backOn June 3, 2026, the Food and Drug Administration (“FDA” or “the Agency”) announced a new draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers” (the “2026 Draft Guidance”).1U.S. Food & Drug Admin., Notice of Availability, 91 Fed. Reg. 33181 (June 3, 2026). See FDA Draft Guidance for Industry: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers (June 2026) [hereinafter 2026 Draft Guidance], https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-and-device-manufacturer-communications-payors-formulary-committees-and-similar-entities. Once finalized, this document is intended to replace the final guidance of the same title issued in June 2018 (the “2018 Final Guidance”).2U.S. Food & Drug Admin., Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Guidance for Industry and Review Staff (June 2018) [hereinafter 2018 Final Guidance].
The 2026 Draft Guidance incorporates statutory changes enacted by the Pre-Approval Information Exchange (“PIE”) Act, otherwise known as Section 3630, “Facilitating Exchange of Product Information Prior to Approval” of the Consolidated Appropriations Act, 2023.3Pub. L. No. 117-328, 136 Stat. 4459 (2022), https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf. The PIE Act added Section 502(gg) to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).421 U.S.C. § 352(gg). Section 502(gg) provides that “no drug or device shall be deemed to be misbranded” 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 (collectively “payors”) regarding investigational medical products and investigational uses of approved or cleared medical products. The new draft guidance also reflects amendments that extend the healthcare economic information (“HCEI”) provisions of Section 502(a) to medical devices. These changes collectively implemented substantial updates to FDA’s statutory framework for manufacturer-payor communications.
Unified Framework for Drugs and Devices
Historically, the HCEI-related provisions in Section 502(a) of the FD&C Act applied only to drugs.5See Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296, Section 114 (1997) (popularly referred to as FDAMA 114). In the 2018 Final Guidance, FDA addressed devices in a separate section, noting that although the HCEI provisions in Section 502(a) did not directly cover devices, FDA believed the same recommendations were “generally applicable” to device manufacturers’ communications of HCEI to payors.62018 Final Guidance at 17. As amended by the PIE Act, Section 502(a) now explicitly references “drugs or devices” throughout its HCEI provisions. Accordingly, the 2026 Draft Guidance consolidates the treatment of drugs and devices under a single set of questions and answers, removing the separate device section entirely. The term “medical products” is now used throughout the new guidance to encompass both drugs and devices. The PIE Act and 2026 Draft Guidance reflect a unified framework in which device manufacturers are subject to the same statutory standards for HCEI communications with payors that previously applied only to drug manufacturers under Section 502(a).
Statutory Safe Harbor for Communications About Investigational Medical Products and Investigational Uses
The most significant change in the 2026 Draft Guidance is the inclusion of the statutory safe harbor for communications with payors about investigational medical products and investigational uses of approved/cleared medical products. The 2018 Final Guidance relied on a non-binding framework under which FDA stated that it did “not intend to object” under 21 C.F.R. §§ 312.7(a) or 812.7(a) to certain pre-approval communications, provided the information was “unbiased, factual, accurate, and non-misleading.”72018 Final Guidance at 18. The 2026 Draft Guidance outlines the statutory standard articulated under Section 502(gg) for which a medical product shall not be deemed misbranded if the communication to a payor satisfies four conditions:
- The information is the type of “product information” set forth in Section 502(gg)(2) (e.g., product descriptions, indications being investigated, anticipated approval timelines, pricing information, patient utilization projections, product-related programs, and factual presentations of study results that do not characterize or make conclusions regarding safety or efficacy);
- The information is truthful and not misleading;
- The information is presented with the required disclosures set forth in Section 502(gg)(1)(A) (including a clear statement that the product or use is not approved/cleared and safety and effectiveness has not been established; information on the stage of development; descriptions of material aspects and limitations of study design; any approved indications and current labeling, if applicable; and any updated information, if previously communicated information is outdated); and
- The information does not include the prohibited representations set forth in Section 502(gg)(1)(B)(i.e., representations that the product has been approved/cleared or has been determined to be safe or effective for the purposes being studied).
In sum, Section 502(gg) elevated many of the disclosures and prohibitions that FDA had previously characterized as non-binding recommendations under the 2018 Final Guidance to statutory requirements. The 2026 Draft Guidance updates FDA recommendations for manufacturer-payor communications consistent with the statute.
Reaffirming the Obligation to Provide Updated Information
One notable enhancement in the 2026 Draft Guidance is the strengthened obligation regarding follow-up communications. The 2018 Final Guidance suggested that firms provide follow-up information to payors if previously communicated information became materially outdated. Consistent with Section 502(gg)(1)(A), the 2026 Draft Guidance states that firms “must 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 is determined to not be ready for approval upon completion of the review cycle, a study is placed on a clinical hold).”82026 Draft Guidance at 19-20.
Information Beyond Investigational Products and Uses
Importantly, the 2026 Draft Guidance extends the scope of the statutory safe harbor beyond products and uses that are technically “investigational.” Although Section 502(gg) applies by its terms to “investigational” medical products and “investigational uses,” the 2026 Draft Guidance continues FDA policy articulated in the 2018 Final Guidance that extends permissible payor communications to unapproved or uncleared uses of approved or cleared medical products, even when such uses are not actively being investigated. Specifically, the 2026 Draft Guidance states that FDA does not intend to object under Section 502(f)(1) to a firm’s communication of product information to payors concerning unapproved medical products or unapproved uses, even when such products or uses may not qualify as “investigational,” provided the communication is consistent with Section 502(gg).92026 Draft Guidance at 18. The 2026 Draft Guidance further adds that FDA does not intend to object under either 21 C.F.R. §§ 312.7 and 812.7 to such communications and or to treat them, standing alone, as evidence of a new intended use.
Takeaways From the 2026 Draft Guidance on Communications With Payors
The 2026 Draft Guidance represents a meaningful evolution in FDA’s approach to manufacturer-payor communications, driven by statutory changes that provide the legal foundation for both HCEI dissemination about approved/cleared products and communications about investigational products and uses. Although the 2026 Draft Guidance does not materially change FDA’s approach to manufacturer-payor communications, companies should continue to carefully evaluate their existing payor communications against this framework.
The 2026 Draft Guidance is not yet in effect for implementation purposes. FDA is accepting comments until August 3, 2026.