Drug Labeling, Software, and the First Amendment: FDA Finalizes Guidance on Prescription Drug Use-Related Software While Defending Its Authority

On October 21, 2026, the U.S. Food & Drug Administration (“FDA”) published final guidance titled “Regulatory Considerations for Prescription Drug Use-Related Software” (“PDURS Guidance”). The guidance updates and finalizes draft guidance published in 2023, which we discussed in a prior Alert.

The PDURS Guidance describes how FDA intends to regulate prescription drug use-related software (“PDURS”) — i.e., software disseminated by or on behalf of a drug sponsor and related to one of the sponsor’s drug products — as labeling. PDURS may include, for example, mobile and web apps that help patients and healthcare providers track drug use and symptoms, provide individualized dosing recommendations, or help manage side effects. Certain PDURS functions may also render the software an FDA-regulated medical device, although that regulatory analysis is outside the scope of the PDURS Guidance.

The PDURS Guidance addresses three key questions:

1. When will PDURS end-user output be treated as FDA-required labeling versus promotional labeling?
2. How should FDA-required labeling, particularly the Prescribing Information (“PI”), describe PDURS?
3. When and how should sponsors submit the end-user output of PDURS to FDA?

FDA’s framework is largely unchanged from the 2023 draft guidance, but FDA has clarified several aspects in response to industry feedback.

In conjunction with its release of the PDURS Guidance, FDA posted a memorandum titled “Outline of FDA’s Approach to Prescription Drug Use-Related Software’s End-User Output” (“Memorandum”) to the PDURS Guidance docket on regulations.gov. The Memorandum is not referenced in either the PDURS Guidance or the accompanying Federal Register notice. The Memorandum defends FDA’s approach to regulating PDURS output as labeling, and in particular the broad conception of “labeling” embodied in both the draft and final PDURS Guidance, under the agency’s statutory authorities and the First Amendment. The unannounced Memorandum recalls the First Amendment-related “Addendum” that FDA posted to a docket when it finalized its 2025 guidance, Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers (“SIUU Guidance”), which we discussed in a previous Alert.

The PDURS Guidance

Scope

The PDURS Guidance applies to PDURS, defined as software that (1) is disseminated by or on behalf of a drug sponsor and (2) produces an end-user output that “supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products, regardless of whether the software is regulated as a device” under the Federal Food, Drug, and Cosmetic Act (“FDCA”). Software is disseminated “on behalf of” a drug sponsor where, for example, “a software developer working under an agreement with the drug company distributes or directs end users to the software.”

The scope of the PDURS Guidance is unchanged from the draft guidance. It continues to advance an extremely broad interpretation of “labeling,” citing Kordel v. United States, 335 U.S. 345 (1948) for the proposition that software output that “supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products” is labeling subject to FDA’s regulatory oversight. In apparent answer to stakeholder comments objecting to FDA’s interpretation as an overstatement and misrepresentation of Kordel and other relevant case law, FDA doubled down on its position in the Memorandum. The practical implications of FDA asserting authority over PDURS output that is merely “textually related” to a drug are significant. This position arguably purports to bring within FDA’s oversight any software output that names, or perhaps even merely implies something related to, the sponsor’s drug.

Although the scope of the guidance is fundamentally unchanged, FDA offers one helpful clarification. Industry comments on the draft guidance had raised concerns that FDA’s definition of PDURS could be read to bring purely disease-focused software functions within FDA’s oversight. A new footnote clarifies that “in cases where the end-user output is not specific to the sponsor’s prescription drug product or products (e.g., output that is entirely disease state-focused), then the software and output would generally fall outside the scope of prescription drug use-related software.” FDA leaves unanswered how it will treat software that combines disease-awareness functions with PDURS functions.

Regulatory Framework

Consistent with the draft guidance, the PDURS Guidance takes the position that PDURS end-user output (i.e., the material the PDURS presents to users, including screen displays as well as sounds or audio messages) is a type of prescription drug labeling regulated by FDA. Depending on several factors, PDURS output may be regulated as either FDA-required labeling, which generally requires FDA approval prior to dissemination, or as “promotional labeling.” These factors include:

1. whether the PDURS is essential to the safe and effective use of the product,
2. whether FDA determines based on evidence provided by the sponsor that there is a meaningful improvement in a clinical outcome when the PDURS is used with the drug, and
3. whether the PDURS includes “device-connected PDURS software functions,” meaning it relies on data from the device or device constituent part of a combination product (e.g., an asthma inhaler that provides data on usage and amount of medication remaining).

