The head of the New England Compounding Center (NECC), a compounding pharmacy whose mold-tainted drugs killed dozens of people in 2012, bragged in training videos about state regulators who didn’t have a clue about the company’s business. Exhibits introduced into evidence in the man’s murder trial revealed that Barry Cadden can be seen in the videos, from 2011 and 2012, telling employees that when the Massachusetts Board of Pharmacy came to investigate the New England Compounding Center, they would quickly leave. In fact, Cadden said he actually taught the regulators what a compounding pharmacy is. It appears that the state began to trust Cadden so much that when concerns would come in from other states, Massachusetts would simply ignore them.
Prosecutors say that Cadden’s management of the company led to a reckless lack of internal oversight and an outbreak of meningitis that killed 64 people. Cadden had this to say about the regulation in a video:
They look around, they have no clue. ‘Oh, Barry, this place looks great. Hey, I gotta go.’ Cup of coffee, out the door.
The NECC was regulated the same way a corner pharmacy was, even though it was doing something vastly different than selling prescriptions to customers who walked in off the street. The meningitis outbreak that began at NECC led to new laws in Massachusetts and elsewhere that tightened restrictions on such outfits.
Compounding pharmacies are supposed to make tailor-made drugs for specific patients, like a drug that lacks an ingredient that someone is allergic to. But under Cadden’s leadership, prosecutors say, he ran the company like a high-volume manufacturer, evading U.S. Food and Drug Administration (FDA) oversight. Cadden gave a chilling view of regulation when he said in a 2012 video:
They don’t understand us, so how can they come in and inspect me? They don’t even know what they’re looking at.
Jurors also heard from Joseph Connolly, a technician who worked at NECC from 2010 to when it was closed in October 2012. Connolly said that he began to grow concerned about the increased demands on pharmacy technicians who were making the drugs. “Something’s going to happen,” Connolly said he told supervising pharmacist Glenn Chin, who has also been charged with murder. “Something’s going to get missed. We are going to get shut down.” Connolly, on direct examination by assistant U.S. attorney Amanda Strachan, also testified about a co-worker who got a job as a technician at New England Compounding despite having lost his license in 2007. That man was his brother, Scott Connolly.
Hopefully the regulators in Massachusetts learned a valuable lesson in their dealings with the NECC debacle. We will see!
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