Mass. gov: Drug firm may have misled regulators

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

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.