PRESS RELEASE: FDA Advisors Declare 'FDA Science and Mission at Risk'

FDA Advisors Declare 'FDA Science and Mission at Risk'

Broad-ranging Report Concludes that Increased Resources Are An Essential First Step

WASHINGTON, Dec. 3 -- The nation's food supply is at risk, as are the regulatory systems that oversee the nation's drug and device supplies, according to a subcommittee of the FDA's Science Board in a report to be presented today. The subcommittee attributes the deficiencies to soaring demands on the FDA; and resources that have not increased in proportion to those demands. They conclude that "this imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public."

The result of a year-long review by a distinguished panel of experts, the Subcommittee's 300-page report concludes that the state of FDA's scientific and regulatory programs could not be separated from the lack of resources. It urged funds to support the agency's scientific base, hire a broadly-capable scientific workforce, and build a sophisticated, modern information technology infrastructure.

The FDA Science Board meets from 8 a.m. to 5:30 p.m. on December 03, 2007 at the Gaithersburg, MD Hilton. The Subcommittee is scheduled to present at 12:30 p.m., with discussion continuing until 4 p.m. Its report has been posted on the FDA website in advance of the meeting and is available at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html [1].

Comments on the report:

"Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of the FDA. As this new report makes clear: our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is definitely better."

--Mark McClellan, MD, former FDA commissioner and chairman of the new Reagan-Udall Institute.

"FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources. Congress is negotiating FDA's FY 2008 (current year) budget right now and can start to fix this critical problem."

--Don Kennedy, PhD, former FDA commissioner and editor-in-chief of Science.

"That FDA needs more resources should be obvious. What makes this report so extraordinary is the qualifications of the individuals who wrote it, the year-long process to put it together, and the depth of analysis that supports its conclusion: FDA's mission is at risk for lack of support for its scientific capabilities."

--Jane Henney, MD, former Commissioner of FDA and Senior Vice President and Provost for Health Affairs, University of Cincinnati.

About the FDA Alliance and the Coalition for a Stronger FDA

In response to the unmet resource needs of the FDA and the threat this poses to America's health, safety and commerce, two organizations were formed in 2006 to educate and advocate about the importance of FDA and the need for better funding. More about each group can be found on their websites: www.StrengthenFDA.org [2] (FDA Alliance) and www.FDACoalition.org [3] (Coalition for a Stronger FDA).