Off-Label Communications Bill Allowing Discussion Of Unapproved Drugs Advances

18 Jan 2018

Safe harbor for off label discussions between manufacturers and payers clears US House Energy & Commerce Health Subcommittee. Bill covers unapproved drugs as well as off label uses for approved agents.

Render illustration of computer keyboard; with the print OFF-LABEL on a red button; and a small bottle of pillls.

Legislation allowing for communication between manufacturers and payers of clinical and economic information for unapproved drugs cleared the House Energy & Commerce Health Subcommittee Jan. 18, marking the first time a bill clearing the way for pre-approval information exchange has made it that far.

HR 2026, sponsored by Rep. Guthrie, R-Ky., now advances to the full Energy & Commerce Committee for consideration. It was...