Monday, October 22, 2012

Reuters: Regulatory News: Pharmacy tied to meningitis deaths sidestepped punishment in 2006

Reuters: Regulatory News
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Pharmacy tied to meningitis deaths sidestepped punishment in 2006
Oct 23rd 2012, 01:14

BOSTON | Mon Oct 22, 2012 9:14pm EDT

BOSTON Oct 22 (Reuters) - The pharmacy tied to a deadly U.S. meningitis outbreak fended off discipline from health regulators in 2006 that could have fatally damaged the company's reputation and put it out of business, records released on Monday revealed.

The Massachusetts-based New England Compounding Center faced three years' probation and a public reprimand amid allegations that the pharmacy violated accepted standards for compounding methylprednisolone acetate, the same steroid that is linked to the current fungal meningitis outbreak. Twenty-three people have died and nearly 300 have been infected after receiving the steroid treatment made by NECC.

The proposed discipline, outlined in a 2004 letter from the Massachusetts Board of Pharmacy, is detailed in documents obtained by Reuters.

NECC's defense attorney Paul Cirel recognized the impact of a public reprimand and pleaded with regulators at the time not to resolve the complaint with a disciplinary sanction, records show.

"The collateral consequences to many, if not all of NECC's 42 other licenses, would be potentially fatal to the business," Cirel said in a Nov. 11, 2004, letter to the pharmacy board. "Such a catastrophe is clearly not the intended result of the proposed reprimand, nor is it warranted in this case."

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