Title: Right Drug Dose Now Act
Policy area: Health

Summary:
Right Drug Dose Now Act
This bill sets out requirements and activities to address adverse drug events, including using pharmacogenomic testing to prevent them. (Pharmacogenomic testing uses a patient's genetic information to help determine the safety, efficacy, and dosage of medications for treatments.)
Specifically, the Department of Health and Human Services (HHS) must report to Congress about the implementation of a national plan to prevent adverse drug events. Additionally, HHS must coordinate with relevant federal agencies on the report and convene a steering committee to update the plan.
HHS must also (1) require, as a condition of certification, that health information technologies automatically indicate when pharmacogenomic testing is appropriate before a medication order is completed; and (2) assess electronic health records to identify improvements necessary for developing the capacity for collecting real-world evidence in pharmacogenomics.
Furthermore, HHS must consult with the Food and Drug Administration (FDA) to carry out a program to improve reporting of adverse drug events and their association with a patient's genetic status. In addition, the FDA must issue regulations and make other administrative changes to update adverse drug event reporting processes, including to facilitate the acceptance of information directly from electronic health records.
The bill also requires the National Human Genomics Research Institute, which is part of the National Institutes of Health, to (1) carry out a public awareness campaign on adverse drug events, and (2) establish a program to educate health care providers and related professionals about pharmacogenomic testing and associated issues.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6875 Introduced in House (IH)]

<DOC>






117th CONGRESS
  2d Session
                                H. R. 6875

To update the National Action Plan for Adverse Drug Event Prevention to 
      provide educational information on adverse drug events and 
   pharmacogenomic testing, to improve electronic health records for 
          pharmacogenomic information, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 28, 2022

Mr. Swalwell (for himself and Mr. Emmer) 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 
      provide educational information on adverse drug events and 
   pharmacogenomic 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''.

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 awareness.
Sec. 5. Improving EHR systems to improve the use of pharmacogenomic 
                            information.
Sec. 6. Increased authorization for pharmacogenomics implementation 
                            research.
Sec. 7. Definition.

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

    The Secretary of Health and Human Services 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 including the Director of the 
        National Human Genome Research Institute, and in consultation 
        with the Director of the Eunice Kennedy Shriver National 
        Institute of Child Health and Human Development, the Director 
        of the National Center for Biotechnology Information, and the 
        Director of the National Library of Medicine, submit a report 
        to the Congress on--
                    (A) the implementation of the National Action Plan 
                for Adverse Drug Event Prevention of the Department of 
                Health and Human Services; and
                    (B) the progress in meeting the target approved by 
                the Federal Interagency Steering Committee for Adverse 
                Drug Events for a 10-percent reduction for--
                            (i) the rate of adverse drug events from 
                        anticoagulants among United States inpatient 
                        stays;
                            (ii) the rate of adverse drug events from 
                        hypoglycemic agents among United States 
                        inpatient stays;
                            (iii) the rate of adverse drug events from 
                        opioid analgesics among United States inpatient 
                        stays;
                            (iv) the rate of visits to United States 
                        hospital emergency departments for adverse drug 
                        events associated with injury from oral 
                        anticoagulants;
                            (v) the rate of visits to United States 
                        hospital emergency departments for adverse drug 
                        events associated with injury from insulin; and
                            (vi) the rate of visits to United States 
                        hospital emergency departments for adverse drug 
                        events associated with therapeutic use of 
                        opioid analgesics;
            (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-
                drug interactions, 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 surveillance systems and 
                expand capabilities to identify genetic associations in 
                adverse events.

SEC. 4. ADVERSE DRUG EVENT AND PHARMACOGENOMIC TESTING AWARENESS.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the following:

``SEC. 399V-7. ADVERSE DRUG EVENT AND PHARMACOGENOMIC TESTING 
              AWARENESS.

