Fungal meningitis--why we need government reg enforced

As MTs you are no doubt aware that at least 344 people in 18 states have been infected by fungal meningitis and 25 have died so far.  I wonder if these families are concerned that drug safety regulations and enforcement are bad for business? 

This contaminated steroid is linked back to a compancy, NECC, in Massachusetts. The Massachusetts Department of Health released documents dating back more than a decade that revealed a series of regulatory citations involving NECC.

In all, Massachusetts state records revealed that between 2003 and 2006, there were six complaints regarding NECC and its co-owner, Barry Cadden. At least one of these complaints alleged that NECC’s methylprednisolone acetate failed to comply with pharmaceutical standards. This is the same drug involved in the current epidemic.

In October 2004, the Massachusetts Board of Registration in Pharmacy, a state regulatory agency reporting to Gov. Romney, offered to let NECC enter into a consent agreement that would have acknowledged professional misconduct by NECC warranting disciplinary action, a public reprimand and three years probation.

But in a letter dated Nov. 11, 2004, Paul Cirel, an attorney for NECC, argued that such disciplinary action would be “potentially fatal” to NECC’s business. In a footnote, he asserted, “Once disclosed, the reprimand will surely result in investigations/inquiries/investigations in those other jurisdictions. Regardless of the derivative actions taken, the attendant legal and administrative costs will be devastating.”

The letter added that instead of having the state monitor the company, NECC would be willing to “bear the burden of cost and monitoring and reporting compliance” in exchange for a non-disciplinary resolution.

The Board of Registration subsequently dropped the reprimand. Meanwhile, in 2005, NECC was the subject of another complaint. Nevertheless, the Board of Registration went forward with a Consent Agreement that was, according to Oliver, “even more advantageous to the company than was requested by NECC.”

The term of the “probation” would be one year, not three, and it was to be a non-disciplinary agreement that would not be reported to the National Association of State Boards of Pharmacy or other outside agencies.

Subsequently, in 2006, NECC was effectively permitted to monitor itself simply by assuring the board it was in compliance with all procedures. In a May 22, 2006, letter obtained by Salon, NECC co-owner Barry Cadden wrote the board a short letter saying, “I am pleased to report that the following actions have been completed” regarding several safety precautions.

“Romney was responsible for these agencies,” said Oliver, who is the lead attorney attempting to consolidate the meningitis cases. “They reported to him.” . . .

WCVB-TV in Boston has reported that NEC president Greg Coniglario hosted a fundraiser for Sen. Scott Brown, bringing in $37,000 for the Brown campaign against Elizabeth Warren. Conigliaro and members of his family have reportedly given $10,000 of their own money to Brown.

In July, Brown was one of 10 senators to sign a letter to the Drug Enforcement Agency  arguing that regulations on the compounding industry should be loosened.

Conigliaro also contributed $2,500 to the Romney for president campaign.

Information from Salon.com and MDOH report.