FDA Advisors Declare FDA Science and Mission at Risk

December 3, 2007 - The nation’s food supply is at risk, as are the regulatory systems that oversee the nation’s drug and medical 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 “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 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 report has been posted on the FDA Web at www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html.

For more information: www.strengthenfda.org, www.fdacoalition.org