FDA Advisory Committees - FDA Office of the Commissioner (OC) - Science Board to the Food and Drug Administration (SBFDA)
The Board will hear an update on FDA's biotechnology activities related to plant-derived food and animals and will hear a report from the National Antibiotic Resistance Monitoring System Review Subcommittee.
The Board met to provide recommendations on the Agency’s work plan on the allocation of innovation funds. Section 1002 of the 21st Century Cures Act provides $495 million in funding to the FDA from fiscal year (FY) 2017 through FY 2025 for FDA Innovation Projects. The Act requires the FDA Commissioner to submit a work plan that describes the budget for planned activities and provides justification based on advancing public health. The plan must be submitted by June 11, 2017, which is within 180 days of the bill’s passage (December 13, 2016). The Act states that prior to submitting the work plan to Congress, the Commissioner must seek recommendations from the SBFDA and include these recommendations in the work plan.
The Board heard reports from the FDA and discussed topics including: 1. Strategic goals for regulatory science at the Center for Biologics Evaluation and Research (CBER); 2. Progress updates on FDA’s Opioid Action Plan and the Bovine Heparin Initiative; 3. Response from the Office of Scientific Professional Development to the Science Board’s report on the Commissioner’s Fellowship Program; 4. Report from the Scientific Engagement Subcommittee; and 5. Report from the Food Emergency Response Network Cooperative Agreement Program Evaluation Subcommittee.
The Science Board heard about and discussed: (1) The role of opioids in pain management; (2) scientific challenges facing FDA in supporting the development of pain medications, including opioids, that have reduced risks of being abused; (3) scientific challenges facing FDA in seeking to understand the real-world use of opioids to treat pain, including the impact of opioids with potentially less risk for abuse;(4) the role that FDA plays as a part of a larger Federal, State, and local response to the challenges of providing appropriate pain treatment while reducing opioid abuse; and (5) postmarket surveillance activities related to opioids. The Science Board will also receive a final report from the Centers of Excellence in Regulatory Science and Innovation Program Evaluation Subcommittee.
The Board heard updates from the CERSI (Centers of Excellence in Regulatory Science and Innovation) Evaluation Subcommittee and the ORA FERN (Food Emergency Response Network) Evaluation Subcommittee. The Board also heard about the scope of FDA’s involvement in precision medicine, including overviews of specific FDA health informatics initiatives, including precisionFDA, OpenFDA, and Chillax. The Board also heard about FDA’s laboratory safety initiative, and a recipient of one of the FY2014 Scientific Achievement Awards (selected by the Board) presented an overview of the activities for which the award was given.
The Committee heard a report on the work that the Science Looking Forward Subcommittee has done, entitled, “Mission Possible: How FDA Can Move at the Speed of Science.” A progress report on this work was given in the previous SBFDA meeting on July 29, 2015.
The Board was provided with reports from the Commissioner’s Fellowship Program Evaluation Subcommittee and from the Science Looking Forward Subcommittee. The Board heard from the Center for Veterinary Medicine about the Veterinary Laboratory Investigation and Response Network and about the National Strategy for Combating Antibiotic-Resistant Bacteria. A recipient of one of the Fiscal Year 2014 Scientific Achievement Awards (selected by the Board) discussed the regulatory review of next generation sequencing data. A status update on the 21st Century Cures Act was presented, and the Deputy Commissioner for Medical Products and Tobacco discussed his vision for the Office of Medical Products and Tobacco.
The Science Board met to discuss ten topics:
1) An update on Science at the FDA
2) Bovine Heparin
3) The Public Access Policy
4) Scientific Achievement Award Recipient Presentation
5) Science-Related Activities at the Center for Tobacco Products
6) The Commissioner's Fellowship Program Evaluation Subcommittee
7) Commissioner’s Report
8) Open Public Hearing
9) The Science Moving Forward Subcommittee
10) Regulatory Science Training Coordination (RSTC)
Science Board to the Food and Drug Administration (SBFDA)
The Science Board provides advice to the Commissioner and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board will provide advice that supports the Agency in keeping pace with technical and scientific developments, including in regulatory science; and input into the Agency’s research agenda; and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs.