Last week, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a new draft guidance on drug and device manufacturer communications with payors, formulary committees, and similar entities (the “Draft Guidance”). When finalized, it will replace the final guidance of the same title issued in June 2018 (the “2018 Guidance”). The Draft Guidance reflects two major legislative changes that Congress enacted as part of the Consolidated Appropriations Act, 2023, and represents the most substantive update to FDA’s payor communications policy in nearly a decade. While much of the Draft Guidance closely tracks the language of its predecessor, several changes — including the incorporation of the statutory safe harbor, the broadening of certain prohibitions, and the elevation of previously optional recommendations to mandatory requirements — carry meaningful implications for how drug and device companies structure and review their payor-facing communications.
A. Key Changes from the 2018 Guidance
The 2018 Guidance and the Draft Guidance are intended to provide answers to common questions concerning communication of certain healthcare economic information (“HCEI”)[1] and product-related information by firms (i.e., medical product manufacturers, packers, and distributors, including representatives of these entities) regarding their prescription drugs and medical devices to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis.
To appreciate what the Draft Guidance changes, it helps to understand the trajectory of the guidance. The 2018 Guidance was itself a significant development from a 2017 draft guidance — notably, it expanded the framework from one focused primarily on “investigational” products to one covering the broader category of unapproved products and unapproved uses of approved or cleared products. The Draft Guidance maintains that broader framing while layering in new statutory protections.
1. Medical Devices Are Now Expressly Included
At the time the 2018 Guidance was published, the relevant statutory provision on HCEI at FDCA 502(a) applied only to drugs. In the 2018 Guidance, FDA stated that it believed the same principles should apply to devices, but this was largely an Agency policy position rather than an express statutory safe harbor. However, the Draft Guidance incorporates amendments made to FDCA 502(a) by the Consolidated Appropriations Act, 2023, and now explicitly applies to both drug and device HCEI communications.
The Draft Guidance creates substantially greater certainty that device firms can rely on the same statutory protections available to drug firms for HCEI communications to payors. Device-related HCEI materials must now be developed under the same statutory framework as drug HCEI materials, not merely by analogy. Device companies that have historically relied on the 2018 Guidance’s policy-based extension of HCEI protections should consider whether their existing payor communication materials and internal review processes reflect the requirements of the statutory framework as now codified.
2. A New Statutory Safe Harbor for Investigational Products
The Draft Guidance incorporates new FDCA 502(gg), also created by the Consolidated Appropriations Act, 2023, which provides that communications to payors regarding investigational medical products and/or investigational uses of approved or cleared products will not be considered “misbranded” under FDCA 502(f)(1) when certain statutory conditions are met.[2] Specifically, these communications must [3]include: (i) a clear statement that the investigational product or use has not been approved or cleared by FDA and that safety and effectiveness have not been established; (ii) information related to the stage of development;[4] (iii) for factual presentations of study results — which shall not be selectively presented (as discussed further below) — a description of all material aspects of study design, methodology, and all material limitations; (iv) where applicable, a prominent statement disclosing the approved or cleared indication(s) and a copy of the most current required labeling; and (v) updated information if previously communicated information becomes materially outdated due to significant changes or new information regarding the product or its review status. However, this product information must not include: (i) information that represents that an unapproved product has been approved, cleared, etc. by FDA or has otherwise been determined to be safe or effective for the purpose(s) for which it is being studied; or (ii) information that represents that an unapproved use of a product that has been approved, cleared, etc. by FDA is so approved, cleared, etc. or that the product is safe or effective for the use(s) for which the product is being studied.
This represents FDA’s acknowledgement of a significant shift for payor communications regarding investigational products — from Agency enforcement discretion, which can be revised or withdrawn at any time, to a Congressionally established statutory safe harbor. The practical effect is substantially greater legal certainty for manufacturers communicating with payors about products in the development pipeline. Notably, FDA further expands the scope of protection by clarifying that it does not intend to consider a product misbranded based on communications of product information to payors about unapproved medical products or unapproved uses of approved or cleared medical products, even when such products or uses may not be considered “investigational,” provided the communication is consistent with FDCA 502(gg). That said, the safe harbor’s conditions are detailed and specific, and manufacturers should ensure that each element is satisfied before relying on this protection.
3. A More Detailed “Product Information” Category
Product information was mentioned as a type of protected information in the 2018 Guidance, but no detail was given; however, FDCA 502(gg) and the Draft Guidance elaborate on what “product information” entails. Per the Draft Guidance, product information includes: information describing the medical product, such as drug class, device description, and features; information about the indication or indications being investigated; anticipated timeline for possible FDA approval or clearance; medical product pricing information; patient utilization projections; medical product-related programs or services such as patient support programs; and factual presentations of results from studies that do not characterize or make conclusions regarding safety or efficacy of the unapproved medical product or use.
Drug and device manufacturers now have a clearer pathway for communicating non-economic product information to payors before approval, representing a meaningful expansion beyond traditional HCEI. For companies with products in late-stage development, this framework may facilitate earlier and more structured engagement with payors on topics such as anticipated pricing, patient support infrastructure, and utilization projections — areas that are increasingly important to formulary positioning and market access planning.
