This week, the U.S. Department of Justice ("DOJ") indicted 14 owners and senior officials of a Massachusetts pharmacy that manufactured and distributed contaminated drugs that killed 64 people in a 2012 fungal meningitis outbreak. The owner/head pharmacist and the supervisory pharmacist of the New England Compounding Center ("NECC") were charged with second degree murder, and 12 others were charged with racketeering, mail fraud, conspiracy, and other crimes. NECC's products were distributed nationwide, making more than 700 people ill and leading to 64 deaths from a rare and hard-to-treat spinal cord fungal infection. DOJ alleges that NECC's steroid injections for pain, which had been marketed as individually formulated products, contained mold and bacteria. DOJ further alleges that both pharmacists knew the products were not sterile but conspired to cover it up by, for example, providing guidance on creating fake prescriptions. Investigations after the outbreak revealed NECC's staff failed to observe hygiene rules and took shortcuts in sterilization, among other violations. The 2012 outbreak triggered congressional investigations and statutory changes on how FDA oversees compounding pharmacies. NECC filed for bankruptcy in 2012.
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