Opinion: FDA allows off-label health care economic discussions. Is there more to come?

The Trump administration has issued final guidance that allows drug companies and device makers to provide health care economic and other supporting information to payers and formulary committees, even if the information is outside of the FDA approved labeling and was not submitted to the agency in the course of product approval. This is a welcome and long-overdue development, one that raises the question of whether the agency will take steps to allow companies to provide truthful off-label information to physicians and patients in other contexts.

Health care economic and other supporting information, known as HCEI, can include clinical data or other evidence that attempts to measure or describe the economic outcomes or health consequences of using a drug or device, and may be evaluated in comparison with other health care interventions or with no intervention at all.