4. The “Standing Alone” Qualifier Narrows Intended Use Protections
The Draft Guidance adds the “standing alone” qualifier to the following statement: “FDA does not intend to use HCEI that is disseminated consistent with this guidance, standing alone, as evidence of a new intended use,” which represents a material narrowing of this protection.
This qualifier signals that FDA reserves the ability to consider compliant HCEI and product-related communications as one factor in a broader body of evidence supporting a finding of a new intended use, even if the Agency will not rely on such communications as the sole basis for that determination. For manufacturers — particularly those with products in pre-approval stages or with active supplemental indication strategies — this underscores the importance of evaluating payor communications not in isolation, but in the context of the totality of the company’s communications, including promotional materials, scientific exchange activities, and other external-facing content. Reliance on the FDCA 502(a)/502(gg) framework should not be treated as a blanket shield against intended use findings.
5. The Prohibition on Misrepresentation Has Been Broadened
The 2018 Guidance established that “firms should not misleadingly represent that the clinical assumptions that vary from the FDA-approved labeling have been found by FDA to be safe and effective.” However, the Draft Guidance removes the “misleadingly” qualifier, such that the statement now reads: “firms should not represent that the clinical assumptions that vary from the FDA-approved labeling have been found by FDA to be safe and effective.”
The removal of the “misleadingly” qualifier broadens this prohibition in a manner that warrants careful attention. Under the Draft Guidance, any representation — whether or not it could be characterized as misleading — that off-label clinical assumptions have been found by FDA to be safe and effective is prohibited. Companies should review existing payor-facing materials, including HCEI presentations and dossiers, to confirm that no language could be read as conveying FDA endorsement of clinical assumptions that extend beyond the approved labeling.
6. The Risk Disclosure Standard Has Been Revised
The Draft Guidance requires that HCEI and product-related communications disclose risk information related to clinical assumptions in economic analyses that is materially different from the FDA-approved labeling, while the 2018 Guidance required disclosure of risk information related to clinical assumptions that varies from the FDA-approved labeling.
The shift from a “varies from” to a “materially different” standard introduces a threshold analysis that was not previously required. While this may reduce the volume of required disclosures by excluding immaterial variations, it also requires firms to develop and document a principled basis for determining what constitutes a “material” difference from the approved labeling — a judgment that may be subject to scrutiny. Internal medical, legal, and regulatory review processes should be calibrated accordingly.
7. Certain Recommendations Have Been Elevated to Mandatory Requirements
One of the most action-oriented changes in the Draft Guidance is the elevation of previously optional recommendations to affirmative legal obligations. The Draft Guidance now affirmatively requires the following, which were previously just recommendations: providing follow-up information to payors if previously communicated information becomes materially outdated;[5] describing material aspects, methodology, and limitations of study design; and not selectively presenting study results.[6]
These changes from recommendations to mandatory requirements are among the most operationally significant aspects of the Draft Guidance. Firms that previously treated these activities as discretionary best practices must now treat them as affirmative obligations. In particular, the requirement to provide follow-up information when previously communicated data becomes materially outdated will require companies to establish or strengthen systems for monitoring and tracking prior payor communications — a function that many organizations have not historically maintained in a systematic way. External communications teams, including market access and medical affairs functions, should audit existing processes, templates, and review procedures to ensure these obligations can be met consistently and in a timely fashion.
B. Comment Period
This guidance document is being distributed for comment purposes only, and comments and suggestions are due by August 3, 2026.
The comment period presents an opportunity for manufacturers and their regulatory and legal teams to evaluate how the proposed changes affect existing payor communication practices and to consider whether to submit comments to FDA on provisions that may benefit from additional clarification or modification before the Draft Guidance is finalized. It is also worth noting that the broader legal landscape governing manufacturer communications with payors continues to evolve, including ongoing judicial and scholarly consideration of the First Amendment dimensions of truthful, non-misleading commercial speech in this context — a backdrop that may inform both FDA’s finalization of the Draft Guidance and industry’s approach to compliance.
Footnotes
[1] Section 502(a)(2)(A) of the Food, Drug, & Cosmetics Act (the “FDCA”) defines HCEI as “any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug or device. Such analysis may be comparative to the use of another drug or device, to another health care intervention, or to no intervention.” HCEI can be presented in a variety of ways that can include but are not limited to an evidence dossier, a reprint of a publication from a peer-reviewed journal, a software package comprising a model with a user manual, a budget-impact model, a slide presentation, or a payor brochure.
[2] Section 502(gg)(1) provides that “no drug or device shall be deemed to be misbranded” under Section 502(f)(1) because of certain truthful and not misleading information provided to payors, formulary committees, and other similar entities with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement.
[3] See Section A(3) for examples of “product information.”
[4] E.g., the status of any study or studies in which the investigational product is being studied, how the study or studies relate to the overall plan for the development of the product, and whether an application, premarket notification, or request for classification for the investigational product or use has been submitted to FDA and when such a submission is planned.
[5] Firms must now provide updated information to payors if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the medical product (e.g., failure to meet the primary effectiveness endpoint in the pivotal trial) or its review status (e.g., an application being determined not ready for approval upon completion of the review cycle, or a study being placed on a clinical hold).
[6] This means that both positive and negative or null findings must be presented.
