The "Right Drug Dose Now Act of 2025" aims to improve patient safety by advancing the use of pharmacogenomics to prevent adverse drug events through updated guidelines, enhanced electronic health records, and improved adverse event reporting systems.
Eric Swalwell
Representative
CA-14
The "Right Drug Dose Now Act of 2025" aims to improve patient safety and healthcare outcomes by advancing the use of pharmacogenomics to prevent adverse drug events. It directs the Secretary of Health and Human Services to update the National Action Plan for Adverse Drug Event Prevention, provide guidance to healthcare professionals on pharmacogenomic testing, and improve electronic health record systems to better utilize pharmacogenomic information. The act also seeks to enhance the FDA's adverse event reporting system to include drug-gene interaction data and improve drug labeling. Additionally, it requires studies and recommendations on how to further integrate pharmacogenomics into healthcare practices.
Bill Pushes Tech Upgrades for Safer Meds Through Genetic Info: EHRs and Reporting Systems Targeted
This part of the Right Drug Dose Now Act focuses squarely on updating the tech behind your healthcare to better handle genetic information when it comes to medications. Specifically, Section 5 directs the Secretary of Health and Human Services (HHS) to get healthcare providers and systems up to speed on using pharmacogenomics – that's the study of how your genes affect your body's response to drugs. The goal is to prevent dangerous side effects by making sure your genetic makeup is considered before you get a prescription.
Getting Health Records Smarter About Your Meds
The bill mandates HHS to guide doctors and hospitals on using health IT smartly. Imagine your electronic health record (EHR) automatically flagging when a genetic test might be a good idea before you start a new medication, based on the drug itself, known interactions, your allergies, and any previous genetic test results you might have. Section 5 requires HHS to issue and update guidance at least twice a year on these drug-gene interaction alert systems, incorporating the latest info from drug labels and medical guidelines. It also pushes for EHR systems that can directly report bad reactions to the FDA, streamlining the process.
Making Bad Reactions Count (Genetically)
When bad drug reactions do happen, this bill wants to make sure we learn from them, especially if genetics played a role. Section 5 requires updates to the FDA Adverse Event Reporting System (FAERS). Key changes include:
- An optional way for patients and doctors to note if a bad reaction might be linked to a drug-gene interaction.
- Allowing FAERS to accept reports sent directly from provider EHR systems.
- Creating patient-friendly reporting options, like a mobile app.
A report back to Congress on how these FAERS updates are going is required within one year.
Keeping Tabs: Studies and Reports
To ensure this all moves forward effectively, the bill includes oversight. HHS needs to report to Congress within 180 days on what further EHR improvements are needed to better capture and use pharmacogenomic data from the real world, including details about the specific labs and tests used. Separately, the Comptroller General has 180 days to study and recommend how the FDA can better update drug labels with information about drug-gene interactions. While the aim is safer, more personalized medicine, these tech upgrades and new reporting pathways will likely mean adjustments and potential costs for healthcare providers and hospital systems needing to update their software and workflows.