Patients’ Right to Know Their Medication Act of 2025

Key Points

• This bill requires drug manufacturers to include a standardized, printed paper guide with every prescription dispensed in non-hospital settings. The guide must use plain language, graphics, and pictures so patients can easily understand how to use their medication safely.
• Each guide must contain specific information including the drug's name, approved uses, directions, contraindications, warnings, side effects, drug interactions, and special warnings for groups like children, pregnant women, and the elderly. The information must be scientifically accurate and non-promotional.
• The FDA must issue final regulations within one year of enactment covering the content, format, font size, color, and printing requirements for these guides. The rules must be based on documented patient research showing improved understanding of safe medication use.
• Congress estimates that standardized paper medication guides could reduce emergency room visits and hospital admissions related to bad drug reactions, saving between $14.6 billion and $26.2 billion each year.
• If a prescription drug is sold without the required paper guide, it would be considered "misbranded" under federal law, which carries penalties for the manufacturer. This enforcement mechanism ensures companies actually comply with the new requirement.