The Right Drug Dose Now Act of 2025 directs the Secretary of Health and Human Services to update the National Action Plan for Adverse Drug Event Prevention . Within 180 days, the Secretary must report to Congress on the current plan's implementation and then convene the Federal Interagency Steering Committee for Adverse Drug Events to revise the plan. This update must consider scientific advances in drug-gene interactions , clinical outcomes, and the decreasing cost of genetic testing, while also assessing pharmacogenetics testing as an evidence-based prevention tool. The bill also requires the Secretary to issue guidance for a wide range of healthcare professionals, including physicians, pharmacists, and genetic counselors, on pharmacogenomic testing . This guidance will cover its ability to prevent adverse drug reactions, drug interaction alerting systems, when to consult genetics providers, and federal standards of care for patients with genetic variants affecting drug metabolism. It also emphasizes encouraging appropriate testing and the importance of reporting relevant pharmacogenomic information to the FDA Adverse Event Reporting System (FAERS). Furthermore, the legislation focuses on improving electronic health record (EHR) systems to better utilize pharmacogenomic information. The Secretary will provide guidance for EHRs and e-prescribing systems to automatically indicate when pharmacogenomic testing is appropriate and alert users to drug-gene and drug-drug-gene associations. Routine and biannual updates to guidance on drug-gene interaction alerting systems in EHRs are also mandated, incorporating new drug labels and peer-reviewed guidelines. To streamline reporting, the bill encourages the development of EHR systems that allow direct reporting of adverse drug event information to FAERS. It also requires updates to FAERS to include an optional tool for reporting drug-gene interactions and to accept data directly from EHRs. Additionally, the Secretary must work to create patient-friendly electronic options for reporting adverse drug events, such as through mobile applications, and report on this progress to Congress within one year. Finally, the bill mandates a Government Accountability Office (GAO) study within 180 days on how the Food and Drug Administration can include and update information on drug-gene interactions on drug labels. The Secretary must also complete a report within 180 days on additional EHR system improvements needed to advance real-world evidence in pharmacogenomics, including capturing information about the laboratory and test used for pharmacogenomic testing.
Referred to the House Committee on Energy and Commerce.
Health
Right Drug Dose Now Act of 2025
USA119th CongressHR-2471| House
| Updated: 3/27/2025
The Right Drug Dose Now Act of 2025 directs the Secretary of Health and Human Services to update the National Action Plan for Adverse Drug Event Prevention . Within 180 days, the Secretary must report to Congress on the current plan's implementation and then convene the Federal Interagency Steering Committee for Adverse Drug Events to revise the plan. This update must consider scientific advances in drug-gene interactions , clinical outcomes, and the decreasing cost of genetic testing, while also assessing pharmacogenetics testing as an evidence-based prevention tool. The bill also requires the Secretary to issue guidance for a wide range of healthcare professionals, including physicians, pharmacists, and genetic counselors, on pharmacogenomic testing . This guidance will cover its ability to prevent adverse drug reactions, drug interaction alerting systems, when to consult genetics providers, and federal standards of care for patients with genetic variants affecting drug metabolism. It also emphasizes encouraging appropriate testing and the importance of reporting relevant pharmacogenomic information to the FDA Adverse Event Reporting System (FAERS). Furthermore, the legislation focuses on improving electronic health record (EHR) systems to better utilize pharmacogenomic information. The Secretary will provide guidance for EHRs and e-prescribing systems to automatically indicate when pharmacogenomic testing is appropriate and alert users to drug-gene and drug-drug-gene associations. Routine and biannual updates to guidance on drug-gene interaction alerting systems in EHRs are also mandated, incorporating new drug labels and peer-reviewed guidelines. To streamline reporting, the bill encourages the development of EHR systems that allow direct reporting of adverse drug event information to FAERS. It also requires updates to FAERS to include an optional tool for reporting drug-gene interactions and to accept data directly from EHRs. Additionally, the Secretary must work to create patient-friendly electronic options for reporting adverse drug events, such as through mobile applications, and report on this progress to Congress within one year. Finally, the bill mandates a Government Accountability Office (GAO) study within 180 days on how the Food and Drug Administration can include and update information on drug-gene interactions on drug labels. The Secretary must also complete a report within 180 days on additional EHR system improvements needed to advance real-world evidence in pharmacogenomics, including capturing information about the laboratory and test used for pharmacogenomic testing.