Off-Label Communications Bill Allowing Discussion Of Unapproved Drugs Advances

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legislation

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By 

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

Advocates Want New Bipartisan PBM Reform Package To Stand Alone

 
• By 

A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.

Biktarvy, Trikafta Affected As Medicaid Cuts Could Increase Patient Assistance Demands

 
• By 

Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

More from Pink Sheet

Danish Medicines Agency Wants Companies To Use “Better Data Format” To Submit Bioequivalence Studies

 

The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.

England’s NICE Hunts For New Chief As Sam Roberts Prepares To Step Down

 

Sam Roberts, chief executive of the health technology assessment institute, NICE, will step down from her role at the end of the year. The agency is now on the lookout for a new leader, who will be the fourth in its history.

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.