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Bankrupt medical device maker ReGen Biologics Inc. has sued the Food and Drug Administration, claiming that the agency overstepped its authority when it reclassified the company’s knee implant and forced it off the market. Such a reclassification is unprecedented, and ReGen argues the FDA has no right to do it. But FDA officials have faulted their predecessors for greenlighting ReGen’s device in the first place, saying the review process was wrongly influenced by lobbying and intense Congressional scrutiny. In a suit filed in U.S. District Court for the District of Columbia Tuesday, ReGen is asking the court to set aside the FDA’s March 30 rescission of the device, known as the Collagen Meniscus Implant, which is used for reinforcement and repair of soft tissue injuries in knee cartilage. It’s been available in Europe for about 10 years. “This action has forced a small public U.S. company, committed to improving patients’ lives, into bankruptcy,” said Gerald Bisbee, Jr., CEO of Hackensack-based ReGen, in a news release. ReGen is represented by Goodwin Procter’s Mark Heller, who is chair of the firm’s FDA group, and Matthew Hoffman, as well as Gibbons P.C. lawyers David DeLorenzi, Kevin McNulty and Scott Etish. Heller could not be reached for comment. Medical devices come in three categories — at one end of the spectrum is Class I (a tongue depressor, for example), while at the other are Class III — devices like a pacemaker that support or sustain human life and typically require extensive pre-market approval. In the middle is Class II. That’s where ReGen wanted to be. The key to getting on the market without costly premarket approval was showing its device was “substantially equivalent” to one already approved. Before its device was cleared for marketing in 2008, ReGen had twice before submitted so-called 510(k) applications for it, only to be denied because it was “Not Substantially Equivalent” to other devices. In December 2008, the FDA changed course and classified ReGen’s implant as Class II, determining that it was substantially equivalent to a surgical mesh, and would be subject to the same regulatory controls. At that point, ReGen began commercial distribution of its product. But in 2009, after Obama administration appointees arrived at the FDA, the agency announced it was taking a new look at ReGen’s device. “What we have concluded is the integrity of our process for reaching a decision was compromised in this case and so we are revisiting and re-evaluating the record and the basis for making that decision,” said Jeff Shuren, acting director of the Center on Devices and Radiological Health, during a Sept. 24, 2009 press conference call, according to a FDA transcript. Deputy Commissioner Josh Sharfstein added, “The concerns we have are about the process that led to the approval, not about specifically the safety of the device.” In a 31-page preliminary report, the FDA in September 2009 concluded that, “In the ReGen review, unusual perhaps unprecedented Congressional interest, the degree of senior agency official participation, and an aggressive company all exerted significant pressures on a complicated system of submission review.” The report continued, “The Director of FDA’s Office of Legislation described the pressure from the Hill as the most extreme he had seen and the agency’s acquiescence to the company’s demands for access to the Commissioner and other officials in the Commissioner’s office as unprecedented in his experience.” The FDA then announced it would re-evaluate its decision to clear the device. ReGen in its suit protested that the 2009 report “contains inaccuracies, misrepresentations, and speculative conclusions, and it omits material information.” The company also complained that the FDA did not solicit any input from ReGen in preparing the report, and has refused to correct errors. On March 30, 2011, the FDA rescinded the device’s Class II designation because the “substantial equivalence determination for this device was in error,” according to the FDA’s letter to the company. The FDA bumped the device up to Class III, requiring pre-market approval, and ordered ReGen to stop selling it immediately. ReGen contends there is “no statutory or regulatory basis for a rescission of a device classification… FDA removed a safe and effective device from use without the statutory process required under the [Food, Drug and Cosmetic Act].” Contact Jenna Greene at [email protected].

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