FDA Issues Draft Guidance on Payor Communications to Address Statutory Changes

June 10, 2026Lobbying & Public Policy, Policy & Regulation, Medical Devices, Health Care, Food and Drug Administration (FDA), Drug Development

On June 2, 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on how drug and device companies may communicate health care economic information (HCEI) with payors (e.g., health insurance companies), formulary committees (e.g., pharmacy and therapeutics committees) and similar entities. The guidance, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers, is now open for comment.

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