A US district court judge yesterday sentenced Barry Cadden, owner and head pharmacist of a Massachusetts compounding pharmacy implicated in a 2012 fungal meningitis outbreak linked to contaminated corticosteroid shots, to 9 years in prison.
The sentencing followed Cadden's Mar 22 conviction by a federal jury of racketeering and mail fraud charges, while acquitting him of all 25 counts of second-degree murder.
The 2012 outbreak sickened 753 people, 64 of them fatally, and prompted extensive federal inspections and stricter oversight of compounding pharmacies. The outbreak was the largest public health crisis ever tied to a pharmaceutical product.
Judge hands down less than maximum sentence
In a statement yesterday, the US Attorney's Office for the Massachusetts district said Cadden, age 50, was sentenced by Judge Richard Stearns to 108 months in prison and 3 years of supervised release, plus forfeiture and restitution to be determined later. According to an earlier report, he could have faced a maximum of 20 years in prison on each of the mail fraud and racketeering counts.
Patients and family members of people affected by the outbreak appeared in court yesterday and asked the judge to give Cadden a severe sentence, and were disappointed by the judge's ruling, the Boston Herald reported.
The attorney's office said Cadden authorized and directed the shipment of contaminated methylprednisolone acetate injections to nationwide customers of New England Compounding Center, sometimes before tests to confirm sterility were completed. He never notified customers when the products had nonsterile results or ingredients were expired. Some batches were made by an uncertified pharmacy technician, and Cadden repeatedly took steps to evade US Food and Drug Administration (FDA) oversight.
Outbreak fallout led to tighter oversight
FDA Commissioner Scott Gottlieb, MD, said in the attorney's office statement that protecting Americans from unsafe and contaminated drugs is the core of the FDA's mission.
"Since this tragedy, Congress has given the FDA important new authorities, and the agency has implemented key policies, all to provide a greater assurance of safety over compounded medicines. As part of these efforts, we will continue to hold accountable those who violate the law and put patients at risk," he said.
In a separate statement yesterday, the FDA said since the outbreak and enactment of the Drug Quality and Security Act (DQSA) in late 2013 it has devoted extensive resources to compounding oversight and implementing the new law's provisions.
As of Jun 1, the FDA said it has conducted more than 400 inspections, including 109 at outsourcing facilities, and has issued more than 150 warning letters advising compounders of significant violations. Also, the FDA has sent more than 50 letters detailing inspection findings to state regulators and has overseen 125 recalls involving compounded drugs.
Also, in implementing the DQSA the FDA has issued 21 draft guidance documents, 10 final guidance documents, three proposed rules, one final rule, and a draft memorandum of understanding.
Jun 26 US Attorney's Office statement
Jun 26 Boston Herald story
Jun 26 FDA statement
Mar 23 CIDRAP News scan "Executive convicted in fungal meningitis outbreak trial"