HR 5133119th CongressIn Committee

Patients’ Right to Know Their Medication Act of 2025

Introduced: Sep 4, 2025

Sponsor: Rep. Bentz, Cliff [R-OR-2] (R-Oregon)

Healthcare

Standard Summary

Comprehensive overview in 1-2 paragraphs

The Patients’ Right to Know Their Medication Act of 2025 would require a standardized, printed patient medication information (PMI) document to be provided with every prescription drug. Introduced by Rep. Bentz (and Rep. Golden of Maine) on September 4, 2025, the bill directs the FDA to issue final regulations within one year that set the format, content, and dissemination rules for PMI. The PMI must be scientifically accurate, non-promotional, written in plain language (with graphics where appropriate), and printed on paper. It would cover key safety information, usage directions, drug interactions, subpopulations, storage/disposal, and contact information for the manufacturer, among other items, and must accompany each prescription dispensed. Failure to provide PMI as required would be a misbranding offense under the FD&C Act. The bill emphasizes paper PMI as essential, aiming to reduce adverse drug events and associated health costs, especially for patients with limited access to electronic labeling. It also requires that PMI be developed by manufacturers as part of the drug approval process and kept up-to-date as new information becomes available. An “adequate supply” standard would require one printed PMI per prescription in packaging.

Key Points

1Establishes a new regulatory section (505H) requiring patient medication information for prescription drugs, with the FDA issuing final regulations within 1 year of enactment.
2PMI content and format rules: scientifically accurate, safety-focused, approved by the Secretary, plain language, possible graphics, standardized format, minimum font/consistent color, printed on paper, and not promotional.
3Required PMI contents: drug name, approved indications, general use directions, contraindications/warnings, common and important adverse effects, subpopulation considerations, steps to reduce risk, when to contact a health professional, storage/disposal guidance, known interactions, data on use in specific subpopulations, manufacturer contact information, and a toll-free number plus a current link to Form FDA 3500B for voluntary adverse event reporting.
4Printing and distribution: PMI must be provided in printed form with each prescription, accompanying the drug packaging, and produced in an adequate supply.
5Enforcement: Misbranding penalties extended to cover failure to provide PMI in accordance with the new 505H requirements.

Impact Areas

Primary group/area affected:- Patients and consumers who receive prescription medications, particularly those with limited access to electronic labeling.- Pharmacies, dispensing sites, and drug manufacturers who must produce and include PMI with every prescription.Secondary group/area affected:- Healthcare professionals who counsel patients (physicians, pharmacists, nurses) who will reference PMI in patient conversations.Additional impacts:- Potential reduction in adverse drug events and related healthcare costs, through improved patient understanding and adherence.- Increased regulatory and manufacturing burden on drug sponsors to develop, format, review, and periodically update PMI; potential cost implications for packaging and distribution.- Legal compliance risk for firms if PMI is not provided, via misbranding penalties.The bill cites findings on high prescription drug use, potential safety improvements from paper PMI, and projected cost savings from reducing adverse events (though the exact savings are in the legislative findings).Sponsor information in the bill shows introduction by Rep. Bentz (with Rep. Golden of Maine) and referral to the Energy and Commerce Committee; status is introduction and referral.

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