Knee-Repair Device Reveals Political Pressures at the FDA

October 6, 2009
Category: Uncategorized

There’s an old adage, “Any publicity is good publicity,” but the exposure of four New Jersey lawmakers on the front page of the New York Times was anything but good news for them.  The article reported that Menaflex, a medical device that reinforces damaged knee tissue, was approved only after the two senators and two congressmen pressured then-FDA-Commissioner Andrew von Eschenbach.

According to FDA sources who spoke with the Associated Press, unprecedented access to the FDA commission was granted to Sens. Frank Lautenberg and Robert Menendez, and Reps. Frank Pallone and Steve Rothman (all Democrats). FDA staffers were quoted as describing the approval process for Menaflex as “the worst experience in their professional careers.” FDA scientists had twice rejected approval of the device, which is manufactured by ReGen Biologics, stating there was no benefit to patients. Von Eschenbach overrode the FDA’s own scientists after Lautenberg, Menendez, Pallone and Rothman leaned on him.
FDA officials called the situation “an anomaly.”  However, it is quite clear there is nothing to stop similar political pressure from influencing future decisions at the FDA. This betrays all U.S. consumers who count on the FDA for the safety of their food, medical devices and drugs.

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