FDA Proposes Revised Payor Communications Draft Guidance to Formally Include Devices and Reflect New Statutory Safe Harbor While Balancing Substantial Government Interests

On June 3, 2026, the U.S. Food and Drug Administration (FDA or the Agency) issued a new draft guidance titled Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (the 2026 Draft Payor Guidance). Once finalized, the 2026 Draft Payor Guidance will replace the 2018 final guidance on the same topic. The 2026 Draft Payor Guidance provides updated answers to commonly asked questions regarding the communication from firms to payors of: (1) healthcare economic information (HCEI) about approved or cleared prescription drugs and medical devices; (2) information about prescription drugs or medical devices for which approval or clearance is forthcoming; and (3) information about unapproved uses of approved or cleared prescription drugs or medical devices. It also reinforces how FDA has referred to the substantial government interests at play in the Agency’s regulation of drug and device sponsors’ commercial speech, discussed in more detail below.

The 2026 Draft Payor Guidance largely reflects the recent statutory amendments and additions to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which were enacted by the Pre-Approval Information Exchange (PIE) Act.¹ In particular, amendments to section 502(a) of the FD&C Act extended HCEI provisions to medical devices; the addition of section 502(gg) provided that “no drug or device shall be deemed to be misbranded” as a result of the provision of certain types of truthful and not misleading information to payors and other similarly situated entities (collectively “payors”).

The updated 2026 Draft Payor Guidance brings FDA’s payor communications framework more closely in line with these statutory provisions, providing firms with greater regulatory clarity and predictability regarding communications with payors about their medical products. The draft guidance also extends beyond the PIE Act provisions by applying a similar framework to communications of product information for unapproved medical products and unapproved uses of approved/cleared medical products. Because such communications are not expressly addressed by either section 502(a) or section 502(gg), this aspect of the 2026 Draft Payor Guidance appears intended to address a potential gap in FDA’s approach to payor communications.

Despite providing greater clarity in several areas, the 2026 Draft Payor Guidance leaves certain practical implementation questions unresolved, including how firms are expected to satisfy the requirement to provide updated information when previously communicated information becomes materially outdated. Firms should continue to monitor the development of the guidance and evaluate whether existing market access, health economics, and managed care communication practices adequately address these evolving expectations.

The 2026 Draft Payor Guidance, if finalized, will replace the Agency’s final guidance bearing the same name that was released in June 2018. We covered the 2018 final guidance in a June 2018 Advisory.

Key Proposed Updates

A Single Framework for Drugs and Devices

Consistent with the statutory amendments (described in further detail below), the 2026 Draft Payor Guidance broadens its recommendations to devices — not only prescription drugs. It refers to prescription drugs and devices together as “medical products.”² As a result, FDA puts forth a uniform framework for understanding the Agency’s position regarding communications from firms to payors.

This uniform framework includes the extension of the section 502(a) HCEI-related safe harbor protections to devices. Section 502(a) previously applied only to drugs (the 2018 final guidance had taken the position that, while the then-section 502(a) language applied only to drugs, the Agency’s recommendations with respect to HCEI communications to payors would be generally applicable to devices as well).³ The 2026 Draft Guidance formally extends the safe harbor protections to devices, providing that the provision of HCEI to a payor shall not be considered to be false or misleading (and shall not misbrand a drug or device) if the HCEI relates to an approved indication, is based on competent and reliable scientific evidence, and, where applicable, includes a conspicuous and prominent statement describing any material differences between the HCEI and approved labeling for the drug or device.⁴

The 2026 Draft Payor Guidance also clarifies that its HCEI-related recommendations do not apply to the dissemination of HCEI to non-payor audiences, such as healthcare providers who make individual patient prescribing decisions or consumers.⁵

Establishment of a Statutory Safe Harbor for Communicating Information About Investigational Medical Products and Investigational Uses

FDA’s prior guidance had created an enforcement discretion policy pertaining to communications about certain pre-approval communications. Now, in what may be the most significant change from prior guidance, the 2026 Draft Payor Guidance implements the statutory safe harbor for communications about investigational products and uses established by the PIE Act in section 502(gg) of the FD&C Act. Section 502(gg) establishes a framework for communicating truthful and not misleading product information to a payor about an investigational drug or device or investigational use of an approved or cleared drug or device.⁶ Consistent with that safe harbor, relevant pre-approval communications to payors will not misbrand medical products as long as the communications meet the following conditions:⁷

• The information being communicated is the type of “product information” described in section 502(gg): information describing the product, information about the indication(s) under investigation, the anticipated timeline for potential FDA approval or clearance, medical product pricing information, patient utilization projections, medical product-related programs and services, and factual presentations of clinical study results.⁸
• The information is truthful and not misleading.
• The required disclosures set forth in section 502(gg)(1)(A) are provided, as applicable, including a clear statement that the investigational drug, device, or use has not been approved or cleared, information related to the stage of development of the drug or device, a description of all material aspects of study design, methodology, results, and limitations, a prominent statement disclosing the approved or cleared indication(s) and copy of the most current FDA-required labeling, and “updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status.”⁹
• The communication does not include the prohibited information in section 502(gg)(1)(B), i.e., information that represents that an unapproved medical product or unapproved use of an approved/cleared medical product has been approved or cleared or has been determined to be safe or effective for the purpose(s) for which it is being studied.¹⁰

