FDA’s 2026 Draft Guidance on Payer Communications

What Changed and Why It Matters

FDA Updates the Payer Communications Framework

On June 3, 2026, FDA made available revised draft guidance for industry titled “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers.” The updated guidance underscores the need for payer communications to remain clear, accurate, not misleading, and up to date. Once finalized, the draft guidance will replace FDA’s 2018 final guidance on manufacturer communications with payers, formulary committees, and similar entities.

The revised draft guidance addresses two broad categories of communications: health care economic information, or HCEI, about approved or cleared medical products, and product information about unapproved medical products or unapproved uses of approved or cleared medical products.

Drugs and Devices Move Under One Umbrella 

One of the most important updates is that FDA’s framework now more clearly applies across both prescription drugs and medical devices.

The 2026 draft guidance reflects statutory changes made by Section 3630 of the Consolidated Appropriations Act, 2023, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to make the HCEI provisions applicable to both drugs and devices. As a result, FDA now uses the term “medical products” to refer collectively to prescription drugs and medical devices.

This change also removes the need for the separate device-specific section that appeared in the 2018 guidance.

Key Components of FDA’s 2026 Payer Communications Framework for Approved and Unapproved Medical Products 

Approved or Cleared Medical Products

  • Consistent with 2018 guidance
  • Based on competent and reliable scientific evidence (CARSE)
  • Includes context so that communication is truthful and not misleading
  • Includes conspicuous and prominent statement if HCEI includes material differences from FDA-approved or FDA-required labeling

Not Approved or Cleared Medical Products or Not Approved Uses of Approved or Cleared Medical Products

  • Includes factual product information so that communication is truthful and not misleading
  • Product information is presented factually and does not characterize or make conclusions regarding safety or efficacy/effectiveness
  • When presenting study results, includes a non-selective description of the material study design, methodology, results, and limitations
  • Includes approved or cleared indication and provides the most current FDA-required labeling

Follow-Up Requirements Become More Prominent

Another key practical takeaway from the draft guidance is FDA’s focus on follow-up communications.

If a firm previously shared information with payers and that information becomes materially outdated because of significant changes or new information about the product or its review status, the firm must provide updated information.

Therefore, manufacturers should consider not only what they communicate to payers, but also how they will monitor those communications over time.

Key Takeaways for Manufacturers

AI appears most useful in market access when it helps teams synthesize existing intelligence, including payer interview learnings, policy reports, coverage patterns, published literature, value materials, product profiles, and trend reports.
Applied appropriately, these approaches can support several access strategy activities.

Overall, the 2026 draft guidance largely preserves FDA’s 2018 approach to HCEI for approved or cleared products, while creating a clearer and more formal structure for communications about unapproved products and unapproved uses.

For manufacturers, the practical implications are significant. Companies should review their payer-facing materials, ensure that approval-status disclosures are clear, confirm that study results are presented in a balanced and non-promotional manner, and establish processes for updating payers when previously shared information becomes materially outdated.

The 2026 guidance has not yet been finalized. FDA is accepting comments until August 3, 2026, after which revisions may be made before final guidance is issued.

References:

1. U.S. Food and Drug Administration. Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities: Questions and Answers. Guidance for Industry. Draft guidance. Revision 1. June 2026. Accessed June 16, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-and-device-manufacturer-communications-payors-formulary-committees-and-similar-entities

2. U.S. Food and Drug Administration. Drug and Device Manufacturer Communications With Payers, Formulary Committees, and Similar Entities—Questions and Answers. Guidance for Industry and Review Staff. June 2018. Accessed June 16, 2026. https://www.fda.gov/media/102683/download