FDA DRUG ENFORCEMENT SLOWDOWN DRAWS CONGRESSIONAL CRITICISM

Pharmacy Times, Volume 0, 0

Enforcement activity at the FDA hasdropped sharply over the past 5years. Congressional leaders arewarning that the agency'slackluster efforts to police thenation's drug supply representa "prescriptionfor harm" to theAmerican public.

In a blisteringreport released byHouse GovernmentReform Committee member Rep Henry Waxman (D, Calif), congressionalinvestigators charged that the number of seizures ofmislabeled, defective, and dangerous products has declined by44% since 2000, while the number of warning letters sent out todrug manufacturers and other FDA-regulated firms has plungedby >50% to a new 15-year low.

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

Outside experts contacted by the congressional investigatorsexpressed serious concerns about the refusal of FDAheadquarters to follow through on the enforcement problemsuncovered in the field. Michael Wilkes, MD, PhD, of theUniversity of California, Davis, School of Medicine said thatthe agency has "systematically ignored district field officersand regularly overridden their explicit and well-documentedconcerns 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 takenby FDA has declined precipitously."