With previous rumored Trump picks to lead the FDA, we’ve had to rely on speculation to gauge their approach to mobile and digital health. Not so with former FDA deputy commissioner Dr. Scott Gottlieb, Trump’s final pick as of Friday.
Gottlieb, who will still have to be confirmed by the Senate, has made his feelings about mobile health regulation very clear. In 2014, he co-authored a piece for the Wall Street Journal about the FDA's approach to mobile health and in 2015 he wrote a piece for Forbes. In both, he argued that FDA regulation of mobile health stifles innovation for little benefit.
“The ambiguity created by the guidance and the agency's premarket review processes forces innovators to seek the FDA's nod for every new launch and every small advance,” Gottlieb and co-author Colleen Klasmeier wrote for the Journal. “This slows progress to a crawl. Worse, the lag may be almost entirely unnecessary, as most of these products are not properly regarded as a medical device in the first place.”
Gottlieb argues that regulation for mobile health should be the exception, not the rule.
"Most of these products pose very low risk to consumers," Gottlieb wrote in the Forbes piece. "They’re meant to help people track and interpret their own health information. In that respect, they often do little more than help consumers organize information that they could glean for themselves – albeit far less reliably – using the Internet. But since many of the more sophisticated offerings help people diagnose their own illness, FDA says they meet the definition of being a medical device. That makes them subject to a regulatory scheme that was crafted more than 40 years ago, before these technologies were ever imagined.”
Specifically, Gottlieb argues that the point at which a digital health device or app requires regulation is exactly the point at which it becomes innovative, and as a result large companies like Apple are “dumbing down” consumer products, excluding health features they technically could build to elude the FDA.
“FDA has said it doesn’t intend to regulate ‘general wellness’ apps and mobile tech, like fitness and calorie trackers,” Gottlieb wrote in 2015. “But if these platforms make disease-specific claims, FDA wants to review them. When does an app cross that line? Any time it does something smart. Envision a nutrition app that counts your calories and tracks how your diet might raise or lower your risk for diabetes, or cause blood sugar surges. Or an app that helps correlate your symptoms with a list of probable causes.”
As to a solution, Gottlieb has advocated passing responsibility for digital health tools away from the FDA entirely, either to a newly created government group or to the industry to self-regulate. This is a solution that can sometimes evoke eyerolls, but Gottlieb contends that it’s exactly what was done with EHRs at a time when they were a political priority and those in power at HHS didn’t want their adoption to be stymied by FDA regulation.
As FDA commissioner, Gottlieb would have the opportunity to put these ideas into action, assuming his stance hasn't changed over the last few years. If he does, and he’s right that companies are currently holding back innovations, Gottlieb’s tenure could turn out to be a very interesting one for the digital health space.
