FDA Admits It Shouldn’t Have Approved a Knee Device

In an unprecedented move, the FDA has admitted that it should have never approved a medical device but succumbed to outside influence in approving the Menaflex knee patch manufactured by ReGen Biologics. The pressure came from NJ elected officials including Senators Frank R. Lautenberg, Robert Menendez, Reps. Frank Pallone, Jr. and Rep. Stephen R. Rothman.
Controversy began to swirl around the medical device last year when FDA officials complained that politics had unduly influenced the approval of Menaflex. FDA scientists released a detailed report showing that FDA scientists had found the device not worthy of FDA approval but were overruled by FDA managers who had come under the sway of the New Jersey politicians in whose state the device is manufactured.
According to an article in the NY Times, “Dr. Robert Smith, a former F.D.A. device reviewer who was among those who complained to Senator Grassley, said in an interview that the agency had yet to discipline the managers responsible for the ReGen decision. Some of those managers have since left the agency.
“There was serious managerial wrongdoing during the clearance of the device, and that needs to be investigated, and the managers involved need to be held accountable,” Dr. Smith said.
The controversy and potential improper conduct includes the FDA commissioner who is cited in the report for inappropriate involvement in the approval process.
The four NJ elected officials who pressured the FDA had received significant campaign contributions from ReGen headquartered in Hackensack New Jersey.