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FDA Wanted To Close New England Compounding Pharmacy in 2003

| Nov 13, 2012 | Firm News

According to a report of the House Committee on Energy and Commerce, released on the eve of their November 14, 2012 hearings,  “Documents produced to the Committee by the FDA and the Massachusetts Board show that NECC has a long history of very similar, if not identical, underlying misconduct. Some of the violations observed by regulators as early as 2002 include the company’s failure to maintain adequate safeguards for sterile injectable products – the very issue at the center of the current meningitis outbreak.”

FDA officials in 2003 suggested that the compounding pharmacy be “prohibited from manufacturing” until it improved its operations.  But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections.

In October of 2002, the FDA received new reports that two patients at a Rochester, N.Y., hospital came down with symptoms of bacterial meningitis after receiving a different NECC injection.  The steroid, methylprednisolone acetate, is the same injectable linked to the current outbreak and is typically is used to treat back pain.

At a February 2003 meeting between state and federal officials, FDA staff emphasized “the potential for serious public consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved.”

According to the Center For Disease control, the death toll has risen to 32 and more than 440 people have been sickened by injections from contaminated steroids.

Click here to read the entire article: Report: FDA Wanted to Close Mass. Pharmacy in 2003

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