FDA Finalizes Guidance on Labeling Apps Used With Prescription Drugs

The US Food and Drug Administration on October 20 issued final guidance setting out how drug companies should label and submit the content of apps and other software they distribute for use with prescription medicines.

The guidance, titled "Regulatory Considerations for Prescription Drug Use-Related Software," finalizes a draft issued on September 19, 2023. In its announcement, the FDA said the document "ends 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."

Software output treated as labeling

According to the agency's Federal Register notice, prescription drug use-related software generally includes 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, whether or not the software is regulated as a device. The FDA considers that end-user output, meaning any content the software presents to a patient, caregiver or clinician, to be a type of prescription drug labeling.

The guidance covers drug products and drug-led combination products for which the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research is the lead center.

Two categories of apps

The FDA said the guidance identifies two categories of companion software. Apps connected to a medical device, such as an app paired with an asthma inhaler, generally should be described in the drug's prescribing information because of the role the software plays in how the medicine is used. Standalone apps, such as symptom trackers, dose reminders or health coaching tools, should appear in the prescribing information if the company can show the app is essential for safe and effective use or can demonstrate a meaningful clinical benefit.

"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," the agency said.

The Federal Register notice lists the main changes from the 2023 draft: clarified considerations for standalone software functions; a decision tree to guide sponsors through labeling determinations; example prescribing-information language for both device-connected and standalone software; and a recommended statement in the prescribing information for device-connected software functions for which there is no meaningful improvement in a clinical outcome.

Officials' comments

"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 in CDER, in the FDA release.

CDER Director Michael Davis said the guidance "reflects FDA's commitment to responsible, risk-proportionate oversight of digital health," and that aligning the approach across the drug and device centers gives developers "a clear and consistent pathway." Jared Seehafer, the FDA's deputy commissioner for technology, said: "Companion apps are quickly moving beyond simple dose reminders toward tools that adapt to each patient."

The notice says the guidance is intended to align with digital health initiatives at the Center for Devices and Radiological Health, and to support coordinated review when such software is reviewed as a device. As with all FDA guidance, it is not binding, and the agency accepts comments on it at any time under docket FDA-2023-D-2482. The notice of availability is scheduled for publication in the Federal Register on October 21.