Congress Critical of FDA Oversight

Oversight of compounding pharmacies falls far short of expectations. That’s the conclusion of reports from Congressional investigators and the Food and Drug Administration.
Compounding pharmacies are supposed to tailor customized medications to a particular patient’s needs based upon a prescription from the individual’s physician. But in recent years many compounding pharmacies have expanded their business reach to hospitals, clinics and doctors’ offices across the country.
States have been largely responsible for inspecting compounding pharmacies within their borders, but most states do not allocate adequate resources to do this task well. According to Representative Ed Markey of Massachussetts, “In states from coast to coast, compounding pharmacies are going untracked, unregulated, and under-inspected, exposing patients everywhere to tainted drugs, disease and death.”
The investigation was initiated after the epidemic of meningitis caused by contaminated injections prepared by the New England Compounding Center. Although the FDA maintains that it lacks authority to monitor such operations, a number of Congressmen believe that the agency was too slow to respond to signals of trouble. Representative Tim Murphy of Pennsylvania complained that “Ten years of warning signs, alarm bells, and flashing red lights were deliberately ignored.”