State regulator, pharmaceutical executive cloud picture on fungal meningitis outbreak

A sitting member of Massachusetts’ regulatory agency that oversees pharmaceutical safety has a direct link to the company implicated in the nationwide outbreak of fungal meningitis.

According to a Boston Globe report this week, Sophia Pasedis has recused herself from any matters concerning either of the two companies she represents. Pasedis has served two terms on Massachusetts’ pharmacy board and at the same time has been serving as vice president of regulatory affairs at Ameridose, a pharmaceutical company with the same owners as New England Compounding Center.

New England Compounding Center is the company which manufactured and distributed the contaminated epidural steroid injection that’s been implicated in a deadly nationwide outbreak of fungal meningitis. Only those who received the injection are at risk of acquiring the infection but of the 13,000 people who may have received it, already more than 120 people in 10 states have been diagnosed with fungal meningitis. Twelve people have died as a result of their infection.

The Globe reports that Ameridose is a manufacturer of pharmaceutical products. It is federally regulated unlike New England Compounding Center. NECC and other facilities that compound and mix various drugs for distribution as another product are not subject to federal regulations but do fall under the auspices of state regulations.

NECC mixed methylprednisolone acetate from its Framingham, Mass., facility earlier this year. The company has recalled all products manufactured at this facility, including that injectable drug that’s commonly delivered in the treatment of back pain and inflammation. A Food and Drug Administration investigation revealed that sample vials of the drug tested positive for the presence of a fungus that likely would cause recipients to develop fungal meningitis.

Pasedis’ role with Ameridose and her seat on the Massachusetts pharmacy regulatory board may have some connection to the outbreak. The report notes that NECC is technically only allowed to compound or mix drugs on an individual basis but somehow was able to distribute vials of methylprednisolone acetate on a nationwide basis, let alone manufacture it in such great quantities.

State and federal officials are now investigating a connection between Ameridose and NECC. Outside of Pasedis, it is likely other common bonds exist. The news source indicates that each other’s headquarters are within a city block of each other in Framingham.

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