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The Food and Drug Administration said Thursday that it would rescind the approval of a patch for injured knees that it granted in error in 2008 after being unduly pressured by four New Jersey congressmen and its own commissioner.
The patch, known as Menaflex and manufactured by ReGen Biologics, was so different from earlier devices that it should have been tested far more thoroughly before approval, officials determined.
"We are concluding that the science does not support a decision to clear the device, and therefore we'll move forward to rescind" its approval, Dr. Jeffrey E. Shuren, director of the F.D.A.'s device center, said in an interview.
The F.D.A. had never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.
Gerald E. Bisbee Jr., chairman and chief executive of ReGen, said in a statement that the company was "weighing its options."
"The product has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients, and there has never been a safety issue associated with the device," Dr. Bisbee said.
Because of liability concerns, manufacturers rarely fight F.D.A. decisions to remove a medical product from the market. A ReGen appeal could keep Menaflex on the market for months or even as much as a year, Dr. Shuren said. Once the product's approval is rescinded, ReGen has the right to reapply to sell Menaflex, but must provide convincing evidence that the product is safe and effective, Dr. Shuren said.
Removing Menaflex from implanted knees is unnecessary because the device is eventually absorbed by the body, although patients should talk to their doctor, the F.D.A. said.
The controversy surrounding Menaflex began last year, when a group of F.D.A. medical officers complained to Senator Charles E. Grassley, Republican of Iowa, that the ReGen decision was one of several at the agency in which politics inappropriately trumped science.
The agency responded by releasing a detailed report last year that found that the agency's scientific reviewers had repeatedly and unanimously over many years declared Menaflex unworthy of approval, but that they had been overruled by agency managers after political pressure from four Democrats from New Jersey - Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman. The report also concluded that Dr. Andrew C. von Eschenbach, then the agency's commissioner, had become inappropriately involved in the decision, and that agency procedures had been bypassed.
All four lawmakers made their inquiries about Menaflex after receiving significant campaign contributions from ReGen, which is based in Hackensack, N.J. Dr. von Eschenbach and the four lawmakers said they acted properly.
Dr. Robert Smith, a former F.D.A. device reviewer who was among those who complained to Senator Grassley, said in an interview that the agency had yet to discipline the managers responsible for the ReGen decision. Some of those managers have since left the agency.
"There was serious managerial wrongdoing during the clearance of the device, and that needs to be investigated, and the managers involved need to be held accountable," Dr. Smith said.
Dr. Shuren responded that widespread confusion within the agency about how decisions should be conducted was to blame for the mistakes. He said the agency was in the midst of changing its device approval process, was clarifying how differences within the agency should be resolved, would will soon make clear how parties outside the agency could appeal its decisions.
Published: October 14, 2010