Official: Companies like NECC need more regulations

Posted: 10/10/12 at 12:25 pm EDT      Last Updated: 10/10/12 at 5:41 pm EDT

BOSTON (WHDH) -- The meningitis outbreak linked to a local pharmacy claimed the life of a 12th person.

The New England Compounding Company, the Framingham pharmacy linked to the dangerous anti-fungal meningitis outbreak, voluntarily surrendered its license and ceased operation, but it also owns a similar company called Ameridose in Westboro.

“We do not believe they share manufacturing and we’re in the process of looking at Ameridose and making sure that we either know what practices are,” said Judy Ann Bigby, the secretary of Health and Human Services.

The CDC reports there are now at least 119 cases across 23 states. As many as 13,000 patients may have been injected with the steroid treatment, which is used to relieve back pain.

The Public Health Commission met for the first time Wednesday since the deadly outbreak.

“The Department of Public Health’s joint investigation with the CDC and the FDA will be comprehensive and will cover all issues around this serious outbreak,” said Madeleline Biondolillo of the Mass. bureau of healthcare safety.

NECC made its own drug products, which were not regulated by the FDA. The state is also investigating whether NECC violated its license by producing 17,000 viles of the drug in question and distributing them nationwide.

“Today, the Board of Pharmacy issued an alert to all compounding pharmacies in the commonwealth to reinforce for them the rules they must abide by in Massachusetts. Our statutory and regulatory requirements stipulate that compounding can only be conducting upon receipt of a patient-specific prescription,” said Biondolillo.

Congressman Ed Markey said he’ll draft a bill to give federal regulators more power to oversee these compounding pharmacies.

“Compounding companies fall into a kind of black hole where neither the FDA or state pharmacies boards have the authorities to oversee their work,” said Bigby.

A New Hampshire patient who received a steroid injection is now concerned he has the fungal meningitis that has killed 12 people nationwide.

“I’ve been having symptoms the last few days. My back and my neck’s all stiff, headaches ,” said James Lefebvre.

Officials said the NECC has been cooperative throughout this outbreak; however it is unclear what sanctions the company will face.

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