The U.S. Food and Drug Administration, charged with the important job of keeping food, medicines and medical devices safe, should be independent of political pressure. But it seems no government agency is immune from elected officials who abuse their power for their own gain, with little regard for the health and safety of Americans, including their own constituents.
The FDA said last week that it had approved a patch for injured knees last year under pressure from four New Jersey congressmen and its own commissioner, who has since resigned. The device's manufacturer donated to all four politicians, who demanded the device be approved, despite tests showing it had little or no medical benefit.
The agency's own reviewers unanimously recommended against approving the device, known as Menaflex and manufactured by ReGen Biologics Inc., based in New Jersey. Many patients who received Menaflex during testing had to have further surgery after it failed.
But four New Jersey Democrats -- Sens. Robert Menendez and Frank R. Lautenberg and Reps. Frank Pallone Jr. and Steven R. Rothman -- put tremendous pressure on the agency to approve the device anyway. The new FDA report called their repeated calls and letters "extreme," "unusual" and "persistent."
Their efforts paid off handsomely for the congressmen, if not for patients who received the device. Beginning in October 2007, ReGen executives donated a total of $26,000 to the four representatives not
Somehow, we doubt that.
ReGen's CEO says, "We did what people do all the time in Washington: We went to our congressmen, we went to our senators." Sadly, we do not doubt that.
In January, the Government Accountability Office said the FDA needs a thorough housecleaning because its approval methods rely too much on precedent -- whether similar devices have been approved in the past. The GAO rightly says the agency must start demanding that manufacturers prove the safety and effectiveness of each and every complex device before it goes on the market.
The current system requires only cursory reviews of complex medical devices. That has to change. And Congress members should butt out of the process entirely.



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