United States: FDA Wants To Hear From You: Proposed Framework For Regulating Output Of Digital Health Tools Accompanying Prescription Drugs As Labeling

Last Updated: November 29 2018
Article by Susan S. Lee and Yarmela Pavlovic

On November 20, the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with one or more of their prescription drugs. FDA Commissioner Scott Gottlieb, M.D. touted the proposed framework in his remarks at the Reagan-Udall Foundation on November 19: "We believe the flexible concepts we've put forward will encourage more drug sponsors to advance beneficial and innovative software apps with FDA-approved drugs and biologics."

In issuing this request for comment, the FDA signaled its intention to develop guidance on this topic, but clarified that this notice is not a guidance document itself, but rather is intended to generate discussion. Accordingly, the agency posed a series of questions (noted below) for stakeholders' input. We encourage interested parties to submit comments to this docket to help inform and shape the FDA's views in this developing area.

New terminology: "Prescription drug-use-related software"

In this request for comment, the FDA introduces a new term, "prescription drug-use-related software," (PDS) and defines it as software disseminated by or on behalf of a drug sponsor that accompanies one or more of the sponsor's prescription drugs. Examples of PDS described in the notice include

  • software branded with a drug name that a sponsor intends for patients to use to record and track their use of the sponsor's drug with a mobile app, such as an app for patients to record their degree of physical functioning while taking a drug;
  • software designed by a drug sponsor for its specific drug that enables a health care provider to enter dosing instructions for a sponsor's prescription drug product that the patient can retrieve through the software; and
  • software designed by a drug sponsor to communicate with a device in drug-device combination product regulated primarily as a drug.

The proposed regulatory framework described in this notice relates to the output of the PDS that is presented to the end user, e.g., a patient, caregiver, or health care professional. This output could include screen displays generated by the software, as well as sounds or audio messages. Examples of PDS output described in the notice include

  • software that a sponsor disseminates to patients to record and track their prescription drug use with an app, the PDS output would include the screen display where patients record their ingestion of the drug and can view ingestion records over time;
  • branded software that provides a risk calculator to assist health care providers in deciding when to prescribe a medication and how to calculate the appropriate dose, the PDS output would include the screen display of the risk calculator; or
  • an app that a sponsor disseminates to patients to communicate information from an embedded device that tracks drug ingestion, the PDS output would include screen displays that show the information on drug ingestion, and if the app provides alerts (e.g., that a dose has been ingested) or reminders (e.g., reminding patients to take their medication), these messages also would be considered PDS output.

Proposed regulatory framework for PDS output

In its proposed regulatory framework, the FDA contemplates that the output of PDS could be incorporated in FDA-required labeling or in promotional labeling. PDS output could be incorporated in FDA-required labeling if

  • the drug sponsor demonstrates there is substantial evidence of an effect on a clinically meaningful outcome as a result of the use of the PDS with a drug; or
  • the software is key to one or more of the intended uses of a drug-led drug-device combination product.

Where the PDS output is not incorporated in FDA-required labeling, the FDA proposes to regulate the PDS output as promotional labeling. As such, this PDS output would be subject to FDA's existing regulatory requirement for submission of promotional labeling materials at time of first use under Form FDA 2253 and would not require FDA review prior to dissemination. The proposed submissions under Form FDA 2253 would include "screenshots or other appropriate representations of what the user will experience."

The FDA notes that under certain circumstances, it may be advisable for sponsors to utilize the voluntary advisory comment process prior to disseminating PDS output that would be considered promotional labeling — in particular, if there is uncertainty about whether the PDS output would be consistent with the accompanying drug's FDA-required labeling. The notice provides examples of situations where seeking advisory comments may be appropriate, such as PDS output that instructs patients on when to adjust their dose based on symptoms without first consulting a health care provider (e.g., an app that allows patients to calculate an insulin dose based on published treatment guidelines and recommends a dose different than that prescribed by the patient's physician).

The FDA acknowledges that software reliability is critical to producing the intended and expected PDS output, however, the agency proposes to assume the drug sponsor will be responsible for assuring the reliability of the software and does not intend for this proposed regulatory framework to reach the underlying software code.

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