Published Online: Tuesday, August 1, 2006

Enforcement activity at the FDA has dropped sharply over the past 5 years. Congressional leaders are warning that the agency's lackluster efforts to police the nation's drug supply represent a "prescription for harm" to the American public.

In a blistering report released by House Government Reform Committee member Rep Henry Waxman (D, Calif), congressional investigators charged that the number of seizures of mislabeled, defective, and dangerous products has declined by 44% since 2000, while the number of warning letters sent out to drug manufacturers and other FDA-regulated firms has plunged by >50% to a new 15-year low.

Worse yet, Waxman charged that "FDA headquarters officials have routinely rejected the enforcement recommendations of career field staff" and failed to take the recommended enforcement actions "in at least 138 cases over the last 5 years involving drugs and biological" products.

Outside experts contacted by the congressional investigators expressed serious concerns about the refusal of FDA headquarters to follow through on the enforcement problems uncovered in the field. Michael Wilkes, MD, PhD, of the University of California, Davis, School of Medicine said that the agency has "systematically ignored district field officers and regularly overridden their explicit and well-documented concerns about drug safety and public health."

Waxman's investigators said their findings reveal that "FDA's enforcement efforts have been significantly compromised," and that "the number of enforcement actions taken by FDA has declined precipitously."

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