Framingham Pharmacy Reacts to State's Decision to Revoke License
"it is hard to imagine that the (Massachusetts) Board (Of Registry in Phramacy) has not been fully apprised of both the manner and scale of the company’s operations," said New England Compounding Center's counsel in a statement.
Gov. Deval Patrick, in a press conference Tuesday, announced New England Compounding Center has had its pharmacy license permanently revoked and will be the subject of a federal criminal investigation. He said the Framingham company will never practice again in Massachusetts.
The Framingham company has been at the center of a deadly national meningitis outbreak. Federal health officials say more than 300 people have been infected with fungal meningitis, in 17 states, and 23 are dead. Health officials have tied a steroid produced by the Waverly Street company to the fungal meningitis outbreak.
Tuesday evening, NECC, through it's attorney, released a statement.
"NECC has had a long standing practice of working closely and cooperatively with the Massachusetts Board of Registration in Pharmacy and the Massachusetts Department of Public Health. It has always been the company’s practice to provide the Board with full and complete access to its facility and its records," said Paul Cirel, counsel to New England Compounding Center (NECC), in a written statement.
"As is standard practice in the health care industry, the Board had numerous opportunities, including as recently as last summer, to make first-hand observations of the NECC’s facilities and operations," said Cirel. "Based on that history, it is hard to imagine that the Board has not been fully apprised of both the manner and scale of the company’s operations."
"NECC’s transparency in dealing with the Board since inception in 1998 demonstrates its good faith intention to operate in compliance with the requirements of its license." said Cirel. "Furthermore, the company’s intention and best efforts at compliance are equally applicable in every other state in which it has been licensed."
During Tuesday's press conference with the Governor Department of Pubic Health Bureau of Healthcare Safety Director Madeleine Biondolillo said on 13 occasions, NECC shipped orders from lots before confirming from their own test results that they were sterile.
Patrick said more oversight is needed within Massachusetts for compounding pharmacies and said the pharmacy board will start conducting unannounced inspections of compounding pharmacies, at least once a year.
Markey, who represents Framingham, is the senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA).