Mass.gov: Drug firm may have misled regulators
BOSTON (AP) -- The specialty pharmacy linked to a deadly meningitis outbreak may have misled regulators and done work beyond the scope of its state license, Massachusetts Gov. Deval Patrick said Wednesday.
The New England Compounding Center in Framingham made a steroid that was used in contaminated injections that have sickened more than 130 people in 11 states. Twelve have died.
State and federal agencies "may have been misled by some of the information we were given," Patrick told reporters.
The company was supposed to fill specific prescriptions for specific patients but exceeded that, he said.
"What they were doing instead is making big batches and selling them out of state as a manufacturer would, and that is certainly outside of their state license," he said.
A company spokesman declined comment beyond a statement that company officials are focused on cooperating with the investigation. The company has shut down operations, recalled the fungus-contaminated steroid and is cooperating with investigators.
Also Wednesday, another Massachusetts company run by the same executives who operate the New England Compounding Center has agreed to temporarily shut down, pending inspection by state and federal regulators.
The company, Ameridose, is located in Westborough. There's no evidence of problems, and the state hasn't requested a recall of any Ameridose products, said Dr. Madeleine Biondolillo, director of the state's Bureau of Healthcare Safety.
"The request for a temporary suspension of operations will allow for an onsite investigation, while continuing to safeguard public health," she said.
As many as 13,000 people received steroid shots from the New England Compounding Center, according to the federal Centers for Disease Control and Prevention.
Compounding pharmacies custom-mix solutions, creams and other medications in doses or in forms that generally aren't commercially available. Ameridose compounds drugs at one of its two facilities in Westboro, but also provides sterile medication in prefilled oral syringes to about 3,000 hospitals nationwide.
Compounded drugs have never been reviewed for safety and effectiveness by U.S. Food and Drug Administration. The outbreak has led to calls from lawmakers, including Massachusetts Rep. Edward Markey and Connecticut Rep. Rosa DeLauro, to strengthen the agency's oversight over the drugs.
Patrick said the state has reminded compounding pharmacies that if they manufacture medicines -- which he said the New England Compounding Center is doing -- they need federal permission.
Biondolillo said the state is also requiring all compounding pharmacies to sign an affidavit that they are following all regulations.
The state has 1,100 pharmacies that can compound drugs, according to Markey's office.