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


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.

THANK YOU.

We recently wrapped up the crowdfunding campaign for our ambitious Mother Jones Corruption Project, and it was a smashing success. About 10,364 readers pitched in with donations averaging $45, and together they contributed about $467,374 toward our $500,000 goal.

That's amazing. We still have donations from letters we sent in the mail coming back to us, so we're on pace to hit—if not exceed—that goal. Thank you so much. We'll keep you posted here as the project ramps up, and you can join the hundreds of readers who have alerted us to corruption to dig into.

We Recommend

Latest

Sign up for our newsletters

Subscribe and we'll send Mother Jones straight to your inbox.

Get our award-winning magazine

Save big on a full year of investigations, ideas, and insights.

Subscribe

Support our journalism

Help Mother Jones' reporters dig deep with a tax-deductible donation.

Donate

Share your feedback: We’re planning to launch a new version of the comments section. Help us test it.