GAO Finds Fault with FDA Approval Process

FDA Adverse Event Information, Medical Device Approval Process, and FDA Corruption

GAO Finds Fault with FDA Approval Process

PostPosted by DCNGA » Wed Apr 13, 2011 3:48 pm

http://www.nytimes.com/2011/04/13/healt ... ss&emc=rss


Group Faults the F.D.A. on Oversight of DevicesBy BARRY MEIER

The Food and Drug Administration is allowing some high-risk devices like artificial hips to be sold without strenuous testing, despite promises that it would address regulatory issues affecting them, a federal watchdog group plans to testify on Wednesday.

The group, the Government Accountability Office, found that the F.D.A. has taken some recent steps to determine if certain high-risk medical devices should undergo more testing before being sold. But in the meantime, it is continuing to approve dozens of such devices annually with scant review, exposing patients to risks.

An official with the office is expected to give the testimony on Wednesday at a hearing before the Senate Special Committee on Aging. The office will also present its preliminary findings of what it concluded were shortcomings in how the F.D.A. oversees recalls of troubled devices.

A spokeswoman for the F.D.A., Karen Riley, said that officials there had not seen the G.A.O. testimony and so could not respond directly to it. She added that F.D.A officials planned to testify at the hearing. The panel is also expected to hear from patient advocates and industry representatives.

Among other issues, the Senate hearing is expected to examine the approval and marketing of a now-recalled artificial hip sold by Johnson & Johnson known as the A.S.R., or Articular Surface Replacement. An article last December in The New York Times detailed how the medical products giant continued to sell the hip despite repeated reports by physicians abroad that it was faulty.

The F.D.A. permitted Johnson & Johnson to sell the artificial hip without conducting clinical trials. A few years after implant, it began disintegrating in patients, shedding metallic debris that has left some patients crippled.

According to reports by doctors in England, the device may fail prematurely in about 50 percent of the patients receiving it.

The F.D.A. has two separate procedures for approving medical devices.

For devices that pose a lower level of risk to patients, a manufacturer need only show that a new product is substantially equivalent to one already on the market. For devices that are more critical, like implanted heart defibrillators, producers have to run clinical trials to win approval.

But some categories of high-risk products like artificial hips and external defibrillators that were already on the market when the F.D.A. began to regulate devices can still enter the market through the less-rigorous pathway. Safety advocates have long urged the F.D.A. to close that loophole.

In 2009, the G.A.O. issued a report recommending that the F.D.A. reclassify such devices either into the high-risk category, the one requiring more testing, or in lower-risk categories that do not require testing. The agency has started to do so, but to date it has not made final decisions for nearly all those products.

At the start of the Obama administration, F.D.A. officials indicated that they would take an aggressive approach to the regulation of medical devices. But in more recent months, they appear to have backed away from that stance.

The F.D.A. has asked the Institute of Medicine to review its device approval process. That group is expected to issue its report later this year.
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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