Globus, CEO slapped with $1M fine for distributing unapproved device

Showing it can flex its regulatory muscle, the FDA has reached a $1 million settlement with spinal implant maker Globus Medical over allegations that the company distributed unapproved medical devices. The Audubon, PA-based company will pay $550,000, while CEO David Paul will cough up $450,000 as part of the deal.

Problems for the company started during a September 2010 inspection, when FDA investigators determined that Globus had marketed its NuBone osteoinductive bone graft product without premarket approval or clearance.

Globus had previously tried to obtain clearance for NuBone, but was rebuffed by the FDA. And even though the agency said it could not distribute the product, Globus did so, forcing the FDA's hand.

"The device-clearance process assures the quality and safety of devices before they reach the market. Firms can't simply choose to sell devices that FDA has found are not safe and effective," explained Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health. "We took action against Globus Medical to protect patients and we are pleased with the outcome."

The action against Globus and its CEO is just the latest example of how the FDA has been getting tougher against executives whose companies violate agency rules, as MedCity News notes. Last year, four Synthes executives were sentenced to various prison terms for their role in a clinical trial to test bone cement that resulted in the deaths of three people.

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