Dueling Headlines: Does the FDA Take Too Long to Approve Medical Devices?

Sometimes, reading the news from day to day makes my head spin.

The New York Times headline  on Sunday, February 10 was “Medical Treatment, Out of Reach.” The opening paragraph outlined a southern California biotech company which had packed up and moved to Europe, because the FDA process for approval of cardiac stents took too long.   The article goes on to describe Americans traveling to Europe to gain access to implantable spinal devices not yet approved by the FDA.  American venture capital investment in the medical device sector is reported to have plummeted since 2007.

A tough approval process can lead to life-saving technology not being available to Americans.  It can also lead to higher prices from established manufacturers, who don’t face the competition of new ‘disruptive innovators.’ 

But just four days later, the Archives of Internal Medicine  published a review of 113 medical devices recalled by the FDA from 2005 to 2009.  This was covered in the Times under the headline “Recalled Devices Mostly Untested, New Study Says.”  Under 1/5 of these recalled medical devices had been approved through the standard FDA process; a staggering 71% were approved through the expedited process.  The Government Accountability Office recommended that high risk devices no longer go through the expedited process in a report in early 2009,   but this is apparently still not in effect.  The authors suggest that the FDA should increase the rigor of its evaluation of new medical devices – the rigor that the earlier article had decried. 

What’s the truth?

Many new devices do not increase competition or lower cost.  If the device displaces other more invasive medical therapy, it usually will cost the same or even more.   The track record of spinal disk implants is especially troubled; they often do not help patients nearly as much as promised.   

On the other hand, miniaturization has been a real boon to patients, and medical devices keep people’s hearts beating and keep people on their bikes and on the tennis courts – others hold some promise to treat various neurologic conditions.

The FDA has continued to promised to streamline its review of medical devices. 

It seems to me that patient safety should be paramount, and we should revise regulations to allow the FDA to consider cost-effectiveness in its decisions about approval of new devices. 

And my head will continue to spin as I read the newspaper from day to day.