Company related to Framingham compounding firm implicated in meningitis outbreak agrees to temporarily halt operations
A Westborough pharmacy related to New England Compounding Center, the Framingham company at the heart of a nationwide fungal meningitis outbreak, has voluntarily agreed to cease its compounding operations, pending an investigation, Massachusetts health officials said Wednesday.
Ameridose, which shares owners with New England Compounding, agreed to halt operations while state and federal officials conduct their probe, Dr. Madeleine Biondolillo, director of the state health department’s Bureau of Healthcare Safety, said in a press conference.
“Ameridose, LLC proactively and voluntarily agreed to cease all manufacturing and compounding operations immediately. Ameridose and its partnering distributor, Alanaus Pharmaceuticals, will cease distribution of all products manufactured and compounded by that company or any of the companies under shared ownership for a time-delineated period,” Biondolillo said.
She said officials have not seen any evidence of “products compromised” at Ameridose but said the action was taken to give investigators time to do a comprehensive review of its operations, including the company’s corporate structure.
State health officials, she said, have not “requested a recall at this time” of any Ameridose products, and she stressed the agreement to cease operations is voluntary.
Biondolillo also said the state Board of Pharmacy, which regulates compounding companies, issued an order Wednesday that all compounding companies operating in Massachusetts sign an affidavit they they are complying with state regulations that require compounders to mix medications for a specific patient. Biondolillo could not explain why New England Compounding was allowed to ship thousands of vials of an injectable steroid medication to clinics and physicians offices across the country -- medication that investigators suspect may be the source of 137 illnesses and 12 deaths nationwide from a rare fungal infection in patients who received the medication.
“We do not have any reason to believe at this time that other compounding pharmacies are operating outside of the rules,” she said.
Earlier Wednesday, Governor Deval Patrick told reporters that he believes that state and federal regulators “may have been misled by some of the information we were given” by New England Compounding.
“What they were supposed to be doing is filling specific prescriptions for specific patients, as I think any of us would understand a pharmacy to do,” Patrick 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.”
The Globe reported Wednesday that Ameridose, which supplies medications to hospital pharmacies, has about 400 employees and $100 million in annual revenue, according to federal contracting data from this year. New England Compounding had about 21 employees and $8 million in annual revenue as of 2009, according to the latest federal records available.
The owners of both companies are Barry Cadden of Wrentham and Gregory Conigliaro of Southborough, the newspaper reported, but a spokesman for the companies said they are separate entities, though they have common ownership.Kay Lazar can be reached at email@example.com. Follow her on Twitter @GlobeKayLazar.
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|White Coat Notes covers the latest from the health care industry, hospitals, doctors offices, labs, insurers, and the corridors of government. Chelsea Conaboy previously covered health care for The Philadelphia Inquirer. Write her at firstname.lastname@example.org. Follow her on Twitter: @cconaboy.|
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