H.R. 5133 — Patients’ Right to Know Their Medication Act of 2025

This section declares congressional findings on prescription medications, including that 48.9% of Americans used at least one prescription drug in the past 30 days per CDC data; that paper-format patient medication information (PMI) can prevent most adverse drug events and reduce related emergency and hospital costs by $14.6-$26.2 billion annually; and that no standardized, single-page, patient-friendly paper PMI is currently required under federal law.

This section directs the Food and Drug Administration (FDA) to issue final regulations within one year of enactment requiring printed patient medication information for prescription drugs (i.e., drugs subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act) with each prescription dispensed in adequate supply (i.e., one per prescription, including for bulk packaging). The regulations must require such information to (1) be scientifically accurate, FDA-approved as part of the drug approval application, in plain language with graphics, standardized format and color, non-promotional, and consistent with current good manufacturing practice; (2) include at least the drug name and national drug code, FDA-approved indications, directions for use, contraindications, warnings, precautions, major adverse reactions (especially for subpopulations such as children, pregnant women, and the elderly), risk reduction measures, when to contact a health care professional, non-sharing instructions, storage and disposal guidance, drug/food interactions, subpopulation data availability, manufacturer contact information, and a link to FDA Form 3500B for adverse event reporting; and (3) incorporate timely reviews, class-wide updates to avoid confusion, and specifications based on patient research demonstrating improved adherence, compliance, health outcomes, and cost savings. This section also deems prescription drugs misbranded if such information is not provided in accordance with these requirements.