which has a longstanding commitment to science as the foundation of its work, has renewed its strong stand on science, emphasizing the critical role of regulatory science, as well as science overall, at FDA. This message has reached stakeholders both internally and externally, and is bearing fruit. We have taken numerous steps to enhance science at FDA and to promote scientific collaborations within the Agency and with diverse external partners. We believe that our efforts have resulted in a renewed focus on the critical role of regulatory science across the scientific enterprise and for stakeholders, importantly including patients.
Sustaining and advancing these efforts for the rapidly changing future, despite facing constrained resources, is critical. In addition, since the 2007 report, FDA has been given important new mandates and responsibilities including under major legislative measures such as the FDA Amendments Act (FDAAA) of 2007, The Family Smoking Prevention and Tobacco Control Act of 2009, the Food Safety Modernization Act (FSMA) of 2011, and the FDA Safety and Innovation Act (FDASIA) of 2012. These new laws create major demands on FDA, but also present new needs and opportunities for regulatory science that are critical to their success.
FDA is now asking the Science Board to form a new SC and to help us examine three major domains of regulatory science activities, assessing progress made since the 2007 report and recognizing the ever-expanding set of roles and responsibilities of this agency and the challenges presented by rapidly evolving science and technology, including the scientific implications of the increasing globalization of product development and supply chains.
The overarching issues for the new SC on "FDA Science Looking Forward" are provided in this draft charge. FDA will next provide the SC with its Progress Report including specific questions for input. Given limited staff time and resources available to support and fund intramural, extramural and collaborative research, we specifically ask the SC to provide recommendations that can be implemented with current resources. The SC is welcome to provide additional recommendations for steps the Agency could take if new, additional resources for regulatory science are made available.
Area I: Priorities, Activities, and Emerging Needs
In August 2011, FDA issued its Strategic Plan for Regulatory Science. FDA will seek the SC’s feedback on how well the Plan captures FDA’s cross-cutting scientific needs, whether modifications should be made to the Plan, and recommendations for what additional steps the Agency could take to best position itself to meet emerging and future trends in science, technology and FDA-regulated products.
Area II: Extramural Programs and Collaborations
FDA is currently engaged in extensive collaborations with numerous public and private sector entities. FDA will seek the SC’s input as to opportunities for collaboration, strategies/frameworks for collaboration, and recommendations for potential new collaborations that best advance the Agency’s mission.
Area III: Supporting an Environment of Scientific Excellence
FDA has taken several actions in recent years to foster an environment of scientific excellence. The Agency will seek the SC’s feedback on the actions it has already taken as well as its recommendations for additional steps it could take to further support a culture of scientific excellence and creativity.
The subcommittee’s review in these critical areas, including in response to specific issues and questions in the planned report, is viewed as providing important input to the Agency as it addresses its constantly evolving public health responsibilities and resulting scientific needs and opportunities.