Responding to alleged political interference, the Food and Drug Administration will review the safety of an approved knee-injury aid.

In a report released yesterday, FDA employees performing an internal review of the process used to approve the device faulted “the agency's failure to respond appropriately to external pressure on decision-makers.” That pressure was exerted by the device manufacturer, ReGen, FDA political appointees, and even members of Congress.

ReGen is headquartered in New Jersey. And like any good medical product firm, it keeps a few congressmen in its pocket. Prior to the 2008 approval of the knee device, called Menaflex, FDA scientists warned it may not be safe. Then what happened, New York Times reporters Gardiner Harris and David M. Halbfinger?

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency’s commissioner, said he had acted properly. 

Even if they all truly believe they did act properly, shouldn’t four U.S. Congressmen and the FDA commissioner be sensitive to the appearance of impropriety? No matter how you spin this story, it reeks of corruption.

The story also underscores the need to reform FDA’s expedited review process for medical devices. FDA announced this week that it has asked the Institute of Medicine to review the process, known as 510(k). Merrill Goozner at GoozNews has the full scoop.