On occasion, regulatory approval announcements in healthcare rise above the din and make headlines. Few have done so with the impact of Pear Therapeutics’ reSET, a treatment for substance addiction, which is so significant because it is neither a drug nor a therapeutic medical device, in the traditional sense: it’s an app that runs on smartphones, and it’s the first therapeutic software to win United States’ Food and Drug Administration approval. While this approval is specific to the U.S., the FDA can be viewed as the de facto arbiter of drug and medical devices for most markets.
Digital therapeutics can revolutionize healthcare but the regulatory complexities slow the innovation process. Health tech investors, innovators, and regulators have struggled for more than a decade to reach clear consensus on how software-based diagnostics and therapeutics should be regulated – or whether they should be regulated at all. Mobile apps with medical related functions can be subject to layers of regulation relating to medical devices, privacy, consumer protection, practicing medicine, advertising, kickbacks, data protection and intellectual property. To further complicate matters, regulatory requirements vary from country to country. This uncertainty can dissuade companies from innovating in this space, despite the promising public health benefits. Regulators have tried to provide guidance through white papers on the health claims app developers and other wellness devices (like smartwatches and wearables) are allowed to make but there is still great uncertainty for trailblazing use cases. Industry participants have sought regulatory approval for strong, FDA-backed claims of their apps’ efficacy in treating specific medical conditions such as addiction, attention deficit (ADHD), depression, chronic pain and more, so while Pear’s reSET is the first such milestone, but it likely won’t be the last.
However, while observers may expect that reSET’s precedent heralds an opening of the floodgates to FDA-approved, app based therapeutics, don’t bet on it. Perhaps a few other leaders in ‘digital therapeutics’ are poised to achieve approval within the year, including Akili Interactive’s Project EVO (a game which treats ADHD), but barriers to approval remain and will likely become steeper. While FDA approval is a critical step, hard and expensive work remains to establish billing codes in the US and elsewhere. Convincing insurers to pay for reSET will take time, and may require costly legal battles to enforce patient access. For example, the Mental Health Parity Act mandates insurance coverage and access to treatments for mental health in the US but its specific application to digital therapeutics may have to be tested and clarified in court. Early leaders may work to establish moats around their initial advantages. Regulatory winners like Pear will be strongly incentivised to push hard for FDA enforcement against the language and claims of other apps. The convergence of technology and health care make digital therapeutics poised to be the next intellectual property battleground to further increase the risks and obstacles for participants entering the arena.
Questions remain, too, about ‘side doors’ to market approval, including the FDA’s designation of “substantial equivalence,” the regulatory approval pathway most frequently used by competitors and generic followers of a new therapeutic. Active ingredients – the essential unit of a drug, from a regulatory standpoint – may not be as obvious in an app, and the long term market advantage of regulated digital therapeutics may turn on as-yet-undefined ‘digital active ingredients’. Pear Therapeutics’ FDA approved app is a key milestone for digital health but an early one.
Maya Medeiros is a lawyer, patent agent, and trade-mark agent at Norton Rose Fulbright LLP Canada (Toronto). Maya Medeiros’ practice focuses on the creation and management of intellectual property assets in Canada, the United States and around the world.
Dr. Graeme Moffat is VP Research and Regulatory Affairs at Toronto scale-up InteraXon, developers of the Muse brain sensing headband.