Patients’ Right to Know Their Medication Act of 2025

Summary

Creates a new, mandatory printed patient medication information (PMI) requirement for most prescription drugs: the FDA must issue final regulations within one year that require manufacturers to produce a standardized, one-page printed PMI to be supplied with each prescription. The rules will specify required content (drug name/NDC, indications, directions, contraindications, warnings, adverse reactions, interactions, storage/disposal, manufacturer contact, link to FDA adverse event form, subpopulation data statements, and instructions not to share), formatting and font minimums, non-promotional plain language, printing/distribution practices, FDA approval and review procedures, and manufacturing verification. Failure to provide PMI as required will render the drug misbranded under the FD&C Act. The bill also directs the FDA to set procedures for timely updates (including class-level updates), require patient testing to inform content/format choices, and require evidence that any enhanced PMI improves adherence and reduces costs before adoption.

• FDA must issue final regulations within 1 year requiring a standardized printed patient medication information sheet for most prescription drugs.
• Manufacturers must develop and provide a single-page printed PMI with each prescription and include it in drug approvals and marketing materials.
• PMI must include drug identity, indications, directions, contraindications/warnings/adverse reactions (including subpopulation information), interactions, storage/disposal, manufacturer contact, and link to FDA adverse event form.
• PMI must be plain language, non-promotional, use approved formatting/graphics, meet minimum font and layout standards, and be based on documented patient research.
• Failure to provide PMI as required is treated as misbranding under the FD&C Act, enabling FDA enforcement actions.
• FDA must set rules for timely updates, permit class-level updates to avoid inconsistent messaging, and require manufacturing/CGMP verification for printed PMI.
• The law directs evidence that any enhanced PMI demonstrably improves adherence and reduces health care costs before claiming such benefits.
• Distribution rules require one printed PMI be supplied with each prescription; bulk-packaging must include adequate printed copies per dispensed prescription.