The FDA has issued the revised draft guidance Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers. This guidance answers common questions concerning firms’ communication of health care economic information (HCEI) on prescription drugs and devices to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis. It addresses the communication of HCEI to payors regarding approved/cleared medical products, as well as unapproved medical products and unapproved uses of approved/cleared medical products.
This guidance incorporates updates to the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by section 3630 of the Consolidated Appropriations Act, 2023. When finalized, it will replace the final guidance for industry and review staff Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities: Questions and Answers issued in June 2018. Key changes from the 2018 final guidance include updates to reflect revised statutory text that makes the provisions in section 502(a) of the FD&C Act regarding the communication of HCEI to payors applicable to devices. The guidance also includes updates to align its recommendations with the new section 502(gg) of the FD&C Act, which provides that a drug or device won’t be deemed misbranded under section 502(f)(1) because of certain truthful and not misleading information provided to payors.
FDA is requesting comments on the draft guidance be submitted to Docket No. FDA-2016-D-1307 by August 3, 2026.
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