In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response to comments submitted for) the FDA’s proposed framework, “Prescription Drug Use-Related Software,” which was introduced in November 2018.

The draft guidance was developed with input from and issued by several FDA medical product centers. The guidance describes how the FDA intends to apply its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug-led, drug-device combination product (combination product) that is assigned to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) as the lead center. CDER said that, through the draft guidance, it aims to align with other FDA centers, including the Center for Devices and Radiological Health (CDRH), which has released several recent Digital Health Policy Documents, including draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions,” as described in our prior alert.

Prescription Drug Use-Related Software

As background, digital health technologies are systems that use computing platforms, connectivity, software, and/or sensors for healthcare and related uses that have the potential to provide valuable insights to “end-users” (e.g., patients, caregivers, and healthcare providers) about a patient’s drug usage. Fitting into this definition is prescription drug-use related software. Prescription drug use-related software, including applications designed for mobile devices (mobile apps), plays a vital role in various health-related functions—it can aid patients in monitoring their drug consumption, enable healthcare professionals to oversee patients’ use of prescription medications, and provide guidance on proper drug usage.

In addition to mobile apps where patients manually log their medication use, another type of prescription drug use-related software connects to devices, like asthma inhalers, that automatically record usage and share data with healthcare providers. In the asthma inhaler example, the prescription drug use-related software is considered “device-connected.” As a combination product, the asthma drug with the inhaler would fall under CDER regulatory purview, in consultation with CDRH. This is the type of prescription drug use-related software addressed in the draft guidance, as opposed to unaffiliated software developers intending to be used with drugs or combination products, but who are not associated with the drug sponsor.

Labeling for Digital Health Technologies

The primary objective of the draft guidance is to offer clarity to drug sponsors on how the FDA will apply its drug labeling authorities in relation to the software output produced by or on behalf of a drug sponsor for use with a prescription drug or a combination product that is assigned to CDER or CBER as the lead center. The draft guidance also outlines how FDA-required labeling should describe essential software for safe drug use or software relying on data from device users of combination products.

Section 201(m) of the Food, Drug, and Cosmetic Act defines labeling as all written, printed, or graphic content on an article, its containers, wrappers, or accompanying materials. FDA identifies two main types of prescription drug labeling: FDA-required and promotional labeling. The draft guidance specifically addresses how drug sponsors can describe their software in FDA-required labeling and promotional labeling. The FDA reviews and approves required labeling, which includes the Prescribing Information (PI)—PI is a resource for prescribers that contains a summary of the key scientific information needed for safe and effective drug use. On the other hand, promotional labeling is intended to promote or advertise the drug, and generally is considered any labeling other than FDA-required labeling. Drug sponsors must submit promotional labeling to CDER at the time the labeling is initially disseminated.

For FDA-required labeling, if the drug sponsor submits any evidence that the software use results in a meaningful improvement in patient outcome compared to using the drug alone, the draft guidance recommends that the sponsor include the relevant information in the appropriate PI section(s), like the “Clinical Studies” section. CDER recognizes that some drug sponsors will not have data to demonstrate a benefit to using the software. If that is the case, CDER may determine the PI still should have information about the software, if, for example, the information is necessary to inform a prescribing decision, distinguish between product versions, or let patients know that the software is automatically collecting information during drug use. In those cases, the draft guidance recommends that the sponsor include language about the software in another PI section, like the “How Supplied/Storage and Handling” section.

Next Steps

Members of the industry can submit comments on the draft guidance here—comments are due by December 18, 2023.

We will continue monitoring the note and comment process for the draft guidance. If you are interested in submitting comments to FDA or have questions, please contact Georgia Ravitz, James Ravitz, Eva Yin, Andrea Linna, Paul Gadiock, Shawn Lichaa, Marissa Hill Daley, or any member of the firm’s FDA regulatory, healthcare, and consumer products practice.