This bill would add a new section to the Federal Food, Drug, and Cosmetic Act to require patient medication information (PMI) in printed form for prescription drugs. The Food and Drug Administration (the Secretary) must issue rules within 1 year about what that printed PMI must include, how it must look, who writes it, and how it is given to patients. The rules must require clear plain language, graphics when useful, a standardized format, minimum font size and color, approval by the Secretary, and that manufacturers develop the PMI as part of new drug applications. Required content includes the drug name and NDC, approved uses, directions, contraindications, warnings, common and important adverse reactions, ways to reduce side effects, when to contact a health professional, not sharing medicines, storage and disposal if needed, important interactions, statements about data for subpopulations, the manufacturer name and toll-free number, and a link to the FDA adverse event form. Each prescription must be accompanied by a printed PMI in adequate supply. The bill makes failure to provide PMI as required a misbranding offense.
No publicly available information on federal implementation costs or budgetary effects. The bill text includes a finding that mandatory standardized paper PMI could reduce emergency room visits and hospital admissions related to adverse drug events by $14.6 to $26.2 billion annually.
The bill's sponsors and its findings say that printed, standardized PMI would improve patient safety, prevent many adverse drug events, help patients who cannot access electronic information, and reduce health care costs. The findings also cite a Government Accountability Office concern that fully replacing paper with electronic labeling could harm public health.
No publicly available information.