Device approval exposes political pressure on FDA

WASHINGTON (AP) ¿ The Food and Drug Administration has taken the unprecedented step of acknowledging that it buckled to "extreme" pressure from Capitol Hill in its approval of a knee repair device last year. While FDA officials call the situation an anomaly, experts said Friday there is nothing to stop similar political lobbying from influencing future decisions.

In a sweeping critique Thursday, FDA leadership said the agency failed to protect its scientists from outside pressure after they twice rejected ReGen Biologics' Menaflex device.

The Hackensack, N.J.-based company ultimately won approval last December after enlisting the support of four New Jersey lawmakers, who urged then-FDA Commissioner Andrew von Eschenbach to intervene on the company's behalf.

Approval came despite protests by FDA scientists that Menaflex ¿ which reinforces damaged knee tissue ¿ provided little, if any, benefit to patients.

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