It appears that the entrenched bureaucracy known as the FDA may still be in need of that complete overhaul promised by the Obama administration. The FDA admitted last week that four New Jersey congressmen and a former FDA commissioner unduly influenced the approval decision last year of a patch for injured knees. The good news is the FDA is now revisiting that decision.
The device in question is Menaflex, a C-shaped patch used to repair a damaged meniscus in the knee, manufactured by ReGen Biologics, Inc. which had been repeatedly and unanimously declined over many years because the device often failed, forcing patients to undergo unnecessary second operations.
The FDA’s clinical trials showed the Menaflex medical device did not perform any better than standard surgical procedures. But after repeated extreme pressure from four New Jersey congressman and the former FDA commissioner, the agency overruled its scientists and approved the device for sale in the waning days of the Bush administration in December 2008. It’s not surprising that the four legislators received thousands of dollars in campaign contributions from ReGen executives.
The good news? This is the first time the FDA has publicly questioned its own approval process and admitted that a regulatory decision was influenced by politics. Perhaps this is the first of many good decisions by departments under the Obama administration that will benefit patients instead of the medical device and pharmaceutical manufacturers. The safety of the American public is, after all, the mission of the FDA.
Richard J. Arsenault, 2011
