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U.S. Department of Health and Human Services

Science & Research

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A Collaborative Implementation Framework

Table of Contents: Advancing Regulatory Science for Public Health

FDA has outlined a four-part strategic framework to lead the nationwide effort to advance regulatory science within the agency and around the nation — and deliver the benefits to the public.

  • Leadership, coordination, strategic planning, and transparency to support science and innovation
  • Support for mission-critical applied research, both at FDA and collaboratively
  • Support for scientific excellence, professional development, and a learning organization
  • Recruitment and retention of outstanding scientists

Each part of the plan includes activities that will strengthen FDA’s scientific capacity and promote collaboration with partners in government, industry and academia. Ultimately, this plan should result in organized and tangible efforts to bolster the field of regulatory science globally and promote new and — above all — creative approaches to product development and safety for both food and medical products.

I. Leadership, coordination, strategic planning, and transparency to support science and innovation

The Office of the Chief Scientist will coordinate internal and external outreach to identify critical regulatory science and innovation needs and develop a strategic plan for science at FDA. Within the chief scientist’s office, the Office of Science and Innovation will develop the strategic plan, track the outcomes of our investments, organize cross-center scientific collaborations, and monitor outside partnerships.

Key input will be provided by:

The Science and Innovation Strategic Advisory Council. Internally, FDA has formed a high-level advisory board comprising the Chief Scientist and key senior leadership from the Office of the Commissioner, the centers, and ORA. This board will meet at least twice yearly to identify and communicate key scientific priorities from each center, to help set and discuss major cross-cutting scientific priorities for the agency, and to propose and evaluate major programs and partnerships. This input will help drive the strategic science plan.

The FDA Science Board. The FDA Science Board is already in place to provide advice to the Commissioner, the Chief Scientist and the centers on FDA’s scientific programs and on complex scientific and technical issues within the agency, industry, and academia. The Science Board will be asked to periodically review and inform the scientific strategic plan and regulatory science priorities proposed by the Science and Innovation Strategic Advisory Council and the Chief Scientist.

II. Support for mission-critical applied research, both at FDA and collaboratively

Support within the FDA is critical to expanding the field of regulatory science. An active research program, directly connected to the FDA review process, will not only bring needed advances in regulatory science straight to FDA review, product development, and evaluation but will also add value to guidance and policy development.

In addition, the discipline of regulatory science must be developed though support from both partnerships and external research and collaboration. There are substantial opportunities to enhance and expand current FDA programs and to develop new ones that support effective, more robust, external and collaborative efforts to advance regulatory science. Some projects are already under way:

  • A Joint Leadership Council recently created by FDA and NIH to promote the expansion of regulatory science through enhanced scientific collaboration and jointly supported and administered extramural research grants in regulatory science.
  • Creation and support of academic Centers of Excellence in Regulatory Science to carry out applied regulatory science research both independently and in collaboration with the FDA and as a locus for scientific exchange and training opportunities for both FDA and academic scientists
  • Enhanced strategic collaboration and coordination with other governmental agencies  to develop new programs to advance regulatory science and innovation
  • Enhanced support and focus for the Critical Path Initiative to catalyze and enable partnerships and consortia that advance regulatory science and public health through innovation and modernization of the medical product development and evaluation process
  • Partnership with the Reagan-Udall Foundation on projects in support of regulatory science

III. Scientific excellence, professional development, and a learning organization

FDA will support a culture of and capacity for continuous scientific learning and professional development of our scientific staff. The agency will explore several approaches:

  • Access to cutting-edge, continuing education and professional development for FDA staff — through universities and government agencies, for example — as well as policies and resources that support these activities
  • Scientific exchange programs with academic and governmental institutions and with international regulatory counterparts

IV. Recruitment and retention of outstanding scientists

FDA will seek to recruit and retain an outstanding scientific workforce that is engaged from its laboratories to its review teams, and that is up to date with new and emerging technologies. The Commissioner’s Fellowship program has begun to attract, train, and recruit promising young scientists in key areas of science, innovation, and review and has enriched the FDA environment. FDA will consider other approaches:

  • A program to help recruit and support promising newly independent scientists expert in emerging technologies to be researcher-reviewers throughout the FDA
  • Proposed merit awards, which will be competitively awarded to support the most accomplished and productive FDA scientists to continue their work at FDA
  • Proposed FDA Expert Physician Program to support joint part-time, academic faculty/FDA positions to benefit from expertise in cutting-edge patient care and from improved perspectives in regulatory review, particularly for areas of emerging technologies. Participants, thoroughly screened for conflicts of interest, would spend time working with full-time FDA staff in review and policy activities.

Support for these four approaches will develop and advance the field of regulatory science to help provide the tools and the knowledge required to realize the promise of innovation. These efforts will help us bridge the gap from basic science discoveries to safe, effective products that help patients, protect health and security, enhance the safety of our medicines and foods, and support innovative, effective medicine and public health.