Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers

Why It Matters

The guidance clarifies permissible HCEI disclosures, reducing regulatory risk and shaping market‑access strategies for pharma and device firms.

Key Takeaways

• FDA draft guidance seeks comments by Aug 3 2026
• Addresses HCEI communication to payors for drugs and devices
• Covers rules for unapproved products and off‑label uses
• Aims to clarify compliance and reduce regulatory uncertainty

Pulse Analysis

The FDA has issued a draft Level 1 revised guidance (docket FDA‑2016‑D‑1307) answering common questions on how drug and device makers may share health‑care economic information (HCEI) with payors, formulary committees and similar entities. Co‑authored by the Centers for Biologics, Devices and Drugs, the draft also covers communication about products that lack FDA approval and off‑label uses of approved products. The document carries OMB control number 0910‑0686 and remains in effect until November 30 2026. Though non‑binding, the guidance is open for comment until August 3 2026.

For pharmaceutical and device firms, the guidance clarifies the regulatory perimeter for HCEI disclosures that drive formulary placement and reimbursement negotiations. By specifying permissible content and timing, companies can build market‑access strategies with reduced enforcement risk. The sections on unapproved products and off‑label uses address a long‑standing gray area, allowing firms to share value‑based data while staying within compliance boundaries. Compliance teams will likely revise standard operating procedures to incorporate the new disclosure thresholds and documentation requirements. This clarity is expected to accelerate value‑based contracting and improve payor‑manufacturer dialogue.

Stakeholders are invited to submit written or electronic comments, giving the FDA insight into industry practice before finalizing the rule. A transparent comment period could produce refinements that better align the guidance with commercial realities, potentially speeding adoption of value‑based contracts. If the FDA incorporates major suggestions, the final guidance could be published in early 2027, giving firms a clear compliance deadline. Until the final version is released, companies should treat the draft as a best‑practice framework, updating internal policies and training to reflect its recommendations.