FDA finalizes policy treating drugmakers’ companion apps as drug labeling

By Staff Reporter

WASHINGTON — The Food and Drug Administration on Wednesday finalized guidance that brings the apps, dashboards and other software drugmakers distribute alongside their medicines under the agency’s drug-labeling authority, closing out a policy effort that began with a 2018 public docket.

The guidance, “Regulatory Considerations for Prescription Drug Use-Related Software,” was announced in the Federal Register and finalizes a September 2023 draft. It covers software that is “disseminated by or on behalf of a drug sponsor” and produces output that “supplements, explains, or is otherwise textually related to” the sponsor’s drug, whether or not the software is also regulated as a medical device. That includes apps built by outside developers under contract with a drug company.

What changes

The core of the policy is that FDA “considers end-user output to be a type of prescription drug labeling.” The screens, reminders and data displays a patient, caregiver or doctor sees are treated as labeling, and, unless the software is essential to using the drug, as promotional labeling. That subjects them to the rules against false or misleading claims and requires companies to file the output with FDA on Form FDA 2253 when they first distribute it. The form now includes a “PDURS” material type for those filings, according to the guidance.

Whether an app can be mentioned in a drug’s official prescribing information is a separate and higher bar. According to the guidance, software should be described there only if it is essential to using the drug safely and effectively, if it pulls data directly from a device that is part of a drug-device combination product, or if FDA finds, “based on evidence provided by the sponsor,” that using it produces “a meaningful improvement in a clinical outcome.” That evidence generally has to come from adequate and well-controlled studies.

For standalone apps that rely on what patients type in rather than device data, the guidance says the software “should not be described” in the prescribing information without that showing. Its output “generally would be considered promotional labeling.”

Changes from the draft

According to the Federal Register notice, FDA changed four things after reviewing public comments on the docket:

• It clarified how standalone software functions are treated.
• It added a decision tree to walk companies through the labeling determinations.
• It added sample prescribing-information language for device-connected and standalone software.
• It recommended that prescribing information say so when use of device-connected software is not necessary for safe and effective use of the drug.

The last change has commercial weight. Under the final text, when a connected inhaler or autoinjector app is optional, its description in the label should carry a statement “noting that use of the software is not necessary for the safe and effective use of the product.” That holds “regardless of whether the sponsor has submitted evidence of a meaningful improvement.”

Why it matters

Drugmakers increasingly pair products with connected devices and apps that log doses, display trends and coach patients. The guidance gives them a predictable path, but it also means marketing teams cannot use app screens to make claims they could not put in a brochure. Software updates that leave the output unchanged, such as security patches, do not need to be refiled. FDA says it will focus its review on “issues that could affect the safe and effective use of the drug.”

The policy is led by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Software that is itself a regulated medical device still needs device clearance or approval, and the Center for Devices and Radiological Health will review it in consultation with the drug centers. Like all FDA guidance, the document is nonbinding, and it says companies may use an alternative approach that satisfies the law. Comments can still be filed on the docket at any time.

FDA also stated that it considers the guidance neither a regulatory nor a deregulatory action under Executive Order 14192, the president’s order directing agencies to identify at least 10 existing regulations for repeal for each new one.

The Inquisitor sent requests for comment to the FDA’s Center for Drug Evaluation and Research and its Digital Health Center of Excellence, AdvaMed and Public Citizen’s Health Research Group on Wednesday afternoon, after this story was first published. This story will be updated with any responses.

Photo: The FDA’s White Oak campus in Silver Spring, Md. U.S. Food and Drug Administration, via Wikimedia Commons, public domain.