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Deadly Meningitis Outbreak: Massachusetts pharmacy vice president conspiring to defraud FDA sentenced to prison

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BOSTON (WWLP) – The former vice president and general manager of the New England Compounding Center (NECC) was sentenced to prison in connection with conspiring to defraud the Food and Drug Administration (FDA).

NECC, which no longer exists, was a family-run compounding pharmacy in Framingham. The former vice president and general manager Gregory Conigliaro of Southborough was sentenced to one year in prison and one year of supervised release. He was convicted following a 41-day jury trial of one count of conspiracy to defraud the United States.

The criminal case began in 2014 following a two-year investigation when the Massachusetts facility was charged with a nationwide fungal meningitis outbreak that killed more than 100 people and sickened hundreds. It was traced back to contaminated vials of preservative-free methylprednisolone acetate (MPA) manufactured by NECC.

The indictment did not charge Conigliaro with having any role in the drug manufacturing operations of NECC. It was alleged that Conigliaro conspired with the former co-owner of NECC and head pharmacist, Barry Cadden, and other employees to misrepresent to the FDA and the Massachusetts Board of Registration in Pharmacy that NECC was operating as a pharmacy dispensing drugs only pursuant to patient-specific prescriptions, when, in reality, NECC was shipping drugs in bulk across the nation for over a decade, evading regulatory oversight through fraud and misrepresentation. 

Conigliaro and NECC were able to avoid the FDA’s oversight authority and operate in a slipshod, unsafe manner, ultimately leading to a tragic outbreak of fungal meningitis that killed more than one hundred individuals and injured many hundreds more.

“Mr. Conigliaro and his co-conspirators repeatedly made the choice to put their greed over patient safety,” said United States Attorney Rachael S. Rollins. “In turn, nearly 800 patients suffered terribly and over 100 died. Today’s sentence sends a clear message to healthcare executives – if you lie to regulators, the outcomes can be deadly and we will hold you accountable.”

The former co-owner of NECC, Barry Cadden, was sentenced to 174 months in prison and ordered to pay a forfeiture of $1.4 million and restitution of $82 million.