The U.S. Food and Drug Administration said last month it had acted within its authority when it rescinded marketing clearance for a ReGen Biologics Inc. knee implant — an action the company claims drove it into bankruptcy — because the device had gotten initial approval only due to “severe political pressure.” FDA lawyers claimed during a summary judgment hearing on March 14th that the agency was under “one of the most severe political pressures” it had ever experienced when it first approved ReGen’s collagen meniscus implant, Menaflex, as a Class II device under the Federal Food, Drug and Cosmetic Act in December 2008. FDA counsel Adrienne Elise Fowler said that “ReGen spent over ten years attempting to persuade FDA to allow it to market this device.”
U.S. District Judge Robert L. Wilkins cautioned the agency against making claims of political pressure, noting the company could allege the approval was only reopened due to Congressional pressure in the other direction. But Ms. Fowler didn’t back down and remained adamant that the reclassification was a “science-driven process” and was necessary to rectify the prior mistakes. ReGen blasted the FDA’s allegations of improper political conduct in its favor, claiming the only Congressional communication the FDA had received on the Menaflex issue prior to the approval was a letter from four New Jersey congressmen who requested a “fair and equitable process.”
ReGen initially sued the FDA in May 2011 over the rescission. It filed for Chapter 11 bankruptcy in Delaware on April 8, 2011, a decision the company called a direct result of the FDA’s actions. Its assets were later picked up by Ivy Sports Medicine LLC. ReGen began to distribute the Menaflex device in the U.S. in April 2009, following the FDA’s Class II designation of the device under its 510(k) approval process, despite ReGen’s alleged concerns that the FDA “was applying an incorrect review standard to its premarket notification submission.” Part of the approval process included the convening of an orthopedic advisory panel, a step ReGen’s complaint noted had not been applied to the “more than 400 surgical meshes classified under the FDA’s 510(k) premarket notification classification procedure, including those with new indications for use.” Following positive feedback from the panel and the device’s subsequent approval in December 2008, senior members of the House Energy and Commerce Committee sent a letter to the FDA requesting a probe into the Menaflex clearance history.
The re-evaluation concluded that the approval of the Menaflex device included multiple departures from the FDA’s standard processes for the approval of a device, including succumbing to the pressure to approve the device by the four Congressmen as well as the agency’s failure to recognize the Menaflex device was intended to be used for different purposes and was technologically dissimilar from other devices already on the market, according to the report. ReGen maintained that the FDA failed to go through a necessary formal review process of the device’s classification in favor of the probe.
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