US seeks jail time for co-CEO of New England compounding center after deadly 2012 fungal outbreak
The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.
Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.
Rachael Rollins, US attorney for the district of Massachusetts, said this deception occurred despite knowingly shipping drugs in bulk across the nation.
Samir Nasr, the then-head of the FDA’s compounding team testified that the NECC “always kept saying: We do patient-specific. We are a compounding pharmacy. We are regulated by the state. We’re not – the FDA does not have jurisdiction over us,” with Rollins adding:
Through this deceit, Conigliaro and NECC were able to avoid the FDA’s oversight authority—and the FDA’s requirement that drug-manufacturers follow cGMPs—and operate in a slipshod, unsafe manner, ultimately leading to the tragic outbreak of fungal meningitis that killed more than one hundred individuals and injured many hundreds more.
And while Conigliaro was not involved in the compounding of the preservative-free methylprednisolone acetate that led to the fungal meningitis outbreak, nor did he oversee or work in the clean rooms where those and other substandard drugs were compounded, Rollins said that Conigliaro
committed a grave, serious offense—obstructing the work of a federal agency—the FDA—whose role is precisely to ensure the safety, purity, and efficacy of manufactured drugs. He did so through lies, false schemes, and misrepresentations—all in service of NECC’s profits—of which Conigliaro received millions of dollars. Conigliaro’s dangerous, and ultimately deadly, offense warrants a severe and significant punishment.