<img alt=“menaflex.jpg” src=“https://blogs.nature.com/news/thegreatbeyond/menaflex.jpg” width=“200” height=“272” align=“right” border=0 hspace="10px">The US Food and Drug Administration admitted yesterday that political influence led to the agency’s decision last year to approve a device to repair damaged knees against the recommendation of its own scientists.

Since 2006, the FDA’s scientific reviewers have twice turned down applications for the device, known as Menaflex and manufactured by ReGen Biologics of Hackensack, New Jersey, according to an FDA report. The company did not show “that patients who received the device experienced any benefit”, one scientist wrote in a rejection letter. (AP)

But following persistent lobbying from four New Jersey Democratic congressmen — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr and Steven R. Rothman — FDA officials overruled the scientists’ advice and granted approval for the US$3,000 knee patch last December. All four legislators received significant campaign contributions from ReGen; for example, Rothman alone took in US$13,300 last year, according to OpenSecrets.org.

The director of the FDA’s device division who gave the go-ahead, Daniel Schultz, resigned last month following numerous safety concerns and other scandals. (Reuters)

ReGen’s approval “constitutes a clear deviation from the principles of integrity”, the FDA wrote in a report analyzing its review process.

A senior FDA official described the political pressure 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”, according to the report.

Gerald E. Bisbee Jr, chairman and CEO of ReGen, said that the device was safe and he defended the company’s involvement with lawmakers. “We did what people do all the time in Washington: we went to our congressmen, we went to our senators,” he said. (NY Times)

Yesterday’s report came one day after the FDA announced it was asking the Institute of Medicine to evaluate the rapid-approval process for certain medical devices, known as the 510(k) program. The procedure was set up to clear simple devices, such as bandages and wheelchairs, without requiring thorough clinical trials, but a January report from the US Government Accountability Office found that it had been used to approve hundreds of high risk devices including pacemakers and replacement heart valves.

Senator Charles Grassley (Republican, Iowa), a frequent critic of the FDA, welcomed the report’s findings. “The report today is more good news about the FDA recognizing the shortcomings in its review process for the majority of medical devices,” Grassley said in a statement. For more on Grassley’s crusade against governmental science agency excess, see the feature story in last week’s Nature.

Image: ReGen Bio