FDA Proposes Unified Framework for Drug and Device Communications with Payors
The FDA issued a new draft guidance on June 3, 2026, to update and replace its 2018 guidance on manufacturer-payor communications. It incorporates the PIE Act's statutory safe harbor for sharing information about investigational products with payors. The guidance creates a unified regulatory framework for both drugs and devices.
The U.S. Food and Drug Administration announced on June 3, 2026, a new draft guidance titled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers.” The guidance is intended to replace the final guidance issued in June 2018 and incorporates statutory changes enacted by the Pre-Approval Information Exchange (PIE) Act.
The PIE Act, part of the Consolidated Appropriations Act, 2023, added Section 502(gg) to the Federal Food, Drug, and Cosmetic Act. This provision states that no drug or device shall be deemed misbranded because of certain truthful and not misleading information provided to 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 The new draft guidance also reflects amendments that extend the healthcare economic information (HCEI) provisions of Section 502(a) to medical devices.
A key change in the 2026 Draft Guidance is the creation of a unified framework for both drugs and devices. Previously, the HCEI provisions in Section 502(a) applied only to drugs, with the 2018 guidance addressing devices in a separate section. As amended by the PIE Act, Section 502(a) now explicitly references “drugs or devices,” and the new guidance consolidates the treatment under a single set of questions and answers.
The most significant update is the inclusion of a statutory safe harbor for communications with payors about investigational medical products and investigational uses of approved/cleared products. The 2018 guidance relied on a non-binding framework under which FDA stated it did “not intend to object” to certain pre-approval communications, provided the information was unbiased, factual, accurate, and non-misleading. The 2026 Draft Guidance outlines the statutory standard under Section 502(gg), which requires four conditions to be met for a communication to a payor.
The conditions specify that the information must be the type of “product information” set forth in Section 502(gg)(2), such as product descriptions, indications being investigated, anticipated approval timelines, pricing information, patient utilization projections, and factual study results that do not characterize or make conclusions regarding safety or efficacy. The information must be truthful and not misleading, presented with required disclosures (including a clear statement that the product or use is not approved/cleared and safety and effectiveness has not been established), and must not include representations that the product has been approved/cleared or determined safe or effective for the purposes being studied.
This statutory provision elevates 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 also includes a strengthened obligation regarding follow-up communications.