The chairman of the Food & Drug Administration panel charged with reviewing ReGen Biologics Inc.’s (OTC:RGBO) Menaflex knee implant said the agency is sending the right message in revoking the device’s 510(k) clearance.
The Menaflex 510(k) clearance in December 2008 came despite the fact that the device often failed and required second operations — and over the objections of FDA scientists who opposed clearing the device. In September 2009 the agency admitted that undue influence from four New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced an investigation into the foofaraw.
In March, the agency’s Orthopaedic and Rehabilitation Devices Panel at the Center for Devices and Radiological Health decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying Regen failed to produce adequate evidence that device was safe before it was cleared to hit the market.
Dr. John Kelly of the University of Pennsylvania, who chaired both the initial advisory panel and the March review committee, said the FDA’s decision sends the message that “it can’t be bought or influenced” and that the kind aggressive lobbying campaign ReGen mounted is “out of bounds,” according to the Wall Street Journal‘s Health Blog.
Saying the device should have gone through the FDA’s pre-market approval protocol rather than the shorter, cheaper 510(k) route, Kelly said he is “a little bummed” at the rescission. The Menaflex device isn’t particulary effective but it isn’t dangerous.
“The FDA put the brakes on a product with some promise,” he told the Health Blog. “It wasn’t a Cadillac, more like a Model T.”
ReGen chairman and CEO Gerald Bisbee Jr. yesterday fired back at the FDA, calling the rescission “totally unbelievable.”
“For CDRH to arrive at the decision that the device has a new intended use four years after two senior CDRH officials informed the company that the device could be reviewed through the 510(k) program is totally unbelievable,” Bisbee said. “Even more incredible is that they arrived at that conclusion after the second Orthopedic Advisory Panel of independent experts chosen by FDA was specifically asked about the intended use of the device and confirmed that it functioned like predicates. When they received that answer from the panel, CDRH repeated the same question three additional times in order to try to get the answer that they apparently wanted, but they did not.”
The rescission means Hackensack, N.J.-based ReGen has to keep its Menaflex device off the U.S. market until it can prove its safety and effectiveness to the FDA’s satisfaction.
