Sponsors (2)
This bill could substantially improve medication safety by integrating pharmacogenomics into clinical workflows and federal surveillance, but it requires significant implementation funding, strong privacy protections, and proactive measures to avoid creating access disparities and clinician alert fatigue.
Patients with complex or chronic conditions will be more likely to receive medications tailored to their genetics, reducing adverse drug reactions through expanded pharmacogenetic testing, clinician guidance, and EHR alerts.
Researchers, public-health agencies, and clinicians will get clearer, coordinated federal guidance, biannual standards updates, and improved adverse-event reporting that make it easier to implement pharmacogenomics in clinical care and strengthen drug-safety surveillance.
Hospitals and health systems could see reduced downstream utilization (fewer ED visits and hospitalizations) from better prevention of adverse drug events, lowering clinical burdens over time.
Hospitals, health systems, EHR vendors, labs, and taxpayers may face substantial up-front and ongoing costs to implement pharmacogenomic alerting, EHR reporting features, and IT upgrades, which could increase healthcare spending.
Collecting and transmitting genetic and test-identifying data for testing, alerts, and adverse-event reports raises patient privacy and data-security risks if protections and controls are not strengthened.
If testing is adopted without clear reimbursement and smaller or rural providers lack capacity (access to genetics specialists, IT integration), patients may face out-of-pocket costs and unequal access, widening care disparities.
Based on analysis of 7 sections of legislative text.
Directs HHS to update the federal adverse drug event plan, issue guidance on pharmacogenomic testing, integrate drug–gene data into EHRs/CPOE, and improve FAERS to accept drug‑gene reports.
Introduced March 27, 2025 by Eric Swalwell · Last progress March 27, 2025
Requires the Department of Health and Human Services to update and report on the federal plan to prevent adverse drug events with a focus on pharmacogenomics (how genes affect drug response). Directs HHS to produce reports, convene an interagency steering committee, issue provider-facing guidance on pharmacogenomic testing, and publish technical guidance so electronic health records and drug alert systems incorporate drug–gene and drug–drug–gene information. It also directs improvements to adverse event reporting (FAERS) to accept drug-gene data and direct EHR submissions, and asks GAO to study how FDA can add drug-gene information to drug labels. The law sets deadlines for several deliverables (many within 180 days and one within 1 year), requires biannual updates to alerting guidance, and focuses on integrating genetic test results into clinical workflows to help prevent adverse drug reactions; it does not appropriate new funding or change taxes.