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 original statement; “During an inspection of Globus Medical in September 2010, FDA investigators learned that the company had marketed its NuBone Osteoinductive Bone Graft product without proper premarket approval or clearance, as required by law,” was changed to: “This action is in response to FDA learning that the company had marketed its NuBone Osteoinductive Bone Graft product without proper premarket approval or clearance, as required by law.”
The company issued a statement on February 29 after the FDA posting. The statement said that David Paul, Chairman and CEO of Globus Medical, and the company have reached a settlement with the FDA to resolve, “an administrative complaint alleging Food, Drug and Cosmetic Act violations regarding Globus’ former product, NuBone. There were no patient safety issues reported regarding NuBone. Significantly, the Amended Complaint does not allege any intentional wrongdoing by Globus Medical or Mr. Paul.”
Dara Corrigan, the FDA’s associate commissioner for regulatory affair originally wrote, “This company ignored previous warnings by the FDA and continued to produce and distribute unapproved medical devices.”
The company said it had considered NuBone to be minimally manipulated tissue exempt from premarket notification, but in March 2008 the FDA’s Tissue Reference Group determined that the product required 510(k) clearance. “Globus and FDA maintained an ongoing dialogue regarding NuBone’s regulatory status including two 510(k) submissions with substantial animal data. During that time Globus regularly communicated with FDA regarding NuBone and throughout NuBone’s lifecycle believed that it was acting in a manner that was acceptable to FDA. Despite its history of safe use, Globus decided to discontinue NuBone in 2010.”
The settlement requires Globus to pay a $550,000 penalty and Paul to pay a $450,000 penalty, for a total of $1 million.