Friday, September 25, 2009

FDA Admits Improper Medical Device Approval--and it plans to fix its process/NYT

Important article by Gardiner Harris about the new, improving FDA:
The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting...

The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions,” Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, said in a conference call with reporters...

The F.D.A.’s report said that its Office of Legislation began receiving calls from members of Congress in December 2007 complaining about its review of the device, and the office’s director “described the pressure from the Hill as the most extreme he had seen.”

...On Wednesday, the agency asked the Institute of Medicine to review the entire process by which the agency approves the vast majority of medical devices. The agency report was deeply critical of its device approval process and said that confusion over basic rules and how to resolve differences among reviewers was rife. For decades, most medical devices have received only cursory reviews of their safety and efficacy from the agency.  For equipment like bed pans and shower curtains, experts agree that quick appraisals are appropriate. But the medical device industry is producing more and more complex machinery like pacemakers and stents.

In January, the Government Accountability Office concluded that it was long past time that the agency demanded that manufacturers prove that all complex devices are safe and effective before being approved for sale.
UPDATE:  Here is a sampling of how the game worked, according to the Washington Post.  The device manufacturer paid $300,000 to one of its lobbyists, Michael H. Hutton, who happened to be the former chief of staff of New Jersey Senator Robert Menendez.  (Menendez happens to be a Cuban American who is used to employing hardline tactics to enforce Cuba policies he favors.)  The lobbyist then "contributed nearly $40,000 to Menendez and three other Democrats"--obscuring the source of the funds, which really originated with the device manufacturer.  It seems almost fitting that a Senator with "kneecap-breaking" propensities got a device approved for knee injuries, which resulted in the need for re-operations on the knee since the device was ineffective.

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