Information Beyond Investigational Products and Uses

Going beyond investigational medical products or investigational uses of approved/cleared medical products, the 2026 Draft Payor Guidance takes the position that FDA does not intend to object to a firm’s communication of product information to payors about unapproved medical products or unapproved uses of approved/cleared medical products, even when such products or uses may not be considered investigational, as long as the communications are consistent with the requirements of section 502(gg).¹¹ The 2026 Draft Payor Guidance explains that such policy recognizes the fact that some payors may need to plan for and make coverage and reimbursement decisions far in advance of the effective date of such decisions, so there is an interest in providing information to payors about unapproved medical products and unapproved uses of approved/cleared medical products.¹²

Updating Information to Payors

As noted above, the 2026 Draft Payor Guidance highlights the requirement under section 502(gg) for firms to provide “updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status.”¹³ The 2026 Draft Payor Guidance suggests that firms should notify payors of changes or new information, such as the failure to meet the primary effectiveness endpoint in a pivotal trial, the receipt of a Complete Response Letter, or the imposition of a clinical hold by FDA.¹⁴

Notably, however, the draft guidance provides little clarity regarding how this obligation should be implemented in practice. For example, FDA does not specify the timing for providing updated information, whether updates must be communicated through the same channel as the original communication, or what form such updates should take. As a result, firms may need to develop internal processes for identifying material developments and determining when previously communicated information should be supplemented or corrected.

First Amendment Considerations

As FDA is keenly aware in the recent environment of heightened enforcement, the Agency must justify regulating or restricting otherwise protected commercial speech by demonstrating that it is advancing a “substantial” government interest. The 2026 Draft Payor Guidance justifies its recommendations as an attempt to balance the potentially competing interests at play here: the interests of payors to receive information from firms about unapproved medical products and unapproved uses of approved/cleared medical products against the substantial government interests related to health and safety.¹⁵

The 2026 Draft Payor Guidance acknowledges that “in some situations, payors need to plan for and make coverage and reimbursement decisions for medical products and uses far in advance of the effective date of such decisions. In making decisions on a population basis, payors can draw on a range of expertise in multiple disciplines that allows them to critically evaluate information presented to them by firms, including an evaluation of the limitations and reliability of that information.” Accordingly, “FDA recognizes the value of payors receiving truthful and not misleading information about unapproved medical products and unapproved uses of approved/cleared medical products, as described in section 502(gg) of the FD&C Act, in order to inform their decision-making.”¹⁶

However, the draft guidance also describes the substantial government interests at stake. The 2026 Draft Payor Guidance lists those interests as including:

• Motivating the development of robust scientific data on safety and effectiveness
• Maintaining the premarket review process for safety and effectiveness of each intended use in order to prevent harm; to protect against fraud, misrepresentation, and bias; and to develop appropriate instructions for use for medical products
• Protecting the integrity and reliability of promotional information regarding medical product uses
• Preventing the diversion of healthcare resources toward ineffective treatments¹⁷

FDA believes that the updated recommendations in the 2026 Draft Payor Guidance continue to balance the interests of payors and the substantial government interests “to best advance the public health overall.”¹⁸

While FDA articulated these potentially competing interests in the 2018 final guidance as well, the 2026 Draft Payor Guidance appears to soften restrictions on firm communications in other facets. For example, the 2026 Draft Payor Guidance revises its suggestion that payors should receive “unbiased, factual, accurate, and non-misleading” information about unapproved uses or approved/cleared medical products.¹⁹ It replaces this potentially more exacting (and ambiguous) standard with “truthful and not misleading.” By doing so, FDA aligns the recommendation to the language contained in sections 502(a) (“false or misleading”) and 502(gg) (“truthful and not misleading”), and offers a standard that firms well understand in the context of communicating information to consumers and healthcare providers.²⁰

In another sense, the 2026 Draft Payor Guidance clarifies that the Agency does not intend to use HCEI that is disseminated consistent with the guidance’s recommendations, standing alone, as evidence of a new intended use.²¹ The addition of “standing alone” reveals that FDA recognizes the evolution of First Amendment case law, which has increasingly limited FDA’s ability to rely on truthful and non-misleading speech, without more, as evidence of unlawful conduct or as the basis for taking enforcement action.

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Comments to the 2026 Draft Payor Guidance can be submitted to FDA until August 3, 2026.²² Given the issues discussed in the draft guidance, stakeholders should consider engaging in the comment process to help shape FDA’s final approach to firm communications with payors.

We will continue to monitor FDA developments relating to firm communications with payors and HCEI. If you have any questions about the content discussed or would like more information, please reach out to one of the authors of this Advisory or to your existing Arnold & Porter contacts.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.