Before meningitis outbreak, firm avoided sanctions

From the article:

Problems at the New England Compounding Center (NECC) in Framingham, Massachusetts, date as far back as 1999, the year after it began operations, according to hundreds of pages of documents obtained under a Freedom of Information Act request.

And the documents show regulators refraining from the harshest sanctions available to them, even as the list of complaints against NECC continued to grow.

an outside evaluation firm found inadequate documentation and inadequate process controls involving sterilization at NECC in 2006, the documents show.

…MA BOP agreed not to report the agreement to the National Association of State Boards of Pharmacy or other outside agencies. NECC’s lawyer had pleaded with the board not to issue a public reprimand because it could put the company out of business.

Problems came to light within one year of starting the business… does this suggest that this business was started without the proper training, proper knowledge, proper equipment or something was lacking that would have protected the patients that would be getting the products they compounded?

The MA BOP basically decided to “bury” this information in their archives… so much for transparency… so much for protecting the public’s health & safety.

I guess the current 300 who have fungus based meningitis and the 23 that died from the same contaminated product… are just collateral damage of the “good intentions” of the MA BOP years ago.

Does anyone believe that these MA BOP members should -or will – be held accountable? There were BOP’s in 46 other states – where this firm had mail order licenses – that were putting their trust in the MA BOP doing its job… IMO these BOP members in MA… did not only ignore the health and safety of the citizen of MA… but the citizens in 46 other states…. since three states don’t require mail order licenses… they could have been putting the health & safety of the entire population of the US.. potentially all 300+ million.

Filed under: General Problems