FDA Concedes Mistakes In Approval Of Knee Device

The Food and Drug Administration doesn't often admit mistakes, but the agency today acknowledged all kinds of irregularities in its controversial approval last year of a device to repair damaged knees.

A report on an internal investigation of the agency's handling of the application by ReGen Biologics for an implant to replace torn cartilage in knees raised "troubling questions" about the process that warrant a "reevaluation" of the decision.

In a conference call with reporters, Joshua Sharfstein, FDA's principal deputy director, said the investigation found "definite threats" to the integrity of the agency's process for looking at medical devices, the Wall Street Journal reported.

In March, the Journal reported that a top agency official, responding to pressure from ReGen and members of Congress, overruled staff scientists to approve the implant. FDA reviewers were concerned about the safety of the device Menaflex and insufficient data showing its effectiveness.

In a related move, the FDA asked the Institute of Medicine to take a look at how the agency reviews the majority of medical devices, a process called 510k premarket notification. A final report isn't expected until March 2011.