Patients’ Right to Know Their Medication Act of 2025

Bill Number

H.R. 5133

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-09-04: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-05-12T08:05:44Z

AI-Generated Summary

Purpose The legislation aims to require standardized, printed patient medication information (PMI) for prescription drugs to enhance patient safety, reduce adverse drug events, and ensure access for those without electronic resources.

Key Provisions

• The bill adds a new section 505H to the Federal Food, Drug, and Cosmetic Act, directing the Secretary of Health and Human Services to issue regulations within one year on the authorship, content, format, color, printing, and distribution of PMI for drugs subject to prescription requirements.
• PMI must be scientifically accurate, approved by the Secretary, developed by drug manufacturers, and included in printed form with each prescription dispensed.
• Required content includes the drug's established name and national drug code, approved uses, directions, contraindications, warnings, adverse reactions, interactions, storage and disposal instructions, manufacturer contact information, and a link to the FDA adverse event reporting form.
• PMI must use plain language, graphics where helpful, a consistent standardized format and minimum font size, and be non-promotional; it must be supplied in an adequate quantity for one copy per prescription.
• Regulations must ensure timely updates, consistency across similar drugs, and base formats on patient research showing improved understanding and adherence.
• The bill amends section 502 of the Act to make failure to provide PMI a misbranding offense.

Significant Changes to Existing Law

• Creates a mandatory federal requirement for a single-page, standardized printed PMI, which was not previously required under the Federal Food, Drug, and Cosmetic Act.
• Shifts from reliance on electronic labeling or manufacturer discretion to a uniform paper-based system enforced through misbranding provisions.
• Establishes specific content and format rules that must be developed with demonstrated patient comprehension benefits.

Potential Impacts

• Government agencies, primarily the Food and Drug Administration, would face new responsibilities for reviewing, approving, and updating PMI as part of drug applications and ongoing oversight.
• Citizens would gain consistent access to printed safety information at the point of dispensing, potentially lowering risks from adverse drug events.
• Drug manufacturers would need to prepare and supply compliant PMI with packaging, while pharmacies and dispensers would ensure distribution with each prescription.
• No direct effects on international relations are outlined in the legislation.

Main Stakeholders Affected

• Patients and their agents who receive prescriptions.
• Prescription drug manufacturers responsible for developing and providing PMI.
• The Food and Drug Administration, which must issue regulations and approve content.
• Pharmacies and other non-hospital dispensers required to distribute the printed materials.
• Healthcare professionals who may use the information in patient counseling.

Notable Legal, Constitutional, or Political Implications

• The bill enforces compliance through existing misbranding authority under the Federal Food, Drug, and Cosmetic Act, extending FDA labeling oversight without creating new enforcement mechanisms.
• It addresses gaps in current law by mandating paper PMI, citing limitations of electronic-only approaches for public health protection.
• Implementation depends on timely regulatory action by the Secretary, with potential for updates based on new safety data or class-wide information.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Bentz, Cliff [R-OR-2]

Cosponsors (11)

Rep. Golden, Jared F. [D-ME-2], Rep. Carter, Earl L. "Buddy" [R-GA-1], Rep. Perez, Marie Gluesenkamp [D-WA-3], Rep. Lofgren, Zoe [D-CA-18], Rep. Lieu, Ted [D-CA-36], Rep. Bacon, Don [R-NE-2], Rep. Westerman, Bruce [R-AR-4], Rep. Pappas, Chris [D-NH-1], Rep. Pingree, Chellie [D-ME-1], Rep. Van Orden, Derrick [R-WI-3], Rep. Begich, Nicholas J. [R-AK-At Large]

Recent Actions

• 2025-09-04: Referred to the House Committee on Energy and Commerce.
• 2025-09-04: Introduced in House
• 2025-09-04: Introduced in House

Bill Versions

• Patients’ Right to Know Their Medication Act of 2025 — issued 2025-09-04 — PDF (8 pages)