Mass. gov: Drug firm may have misled regulators
Thursday, October 11, 2012
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.
Dr. Madeleine Biondolillo, director of the state's Bureau of Healthcare Safety, said there's no evidence of problems at Ameridose and the state hasn't requested a recall of any Ameridose products.
A pharmacy manager at Ameridose, Sophia Pasedis, has been a member of the regulatory body, the Massachusetts Board of Registration in Pharmacy, since 2004. But the state said she has recused herself from all matters related to Ameridose and the New England Compounding Center.
Compounding pharmacies supply products that aren't commercially available, based on an individual doctor's prescription. Some have grown into larger businesses, operating across state lines and supplying drugs to thousands of hospitals, clinics and physicians.
Biondolillo said the state has reminded Massachusetts pharmacies that compounding can be done only in response to a patient-specific prescription. She said the state is now requiring all compounding pharmacies to sign an affidavit that they are following all regulations.
The state has 1,100 pharmacies that can compound drugs.
Massachusetts last inspected the New England Compounding Center in March in response to a pending complaint unrelated to the outbreak, officials have said. It also inspected the pharmacy in 2011 when it moved operations, and found no problems.
Asked if the state had tried to determine if the company was making large batches of drugs, a possible signal it was operating outside the bounds of its license, Biondolillo said, "Each time we go out and inspect, we're looking at all aspects of the operation."
She didn't give specifics about what the inspectors found in the most recent visit.
In Ohio, the state's board of pharmacy on Wednesday suspended the company's license to distribute in the state, citing evidence that the company's practices presented a danger of serious and immediate harm to others.
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.
Compounded drugs have never been reviewed for safety and effectiveness by the FDA. The outbreak has led to calls from lawmakers, including Markey and Connecticut Rep. Rosa DeLauro, to strengthen the agency's oversight over the drugs.
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