The FDA is codifying its regulations around mobile apps that go along with prescription drugs, offering a clearer framework for drug companies that want to get in on the evolving digital health technology landscape.
Through a final guidance (PDF) on the topic released Oct. 20, the agency is ending “longstanding uncertainty” with recommendations on which in-app content is subject to FDA submission requirements, when apps should be included in drug labeling and more, it explained in a press release.
Importantly, the guidance groups two distinct categories of mobile apps or “companion software,” with each subject to different regulations. Apps connected to a medical device, such as those that go along with an asthma inhaler, for example, should be included in the associated drug’s official prescription label, as the technology plays a key role in how the product is used.
Meanwhile, “standalone apps” like symptom trackers, dose reminders or health coaching tools should only show up on a drug’s prescribing label if the drugmaker is able to demonstrate that the app is necessary for safe and effective use or can prove a meaningful clinical benefit, the FDA said. If not, that information will be treated as promotional labeling, not FDA-required labeling.
In most cases, the agency said, content that a standalone companion app shows its users will be treated as promotional material, and “consistent with how the FDA handles other drug advertising.”
As the FDA’s deputy commissioner for technology Jared Seehafer pointed out, companion apps are “quickly moving beyond simple dose reminders toward tools that adapt to each patient,” he said in the agency release. “Finalizing this guidance gives drug companies and their technology partners a stable foundation to build on as these technologies advance and helps ensure patients and providers can trust the information they receive.”
“This guidance reflects FDA’s commitment to responsible, risk-proportionate oversight of digital health, an area that is a key priority for the agency and is evolving rapidly and holds significant promise for improving patient care,” director of the FDA’s Center for Drug Evolution and Research (CDER) Michael Davis, M.D., Ph.D. added. “By aligning our approach across drug and device centers, we are giving developers a clear and consistent pathway to bring safe, effective digital health technologies to patients.”
When the draft guidance that the new final guidance replaces originally came out in 2023, legal experts at global law firm Sheppard called the move a “significant step” in the formation of the FDA’s regulatory framework for digital health products, an area that is “consistently evolving to keep up with the rapid pace of innovation.”
Mobile apps were once a major innovative addition to certain drug devices that have now become the norm in products like continuous glucose monitors (CGMs) for diabetes. On the pharma side, meanwhile, in-app counterparts are used as another key marketing tool reflective of the recent migration away from linear TV as the primary outreach channel for pharma advertising.
In 2020, WeGo Health found that while in-house pharma apps weren’t taking off as much with patients, companies were finding success in collaborations with other app makers. The sentiment rings true today, with several tie-ins popping up to help companies boost awareness within their treatment areas.
Eisai, for one, recently teamed up with the Pokémon Sleep App to raise awareness of the importance of good sleep, while Daré Bioscience laid the groundwork for its female sexual arousal drug launch by partnering with women’s health app Rosy Wellness on a series of sexual health education content promoting and explaining the product.
This summer, Bausch + Lomb rolled out a dry eye disease education push through Verily Me, offering expanded information about dry eye disease risk factors, symptoms and treatment options through the app. AI platforms such as Verily Me have carved out a niche of their own in the digital space recently, building on the popularity of AI tools and providing patients with a free and accessible route to personalized health advice.
With the rapid evolution of AI tech and other digital software, the FDA emphasized its “ongoing commitment to modernizing its regulatory framework” to keep pace, it said in its Oct. 20 release, pledging to “reduce unnecessary uncertainty for developers and manufacturers” while keeping the safety and effectiveness standards many rely on.