F.D.A. Admits Error in Approving Knee Device

[mmglobal]

From: http://www.nytimes.com/2009/09/25/he...?_r=1&emc=eta1

By GARDINER HARRIS
Published: September 24, 2009

WASHINGTON — The Food and Drug Administration admitted Thursday that it mistakenly approved a patch for injured knees last year after being pressured by members of Congress and the manufacturer.

The agency promised to re-evaluate the approval.

Internal documents demonstrate that agency’s scientific reviewers repeatedly determined that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving inquiries from four New Jersey legislators — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries after receiving campaign contributions from ReGen.

ReGen declined to comment Thursday on the agency’s action.

The report, sharply critical of the agency and the lawmakers, demonstrates the sharp departure from the past that the Obama administration intends to take in approving devices and publicizing its internal deliberations.

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.

Both the request to the Institute of Medicine as well as the agency’s reassessment of its approval of ReGen’s knee device augurs poorly for the entire medical device industry, for whom the F.D.A. is a crucial gatekeeper. 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 manufacturers prove that such complex devices are safe and effective before being approved for sale.

[mmglobal]

I don't know the implications of this. All I know is that I feel very safe using FDA approved bedpans and shower curtains. Slowing down the process for devices will be a double-edged sword - much like the one we are already used to.... It may save us from inappropriate use of unproven technology, and it also may keep us from gaining access to the life-saving technology that we truly need.

A crystal ball (one that tells the truth) would certainaly be useful here!

Mark

[sahuaro]

This is very disturbing from both ends: first, that a device was approved because of political/financial pressure and second that it will be more difficult to have new devices approved.