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.
Miller further asked the FDA to provide a description of its standard operating procedure for cases – like that involving NECC – where a company is identified as being a manufacturer of drugs, and a possible violator, even though it is 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," Mr. Miller said in his letter.
Although NECC portrayed itself as a compounding pharmacy, it in fact operated as a drug manufacturer. Though it was not formally registered as a manufacturer with the FDA, the company was clearly subject to oversight by the FDA, Miller said in his letter today to Hamburg, elaborating on his testimony before Congress last week.
Miller's testimony was at odds with that of with that of Hamburg, who contended that the FDA's authority over companies like NECC is unclear. "IACP insists that we determine what went on with NECC, and why the FDA did not act under existing regulations," Miller said.
A copy of the letter to the FDA from the IACP was also sent to the President of the Massachusetts State Board of Pharmacy, which has jurisdiction over compounding pharmacies in the state and had been notified of complaints about NECC.
ABOUT THE INTERNATIONAL ACADEMY OF COMPOUNDING PHARMACISTS
The International Academy of Compounding Pharmacists (IACP), based in Missouri City, TX, is an international, professional association established in 1991 to protect, promote and advance the art and science of pharmacy compounding. For more information, please go to www.iacprx.org.
Contact: David Ball, Ball Consulting Group, LLC
On behalf of IACP
SOURCE International Academy of Compounding Pharmacists (IACP)