FDA Cannot Skip Notice Period to Fix Its Mistake

     (CN) – The Food and Drug Administration cannot rescind its approval of a controversial knee implant without a notice period, even if, as the agency now concedes, that approval was the result of political pressure, the D.C. Circuit ruled.
     After years of applications, ReGen Biologics obtained the Food and Drug Administration’s clearance to market a medical device called a collagen scaffold, an absorbable surgical mesh designed for use in knee-replacement surgeries.
     The agency initially rejected the product, finding that the company failed to demonstrate the device was as safe as other approved surgical mesh products.
     But the FDA flipped its position, and approved the collagen scaffold after it received letters from both New Jersey senators in support of ReGen’s application.
     ReGen began selling the devices in 2009, but came under scrutiny later that year after a newspaper article accused the FDA of having succumbed to political lobbying.
     Both Congress and the FDA opened an investigation into the claim.
     “We understand that you may be reexamining the decision to approve this device for marketing,” members of the House Committee on Energy and Commerce wrote to the FDA in May 2009. “Given the questions raised by FDA scientists about the lack of data on the safety and efficacy of this device, we believe this is a prudent course of action.”
     The FDA admitted its mistake and rescinded its approval of collagen scaffold in March 2011.
     This action sent ReGen into bankruptcy, and its successor, Ivy Sports Medicine, quickly sued Health and Human Services Department head Kathleen Sebelius under the Administrative Procedure Act.
     A federal judge sided with the agency last year, ruling that the FDA invoked its proper authority in rescinding its approval of collagen scaffolding.
     But the D.C. Circuit reversed that decision Friday.
     “‘Congress has provided a mechanism capable of rectifying mistaken actions,’ and it would be unreasonable under this statutory scheme to infer that FDA retains inherent authority to short-circuit or end-run the carefully prescribed statutory reclassification process in order to correct the same mistake,” Judge Brett Kavanaugh said, quoting D.C. Circuit precedent.
     Under the statute, the FDA must take certain procedural steps to rescind its approval, including a notice and comment period.
     “FDA obviously thinks notice and comment is unnecessary here, a not-uncommon sentiment among agencies that want to take action more promptly. But notice and comment helps to prevent mistakes, because agencies receive more input and information before they make a final decision,” Kavanaugh said.
     In addition, it is not clear that the agency’s acquiescence to political pressure so tainted its review of the collegan scaffold as to warrant bypassing the statutory requirements.
     The FDA’s internal report on the review process acknowledged that the letters from New Jersey senator’s in support of ReGen were not inappropriate, and “found no evidence that [the] supposed defects affected FDA’s decision,” the 16-page opinion said.
     Judge Nina Pillard dissented, saying, “I believe the majority errs in reading the Act to require that the agency’s erroneous approval of a medical device via the abbreviated substantial equivalence process remain frozen in place unless the agency takes the long way around, through notice and comment rulemaking required for ‘Classification Changes,’ to undo it.”
     She said Congress did not intend the statutory framework cited by the majority opinion to displace the FDA’s authority to correct its own mistakes.

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