Six months before the deadly outbreak of fungal meningitis traced to a Framingham company, state officials had investigated New England Compounding Company, according to Bureau of Health Care Safety and Quality Director Madeleine Biondolillo.
That investigation, which began in March and was prompted by a complaint, is ongoing, Biondolillo told reporters Wednesday. Officials are attempting to determine whether NECC surpassed its license to only produce pharmaceuticals "upon receipt of a patient-specific prescription."
those who died from fungal meningitis tied to NECC has reached 12, with 137 cases in 10 states, from Minnesota to New Jersey to Florida which .
NECC, which has recalled the steroid methylprednisolone acetate because of the meningitis outbreak, shares ownership with Ameridose, a Westborough company that has a Food and Drug Administration license allowing it to produce large batches of pharmaceutical drugs, according to state officials.
On Wednesday afternoon, Ameridose had voluntarily agreed to temporarily stop its operations, and its distributor would stop shipping Ameridose products as well.
According to a statement from Ameridose, it ceased operations on Wednesday and will continue to do so until Oct. 22. The agreement can be appended to end early or be extended.
That cessation of operations will give investigators an opportunity to look into that company's operations, though there is no reason people should stop using Ameridose products, officials said.
"DPH has seen no evidence to suggest that there is a direct concern for compromised product manufactured or compounded by Ameridose and has not requested a recall at this time," Biondolillo said.
The Board of Pharmacy reminded all of the state's compounding companies on Wednesday that they must operate within the law and within regulations, Biondolillo said. She said, "There is, as you have heard, a gray area where some organizations may have operated contrary to regulations."
Asked whether NECC was operating outside of its license, Biondillo said, "NECC is under investigation. That's an ongoing investigation. That is exactly what's being evaluated."
Biondolillo said federal laws are needed to fill a regulatory gap and said the DPH had acted as soon as it learned of problems with NECC.
"DPH took immediate action to protect public safety when first notified of the outbreak late in the evening of Sept. 24," Biondolillo said.
Biondolillo was unable to comment on what could have led to the apparently tainted drugs that caused the outbreak.
"Those specific details of the investigation I don't have access to right now," Biondolillo said.
The investigation is focusing on the corporate governance of NECC. Asked about the apparent inter-relatedness of the company's board of directors, Biondolillo said, "The corporate governance structure is very much at the center of the investigation."
The corporate governance of NECC includes Sophia Pasedis, who is also the pharmaceutical industry representative on the Massachusetts Board of Registration of Pharmacy, a position she was appointed to in 2004, according to a state official.
On Wednesday, Ameridose announced that Barry Cadden, who is one of the owners of NECC and Ameridose had resigned. The statement said Cadden had not had any day-to-day role at Ameridose.
Also on Wednesday, NECC established a recall operations center to process and manage the removal of the company's products which have been recalled as of Oct. 6.
Resources:http://topics.nytimes.com/top/reference/timestopics/subjects/m/meningitis/index.html
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