Right Drug Dose Now Act of 2025
The Right Drug Dose Now Act of 2025 would update the National Action Plan for Adverse Drug Event Prevention to better reflect advances in pharmacogenomics (how genes affect drug response) and to strengthen the use of pharmacogenomic information in electronic health records (EHRs). It requires the Department of Health and Human Services (HHS) to report on progress within 180 days, convene a Federal Interagency Steering Committee to update the plan, and ensure the plan considers new scientific and technological developments in drug-gene interactions, including multi-gene and multi-drug interactions and the decreasing cost of genetic testing. The bill also directs enhanced education for health care professionals on pharmacogenomic testing, drug-gene interactions, and related reporting, and it pushes for improved EHR capabilities—such as automatic pharmacogenomic alerts, safer drug-gene and drug-drug-gene guidance at the point of prescribing, and streamlined adverse drug event reporting to the FDA’s FAERS system. It includes a GAO study on incorporating drug-gene information on labels, and a report on further EHR improvements to support real-world evidence in pharmacogenomics. In short, the bill aims to (1) accelerate integration of pharmacogenomic data into clinical decision-making, (2) improve safety-focused alerts in electronic prescribing systems, (3) ease and modernize adverse event reporting to FAERS, and (4) expand professional education to support these changes.
Key Points
- 1National Action Plan updates: Requires the Secretary of Health and Human Services to report on implementation within 180 days, convene the Federal Interagency Steering Committee for Adverse Drug Events to update the plan, and consider advances in pharmacogenomics, clinical outcomes, health care utilization, and the cost of genetic testing in updating the plan.
- 2Pharmacogenomics education for providers: Directs issuance of guidance for a wide range of health care professionals on pharmacogenomic testing, its role in preventing adverse drug reactions, when to refer to genetics experts, standards of care, medication management integration, and reporting pharmacogenomic information when adverse events occur.
- 3EHR and decision-support improvements: Requires guidance on health IT and electronic prescribing systems for real-time pharmacogenomic decision support, including automatic alerts about when pharmacogenomic testing is appropriate and drug-gene interactions, with updates at least biannually.
- 4Adverse event reporting and FAERS modernization: Encourages EHR-enabled reporting to FAERS, creates patient-friendly reporting options (including mobile tools), and requires a progress report within one year on implementing these improvements.
- 5GAO study and additional reporting: Mandates a GAO study within 180 days on how drug-gene interaction information could be included on drug labels, and requires a report on further needed EHR improvements to capture pharmacogenomic testing details and support real-world evidence.