Come Together: FDA Proposes Updated Guidance on Health Care Economic Information Communications

Key Takeaways

• FDA has proposed a revised guidance on Health Care Economic Information (“HCEI”) communications to payors, formulary committees, or other similar entities that, for the first time, consolidates drugs and medical devices into a single framework.
• The proposed guidance introduces section 502(gg) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) as a new statutory safe harbor for communications about unapproved medical products and unapproved uses, replacing what was previously an enforcement-discretion-only framework.¹
• Life sciences companies communicating HCEI to such entities should evaluate their existing materials and processes to align with the updated statutory framework, including the new mandatory requirement to provide follow-up information when previously communicated information becomes materially outdated.

Overview

We thought of the Beatles 1969 classic, “Come Together,” when we read the proposed changes to FDA’s HCEI guidance, which consolidates past guidance sections for drugs and devices. FDA published a proposed revised draft guidance titled, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers,” which, when finalized, will replace the June 2018 final guidance of the same name.²

The revision incorporates significant statutory changes enacted since 2018, most notably reflecting the 2023 Amendment to the Consolidated Appropriations Act, and introducing a restructured Q&A format that reflects a unified approach to drugs and devices.³

Highlighted Differences Between the 2018 and 2026 Guidance Documents

• The 2018 guidance addressed HCEI for approved drugs in the primary section and then provided a separate, shorter section stating that the same recommendations “generally” applied to devices. The 2026 proposed guidance eliminates this approach, consolidating all HCEI recommendations into a single section applicable to “Approved/Cleared Medical Products.”
• Another significant substantive change involves communications about unapproved products and unapproved uses. The 2018 guidance relied exclusively on FDA’s enforcement discretion, stating that FDA “does not intend to object” if communications were “unbiased, factual, accurate, and non-misleading.” The 2026 proposed guidance now anchors these communications in the new section 502(gg), which provides that “no drug or device shall be deemed to be misbranded” if certain conditions are met. This represents a shift from an enforcement-discretion framework to statutory protection.
• Consistent with section 502(gg), the proposed guidance adopts the statutory concept of “truthful and not misleading” for unapproved product communications, replacing the 2018 formulation of “unbiased, factual, accurate, and non-misleading.”
• The 2018 guidance merely “suggested” that firms provide follow-up information if previously communicated information became materially outdated. The 2026 proposed guidance elevates this to a mandatory requirement: “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.”
• In both the HCEI and unapproved product contexts, the proposed guidance adds a “standing alone” qualifier to FDA’s statement regarding new intended use. FDA now states it “does not intend to use HCEI that is disseminated consistent with this guidance, standing alone, as evidence of a new intended use.”
• The 2018 guidance required disclosure of “any additional risk information related to clinical assumptions in economic analyses that vary from the FDA-approved labeling.” The 2026 proposed guidance introduces a materiality threshold, requiring disclosure of risk information “that is materially different from the FDA-approved labeling.”
• The 2026 proposed guidance adds a new question to the FAQ section that identifies information that the FD&C Act requires be excluded from product information, including representations that an unapproved product has been approved or cleared, or determined to be safe or effective for the purpose for which it is being studied. The 2018 guidance characterized such communications merely as “inappropriate” rather than prohibited.

AGG Observations

• The proposed guidance reflects a meaningful evolution in FDA’s approach to HCEI communications. By anchoring unapproved product communications in the statutory text of section 502(gg) rather than relying solely on enforcement discretion, FDA has provided a more predictable regulatory framework. Companies that have relied on the 2018 guidance’s enforcement-discretion approach may take comfort that a statutory safe harbor now exists but should revisit whether their current communications satisfy the specific conditions set forth in section 502(gg).
• The addition of the “standing alone” qualifier to the new intended use language warrants attention. While this language may simply reflect what FDA has always intended, it signals that HCEI dissemination could potentially be considered alongside other evidence of intended use. Companies should ensure that their HCEI communications are clearly situated within the section 502(a) framework and do not, when viewed in conjunction with other promotional activities, suggest promotion of unapproved uses.
• Companies should not overlook the mandatory follow-up obligation, if finalized. According to the 2018 guidance, providing updated information was merely a suggestion. Now, companies must have systems in place to track when previously communicated information to payors becomes materially outdated — for example, due to a failed pivotal trial or a clinical hold — and must proactively provide updated information. This is particularly relevant for companies in active development programs that are communicating pipeline information to payors in anticipation of coverage decisions.
• Medical device companies no longer need to rely on an analogical extension from a drug-focused guidance. The statutory amendments and this proposed guidance make clear that section 502(a) applies to devices on equal footing with drugs.
• The introduction of a materiality threshold for risk information disclosure provides helpful clarity. Companies need not disclose every conceivable risk difference from the label in their HCEI presentations, only those that are materially different. This should reduce overinclusion of risk information that may not be relevant to the economic analysis being presented.
• Comments on the proposed guidance are due by August 3, 2026, in docket number FDA-2016-D-1307.

Bringing it back to the Beatles, drug and device companies can now “Come Together” over the guidance revisions. For guidance on these issues, please contact a member of AGG’s Food & Drug team.

[1] 21 U.S.C. § 352(gg).

[2] See AGG’s bulletin, “FDA Says Sharing Medical Product Information is Caring, to an Extent.”

[3] 21 U.S.C. § 352(a).