This guidance provides answers to common questions regarding firms’ communication of health care economic information (HCEI) regarding their prescription drugs to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors). This guidance also addresses common questions relating to dissemination of information about investigational drugs and devices (medical products) to payors before FDA approval or clearance of such products.
The questions and answers are grouped in the following categories:
- Communication of HCEI to payors regarding approved drugs
- Communications to payors about investigational drugs and devices (investigational products)
This guidance describes FDA’s current thinking on these topics.