Right Drug Dose Now Act of 2025

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2471 Introduced in House (IH)]

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119th CONGRESS
  1st Session
                                H. R. 2471

To update the National Action Plan for Adverse Drug Event Prevention to
 consider advances in pharmacogenomic research and testing, to improve
  electronic health records for pharmacogenomic information, and for
                            other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 27, 2025

 Mr. Swalwell (for himself and Mr. Crenshaw) introduced the following
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

To update the National Action Plan for Adverse Drug Event Prevention to
 consider advances in pharmacogenomic research and testing, to improve
  electronic health records for pharmacogenomic information, and for
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Right Drug Dose Now Act of 2025''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. National Action Plan for Adverse Drug Event Prevention.
Sec. 4. Adverse drug event and pharmacogenomic testing education for
                            health care professionals.
Sec. 5. Improving EHR systems to improve the use of pharmacogenomic
                            information.

SEC. 3. NATIONAL ACTION PLAN FOR ADVERSE DRUG EVENT PREVENTION.

    The Secretary of Health and Human Services (in this Act referred to
as the ``Secretary'') shall--
            (1) not later than 180 days after the date of enactment of
        this Act, in coordination with the heads of other relevant
        Federal departments and agencies, submit a report to the
        Congress on the implementation of the National Action Plan for
        Adverse Drug Event Prevention of the Department of Health and
        Human Services, including on the progress in meeting the target
        outcomes approved by the Federal Interagency Steering Committee
        for Adverse Drug Events;
            (2) convene the Federal Interagency Steering Committee for
        Adverse Drug Events to update the National Action Plan for
        Adverse Drug Event Prevention; and
            (3) require such Committee, in updating the National Action
        Plan for Adverse Drug Event Prevention--
                    (A) to consider advances in scientific
                understanding and technology pertaining to drug-gene
                interactions (including interactions among multiple
                drugs and genes), clinical outcomes, health care
                utilization, and the decreasing cost of genetic
                testing;
                    (B) to assess the role of pharmacogenetics testing
                combined with clinical decision support as an evidence-
                based prevention tool; and
                    (C) to evaluate operating characteristics for
                Federal adverse drug event monitoring systems and
                expand capabilities to identify genetic associations in
                adverse events.

SEC. 4. ADVERSE DRUG EVENT AND PHARMACOGENOMIC TESTING EDUCATION FOR
              HEALTH CARE PROFESSIONALS.

    The Secretary shall issue guidance for health care providers and
health care leaders, including administrators, primary and specialty
care physicians, pharmacists, nurse practitioners, physician
assistants, physician medical geneticists, laboratory medical
geneticists, genetic counselors, medical educators, and the faculty of
schools of medicine and other schools of health professions, on the
following:
            (1) Pharmacogenomic testing and the extent of its ability
        to prevent adverse drug reactions.
            (2) Pharmacogenomic testing, drug interaction alerting
        systems, when to refer to or consult with a genetics provider,
        and the applicable Federal standards of care for patients who
        are suspected or known to have a genetic variant that is known
        to impact drug metabolism or adverse reactions.
            (3) Evidence-based information that would encourage
        individuals and their health care professionals to consider
        pharmacogenomic testing as part of their health care plan to
        the extent appropriate.
            (4) The role of medical professionals who specialize in
        genetics and genomics.
            (5) How to incorporate pharmacogenomics into comprehensive
        medication management.
            (6) The importance of reporting information about known and
        relevant pharmacogenomic information when reporting adverse
        drug events to the FDA Adverse Event Reporting System.

SEC. 5. IMPROVING EHR SYSTEMS TO IMPROVE THE USE OF PHARMACOGENOMIC
              INFORMATION.

    (a) Certification Criteria.--The Secretary shall provide guidance
for health care providers and health care leaders, including
administrators, primary and specialty care physicians, pharmacists,
nurse practitioners, physician assistants, physician medical
geneticists, laboratory medical geneticists, genetic counselors,
medical educators, and the faculty of schools of medicine and other
schools of health professions, on health information technologies,
including for electronic prescribing systems and real-time pharmacy
benefit checks, regarding how, before a medication order is completed
and acted upon during computerized provider order entry, interventions
might automatically indicate to a user--
            (1) when pharmacogenomic testing is appropriate based on a
        drug product's label or peer-reviewed professional guidelines;
        and
            (2) drug-gene and drug-drug-gene associations, established
        by a drug product's label or peer-reviewed professional
        guidelines, based on a patient's medication list, medication
        allergy list, and results from pharmacogenomic testing.
    (b) Guidance on Drug-Gene Interaction Alerting Systems.--
            (1) Issuance and updates.--The Secretary shall--
                    (A) issue routine guidance on drug-gene interaction
                alerting systems in electronic health records; and
                    (B) not less than biannually, update such guidance
                to incorporate pharmacogenomic information from--
                            (i) new or updated drug labels; and
                            (ii) newly established peer-reviewed
                        professional guidelines on drug-gene
                        associations.
            (2) Rule of construction.--Nothing in paragraph (1) shall
        be construed as prohibiting an entity from updating the results
        of pharmacogenomic testing, or alerting the provider, if a
        medication is contraindicated by the results of pharmacogenomic
        testing.
    (c) Reducing Adverse Drug Events Reporting Burdens.--The Secretary
shall encourage the development of electronic health record systems
that allow for adverse drug event information to be directly reported
to the FDA Adverse Event Reporting System.
    (d) Updating FAERS; Patient-Friendly Reporting.--The Secretary
shall--
            (1) update the FDA Adverse Event Reporting System,
        including to--
                    (A) create an optional selection tool that allows
                individuals to report whether an adverse drug event is
                associated with a drug-gene or drug-drug-gene
                interaction; and
                    (B) accept information directly from health care
                providers' electronic health record systems;
            (2) work with relevant Federal agencies and offices, and
        stakeholders, to create patient-friendly electronic options for
        reporting adverse drug events such as submission through an
        optional designated mobile device application or mobile device
        messaging application; and
            (3) not later than 1 year after the date of enactment of
        this Act, report to the Congress on the progress made in
        implementing paragraphs (1) and (2).
    (e) GAO Study and Recommendations on Inclusion of Information on
Drug-Gene Interactions on Drug Labels.--Not later than 180 days after
the date of enactment of this Act, the Comptroller General of the
United States shall--
            (1) study, and formulate recommendations on, how the Food
        and Drug Administration can include and update information on
        drug-gene interactions on drug labels; and
            (2) submit recommendations to the relevant committees of
        jurisdiction.
    (f) Report on Additional Improvements to Electronic Health Record
Systems.--
            (1) In general.--Not later than 180 days after the date of
        enactment of this Act, the Secretary shall--
                    (A) complete a report on additional improvements to
                electronic health record systems that are needed to
                further the development of real world evidence (as
                defined in section 505F of the Federal Food, Drug, and
                Cosmetic Act (21 U.S.C. 355g)) in pharmacogenomics; and
                    (B) submit such report to the Congress.
            (2) Consideration of needed advancements.--As part of the
        report under paragraph (1), the Secretary shall consider what
        advancements are needed in electronic health record systems to
        capture information about the laboratory and the test used as
        part of pharmacogenomic testing.
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