A subcommittee of the FDA's Science Board says the FDA is grossly overworked and understaffed, and the imbalance poses a “significant risk to the integrity of the food, drug, cosmetic, and device regulatory system, and hence the safety of the public.” The committee's report, the result of a year-long review by a panel of experts, also concludes that “science at the FDA is in a precarious position. The agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.”

The group cites two reasons for their concern: First, the demands on the FDA have soared because of extraordinary advances in scientific discoveries, the complexity of the new products and the claims submitted to the FDA for pre-market review and approval, the emergence of challenging safety problems, and the globalization of the industries that FDA regulates. Second, “resources have not increased in proportion to demands. The result is that scientific demands on the agency far exceed its capacity to respond. 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 report also criticizes the FDA's IT systems, calling it “problematic at best — and at worst it is dangerous.” Many systems reside on technology that has been in service beyond their usual life cycle. Systems fail frequently, and even e-mail systems are unstable. More importantly, the group notes that reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still hand written and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with Customs and other government systems (and often miss significant product arrivals because the system cannot even distinguish, for example, between road salt and table salt). Inadequate emergency backup systems and recent system failures have resulted in the loss of FDA data. Critical data reside in large warehouses sequestered in piles and piles of paper documents. There is no backup of these records, which include valuable clinical trial data. The FDA has inadequate extramural funding programs and collaborations to accelerate the development of critical health information exchanges to support clinical trials and pharmacovigilance activities.”

The 300-page report is the result of a year-long review by a distinguished panel of experts and is available online at www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html.