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

For indispensable reporting on the coronavirus crisis and more, subscribe to Mother Jones' newsletters.


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 didn't know what to expect when we told you we needed to raise $400,000 before our fiscal year closed on June 30, and we're thrilled to report that our incredible community of readers contributed some $415,000 to help us keep charging as hard as we can during this crazy year.

You just sent an incredible message: that quality journalism doesn't have to answer to advertisers, billionaires, or hedge funds; that newsrooms can eke out an existence thanks primarily to the generosity of its readers. That's so powerful. Especially during what's been called a "media extinction event" when those looking to make a profit from the news pull back, the Mother Jones community steps in.

The months and years ahead won't be easy. Far from it. But there's no one we'd rather face the big challenges with than you, our committed and passionate readers, and our team of fearless reporters who show up every day.

Thank you!

We didn't know what to expect when we told you we needed to raise $400,000 before our fiscal year closed on June 30, and we're thrilled to report that our incredible community of readers contributed some $415,000 to help us keep charging as hard as we can during this crazy year.

You just sent an incredible message: that quality journalism doesn't have to answer to advertisers, billionaires, or hedge funds; that newsrooms can eke out an existence thanks primarily to the generosity of its readers. That's so powerful. Especially during what's been called a "media extinction event" when those looking to make a profit from the news pull back, the Mother Jones community steps in.

The months and years ahead won't be easy. Far from it. But there's no one we'd rather face the big challenges with than you, our committed and passionate readers, and our team of fearless reporters who show up every day.

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

We have a new comment system! We are now using Coral, from Vox Media, for comments on all new articles. We'd love your feedback.