November 21st, 2012
WASHINGTON – The International Academy of Compounding Pharmacists (IACP) has asked Food and Drug Administration Commissioner Margaret Hamburg to explain why the agency didn't take specific actions to address complaints it had received about the New England Compounding Center (NECC), which federal officials say is responsible for the deadly meningitis outbreak.
In a letter sent Tuesday to Hamburg, IACP executive vice president and chief executive officer David Miller identified the federal laws and regulations that he said authorize the FDA to shut down operators NECC.
Though acknowledging that changes may be needed in some areas to address federal and state oversight of the compounding profession, IACP said it's first necessary to determine why the FDA's authority wasn't exercised before the health of Americans was put at risk.
"The federal Food, Drug and Cosmetic Act's existing inspection provision, Section 704, allows FDA clear, direct, and certain oversight when a pharmacy is not operating in conformity with governing state laws, or is operating akin to a drug manufacturer," Miller stated in his letter to the FDA. Last week, Miller testified before the Senate Committee on Health, Education, Labor, and Pensions at its Nov. 15 hearing on the meningitis outbreak, which is responsible for the deaths of more than 30 people and the illness of nearly 500.
According to IACP, congressional investigators have requested documents from the FDA that would shed light on why NECC was allowed to continue operating even after complaints about practices there were received by the Massachusetts State Board of Pharmacy and the FDA. The FDA has not yet produced those documents, and Miller said he agreed with House and Senate members that the internal history regarding NECC is key before changes in the law are contemplated.
Miller also asked the FDA to provide a description of its standard operating procedure for cases — like that involving NECC — in which a company is identified as being a manufacturer of drugs, and a possible violator, even though it's not registered as a manufacturer.
"The IACP and its members strongly urge the FDA to explain the delays and inaction in the tragic case of the NECC, to identify which staff members were involved, to provide a timeline surrounding complaints about NECC, and to specify why decisions were made to let the company continue operating," Miller said in his letter.
Although NECC portrayed itself as a compounding pharmacy, it in fact operated as a drug manufacturer, according to IACP. Though it wasn't formally registered as a manufacturer with the FDA, the company was clearly subject to oversight by the FDA, Miller said in his letter to Hamburg.
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