IACP: FDA Authority Is Clear, Direct, And Certain
WASHINGTON, Nov. 20, 2012 /PRNewswire-USNewswire/ -- The International Academy of Compounding Pharmacists (IACP) today asked U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to explain why the agency did not take specific actions to address complaints it had received about the New England Compounding Center, the company that according to federal officials is responsible for 33 deaths and the illness of over 400 more in the current outbreak of meningitis.
In a letter to Hamburg, IACP Executive Vice President and CEO David Miller, R.Ph. identified the specific federal laws and regulations that authorize that federal agency to shut down illegal drug manufacturers like the New England Compounding Center (NECC).
While acknowledging that changes may be needed in some areas to address federal and state oversight of the compounding profession, IACP said it is necessary first to determine why the existing authority of the FDA was not exercised before the health of scores of Americans was placed 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 said in his letter to the FDA. Last week Miller testified before the United States Senate Committee on Health, Education, Labor, and Pensions at its Thursday hearing on the meningitis outbreak. Congressional investigators have requested documents from the FDA that would shed light on why the New England Compounding Center 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 U.S. House and Senate members that the internal history regarding NECC is important before changes in the law are contemplated.
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