Congress finally takes a hard look at FDA's slipshod device approvals

Well it's about time: there are actually some members of the government in our esteemed Congress that are turning their attention to the FDA's incredibly sketchy and suspect approval process on medical devices.

Who knows? Maybe they'll actually save a life or two…

At a recent hearing examining the issue, Democratic Rep. Frank Pallone said that the system's standards, procedures, and rules, "don't meet modern standards of getting medical devices to those in need with confidence in their safety."

Not to toot my own horn, but I've been saying this for years. As you know, I'm always happy (and a little stunned) when someone - especially someone in the government - calls the FDA on the carpet for its inefficiencies and spotty standards. And I've written to you before about the federal agency's penchant for approving medical devices for market with scant and inadequate testing.

Not long ago, there was the case of a cardiologist who questioned the FDA for putting its stamp of approval on a new electrical component for implantable heart devices before any tests had been run on the component's wiring. Remember: this was an implanted defibrillator which regulated heart beats, and yet the FDA didn't feel there was the need to be sure that every precaution had been put in place that the wiring used in these items wouldn't short circuit - a problem that would be lethal to the patient.

Coincidentally, one of the witnesses at the congressional hearing was the head of the nonprofit Medical Devices Safety Institute, who cited the recall of several defibrillator wires as proof of the FDA's ineptitude.

Honestly, if you think too much about the fact that the only thing between you and an unintended medical catastrophe is the FDA, you're sure to lose a lot of sleep.

Thankfully, this time it seems that it's not just a lone congressman turning his attention on the FDA in order to do some political grandstanding. The government's General Accounting Office (GAO) has also weighed in on the issue, with one GAO official claiming that not only is the FDA's pre-approval system on medical devices a wreck, but that the agency also fails to do adequate follow up on medical devices once they've been approved for market.

The congressional hearings covered all medical devices (which, believe it or not, actually include tongue depressors - and perhaps the fact that our government considers an oversized popsicle stick a "medical device" says a lot about why the government should stay out of the healthcare biz). The hearings found that the FDA has compounded the problems caused by its rubberstamp approval process with a failure to fully investigate the countless thousands of reports claiming that "safe" devices were hurting patients.

Remember: we're just talking about medical devices here. As you well know, the FDA is also tasked with the approval and monitoring of ALL the drugs manufactured, imported, and sold in the U.S. And don't forget - they just got the added responsibility of keeping an eye on America's vast tobacco industry thanks to President Obama.

I hate to defend the FDA in any way, but how can an overburdened federal agency that's already flubbing the job for which they've been created be expected to function more smoothly with even more responsibilities?

As heartened as I would like to be that the FDA is getting some needed time under the public microscope, my only fear is that politicians will simply impose stricter (read: more bureaucratic) systems to "correct" the FDA's approval issues - and that will just make things worse.

When it comes to the FDA, the only decent solution is to blow it up and build a new health and safety organization from scratch.