Committee, Von Eschenbach Debate Effect of Funding Shortfalls on FDA

December 4, 2007

Without a significant and sustained increase in funding, the FDA cannot fulfill its mission to protect the public health, a subcommittee of the FDA’s Science Board says in a report detailing the agency’s shortcomings.

A lack of resources, weak scientific base and obsolete IT system are hindering the FDA, the Subcommittee on Science and Technology says in the report discussed at a Science Board meeting Dec. 3. Most of the problems are due to a dearth in funding, according to the report.

The Science Board agreed by voice vote to accept the subcommittee’s report and take steps to provide further review of high priority scientific programs and the scientific capacity and processes of the agency’s Office of Regulatory Affairs.

The subcommittee was cautioned against assessing the FDA’s financial resources but could not review the agency’s shortcomings without discussing resources, subcommittee Chairwoman Gail Cassell said.

FDA Commissioner Andrew von Eschenbach said the agency is undergoing enormous change and must continue to adapt to be successful. Two years ago, the agency was “stressed and stretched” but is now making progress, he added.

Much of the change comes from the FDA Amendments Act (FDAAA), which included more than 200 initiatives the agency can carry out, including the ability to require safety-related label changes and postmarketing studies or clinical trials.

The new authorities are not yet in place, and the FDA must determine which programs will require additional guidances or development of new regulations, FDA Deputy Commissioner Janet Woodcock said.

The FDA needs more employees to focus on postmarketing issues and also will need many new policies and procedures, particularly in clarifying the relationship between the Office of New Drugs and the Office of Surveillance and Epidemiology, Woodcock added.

The subcommittee’s report can be seen at www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf.