FDA Mission Still "at Risk" Says Science Board

With both House and Senate in recess this week, no progress was made on the debt ceiling, appropriations, or the House leadership battle ... or much of anything else. The political and policy vacuum provides me with an excuse to go back a couple of weeks to highlight a story that did not receive the attention it deserved.In mid-September, the FDA Science Board -- a distinguished group of advisors to the Commissioner -- issued a report: Mission Possible: How FDA Can Move at the Speed of Science. The new report notes that FDA has made significant progress in the last 8 years, but FDA’s mission continues to be “at risk.” This is “due to an expanding and extraordinary range of increasingly complex responsibilities and insufficient resources with which to address them.

”There is history behind this report and its findings. The FDA Science Board, which goes back at least as far as the 1990s, 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 provides advice that supports the Agency in keeping pace with technical and scientific developments, including in regulatory science, the Agency's research agenda and upgrading its scientific and research facilities and training opportunities.

In November 2007, the FDA Science Board issued a milestone report, FDA Science and Mission at Risk. The result of more than a year of meetings with both leaders and staff at the agency and outside experts, the primary theme was that the shortfall of resources at FDA had become so acute that the agency was at risk of failing to accomplish its mission and putting the American people “at risk.” Because of recalls and other very public problems affecting the FDA and its regulated community, the report struck a chord among lawmakers and contributed to three straight years of large increases for the agency.

The new report acknowledges that the FDA is not in the dire straits it was in 2007. However, the Science Board points to the additional challenges since the prior report: substantial new responsibilities in every area of FDA jurisdiction; massive expansion of globalization; and dramatic breakthroughs increasing scientific complexity. These run the gamut within the agency: food, drugs, biologics, devices, etc.About the report, Alliance President Jeff Allen of the Friends of Cancer Research has said:

The new Science Board report provides a clear-eyed assessment of what needs to be done for FDA to keep pace with rapidly advancing science and remain the cutting-edge public health agency that our nation needs. As such, the report is warmly welcomed by the FDA stakeholder community. This is a must read for all of us concerned about the agency’s resource needs to execute future priorities and build the scientific capacity of the FDA.

Accordingly, the Alliance has urged Congress, OMB, and HHS, as well as Alliance members, to review this latest report. It tells a compelling story of FDA’s agenda for self-improvement and the multiple areas in which it needs support for future progress.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.