ReGen Biologics Inc. sued the FDA, its top regulator and the secretary of the U.S. Dept. of Health & Human Services, accusing them of overstepping their bounds in rescinding a clearance for ReGen’s Menaflex knee implant earlier this year.
The Hackensack, N.J.-based company declared bankruptcy days after the FDA’s Center for Devices & Radiological Health pulled the 510(k) clearance it granted the device in 2008. The lawsuit calls the decision to pull the FDA clearance "arbitrary and capricious, an abuse of discretion, not in accordance with law, and in excess of statutory jurisdiction, authority and limitations" and asks the U.S. District Court for the District of Columbia to nullify the rescission.
"This action has forced a small public U.S. company, committed to improving patients’ lives, into bankruptcy," ReGen chairman and CEO Gerald Bisbee Jr. said in prepared remarks. "Our company’s experiences with the FDA over the last six years, including the FDA’s unprecedented decisions to re-review the 510(k) and ultimate rescission, have forced ReGen to unnecessarily expend an inordinate amount of time and incur significant expenses."
The lawsuit adds yet another layer to the ReGen story and its protracted and public battle with the FDA. The rescission of the Menaflex device, a bio-absorbable mesh implant designed to encourage the re-growth of damaged knee cartilage, means Hackensack, N.J.-based ReGen has to keep the device off the U.S. market until it can prove its safety and effectiveness to the FDA’s satisfaction.
ReGen wasn’t shy about voicing its displeasure over the rescission, with CEO Gerald Bisbee calling it “totally unbelievable.”
The FDA said it wants ReGen to “discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness,” five years after the company began the 510(k) application process.
ReGen has sunk $30 million into meeting requirements set by the FDA’s Center for Devices & Radiological Health, according to Bisbee, “only to have the agency reverse decisions made by previous CDRH officials by stating that they were in error with no substantial evidence that is true.”
The Menaflex 510(k) clearance in December 2008 came 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 Orthopedic & Rehabilitation Devices Panel 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.
“It’s unbelievable that after more than five years of 510(k) review of this product — and after being told by the ODE Director and the CDRH Director to file two separate 510(k) submissions for this device as a surgical mesh — [CDRH head Dr. Jeffrey] Shuren now says that they were wrong,” Bisbee said in prepared remarks on March 22. “This arbitrary and unsubstantiated intention is an example of why the investment community is increasingly wary of investing in companies with products requiring FDA approval.”
That wasn’t the only shot Bisbee fired across the FDA’s bow.
“We and they both know the agency has no legal authority to rescind its clearance of Menaflex. There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage,” he said. “After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA’s administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients.”