FDA Testing Criticized Again


One would think the Food and Drug Administration (FDA) would get their house in order after a barrage of criticism for various bungling.  The latest, according to the Wall Street Journal, involves accusations from two respected medical journals that say the FDA has approved cardiovascular medical devices based on inadequate and biased tests.

The latest revelation comes as the troubled agency is under strained pressure to overhaul their medical-device approval process after several acknowledged blunders, including approbation of a knee device last year due to political pressure.

The acting director of the FDA’s device division, Jeffrey Shuren, conceded weaknesses in clinical trials for some cardiovascular devices but he contends that the agency has begun ‘toughening standards’ for device approval and intends to do more.

One of the critical articles appeared yesterday in the Journal of the American Medical Association (JAMA) saying many cardiovascular devices are approved based solely on one study, even though they are subject to the FDA’s most ‘stringent review’ process. The JAMA paper concluded that standards are weaker than those used for drugs, which usually require layers of testing.

“The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can,” said JAMA study researchers.

The second study appeared in the American Journal of Therapeutics (AJT) and included an FDA cardiovascular device reviewer as an author.  The researchers determined that studies submitted for cardiovascular device approval “frequently lack important details” such as information regarding research’s participants.

JAMA and AJT researchers scrutinized about 80 cardiovascular devices that were approved from 2000 through 2007.  An American Journal of Therapeutics study author said the unreliability of the data “is why we have been pushing the FDA to raise its clinical trial standards for medical devices.”

A spokeswoman for the device industry’s main advocacy group countered that JAMA study authors didn’t have access to all of the data companies submit to the FDA before receiving approval.

Moot point…researchers had enough information to reveal the obvious: the FDA must adhere to their job description to prevent questionable, potentially dangerous drugs and devices from ever reaching consumers.