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TREAS/IRS RIN: 1545-BR16 Publication ID: 2026 
Title: Branded Prescription Drug Fee Discounts 
Abstract:

The proposed regulation updates 51.4(b)(2)(i)(B) and (iv) of the Branded Prescription Drug Fee Regulations, which currently cite to the Coverage Gap Discount Program described in section 1860D-14A of the SSA (42 U.S.C.1395w-114a), to reflect that the Inflation Reduction Act terminated this program and replaced it with the Manufacturer Discount Program described in section 1860D-14C of the SSA (42 U.S.C. 1395w-114c). The proposed regulations would also update 51.11 to reflect the applicability date for proposed 51.4(b)(2)(i)(B) and (iv). This regulatory action is aligned with Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First (Apr. 15, 2025). Additionally, updating the regulations to conform with recent statutory changes reduces the compliance burden for feepayers.

 
Agency: Department of the Treasury(TREAS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Deregulatory 
CFR Citation: 26 CFR part 51 (Revision)     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Pub. L. 117-169, sec. 11201    26 U.S.C. 7805   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/00/2026 
Additional Information: REG-103430-24 Drafting attorney: Julia Barlow, (202) 317-3305 Reviewing attorney: Charles Langley, (202) 317-5274 Treasury attorney: Shelley Leonard, (202) 622-2172 CC: ECE
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Related to 1545-BJ39 
Agency Contact:
Julia Barlow
Attorney
Department of the Treasury
Internal Revenue Service
1111 Constitution Avenue NW, Room 5316,
Washington, DC 20224
Phone:202 317-3305
Email: julia.c.barlow@irscounsel.treas.gov