HR5133-119

What This Bill Does

The Patients' Right to Know Their Medication Act requires standardized printed patient medication information for prescription drugs. Congress finds that nearly half of Americans recently used a prescription drug, that adverse drug events create safety and cost problems, that paper patient medication information can reduce adverse events and could save $14.6 billion to $26.2 billion annually, that many patients cannot access electronic PMI, and that GAO warned against replacing paper labeling entirely with electronic labeling. The bill directs FDA to issue final regulations within one year covering authorship, content, format, color, printing, and dissemination of PMI for prescription drugs. PMI must be scientifically accurate, include relevant safety information, be FDA-approved, be developed by drug manufacturers as part of drug applications, use understandable plain language with graphics and pictures when applicable, follow a standardized format, minimum font size, and color, be printed on paper using current good manufacturing practice processes, avoid promotional tone, and include required details such as drug name, national drug code, indications, directions, warnings, adverse reactions, risk-reduction measures, when to contact a professional, storage and disposal, interactions, subpopulation data, manufacturer contact, and an FDA adverse-event reporting link. Printed PMI must be provided with each dispensed prescription in adequate supply. Regulations must cover timely reviews, approvals, updates, class-wide information, patient research supporting format choices, and a causal connection to improved adherence, reduced costs, and better outcomes. A prescription drug is misbranded if required PMI is not provided.

Who Benefits and How

Prescription drug patients benefit from standardized paper information about use, warnings, adverse reactions, interactions, storage, disposal, and reporting. Patients without reliable electronic access benefit because paper PMI must accompany dispensed prescriptions. Pharmacists benefit from a standardized patient information format that can reduce confusion at dispensing. Patient safety organizations benefit from FDA-approved PMI tied to adverse-event prevention and reporting.

Who Bears the Burden and How

Drug manufacturers must develop FDA-approved PMI, print it on paper, maintain adequate supply, and update it as information changes. FDA drug labeling staff must issue regulations within one year and review, approve, and update PMI. Pharmacies and distributors must ensure printed PMI accompanies each prescription dispensed from bulk packaging. Manufacturers of noncompliant prescription drugs face misbranding risk if PMI is not provided.

Key Provisions

• Requires FDA final regulations for printed prescription drug patient medication information within one year.
• Requires PMI to be scientifically accurate, FDA-approved, standardized, nonpromotional, understandable, and paper printed.
• Requires drug names, indications, directions, contraindications, warnings, adverse reactions, risk-reduction measures, interactions, subpopulation data, manufacturer contact, and FDA reporting links.
• Requires adequate printed PMI supply with each dispensed prescription.
• Requires timely reviews, updates, patient research, and evidence linking PMI to better adherence, lower costs, and improved outcomes.
• Provides that covered drugs are misbranded if PMI is not provided as required.