Key Takeaways
- • FDA issued draft guidance on June 2, 2026, updating its 2018 framework for how drug and device manufacturers may communicate health care economic information (HCEI) to payors, formulary committees, and similar entities, with a comment period closing August 3, 2026.
- • Statutory changes from the 2023 Consolidated Appropriations Act now anchor communications about unapproved products in law rather than enforcement discretion, with section 502(gg) providing a safe harbor for truthful and non-misleading information about investigational products or investigational uses of approved products.
- • Device manufacturers now operate under the same HCEI framework as drug manufacturers, marking a structural consolidation; the 2018 guidance treated devices separately because the statute previously applied only to drugs.
- • Disclosure obligations are now mandatory by statute rather than discretionary, including requirements to disclose the stage of development, material study limitations, and a continuing obligation to update payors when previously communicated information becomes materially outdated.
- • FDA maintains a "non-objection" posture beyond statutory minimums, signaling it will not object to communications about any unapproved product or unapproved use so long as they comply with the section 502(gg) framework and meet competent and reliable scientific evidence (CARSE) standards.
Summary
The FDA's June 2, 2026 draft guidance represents a modest but legally significant update to its payor communications framework, primarily codifying statutory changes enacted under the 2023 Consolidated Appropriations Act rather than introducing new policy positions. The guidance, titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers," will replace the agency's June 2018 final guidance once finalized and is currently accepting public comment through August 3, 2026.
The most material change reflects a shift from discretionary enforcement to statutory mandate. Under the new section 502(gg) of the Food, Drug, and Cosmetic Act, drug and device manufacturers gain explicit legal protection—rather than reliance on FDA's stated enforcement intentions—for truthful and non-misleading communications to payors about investigational products or investigational uses of approved, cleared, or licensed products. FDA explicitly signals a "non-objection" posture that extends even beyond the statute's literal terms, indicating the agency will not object to communications about any unapproved product or unapproved use, provided they meet the section 502(gg) framework standards.
The guidance maintains continuity with 2018 positions on health care economic information communications for approved indications, reiterating that such communications are permissible if they (1) relate to an approved indication, (2) rest on competent and reliable scientific evidence (CARSE), and (3) include required disclosures about material differences from FDA-approved labeling. The agency continues to impose no format restrictions on CARSE presentation, accepting evidence dossiers, reprinted peer-reviewed journals, and payor brochures alike.
A significant structural consolidation integrates drug and device guidance into a single framework, eliminating the separate device section that existed in 2018 guidance. This reflects section 3630 of the 2023 Consolidated Appropriations Act extending the HCEI framework to devices for the first time. Additionally, disclosure obligations—previously recommended as best practice—are now statutorily mandatory, including disclosures about development stage, material study design limitations, and a continuing obligation to keep payors informed when previously shared information becomes materially outdated.
The timing of this guidance coincides with broader FDA initiatives addressing coverage, reimbursement, and payment considerations prior to approval, including the Commissioner's National Priority Voucher program for drugs and the RAPID coverage pathway for devices, suggesting the agency is systematically facilitating earlier payor engagement throughout the development lifecycle.
The most material change reflects a shift from discretionary enforcement to statutory mandate. Under the new section 502(gg) of the Food, Drug, and Cosmetic Act, drug and device manufacturers gain explicit legal protection—rather than reliance on FDA's stated enforcement intentions—for truthful and non-misleading communications to payors about investigational products or investigational uses of approved, cleared, or licensed products. FDA explicitly signals a "non-objection" posture that extends even beyond the statute's literal terms, indicating the agency will not object to communications about any unapproved product or unapproved use, provided they meet the section 502(gg) framework standards.
The guidance maintains continuity with 2018 positions on health care economic information communications for approved indications, reiterating that such communications are permissible if they (1) relate to an approved indication, (2) rest on competent and reliable scientific evidence (CARSE), and (3) include required disclosures about material differences from FDA-approved labeling. The agency continues to impose no format restrictions on CARSE presentation, accepting evidence dossiers, reprinted peer-reviewed journals, and payor brochures alike.
A significant structural consolidation integrates drug and device guidance into a single framework, eliminating the separate device section that existed in 2018 guidance. This reflects section 3630 of the 2023 Consolidated Appropriations Act extending the HCEI framework to devices for the first time. Additionally, disclosure obligations—previously recommended as best practice—are now statutorily mandatory, including disclosures about development stage, material study design limitations, and a continuing obligation to keep payors informed when previously shared information becomes materially outdated.
The timing of this guidance coincides with broader FDA initiatives addressing coverage, reimbursement, and payment considerations prior to approval, including the Commissioner's National Priority Voucher program for drugs and the RAPID coverage pathway for devices, suggesting the agency is systematically facilitating earlier payor engagement throughout the development lifecycle.
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