Report: FDA Ignores Safety Regs, Risks Lives

Photo from flickr user <a href="http://www.flickr.com/photos/1987porsche944/3283335473/" target="blank">1987porsche944 (Infinite recursion)</a> used under a Creative Commons license

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From last year’s outbreak of salmonella-tainted tomatoes, to an internal analysis (PDF) warning the agency can’t adequately regulate new medical devices or protect the safety of the nation’s food supply, all the bad publicity the Food and Drug Administration has earned in the last two years revealed an agency plagued by lack of funding and incompetence.

A report released Wednesday by Project on Government Oversight, a Washington-based watchdog group, adds another item to the list of bad ink for the FDA, this one a product of downright negligence.

POGO alleges the Food and Drug Administration deliberately disregarded regulations governing non-clinical tests of medical devices such as defibrillators, pacemakers and stents.

According to the report, officials at the Center for Devices and Radiological Health decided not to subject certain devices to the rigorous testing outlined by the Good Laboratory Practice regulation, which ensures the accuracy and integrity of safety data submitted to the FDA. Why? It isn’t quite clear. GLP testing can be costly and lengthy. According to the whistle-blowers (PDF) who contacted POGO, employees were pressured to overlook any false data submitted by device manufacturers who didn’t subject their products to GLP oversight.

An excerpt from one letter sent to POGO by an anonymous FDA staffer:

There is mandatory indoctrination of employees to overlook fraud and omissions in applications. Also incentives (bonuses, outstanding appraisals, and public recognition) reinforce this behavior.

And another:

Irresponsible management, supervisors, and team leaders have put corporate interests above public safety and undermine the health and lives of American citizens. The world does not know about the government’s ineptitude in the review of medical and radiological devices.

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SIX TRUTHS

Reclaiming power from those who abuse it often starts with telling the truth. And in "This Is How Authoritarians Get Defeated," MoJo's Monika Bauerlein unpacks six truths to remember during the homestretch of an election where democracy, truth, and decency are on the line.

Truth #1: The chaos is the point.

Truth #2: Team Reality is bigger than it seems.

Truth #3: Facebook owns this.

Truth #4: When we go to work, we're in the fight.

Truth #5: It's about minority rule.

Truth #6: The only thing that can save us is…us.

Please take a moment to see how all these truths add up, because what happens in the weeks and months ahead will reverberate for at least a generation and we better be prepared.

And if you think journalism like Mother Jones'—that calls it like it is, that will never acquiesce to power, that looks where others don't—can help guide us through this historic, high-stakes moment, and you're able to right now, please help us reach our $350,000 goal by October 31 with a donation today. It's all hands on deck for democracy.

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