FDA’s Globus Oops (Walter Eisner @ OTW)
Oops.
The FDA has changed a statement made in a February 28 press release announcing a $1 million dollar penalty settlement with Globus Medical, Inc. and its CEO for marketing an unapproved medical device.
The agency originally wrote: “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.”
In fact, the agency made no such finding. The FDA did not determine that the product was not safe and effective and Globus asked the FDA to change the statement. The agency changed the language on February 29 from: "devices FOUND NOT to be safe and effective," to; "devices NOT FOUND to be safe and effective.”
Ed Joyce, Director of Investor Relations & Business Development, at Globus contactedOTW and asked us to note the change. He also told us that the NuBone Osteoinductive Bone Graft, the product in question, was on the market since 2007 and had "an excellent safety record, with no implant-related adverse reactions or patient issues."
Joyce also noted another change in the original FDA announcement. The agency's origin...
