Sponsors (2)
The bill would likely make prescribing safer and drug‑safety surveillance stronger by integrating pharmacogenomics into guidance, reporting, and EHRs, but does so at the cost of privacy risks, new expenses and administrative burdens, and potential widening of access gaps for smaller providers and patients without coverage.
Patients with chronic conditions will face fewer harmful adverse drug reactions because pharmacogenomic testing, biannual clinical-decision-support updates, and EHR drug–gene alerts are promoted and better integrated into care.
Clinicians (physicians, pharmacists, nurse practitioners, PAs) will get clearer, evidence-based guidance and decision-support tools for using pharmacogenomics, improving prescribing decisions and reducing medication errors.
FDA, public‑health agencies, and researchers will gain improved adverse‑event reports that include pharmacogenomic information and coordinated federal monitoring to detect drug–gene risks, strengthening drug safety surveillance and informing labeling and policy.
Patients face heightened privacy and data‑security risks because genetic information would be collected, linked to EHRs and adverse‑event reporting systems, and shared unless strong safeguards and consent protections are specified.
Patients may face higher out‑of‑pocket costs for pharmacogenomic testing if insurers do not cover expanded testing, making personalized medication decisions less accessible for many families.
Taxpayers, health systems, EHR vendors, and providers could incur substantial costs to expand testing, update monitoring systems, integrate EHR alerts, and enhance FAERS reporting, shifting financial burden onto taxpayers and care providers.
Based on analysis of 7 sections of legislative text.
Directs HHS, GAO, and FDA to accelerate pharmacogenomics use in preventing adverse drug events through plans, guidance, EHR and reporting upgrades, and studies.
Official title: To update the National Action Plan for Adverse Drug Event Prevention to consider advances in pharmacogenomic research and testing, to improve electronic health records for pharmacogenomic information, and for other purposes.
Introduced March 27, 2025 by Eric Swalwell · Last progress March 27, 2025
Directs HHS and related federal bodies to accelerate use of pharmacogenomics and other drug–gene science to prevent adverse drug events. It requires reports, updated national plans, guidance for clinicians and health system leaders, upgrades to electronic health records and FDA adverse event systems, and short deadlines (180 days to 1 year) for initial deliverables and regular updates thereafter. Aims to expand monitoring and reporting of genetic associations with adverse drug reactions, promote use of pharmacogenomic testing and clinical decision support in clinical practice, and study how FDA can incorporate drug–gene information into labeling and real-world evidence efforts.