FDA Revised Draft Guidance: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers." This revised draft guidance, when finalized, will provide answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs and approved/ cleared (as defined in the guidance) medical devices (collectively referred to in the guidance as approved/cleared medical products) by medical product manufacturers, packers, distributors, and their representatives (collectively referred to as firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis, carrying out their responsibilities for the selection of medical products for coverage or reimbursement (collectively referred to as payors). This revised draft guidance also provides answers to common questions about firms' dissemination of information to payors about medical products that are not yet approved/cleared for any use (collectively referred to as unapproved medical products) and firms' dissemination of information to payors about unapproved uses of approved/cleared medical products.