FDA Issues Revised Draft Guidance on Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers

Today, the U.S. Food and Drug Administration issued the revised draft guidance Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers.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.