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FDA admits mistake in overruling scientists

Fri., Oct. 15, 2010

WASHINGTON – The Food and Drug Administration acknowledged Thursday that it made a mistake in overruling its own scientists and approving a knee implant after the agency was lobbied by four members of Congress.

The FDA said in a statement it will seek to remove the device from the market, but also will meet with the company that makes it, ReGen Biologics Inc. of Hackensack, N.J., to see if the implant could win approval in a new application.

The device, called a Menaflex Collagen Scaffold, was approved by the FDA in December 2008 to repair and reinforce the meniscus, in the knee joint.

The approval came over the objections of FDA scientific staff who said the device offered little benefit over existing treatments.

Four New Jersey Democrats, Sens. Frank Lautenberg and Robert Menendez and Reps. Steven Rothman and Frank Pallone Jr., lobbied FDA administrators on behalf of ReGen.

In early 2009, a group of FDA scientists complained to Sen. Charles Grassley, R-Iowa, that the approval was one of several in which politics won out over scientific decision-making.

In a September 2009 review, the FDA stated that several employees “describe the ReGen matter as among the worst experiences of their professional careers because of … pressure on agency decision-makers” from members of Congress, lobbyists and “from FDA leadership – in particular the FDA commissioner.”

The FDA’s admission of error “is very good news,” said Francesca Grifo of the Union of Concerned Scientists. “There’s an inherent tension between businesses with millions of dollars on the line and FDA scientists seeking to determine if a product is safe and effective.”


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