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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7848 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 7848

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 29, 2024

 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 2024''.

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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