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Mass. gov: Drug firm may have misled regulators

Associated Press Modified: October 10, 2012 at 7:04 pm •  Published: October 10, 2012
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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.

Meanwhile, a second pharmacy connected to the New England Compounding Center in Framingham has shut down for state and federal inspection.

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 been sickened. Twelve have died.

On Wednesday, Patrick told reporters that state and federal agencies "may 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 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.

On Wednesday afternoon, the state announced that the pharmacy Ameridose has agreed to temporarily shut down, pending inspection by state and federal regulators. Ameridose was founded in 2006 by Greg Conigliaro and Barry Cadden, who opened the New England Compounding Center eight years earlier.

Ameridose said in a statement that its shutdown ends Oct. 22, though the agreement with the state allows the shutdown to be extended or shortened. The company said that as part of the agreement, Cadden has resigned all corporate positions with the company, where he has not had a day-to-day role.

Ameridose compounds drugs at one of its two facilities in Westborough, but also provides medication in prefilled oral syringes to hospitals nationwide.

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