BOSTON (AP) — Massachusetts regulators in 2004 proposed a formal reprimand for a company now linked to deadly meningitis outbreak, but they never delivered it after the company protested the reprimand could be "fatal to the business."
The sanction by the Board of Registration in Pharmacy was included in a proposed consent agreement that was meant to resolve complaints against the New England Compounding Center in Framingham. The complaints included a failure to meet accepted standards for making the same steroid that's been connected to the outbreak.
The agreement was among documents released this week by the state Department of Health that provide more details about past incidents at NECC, which was shut down in the wake of the fungal meningitis outbreak that has reached 17 states, sickening 317 people, 24 of whom have died. The outbreak has been linked to a steroid made by the NECC and taken mainly for back pain. Compounding pharmacies like NECC custom mix solutions in doses or forms generally not commercially available.
The state has now moved to revoke NECC's license, but the reprimand represents a missed opportunity to crack down on the lab years before the current outbreak.
The proposed consent agreement, sent to owner Barry Cadden for review in October 2004, included the reprimand and a three-year probationary period for the company's registration and Cadden's license.
In its response, the company's attorney wrote that the board's dealings with the company were "a success story" and a reprimand was unwarranted.
"The collateral consequences to many, if not all of NECC's 42 other licenses (to operate in other states), would be potentially fatal to the business," attorney Paul Cirel wrote.
"Such a catastrophe is clearly not the intended result of the Board's proposed reprimand, nor is it warranted in this case," Cirel wrote. "The Board's mandate is to protect the public health safety and welfare, not punish the licensees."
In a footnote, he wrote, "Once disclosed, 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."
The case ended without disciplinary action as part of a different consent agreement reached with the board in 2006.
Cirel did not respond to requests for comment from The Associated Press.
Alec Loftus, a spokesman for the state's office of health and human services, said the state has expanded its investigation to include how the 2006 consent agreement was reached, including why the board never issued the reprimand and whether that was related to the protest from the company.
The agreement was signed under then-Gov. Mitt Romney's administration, but some members from that time remain on the pharmacy board.
"All options are on the table, and no actions have been ruled out," Loftus said. "We won't be satisfied until all of those responsible for these troubling events are held accountable."
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