The Food & Drug Administration admitted to undue influence from four congressmen and former commissioner Andrew von Eschenbach in its approval of ReGen Biologics’ Menaflex knee implant despite opposition from FDA scientists, according to news reports.
The approval came despite the fact that the device, used to repair torn knee cartilage, often failed and required second operations. An FDA report called pressure from four New Jersey Democrats — Sens. Robert Menendez and Frank Lautenberg and Reps. Frank Pallone Jr. and Steven Rothman, all of whom received “significant” campaign contributions from New Jersey-based ReGen, according to the New York Times — extreme, unusual and persistent and said it helped lead agency managers to overrule the agency’s scientists.
The legislators all said they had acted appropriately and were not influenced by the money. For his part, von Eschenbach also denied any impropriety.
“My responsibility as that process was coming to a close was to make sure that it was continued in an orderly and appropriate fashion, and that’s what I believe I did,” he told the Time.
It’s the first time the FDA has gone public with questions about its own approval process and admitted that politics played a part in approving a device or drug.
The criticism of a former commission is also unprecedented, but it’s not the first time von Eschenbach has drawn fire. Critics cited the George W. Bush appointee, who helmed the agency from 2006 until earlier this year, for apparent conflicts of interest as FDA chief. He was director of the National Cancer Institute and founder of anti-cancer forum C-Change while he was FDA commissioner.
The FDA’s report said the political pressure moved von Eschenbach to become “personally engaged” in the approvals process, which is typically handled by scientific staff, and “was demanding not only an expedited process but also an outcome in favor of ReGen.”
“Congressional interest in the ReGen matter — and the unusual responsiveness of the commissioner to that interest — initiated a chaotic new phase in the agency’s handling of the [ReGen application],” according to the report.
“The message here is that there were problems with the integrity of FDA’s decision-making process that have solutions,” principal deputy commissioner Joshua Sharfstein said in a conference call with reporters, adding that patients who have already been implanted with a Menaflex device should wait for a full review of the device’s approval.
ReGen chairman and CEO Gerald Bisbee Jr. told the newspaper that the report was “inaccurate” and defended the company’s lobbying efforts and political donations.
“We did what people do all the time in Washington: We went to our congressmen, we went to our senators,” he told the Times.
The report, a rare peek under the FDA’s hood, won’t be the last. The agency tapped the Institute of Medicine for a $1.3 million audit of its 501(k) medical device approval process.
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