F.D.A. Says It Approved Device in Error After Official Pressure

Posted on Oct 19, 2010 in Uncategorized

By GARDINER HARRIS

WASHINGTON — The Food and Drug Administration vowed Thursday to reverse the approval of a patch for injured knees that it granted in 2008 after being pressured by four New Jersey congressmen and its own commissioner.

The patch, known as Menaflex and manufactured by ReGen Biologics Inc., works in a fundamentally different way than devices that ReGen had claimed were similar enough that Menaflex did not need to be tested thoroughly, the F.D.A. decided. Its approval was an “error,” the agency said in a press release.

“These differences can affect the safety and effectiveness of the Menaflex device,” the agency said. “Because of these differences, the Menaflex device should not have been cleared by the agency.”

The F.D.A. has never admitted that it approved a drug or device mistakenly, never reversed such an approval without citing new information about the product, never acknowledged that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

But last year, a group of unhappy medical officers within the F.D.A. complained to Senator Charles E. Grassley, Republican of Iowa, that the ReGen decision was one of several at the agency in which politics trumped science.

The agency responded by releasing a detailed report last year that found that its scientific reviewers had repeatedly and unanimously over many years declared the Menaflex device as unsafe and unworthy of approval, but that they had been overruled by agency managers under political pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman.

All four lawmakers, as well as the F.D.A. commissioner at the time, Dr. Andrew C. von Eschenbach, said they acted properly.

The lawmakers made their inquiries about Menaflex after receiving significant campaign contributions from ReGen, which is based in New Jersey.

Patients who have already had Menaflex inserted into the knee should probably keep it there, the F.D.A. said, because the device is eventually absorbed by the body and replaced with new tissue.

“However, patients who have had the Menaflex device implanted should talk with their surgeon or other health care professional about what, if any, steps should be taken,” the agency stated.