Patients’ Right to Know Their Medication Act of 2025

This bill would require a simple, printed handout to come with every prescription drug you pick up outside a hospital. The handout must use plain language, include helpful graphics when useful, follow a consistent format and font, and avoid any promotional tone. It must list the drug’s name and code, what it’s for, how to use it, key warnings and common/serious side effects (including for groups like children, pregnant people, and older adults), ways to lower risks, when to call a doctor, not to share meds, storage and disposal tips, known interactions (like with other drugs or food), whether enough data exists for certain groups, the manufacturer’s contact number, and a link to FDA’s consumer reporting form. Manufacturers must supply these on paper and include enough copies inside or on the packaging so one printed sheet goes out with each prescription. The FDA must approve the content and keep it updated.

The goal is to cut medication mistakes and emergency visits, especially since many people can’t access electronic information and relying only on electronic labels could harm public health. Congress cites potential savings of $14.6 to $26.2 billion a year in avoided ER and hospital costs. The FDA would have 1 year to issue final rules, based on patient research that shows what helps people understand and use their medicines safely. Not providing this handout would count as misbranding under federal law.

Key points:

• Who is affected: People filling prescriptions outside hospitals; drug manufacturers that must create and supply the printed handouts.
• What changes: A clear, standardized paper sheet must be included with each prescription, approved by the FDA and kept up to date.
• When: The FDA must issue final regulations within 1 year of the law taking effect.