Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities
The draft guidance clarifies when manufacturers may share health care economic information and certain pre approval product details with payors, as long as the information is truthful, non misleading, and properly qualified. It effectively expands and codifies the framework for HCEI and PIE communications by defining what information fits within 502(gg), who the appropriate audiences are, and what conditions help minimize misbranding risk.

The Special Advisory Bulletin issued in January 2026 highlights how the federal Anti Kickback Statute applies when drug manufacturers sell prescription medications directly to patients who are covered by federal health care programs. It warns that manufacturer to patient sales can create kickback risks-especially when discounts, copay support, or other financial inducements could steer federally insured patients toward specific products. The OIG emphasizes that manufacturers must structure any direct to consumer arrangements to avoid improper remuneration and ensure compliance with federal fraud and abuse laws.