ReGen Biologics Inc. (OTC:RGBO) terminated its common stock registration in connection with its bankruptcy proceedings connected to the FDA’s rescission of 510(k) clearance for the company’s Menaflex knee implant.
Earlier this month ReGen sued the FDA, its top regulator, and the secretary of the U.S. Department of Health & Human Services, accusing them of overstepping their bounds in rescinding the clearance.
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.
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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 knee implant in 2008.
The Menaflex won 510(k) clearanceover 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 2010, 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.
ReGen wasn’t shy about voicing its displeasure over the rescission, with CEO Gerald Bisbee calling it “totally unbelievable.”
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A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
