Prepared for the FDA Science Board
United States. Food and Drug Administration -- Research -- Management, Science and state, Food supply -- United States -- Safety measures, Medical innovations, Public-private sector cooperation
In 2013, the Commissioner of Food and Drugs charged the Food and Drug Administration’s (FDA’s) Science Board, an advisory committee of national experts across various scientific disciplines, to make recommendations on areas deemed critical to the Agency’s ability to carry out its scientific mission. The Science Looking Forward Subcommittee was created to evaluate these three principal areas:
- How FDA can meet emerging and future trends in science and technology
- How FDA can better use collaborations to advance its mission and
- How FDA can support a culture of scientific excellence and creativity.
The Subcommittee was also asked to assess progress since the Science Board’s 2007 FDA Science and Mission at Risk report (“Mission at Risk”), which made recommendations to address serious impediments at that time. Some of the most significant conclusions from the 2007 report were:
- FDA could not fulfill its mission, due to a weak scientific base and inadequate scientific workforce
- A disparity between FDA’s responsibilities and resources seriously threatened the Agency’s ability to perform its mission
- FDA did not have the capacity to ensure the safety of the nation’s food supply and
- FDA’s ability to ensure the rapid entry onto the market of life-saving new medical therapies – especially those resulting from new and emerging technologies – was highly doubtful.
The 2007 report and its conclusions were broadly considered at the time by the scientific and medical communities to be an important assessment of FDA’s capabilities and a valuable roadmap for FDA-wide improvements – and were also well received by Congress and the public at large.
The responsiveness of FDA to the Mission at Risk report and those responsible for overseeing its work has been extensive, transformative, and laudable. Many substantive changes have been made in FDA’s organization, authorities, and programs that significantly address issues identified in 2007.
Anderson, M., Cassell, G., Freire, M., Goldman, L., Honig, P., Kushner, F., McLellan, M., McNeil, B., Philbert, M., Psaty, B., Russell, A., & Sigal, E. (2015) Mission Possible: How FDA Can Move at the Speed of Science. Science Looking Forward Subcommittee for FDA Science Board