If There's a Health App For That, the FDA Wants to Regulate It
Ready for the Food and Drug Administration to start regulating your iPad? It might not be long. This week, the agency released proposed rules governing regulation of applications designed to run on a host of handheld devices. Currently, there are about 200 million such medical apps in use, with about 600 million expected to be available over the next few years. But the FDA says its new rules will only cover a narrow slice of those apps—those that, say, operate medical hardware or perform dosage calculations for doctors.
At least for now, that is. The agency is clearly looking for an excuse to extend its regulatory reach even further. In addition to the relatively small class of apps its already plans to regulate, it will reportedly "monitor the performance of apps that fall outside of its guidance and then determine whether any additional measures are necessary to protect public health."
As with all such regulation, there are tradeoffs involved. More FDA oversight means medical apps will be slower to market and more expensive. And because these apps will be slower to develop and slower to release, fewer developers will want to commit to working on them, so patients and providers will have less access, overall, to medical technology on their mobile devices.
But what about consumer safety? Shouldn't the FDA be looking out for patients? On that front, we can already see instances in which the FDA's oversight of the traditional device market does more harm than good by needlessly delaying products with proven track records.
Earlier this week, the House Energy and Commerce Commission held a hearing on the FDA's device regulation process. They heard testimony from Marti Conger, a patient advocate who in 2006 was diagnosed with a severe spinal problem. After discussing options with her doctor, she decided she wanted an artificial disc replacement that would help her retain better neck motion and avoid chronic pain associated with other potential treatments. The only problem? The device she wanted to use wasn't yet approved by the FDA. Approval was supposed to take just a few months. It took a year.
It was a hell of a wait. "While I waited for device approval," she told members of Congress, "my spine degenerated to the point that my neurosurgeon and I feared I was in serious danger: all of my limbs were numb, my continence was a huge issue, my balance and grip unreliable. I was nearly a prisoner in my home for fear of paralyzing accidents."
Finally in 2009, after much delay and additional diagnosis, Conger got her treatment—in England. The implants she wanted to use were available there, but not in the U.S. Indeed, she told Congress, thanks to the FDA, they're still not available to many Americans: "The devices I traveled to England to receive have been available in Europe since 2005 with a strong track record, and are still years away from the marketplace in the US."
We may not see the same sort of truly heartbreaking stories as a result of the FDA's initial regulation of mobile medical apps, at least not right away. But the underlying effect on the market will likely be the same: Higher costs, longer waits for new treatments, and less access to medical technology that can ease an individual's pain, help doctors provider better care, or make completing a treatment regime easier.