FDA finalizes guidance on prescription drug apps
The US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and label software applications (apps) used alongside prescription medicines. These can include apps that are used with asthma inhalers or stand-alone symptom trackers, dose reminders, or health coaching tools.
In an announcement, FDA said the guidance resolves “longstanding uncertainty by providing recommendations about when app content is subject to FDA submission requirements, when an app should be mentioned on a drug’s official label, and what companies should submit to the agency.”
The guidance clarifies how FDA intends to apply its drug labeling authorities to the output of prescription drug use-related software intended for end-users, and how FDA-required labeling, particularly the prescribing information (PI), should describe prescription drug use-related software functions. It also addresses when and how sponsors should submit end-user output to FDA.
In the final guidance, FDA defines prescription drug use-related software as including software that “is disseminated by or on behalf of a drug sponsor and produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products.” FDA regards end-user output from prescription drug use-related software as a form of prescription drug labeling.
“Mobile apps are playing a growing role in how patients manage their medications and health conditions,” said Captain Chris Wheeler, director of the division of medical policy programs within FDA’s Center for Drug Evaluation and Research (CDER). “This guidance helps ensure that the information these tools provide is accurate, evidence-based, and clearly communicated to both patients and their providers.”
The guidance revises a draft guidance issued on 19 September 2023. (RELATED: FDA releases guidance on labeling of drug use-related software outputs, Regulatory Focus 21 September 2023).
According to a Federal Register notice, the final draft clarifies the considerations for standalone software functions; introduces a decision tree to guide sponsors through labeling determinations; provides examples of PI language for both device-connected software and standalone software; and recommends adding a PI statement for device-connected software functions that do not demonstrate “meaningful improvement in a clinical outcome.”
There have also been certain terminology changes; the term “digital health technologies” has been replaced with “software with prescription drugs.” Additionally, Appendices A and B have been updated. Appendix A includes a decision tree for labeling related to prescription drug-use software, while Appendix B provides examples that describe the constituent parts of the device and the software functions connected to it within the prescribing information.
FDA said the guidance covers three key issues for industry: When app content is considered to be FDA-required labeling versus promotional labeling; when an app should be included in a drug’s official Prescribing Information (PI), and what companies should submit to FDA when they distribute app content to users.
The guidance categorizes companion software into two distinct types. The first type is software that is connected to a medical device, such as an app that pairs with an asthma inhaler. This type of software should be included in the drug’s official prescribing label because of the significant role it plays in the usage of the medication.
The second type covers standalone apps, which include symptom trackers, dose reminders, or health coaching tools. These apps should also be mentioned on the prescribing label if the company can demonstrate that the app is essential for the safe and effective use of the product or if it can show a meaningful clinical benefit.
The guidance states that “in most cases, content a companion app displays to users will be treated as promotional material, consistent with how the FDA handles other drug advertising.”
FDA stated that sponsors do not need to resubmit end-user output for software updates that do not alter the content of previously submitted outputs.
The agency said it plans to concentrate its review of end-user output on factors that could impact the safe and effective use of the drug, including considerations related to promotional labeling. “As FDA gains more experience with the PDURS [Post-Market Drug Utilization Review System] including updates to end-user output from PDURS submitted to FDA, we may provide additional guidance for certain kinds of updates/changes to end-user output.”
CDER Director Michael Davis said 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. y 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.”
“Companion apps are quickly moving beyond simple dose reminders toward tools that adapt to each patient,” said Jared Seehafer, FDA deputy commissioner for technology. “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.”
Final Guidance, Notice, Announcement
