Summary

Directs the Department of Health and Human Services to accelerate federal action on preventing adverse drug events by integrating pharmacogenomics (drug–gene interaction information) into clinical care, electronic health records, adverse event reporting, and federal monitoring systems. It requires updated national planning, regular agency guidance for clinicians and health system leaders, EHR and FDA reporting system enhancements, and short-term reports to Congress and GAO on implementation and labeling of drug–gene information.

• Mandates HHS report to Congress within 180 days on progress implementing the National Action Plan for Adverse Drug Event Prevention and reconvene the interagency steering committee.
• Requires the Plan update to assess drug–gene interaction science and pharmacogenetic testing as a prevention tool for adverse drug events.
• Directs HHS to issue clinician and health-system guidance on pharmacogenomics, clinical decision support, referrals to genetics specialists, and reporting genetic data with adverse event reports.
• Orders EHR functional improvements and biannual guidance updates so pharmacogenomic data can be used in medication ordering and safety systems.
• Requires FAERS and patient-facing adverse-event reporting enhancements and a HHS report to Congress on FAERS improvements within one year.
• Directs GAO to study and report on how FDA can add or update drug–gene interaction information on product labeling within 180 days.
• Requires an HHS report on EHR improvements to support real-world evidence generation for pharmacogenomics within 180 days.
• Does not itself appropriate funding in the text provided; it relies on agency actions, guidance, system updates, and interagency coordination.