Menaflex Approval Influenced by Political Pressure, FDA Report Says

Influenced by political pressure A report from the Food & Drug Administration (FDA) says the agency  caved to political pressure when it approved ReGen Biologics Inc.’s Menaflex knee device.  According to The Wall Street Journal, the FDA is now reconsidering its approval of Menaflex.

Menaflex is meant to repair a torn meniscus, which basically acts as a shock absorber for the knee. Menaflex was approved through a process known as 510(K), which doesn’t require human clinical trials, and is meant for devices that are substantially similar to products already on the market.

As we’ve reported previously, ReGen’s 510(K) application for Menaflex was rejected by FDA scientists on three occasions, with the agency’s staff asserting it wasn’t eligible for the process.

But several New Jersey Democrats – Sens. Frank Lautenberg and Robert Menendez, and Reps. Steve Rothman and Frank Pallone Jr. – contacted the FDA in 2007 and 2008 to encourage it to speed its review of the ReGen device, The Wall Street Journal said.  Agency managers  ultimately overruled the scientists and approved Menaflex in December.

FDA officials repeatedly deviated from procedures

The report issued yesterday said the FDA  officials repeatedly deviated from procedures in approving Menaflex, the Journal said.  According to the report, the FDA’s Congressional Liaison said the pressure put on the agency  was “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.”

The document also criticized  former FDA Commissioner Andrew von Eschenbach for pressuring other FDA officials to act quickly.

In a conference call yesterday, FDA Deputy Commissioner Dr. Joshua Sharfstein said the FDA will be reviewing the approval of Menaflex, and that it could take the agency a few months to decide if the device should stay on the market.

He also said that the Menaflex approval was one of the reasons the FDA had decided to review the 510(K) process.  As we reported, the FDA has commissioned the Institute of Medicine to conduct that review.

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