At least 16 specialty pharmacies that mix their own medicines were warned by U.S. regulators for major violations since 2003, some similar to those found at the compounding pharmacy linked to this year’s deadly meningitis outbreak, a government watchdog group found.
The U.S. Food and Drug Administration cited the pharmacies operating in 15 states for making drugs on a large scale instead of responding to individual prescriptions, copying commercially available drugs and making drugs out of ingredients that aren’t agency approved, according to Public Citizen, a Washington-based consumer group. Compounding pharmacies are supposed to produce prescriptions in response to specific doctor’s orders to fulfill requests for tailored drugs such as those without preservatives or in different doses.
The FDA doesn’t appear to have followed up its warnings to the facilities issued as far back as 2003, the group said, citing agency documents. Public Citizen urged the agency to reinspect the pharmacies, many of which are still in business.
“On a smaller scale, patients have been harmed or killed from compounding pharmacies,” Michael Carome, deputy director of the Health Research Group at Public Citizen, said in a telephone interview. “They have done a number of inspections and consistently noted violations. Why haven’t they consistently followed up when they’ve noted serious problems?”
In 2006, the FDA warned New England Compounding Center about large-scale production and inadequate safety measures. The agency failed to reinspect the company, The pharmacy made tainted steroid injections linked to an outbreak of fungal meningitis blamed for 510 infections and 36 deaths this year.
A death tied to contaminated sugar water injections and another associated with an overdose of a topical anesthetic gel that wasn’t labeled properly and at least 70 reports of adverse events related to incorrect amounts of preservatives added to a steroid shot were noted in a sampling of the FDA’s warning letters to the other pharmacies, Public Citizen said.
Excluding the latest incidents stemming from the New England Compounding Center, FDA records documented 23 deaths and 86 serious injuries since 2001 associated with compounding pharmacies, according to an Oct. 29 report from U.S. Representative Edward Markey, a Democrat from Massachusetts. The deaths ranged from more meningitis illnesses to overdoses of numbing cream for laser hair removal that was made much more potent than was allowed.
Pharmacies are largely regulated by the states. The FDA plans to have a meeting Dec. 19 with state officials to determine how to better oversee compounding companies.
Federal officials asked for additional authority over compounding pharmacies earlier this month during congressional hearings. Lawmakers were skeptical that the agency has used to the fullest extent its current power over pharmacies that act like drug manufacturers.
“The FDA’s warning letters show that the agency doesn’t need any additional actions by Congress to enforce the Food, Drug, and Cosmetics Act against pharmacies that engage in illegal drug manufacturing,” Carome said in a statement. “By not fully investigating what could potentially be deadly violations of the law, the FDA is disregarding its primary purpose, which is to protect the lives of citizens.”
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