Crime

Former co-owner of Mass. compounding pharmacy gets jail time for defrauding FDA

Gregory Conigliaro was sentenced to one year in prison for lying to federal regulators about the operations at the shuttered New England Compounding Center.

A former co-owner of a Massachusetts compounding pharmacy responsible for a deadly fungal meningitis outbreak will serve one year in prison for lying to federal regulators.

The U.S. District Attorney’s Office announced that Gregory Conigliaro, 57, of Southborough, was sentenced to a year in prison for conspiring to defraud the federal government. He was also sentenced to one year of supervised release.

Conigliaro previously co-owned the now-defunct New England Compounding Center in Framingham. The compounding pharmacy is well-known for its criminal case related to a 2012 nationwide outbreak of fungal meningitis that was traced back to contaminated vials of preservative-free methylprednisolone acetate (MPA) manufactured by the center. 

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Prosecutors said Conigliaro and the pharmacy dodged the Food and Drug Administration (FDA)’s oversight requirements and operated “in a slipshod, unsafe manner,” which led to an outbreak of fungal meningitis that killed more than 100 patients and sickened 800 in 20 states. The patients were diagnosed with a fungal infection after getting injections of pharmacy-manufactured MPA. The outbreak is considered the largest public health crisis ever caused by a contaminated pharmaceutical drug.

“Mr. Conigliaro and his co-conspirators repeatedly made the choice to put their greed over patient safety,” U.S. Attorney Rachael S. Rollins said in a news release. “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.”

Conigliaro was the center’s vice president and general manager and also served as its primary point of contact with federal and state regulators. Prosecutors say Conigliaro conspired with the former center’s co-owner and head pharmacist, Barry Cadden, who is Conigliaro’s brother-in-law, and others at the company to mislead regulators. 

According to the district attorney, the compounding pharmacy misrepresented itself to the FDA and the Massachusetts Board of Registration in Pharmacy by leading them to believe the center was operating as a pharmacy dispensing drugs with patient-specific prescriptions. But prosecutors say the center was shipping drugs in bulk across the U.S. from 2002 to 2012, evading regulatory oversight.  

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Conigliaro and his co-conspirators even went so far as to create fake prescriptions and present them to regulators to mask the center’s actual activities, prosecutors said.

Conigliaro and 13 other of the company’s officials were indicted in December 2014, though Conigliaro was not charged with having any role in drug manufacturing operations. He was convicted on the conspiracy charge in December 2018.

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