WASHINGTON — The U.S. Food and Drug Administration said Thursday it still has “troubling” questions about the approval of ReGen Biologics Inc.’s knee device and wants the approval completely re-evaluated.
In a report, the FDA said a review of the decision to approve ReGen’s Menaflex knee device showed there wasn’t enough evidence to dispel questions about outside influence to approve the product. The device was approved in December 2008 despite recommendations from a handful of FDA scientists against its approval.
Joshua Sharfstein, deputy director of the FDA, said in a conference call that the report showed there were “definite threats” to the integrity of the FDA’s medical-device-review process.
The FDA report said that over the device’s 17-year approval history, “multiple departures from processes, procedures, and practices occurred” and key important FDA reviewers failed to document the reasons for their decisions.
“This failure constitutes a clear deviation from the principles of integrity used in this review and undermines the ability of the agency to counter the suggestion that lobbying on behalf of ReGen affected the decision,” the FDA report said.
The FDA’s report could have far-reaching effects for ReGen and the medical-device industry, as the FDA announced Wednesday that it is reviewing its rapid-approval process for medical devices. ReGen’s device went through the FDA’s rapid-approval process.