On September 4, 2025, Representative Jared Golden (D-ME-02), co-chair of the Congressional Printing Caucus, and Representative Cliff Bentz (R-OR-02) reintroduced the bipartisan Patients’ Right to Know Their Medication Act (H.R. 5133). The legislation would require drug manufacturers to provide printed, FDA-approved patient medication information (PMI) covering dosage, side effects, and other essential details to every patient picking up a prescription in an outpatient setting. The bill standardizes these materials to a concise, one-page format and requires updates as new safety information becomes available.
The legislation will benefit printers that specialize in pharmaceutical printed literature. Niche pharmaceutical printers, those already equipped for current Good Manufacturing Practices (cGMP), like quality, traceability, and secure workflows—stand to gain steady, spec-driven demand from a standardized, one-page PMI. Regular FDA updates will generate frequent, time-sensitive reprint cycles, rewarding printers with agile change control, lot/batch tracking, and services such as just-in-time fulfillment. While these updates create new opportunities for printers, they also highlight a critical gap in patient safety: the lack of a national standard for printed medication information.
Nearly half of Americans take at least one prescription drug each month. However, there is currently no national standard requiring patients to receive consistent, readable drug information with their prescriptions. As a result, the content and format of printed medication information vary widely by pharmacy, and many patients receive incomplete or unclear guidance. This lack of consistency contributes to medication errors, adverse events, and increased healthcare costs.
The intent of the legislation is to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively. A standardized, FDA-approved printed PMI would improve comprehension and adherence, reduce preventable medication errors, and ultimately save lives, while also lowering costs for patients and the broader healthcare system.
The measure responds to efforts by the pharmaceutical industry to replace printed PMIs with electronic patient information. Lawmakers and stakeholders warn that an online-only approach would create barriers for patients, especially those with limited internet access or in rural areas, and could lead to confusion, mistakes, and avoidable healthcare costs.
Rep. Golden has previously opposed attempts to mandate electronic-only distribution of medication information, citing patient access and safety concerns. In a press release, Rep. Bentz emphasized that reliable internet access is not always available in rural Oregon—and that clear, printed instructions on how to take medication safely should be guaranteed.
In conjunction with the Pharmaceutical Printed Literature Association (PPLA), PRINTING United Alliance has long advocated for the passage of the Patients’ Right to Know Their Medication Act. The bill was referred to the Energy and Commerce Committee. The Government Affairs team will track and report on any developments as the legislation makes its way through the House.
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In this article, Stephanie Buka, Government Affairs Manager, PRINTING United Alliance, reports on the Patients’ Right to Know Their Medication Act of 2025. More information can be found at Business Excellence-Legislation or reach out to Steph should you have additional questions specific to how these issues may affect your business: sbuka@printing.org.
To become a member of the Alliance and learn more about how our subject matter experts can assist your company with services and resources such as those mentioned in this article, please contact the Alliance membership team: 888-385-3588 / membership@printing.org.