Patients’ Right to Know Their Medication Act of 2025
Sponsored By: Representative Bentz
Introduced
Summary
Standardized printed patient medication information would be required with every prescription. The bill would set detailed rules for what that paper information must say, how it looks, how it is given to patients, and create penalties for failing to include it.
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- Patients and families would get a one-page printed patient medication information sheet with each prescription to improve access to clear safety warnings and directions. This change targets a group that the bill notes includes about 48.9% of Americans who used a prescription drug in the prior 30 days.
- Drug manufacturers would have to develop and submit the printed information as part of drug approval, follow plain-language, formatting, and printing standards, and include items like indications, warnings, storage guidance, a toll-free contact, and a link to Form FDA 3500B. Not providing the required paper sheet would be a new misbranding offense.
- Regulators and pharmacies would face new duties. The Food and Drug Administration would have to issue final rules within one year and require timely updates and patient-tested formats. Pharmacies must provide one printed sheet per prescription and keep adequate printed supplies for bulk packaging.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Printed drug guides with each prescription
If enacted, FDA would set final PMI rules within 1 year. Drug makers would need FDA-approved, plain-English, standardized, non-promotional printed guides. The guide would include uses, directions, warnings (including for kids, pregnancy, and seniors), interactions, storage, and disposal. It would say when to contact a health professional and how to reduce side effects. It would list the maker’s toll-free number and a link to FDA Form 3500B to report problems. You would get a paper guide with every prescription, even from bulk packs. PMI would be updated as new safety facts emerge and tested with real patients to improve understanding. Once enacted, a prescription missing PMI would be misbranded and face existing penalties.
Sponsors & CoSponsors
Sponsor
Bentz
OR • R
Cosponsors
Rep. Golden, Jared F. [D-ME-2]
ME • D
Sponsored 9/4/2025
Rep. Carter, Earl L. "Buddy" [R-GA-1]
GA • R
Sponsored 10/3/2025
Rep. Perez, Marie Gluesenkamp [D-WA-3]
WA • D
Sponsored 10/3/2025
Lofgren
CA • D
Sponsored 11/19/2025
Rep. Lieu, Ted [D-CA-36]
CA • D
Sponsored 12/2/2025
Rep. Bacon, Don [R-NE-2]
NE • R
Sponsored 12/3/2025
Rep. Westerman, Bruce [R-AR-4]
AR • R
Sponsored 1/7/2026
Rep. Pappas, Chris [D-NH-1]
NH • D
Sponsored 2/2/2026
Pingree
ME • D
Sponsored 4/27/2026
Rep. Van Orden, Derrick [R-WI-3]
WI • R
Sponsored 4/28/2026
Rep. Begich, Nicholas J. [R-AK-At Large]
AK • R
Sponsored 5/11/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov