NECC Argued Reprimand Would Be 'Fatal'

By Phil Williams
Chief Investigative Reporter

NASHVILLE, Tenn. -- New documents show the New England Compounding Center fought hard to keep a lid on information about an earlier problem it had with contaminated drugs.

Massachusetts authorities released more than 1,000 pages of documents late Monday from its files on New England Compounding Center (NECC) and a sister facility, Ameridose. NECC has been implicated in the nationwide outbreak of fungal meningitis.

Those documents confirm that there were serious problems there dating back a decade ago at the pharmacy, but the company's attorney convinced regulators not to issue a formal reprimand, arguing it would be "fatal" to the company and its licenses in other states.

"The collateral consequences to many, if not all of NECC's 42 other licenses, would be potentially fatal to the business," attorney Paul Cirel wrote Massachusett's pharmacy board on Nov. 11, 2004.

That followed complaints against New England Compounding about potentially tainted drugs in late 2002 and early 2003. One of them was the very same injectable steroid drug implicated in the latest meningitis outbreak.

Investigators recommended a formal reprimand.

But NECC's lawyer argued that would be bad for business.

"Once disclosed," he added, "the reprimand will surely result in inquiries/investigations in those other jurisdictions. Regardless of the derivative actions taken, the attendant legal and administrative costs will be devastating."

View selected NECC documents

Ultimately, the attorney convinced Massachusetts authorities to go along with a consent agreement where it essentially promised to clean up its act.

That agreement specifically stated that the problems would not be reported to any other state.

Also, among the documents is an independent review of NECC's facilities that was done in 2006. It found all sorts of problems -- including floors that had not been cleaned in three months.


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