H.R. 2471 — Right Drug Dose Now Act of 2025

This section directs the Secretary of Health and Human Services, not later than 180 days after enactment, to submit to Congress a report on the implementation of the Department of Health and Human Services' National Action Plan to Prevent Adverse Drug Events—including progress toward target outcomes set by the Federal Interagency Steering Committee for Adverse Drug Events—and to convene that committee to update the plan. The section requires the updated plan to (1) consider advances in scientific understanding and technology related to drug-gene interactions (including among multiple drugs and genes), clinical outcomes, health care utilization, and decreasing genetic testing costs; (2) assess pharmacogenetic testing (i.e., genetic testing to predict drug response) combined with clinical decision support as an evidence-based prevention tool; and (3) evaluate operating characteristics of federal adverse drug event monitoring systems and expand their capabilities to identify genetic associations in adverse events.

This section directs the Secretary to issue guidance for health care providers and leaders—including administrators, primary and specialty care physicians, pharmacists, nurse practitioners, physician assistants, physician medical geneticists, laboratory medical geneticists, genetic counselors, medical educators, and faculty of schools of medicine and other health professions—on the following: (1) pharmacogenomic testing (i.e., genetic testing to predict drug response) and its ability to prevent adverse drug reactions; (2) pharmacogenomic testing, drug interaction alerting systems, when to refer to or consult with a genetics provider, and applicable federal standards of care for patients suspected or known to have a genetic variant impacting drug metabolism or adverse reactions; (3) evidence-based information encouraging individuals and health care professionals to consider pharmacogenomic testing as part of health care plans where appropriate; (4) the role of medical professionals specializing in genetics and genomics; (5) incorporating pharmacogenomics into comprehensive medication management; and (6) the importance of reporting known relevant pharmacogenomic information when submitting adverse drug events to the FDA Adverse Event Reporting System.

This section directs the Food and Drug Administration (FDA) to issue guidance for health care providers and leaders on integrating pharmacogenomic information into health information technologies, including electronic prescribing systems and electronic health records (EHRs), to automatically alert users on appropriate pharmacogenomic testing and drug-gene or drug-drug-gene interactions based on drug labels, peer-reviewed guidelines, patient medication lists, allergies, and test results. It further requires FDA to (1) issue and update at least biannually guidance on drug-gene interaction alerting systems in EHRs to incorporate new or updated drug labels and peer-reviewed guidelines on drug-gene associations; (2) encourage EHR systems that enable direct reporting of adverse drug events to the FDA Adverse Event Reporting System (FAERS); and (3) update FAERS to include an optional tool for reporting drug-gene or drug-drug-gene interactions, accept data directly from EHRs, and develop patient-friendly electronic reporting options such as mobile apps, with a report to Congress on progress within one year after enactment. Finally, it requires the Government Accountability Office (GAO) to study and recommend, within 180 days after enactment, how FDA can include and update drug-gene interaction information on drug labels; and directs FDA to submit to Congress, within 180 days after enactment, a report on EHR improvements needed to develop real world evidence (as defined in section 505F of the Federal Food, Drug, and Cosmetic Act) in pharmacogenomics, including capturing laboratory and test details from pharmacogenomic testing.