There’s an App for That and Now FDA Has a Framework for It: FDA’s Final Guidance on Prescription Drug Use-Related Software

The US Food and Drug Administration (FDA) just released its final guidance, “Regulatory Considerations for Prescription Drug Use-Related Software” (the Guidance). The Guidance finalizes the September 2023 draft and sets out how FDA will apply its regulations to apps and other software that drug sponsors distribute for use with their prescription products, including AI-enabled software. For pharmaceutical and biotech companies, and the technology partners that build their companion apps, it brings needed clarity on three questions:

• when app content is FDA-required labeling versus promotional labeling;
• when software should be described in the Prescribing Information (PI); and
• what must be submitted to FDA when companies distribute app content to users.

FDA’s Guidance applies to a drug sponsor’s software that produces an “end-user output” that supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products, whether or not the software is itself regulated as a medical device. The Guidance affects prescription drugs and drug-led, drug-device combination products for which FDA’s Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) is the lead center. End-user output means any content the software presents to a patient, caregiver, or health care practitioner. FDA’s central premise is that this output is a type of prescription drug labeling.

How Does FDA’s Final Guidance Address Software Labeling, Promotion, and Device Oversight?

• App content is labeling. FDA treats end-user output as prescription drug labeling, so content a sponsor-distributed app displays is subject to FDA’s labeling framework.
• Device-connected software generally belongs in the PI. Software that works with a device constituent (for example, an app paired with a connected inhaler) generally should be described in the PI, given its central role in how the product is used.
• Standalone software faces a higher bar for PI inclusion. Symptom trackers, dose reminders, coaching tools, and similar standalone functions should be described in the PI only where the sponsor can show the function is essential to safe and effective use or delivers a meaningful clinical benefit. FDA expects most such content to be treated as promotional material, consistent with its approach to other drug advertising and promotion.
• New PI disclosure for device-connected functions without demonstrated benefit. In a change from the draft, the final Guidance recommends adding a PI statement for device-connected software functions that do not show a meaningful improvement in a clinical outcome.
• More practical tools than the draft. FDA clarified the considerations for standalone functions, added a decision tree for labeling determinations, and included illustrative PI language for both device-connected and standalone software.
• Coordinated drug and device oversight. FDA states that the Guidance aligns with digital health initiatives at the Center for Devices and Radiological Health (CDRH). The goal of consistent regulation and coordinated review where prescription drug use-related software is reviewed as a device.

What Should Drug Sponsors Do Next?

• Inventory your software. Identify every app, web tool, and software function disseminated by or on behalf of the company that relates to a prescription product, including tools built or operated by vendors and agency partners, and map each function to its end-user outputs.
• Classify each function using FDA’s decision tree. Determine whether each function is device-connected or standalone and whether it belongs in the PI, and document the rationale and supporting evidence, particularly for any claim that a standalone function is essential or clinically beneficial.
• Route app content through promotional review. Bring end-user output within the medical, legal, and regulatory (MLR) review process, confirm it is accurate, balanced, and consistent with approved labeling, and build in procedures for submitting promotional labeling to FDA as required.
• Govern updates as labeling changes. Software iterates quickly. Establish change control so that new features, revised content, and algorithm updates are assessed for labeling and submission implications before release, rather than after.
• Plan PI strategy early in development. For products in development, consider during clinical planning whether software claims will be pursued in the PI and what data will be needed. For device-connected functions, prepare for the new disclosure where no meaningful clinical improvement is shown.
• Revisit vendor and partner agreements. Content distributed “on behalf of” a sponsor is covered. Contracts with app developers and digital health partners should allocate content-approval rights, update controls, and regulatory cooperation obligations accordingly.
• Align privacy and data practices. Companion apps typically collect sensitive health data. As software functions are reassessed, confirm that privacy notices, consent flows, and data-sharing arrangements are consistent with how the app is described in labeling and promotion. They should also comply with applicable state and federal privacy and consumer protection requirements.

Companies with marketed companion apps should begin this assessment now, as FDA expects to apply its current thinking going forward and will look to the Guidance in evaluating both labeling and promotional materials.

If you have questions about the Guidance or its application to your products, please contact Georgia C. Ravitz, Shari Esfahani, Thora Johnson, Amy Joseph, or Jeremy Sherer.