June 27, 2006

A key House Democrat is blasting the FDA's enforcement policies, arguing that the agency is falling down on the job in its efforts to protect public safety.

Rep. Henry Waxman (D-Calif.), a frequent agency critic, released a report June 26 alleging that the FDA's enforcement has been on the decline since the start of the Bush administration. The report, "Prescription for Harm: The Decline in FDA Enforcement Activity," maintains the agency has slashed the number of enforcement actions it has taken since 2000. The study also argues that FDA headquarters officials routinely rejected enforcement recommendations from career staff.

Specifically, the 15-month study found that the number of warning letters issued by the agency for violations of federal requirements fell by more than 50 percent since 2000, from 1,154 that year to 535 in 2005. During that same period, seizures of medical products dropped by 44 percent. Waxman's report also found that in at least 138 cases over the past five years, FDA failed to take action despite receiving recommendations from its field inspectors.

The report is available at http://www.democrats.reform.house.gov/Documents/20060626113852-23476.pdf (http://www.democrats.reform.house.gov/Documents/20060626113852-23476.pdf).