If the PDURS meets factor 1 (essential to safe and effective use) or factor 2 (demonstrates a meaningful improvement in a clinical outcome), then the end-user output generally would be FDA-required labeling, and the PDURS should be described in the PI. If the PDURS meets only factor 3 (device-connected PDURS software function), then the end-user output would constitute promotional labeling, though the software function should generally be described in the PI. If the PDURS meets none of these factors, then the end-user output would be promotional labeling, and the PDURS should not be described in the PI.

For each scenario, the PDURS Guidance describes how FDA analyzes the factor and what type of information should be included in the PI and in which section. The final guidance is generally consistent with the draft guidance on these points, but FDA has added a new decision tree to aid sponsors in assessing PDURS as well as example language for inclusion in the PI, where applicable. Where PDURS end-user output is considered promotional labeling, the end-user output must be submitted to FDA at the time of initial dissemination using Form 2253 (or prior to use, in accordance with regulatory requirements, in the case of accelerated approval products). One substantive change is that the PDURS Guidance no longer includes an exception for PDURS that is also a medical device. Under the draft guidance, FDA would not have required a Form 2253 submission for PDURS end-user output if the PDURS were also a device requiring a marketing submission to CDRH, although it would have required a Form 2253 submission for subsequent changes to such output that would not also require a new device marketing submission. Under the final guidance, end-user output considered promotional labeling must be submitted using Form 2253 regardless of whether the PDURS is also a medical device requiring a marketing submission.

Notably, the final guidance still treats PDURS end-user output that demonstrates a meaningful improvement in a clinical outcome as FDA-required labeling, even where the PDURS is not essential to safe and effective use. This means that the end-user output would be subject to FDA’s exacting regulations governing FDA-required labeling, and changes to the output could require prior FDA approval. We expect that this approach may discourage drug sponsors from seeking to include information in the PI about PDURS software functions that may have a clinically meaningful benefit, particularly where they might still discuss those benefits in a promotional context in accordance with FDA’s guidance on “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers” (2018).

The Memorandum

In conjunction with its release of the PDURS Guidance, FDA published the Memorandum, detailing its legal arguments for regulating PDURS end-user output as labeling:

1. PDURS end-user output is labeling under the FDCA;
2. FDA’s regulation of labeling serves an important public health purpose; and
3. Regulating PDURS output as labeling does not violate the First Amendment.

FDA’s defense of its statutory authority to regulate PDURS output as labeling under the FDCA echoes prior FDA statements to advance an expansive interpretation of “labeling” subject to its regulatory authority. As in the PDURS Guidance itself and in the earlier draft guidance, FDA relies on Kordel and related cases to argue that labeling encompasses any materials that “supplement, explain, or are otherwise textually related to” a regulated product. Although FDA acknowledges that, under Kordel, the material and drug must be part of an “integrated distribution program” to qualify as labeling, FDA all but reads this requirement out of the case. In FDA’s view, if the material is distributed “by or on behalf of the drug sponsor” and is “textually related” to that sponsor’s drug, then it is part of an integrated transaction and is labeling.

The Memorandum’s other arguments also largely echo positions FDA has taken previously in defending its regulation of manufacturer communications under the First Amendment, including in its 2017 First Amendment-focused memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, and its 2025 “Addendum” to that memorandum issued in conjunction with FDA’s SIUU Guidance. Like the 2025 Addendum, the latest Memorandum asserts that the First Amendment is not directly implicated by FDA’s regulatory approach and that, if it were, the PDURS Guidance would “easily pass” constitutional muster. FDA further argues that, because the First Amendment does not protect misleading speech or speech concerning unlawful conduct, it is necessarily permissible for FDA to review PDURS output “to help ensure it is accurate, truthful, and non-misleading.”

Implications for Drug Company Sponsors

Drug companies that are considering developing software for use with their prescription drug products should carefully consider the recommendations in FDA’s PDURS Guidance. The regulatory framework articulated in the PDURS Guidance is largely consistent with that described in the draft version of the guidance, broadly treating all PDURS end-user output as prescription drug labeling subject to FDA regulation. Importantly, the PDURS Guidance is only one of the FDA regulatory frameworks that may apply to software tools, and sponsors must also consider whether the software is an FDA-regulated medical device.

The PDURS Guidance and accompanying Memorandum also have important implications for drug sponsors beyond the software context. FDA’s continued assertion of an overly broad conception of labeling, as well as the First Amendment defenses articulated in the Memorandum, underscore the agency’s increasingly expansive view of its authority with regard to the regulation of manufacturer communications. FDA’s positions in the Memorandum are likely to prove controversial, given that FDA continues to disregard contrary constitutional and statutory arguments that industry advocates have repeatedly raised.

Ropes & Gray will continue to monitor developments relating to advertising and promotion and digital health. If you have any questions regarding this Alert, please contact any member of Ropes & Gray’s FDA regulatory practice or your usual Ropes & Gray advisor.