Sponsors (12)
The bill would make medication information more uniformly accessible on paper—helping many patients (especially seniors and those without internet) understand and report problems—while imposing real costs, workflow and environmental burdens and risking oversimplification of complex drug information.
Patients (especially people with chronic conditions and seniors) will receive a standardized, single-page printed medication information sheet that improves understanding of indications, directions, and warnings and can reduce adverse drug events and related ER/hospital visits.
People without reliable internet access (including uninsured individuals and some seniors) gain concrete, accessible printed instructions, increasing equitable access to medication information and safer use.
Patients will have an easy way to report problems and get help because the printed PMI must include an FDA Form 3500B link and a toll-free manufacturer phone number, which can improve adverse-event reporting and follow-up.
Manufacturers, pharmacies, and possibly the FDA will face added design, printing, packaging, and compliance costs that may be passed to consumers or taxpayers and increase administrative burdens.
A rigid, single-page standardized format and non-promotional content rules risk oversimplifying complex drug information and limiting nuanced, patient-tailored guidance that clinicians and pharmacists currently provide, potentially harming patients who need detailed guidance.
Requiring one printed PMI per prescription will increase paper use and create environmental waste and logistical burdens for pharmacies (especially small or mail-order outlets).
Based on analysis of 3 sections of legislative text.
Requires FDA-regulated, standardized single-page printed patient medication information for most prescription drugs and makes failure to provide it a misbranding violation.
Official title: To amend the Federal Food, Drug, and Cosmetic Act regarding the patient medication information required to be included in the labeling of prescription drugs, and for other purposes.
Introduced September 4, 2025 by Cliff Bentz · Last progress September 4, 2025
Requires the FDA to create mandatory, standardized single-page printed patient medication information (PMI) for most prescription drugs and makes failure to provide that printed PMI a misbranding violation. The bill sets detailed rules on PMI content, format, distribution, plain-language requirements, FDA review and updates, and requires manufacturers to develop PMI as part of drug approvals, with final FDA regulations due within one year.