Drug firm might have misled probe
Thursday, October 11, 2012
BOSTON -- The specialty pharmacy linked to a deadly meningitis outbreak might have misled regulators and done work beyond the scope of its state license, Massachusetts Gov. Deval Patrick said Wednesday.
The New England Compounding Center made a steroid that was used in injections for back pain that were later found contaminated. More than 130 people in 11 states have become ill. Twelve have died.
Patrick said state and federal agencies "might have been misled by some of the information we were given" by the New England Compounding Center.
The company was licensed 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.
Massachusetts U.S. Rep. Ed Markey seized on Patrick's statement, and sent a letter to the U.S. Food and Drug Administration, asking if it believes it was misled by the company.
"This company may have disregarded federal guidelines, and we need to know from the FDA whether the company misled regulatory authorities and if sanctions against the company are available or warranted," Markey said.
A company spokesman declined to 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.