Pay(or) Attention, Drug and Device Makers: FDA’s New Guidance for Talking to Health Plans

When finalized, it will replace the 2018 guidance. The revision incorporates statutory changes US Congress made in 2023. Companies now have a single, clearer framework for sharing economic data about approved products and factual information about products still in development. Device makers should pay special attention: for the first time, they are covered by the same statute that has governed drug makers for decades. Comments are due August 3.

Who Should Read This

This guidance matters most to pharmaceutical, biotech, and medical device manufacturers that communicate with payors, and to the regulatory, medical affairs, and compliance teams that support them. It also matters to payors (health plans, PBMs, formulary committees, and technology assessment panels) because it sets expectations for what manufacturers should include in their presentations.

What the Guidance Covers

The guidance addresses two types of manufacturer-to-payor communications. The first is health care economic information (HCEI) about products already on the market. Under Section 502(a) of the federal Food, Drug, and Cosmetic Act (FDCA), HCEI is defined as any analysis that “identifies, measures, or describes” the economic consequences of the use of a drug or device, such as cost-effectiveness studies or budget-impact models. The second is factual information about “pipeline” product — drugs or devices not yet approved or cleared for any use or unapproved uses of approved or cleared products. Payors often need this information months or years ahead to plan budgets and coverage policies. The guidance does not cover communications aimed at prescribers making individual patient decisions or at consumers. It applies only to audiences with knowledge and expertise in health care economic analysis who are carrying out responsibilities for the selection of medical products for coverage or reimbursement.

What Changed and Why

The 2018 guidance relied on FDA enforcement discretion under a more limited statute. In 2023, Congress passed the Pre-Approval Information Exchange (PIE) Act, Section 3630 of the Consolidated Appropriations Act, rewriting the legal foundation in two key ways.

First, devices are now explicitly covered. Before the PIE Act, the HCEI rules in Section 502(a) of the FDCA only mentioned drugs. The PIE Act amended Section 502(a) to say “drugs or devices” throughout, and the 2026 guidance drops the old separate device section entirely.

Second, pipeline communications now have a statutory safe harbor. The PIE Act created Section 502(gg), which provides that a drug or device “shall not be deemed to be misbranded” under Section 502(f)(1) — the adequate-directions-for-use requirement — when a manufacturer shares truthful, non-misleading information with payors about products or uses still being investigated. That is a legal protection in statute, not a discretionary promise. It is important to note, however, that the safe harbor is specific to Section 502(f)(1) misbranding; communications that are untruthful or misleading could still face scrutiny under other provisions.

The protection under Section 502(gg) applies when four conditions are met: (1) the information is of the type described in Section 502(gg)(2) (discussed below under “Rules for Pipeline Communications”), (2) it is truthful and not misleading, (3) it includes certain required disclosures specified in Section 502(gg)(1)(A), and (4) it does not include prohibited representations specified in Section 502(gg)(1)(B). 

The guidance extends this framework beyond technically “investigational” products and uses. The FDA states that it does not intend to object to communications about any unapproved product or use even when the product or use “may not be considered investigational,” provided the communication is consistent with Section 502(gg), and confirms that such communications will not, standing alone, be treated as evidence of a new intended use.

One new obligation: Section 502(gg) requires firms to provide updated information to payors if previously communicated information becomes materially outdated (a failed trial, a clinical hold, a regulatory setback). Under the 2018 guidance, this was a suggestion; it is now a statutory requirement. 

Rules for HCEI About Approved Products

HCEI must relate to an approved indication, be based on “competent and reliable scientific evidence” (CARSE) and include a prominent statement describing material differences from the FDA-approved labeling. The guidance reads “relates to an approved indication” broadly. Companies can model longer time horizons, extrapolate to different care settings, or use real-world dosing data. But an analysis claiming a symptom-relief product cures the underlying disease would not qualify. For CARSE, the FDA will benchmark against good research practices from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the International Society for Pharmacoepidemiology (ISPE), the Patient-Centered Outcomes Research Institute (PCORI), and the Agency for Healthcare Research and Quality (AHRQ), applied to every component of the analysis including clinical assumptions. Companies should include in covered communications contextual information such as study design, limitations, sensitivity analyses, risk information, and financial bias disclosures. The FDA treats HCEI as promotional labeling; for drugs, firms must submit materials via Form FDA 2253 at initial dissemination (accelerated-approval drugs face a stricter pre-dissemination requirement), while device HCEI has no such requirement. The FDA does not regulate value-based contract terms themselves. Notably, the FDA does not intend to enforce postmarketing submission requirements (such as Form FDA 2253) for pipeline communications made in accordance with this guidance.

Rules for Pipeline Communications

The guidance permits companies to share product descriptions, the indication being studied, anticipated approval timeline, pricing, utilization projections, product-related programs, and factual study results. The key restriction: results must be presented factually, without characterizing safety or efficacy. “A statistically significant improvement was observed on the primary endpoint” is fine. “PRODUCT allows providers to optimize pain relief” is not. Communications must clearly state the product is not approved, describe the development stage, and present both positive and negative findings with material limitations.

Conclusion

This is the most significant update to the FDA’s manufacturer-payor communication rules in eight years. Devices are fully covered by the same framework as drugs, and pipeline communications rest on a statutory safe harbor rather than enforcement discretion. The guidance also adds a mandatory update obligation. It is still in draft, but the underlying statute is already law. The FDA is accepting comments through August 3. Companies should weigh in and treat this draft as a clear signal of where compliance expectations are headed.

For questions about this alert or how the FDA’s revised guidance on manufacturer-to-payor communications may affect your organization, please contact one of the authors.