Gingrich Productions FDA Shouldn’t Get to Veto Apps FDA Shouldn’t Get to Veto Apps Have you heard of the Jawbone Up? The Fitbit? The Nike Fuel Band? Even if you don’t recognize the names of these fitness accessories that connect to your smartphone to track your daily exercise and sleeping patterns, chances are you’ve seen them. They’re suddenly on wrists everywhere. So far, the FDA hasn’t asserted the authority to regulate these fitness apps. But what will happen when Fitbit wants to include a heart monitor in its device? And what will happen when its app could suggest you visit your doctor to check out that irregular heartbeat? Under a law written in 1976--the same year Steve Jobs introduced the Apple I computer with 4 kilobytes of memory (less than the amount required to store this newsletter)--the FDA could regulate this or nearly any other health-related technology as a medical device. That means health apps and smartphone accessories, no matter how innocuous they might seem, might be subject to all the paperwork, bureaucracy, and delays the obsolete FDA approval process entails. This is an enormous barrier to innovation for the small and medium-sized companies which often generate the best new ideas. Many simply cannot afford to spend the years it takes to win FDA signoff before selling their products to consumers. That timeframe is no exaggeration. Withings, a company which sells a scale and body-fat calculator that connects to your iPad, has had to wait from two to three years for FDA clearance. In the world of consumer electronics, three years is an eternity. We are only seeing the early stages of a breakout in individualized medicine, but the few products that the FDA has approved suggest the field’s enormous potential. My friend Congressman Michael Burgess is a former physician who has a half dozen attachments for his iPhone to give him everything from his blood glucose level to a full electrocardiogram. Within the next few years, we could see incredible innovation that offers us much better health at much lower cost--if the FDA doesn’t get in the way of the low-risk apps and devices that could power it. Congress never intended for the FDA to have extensive control over consumer electronics, and it could scarcely have imagined the smartphone accessories and software that are now becoming possible. The agency simply lacks the competence and authority to regulate these products in a sensible way that does not stifle innovation. Two bills in Congress, the SOFTWARE Act in the House (H.R. 3303) and the PROTECT Act in the Senate (S. 2007), would reform the FDA so that it could approve low-risk software and devices efficiently and effectively. Champions of the future like Congresswoman Marsha Blackburn and her cosponsors in the House, along with Senators Deb Fischer and Angus King on the other side of the Capitol, understand that over-regulation of medical technology can be just a great a threat to our health as underregulation. And when it comes to low-risk devices that give consumers more information about their health, it can often be even more dangerous. Contact your representatives in Congress today and urge them to support this breakout legislation.
Posted on: Sat, 08 Mar 2014 12:49:53 +0000
Trending Topics
Recently Viewed Topics
© 2015