Mass. Gov: Drug Firm May Have Misled Regulators
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 10 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 message requesting comment was left with a company spokesman. The company has shut down operations, recalled the fungus-contaminated steroid and is cooperating with investigators.
As many as 13,000 people received steroid shots from the company, 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.
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.
On Wednesday, Patrick said he had given unspecified directives to other facilities owned by New England Compounding Center, but did not elaborate.
He also said the state is reminding compounding pharmacies that if they manufacture medicines - which he said the New England Compounding Center is doing - they need federal permission.