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FDA Fails In Oversight Of Company Causing Meningitis Outbreak And Deaths
CAPT Mutahar Shamsi who is responsible at the FDA for oversight of the NECC. He has failed to properly supervise these companies and take action to protect workers and the public.
FDA Fails In Oversight Of Company Causing Meningitis Outbreak And Deaths-FDA Officer Responsible Has Drug Industry Connections Through Wife
October 23, 2012
The FDA failed to provide proper oversight of New England Compounding Center (NECC), a manufacturing pharmacy, causing a series of deaths and illnesses throughout the country this month. NECC compounded and released a fungal-contaminated injectable intraspinal drug with no proper inspectional oversight. The pharmacy was compounding large batches for future sale and shipping the products in interstate commerce.
, the District Director for the New England District Office of FDA Office of Regulatory Affairs, was responsible for federal oversight of NECC. During an October 4th press conference, Shamsi did not address why his agency failed to perform appropriate prior inspections or take earlier action on NECC since documented problems with the company dated back to 1999.
Even with limited jurisdiction, the FDA has authority to perform inspections or take regulatory action against a drug manufacturer/compounding pharmacy with prior complaints. Yet, there has been no FDA documents released to suggest that Boston FDA performed an inspection of NECC upon prior complaints. Nor did FDA inspect to determine if the firm was exempt from FDA jurisdiction as a true compounding pharmacy or falls under FDA’s law as a drug manufacturer.
Shamsi who acts as a business liaison for the FDA, as well as, the FDA Regulatory Director for the Boston district has both professional and personal ties to industry. His spouse works for a private biotech corporation in regulatory affairs to which his office provides regulatory oversight.
The FDA’s lack to manage prioritization of inspectional oversight of a compounding pharmacy/drug manufacturer with documented prior complaints is worrisome, especially, since it led to numerous tragic deaths and illnesses in the U.S.
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