Greed Destroys New England Compounding Center

Greed Destroys New England Compounding Center

March 8th, 2013 // 7:11 pm @ jmpickett

Which FDA District Offices Are Most Aggressive?

For the past few months, the New England Compounding Center, the pharmacy that has been linked to 720 cases of fungal meningitis, and as many as 58 deaths (see this), has been battered by government probes, bankruptcy and civil lawsuits. Not surprisingly, one of the owners pleaded the Fifth Amendment at a recent congressional hearing.

The episode has been described as one of the worst public health crises in the US in decades and prompted stinging criticism of the FDA for failing to take action, despite issuing a warning letter. The agency, however, argues court rulings have tied its institutional hands, even though FDA officials previously indicated they would pursue compounders that engaged in activities that constittuted larger manufacturing. The FDA has since responded by cracking down on ‘risky compounders’ (back story) and has issued inspection reports to 17 pharmacies in recent weeks.

Which FDA District Offices Are Most Aggressive?

Now, though, employees are starting to come forward to discuss what went wrong and provide a glimpse of the inner workings beyond FDA inspection reports (you can read more here, here, here, here and here). And 60 Minutes speaks with two of them this coming weekend, as the above clip indicates.

“The underlying factor is that the company got greedy and overextended and we got sloppy, and something happened,” he says.”We became a manufacturer overnight,” says lab tech Joe Connolly. “So we were basically trying to have the best of both worlds. It was trying to manufacture without the oversight of a manufacturer. And it was just — we all got over-taxed and everything.”

A month before the first steroid death, Connolly says he warned his supervisor. “Something’s gonna happen, something’s gonna get missed and we’re gonna get shut down,” Connolly tells 60 Minutes. “We were gonna hurt a patient. We were just thinking we’d hurt a patient. We weren’t compounding anymore, we were manufacturing.”

And when he told his supervisor about his concerns, Connolly says he shrugged. He interpreted the response as “just do it… He either didn’t care, or he was powerless to change it,” Connolly says “That’s verbatim. He shrugged… That was his response for a lot of our questions or comments or concerns, was a shrug.”

H/T: Pharmalot