FDA Updates Draft Guidance on Drug and Device Manufacturer Communications with Payors, Incorporating PIE Act Provisions

The US Food and Drug Administration (FDA) issued a revised draft guidance on June 2, 2026, titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers." Once finalized, this document will replace the agency's 2018 final guidance on the same topic and reflects statutory changes enacted through the Consolidated Appropriations Act of 2023.

The updated guidance addresses common questions about health care economic information (HCEI) that companies may share with payors, formulary committees, and similar entities conducting healthcare economic analyses of approved, cleared, and pre-approval products.

Incorporating the PIE Act and Section 502(gg)

The most significant change in the 2026 draft guidance is the inclusion of a statutory safe harbor for communications about investigational medical products and investigational uses of approved or cleared products. The Pre-Approval Information Exchange (PIE) Act, enacted as Section 3630 of the Consolidated Appropriations Act of 2023, added Section 502(gg) to the Federal Food, Drug, and Cosmetic (FD&C) Act.

Under Section 502(gg), a drug or device shall not be deemed misbranded when certain truthful and not misleading information is provided to payors, provided four conditions are met: the information falls within the defined scope of "product information" (including product descriptions, indications being investigated, anticipated approval timelines, pricing information, patient utilization projections, and factual presentations of study results that do not characterize or make conclusions regarding safety or efficacy); the information is truthful and not misleading; required disclosures are presented, including a clear statement that the product or use is not approved or cleared and that safety and effectiveness have not been established; and the communication does not include prohibited representations that the product has been approved or determined safe or effective for the purposes being studied.

This statutory framework elevates many of the disclosures and prohibitions that FDA had previously characterized as non-binding recommendations under the 2018 final guidance to statutory requirements.

Unified Framework for Drugs and Devices

Historically, the HCEI-related provisions in Section 502(a) of the FD&C Act applied only to drugs. The 2018 final guidance addressed devices in a separate section, noting that although the HCEI provisions did not directly cover devices, FDA believed the same recommendations were "generally applicable" to device manufacturers.

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 to encompass both categories.

Strengthened Obligation for Updated Information

The 2026 draft guidance reinforces the obligation for manufacturers to provide follow-up communications. While the 2018 final guidance suggested that firms provide updated information if previously communicated material became outdated, the new 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)."

Scope Beyond Investigational Products

The draft guidance extends the scope of the statutory safe harbor beyond products and uses that are technically "investigational." FDA states that it 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). The guidance further adds that FDA does not intend to object under 21 C.F.R. §§ 312.7 and 812.7 to such communications or to treat them, standing alone, as evidence of a new intended use.

Balancing Public Health Interests

FDA acknowledged the tension between public health interests advanced by premarket review requirements and the needs of payors. "FDA recognizes that in certain instances, there can be tension between the public health interests directly advanced by the premarket review requirements and other important interests," the agency stated. "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."

At the same time, FDA cautioned that "some firms' communications regarding unapproved medical products or unapproved uses of approved/cleared medical products may undermine substantial government interests related to health and safety," including potentially affecting the development of robust scientific data on safety and effectiveness.

Stakeholders may submit comments on the revised guidance at www.regulations.gov under docket number FDA-2016-D-1307 until August 3, 2026.