    ``(a) Public Education Campaign.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the National Human Genome Research Institute, in 
        consultation with the Director of the Eunice Kennedy Shriver 
        National Institute of Child Health and Human Development, the 
        Director of the National Center for Biotechnology Information, 
        and the Director of the National Library of Medicine, shall 
        conduct a national evidence-based education campaign to 
        increase the public's awareness regarding--
                    ``(A) the prevalence of adverse drug events and 
                adverse drug reactions;
                    ``(B) specific risk factors that increase an 
                individual's likelihood of experiencing an adverse drug 
                event or adverse drug reaction;
                    ``(C) basic information about pharmacogenomic 
                testing and how its use, including incorporation in 
                comprehensive medication management, may prevent 
                adverse drug reactions in certain clinical situations;
                    ``(D) the role of health care providers in 
                performing pharmacogenomic testing, interpreting the 
                results of such testing, and adjusting medications 
                based on such results;
                    ``(E) the availability of pharmacogenomic testing;
                    ``(F) comprehensive medication management; and
                    ``(G) how the benefits of an individual's 
                pharmacogenomic test results might change or be 
                relevant over time.
            ``(2) Consideration of advice of stakeholder experts.--The 
        education campaign under paragraph (1) shall take into 
        consideration the advice of stakeholder expects, such as those 
        specializing in medical genetics and pharmacogenetics and 
        collaborative communities focused on pharmacogenomics.
            ``(3) Media campaign.--In conducting the education campaign 
        under paragraph (1), the Secretary, after considering the 
        advice of stakeholder experts pursuant to paragraph (2), may 
        award grants or contracts to entities to establish national 
        multimedia campaigns that may include advertising through 
        television, radio, print media, billboards, posters, all forms 
        of existing and especially emerging social networking media, 
        other Internet media, and any other medium determined 
        appropriate by the Secretary.
            ``(4) Rural regions, health professional shortage areas, 
        and underserved communities.--The Secretary shall ensure that 
        the education campaign under paragraph (1)--
                    ``(A) reaches rural and medically underserved 
                communities (as defined in section 799); and
                    ``(B) includes the involvement of community health 
                centers, community pharmacies, and other local health 
                clinics.
    ``(b) Health Care Professional Education Campaign.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the National Human Genome Research Institute, in 
        consultation with the Director of the Eunice Kennedy Shriver 
        National Institute of Child Health and Human Development, the 
        Director of the National Center for Biotechnology Information, 
        the Director of the National Library of Medicine, and the 
        Administrator of the Health Resources and Services 
        Administration, shall establish a national health education 
        program for health care providers and health care leaders, 
        including administrators, pharmacists, nurse practitioners, 
        physicians' 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:
                    ``(A) Pharmacogenomic testing and the extent of its 
                ability to prevent adverse drug reactions.
                    ``(B) Pharmacogenomic testing, drug interaction 
                alerting systems, when to refer to or consult with a 
                genetics provider, and the standards of care for 
                patients who are suspected or known to have a genetic 
                variant that is known to impact drug metabolism.
                    ``(C) 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.
                    ``(D) The role of medical professionals who 
                specialize in genetics and genomics.
                    ``(E) How to incorporate pharmacogenomics into 
                comprehensive medication management.
            ``(2) Grants.--
                    ``(A) Award.--In carrying out the national health 
                education program under this subsection, the Secretary, 
                acting through the Director of the National Human 
                Genome Research Institute, may award grants to 
                nonprofit organizations to carry out educational 
                activities with respect to the topics listed in 
                subparagraphs (A) through (D) of paragraph (1).
                    ``(B) Use of funds.--A grant under subparagraph (A) 
                may be used to support one or more of the following 
                activities:
                            ``(i) Increasing the knowledge and 
                        awareness of health care providers and health 
                        care leaders about pharmacogenomic testing and 
                        drug interactions.
                            ``(ii) Increasing the number of health 
                        professional schools that incorporate 
                        pharmacogenomic curricula in classroom 
                        instruction.
                            ``(iii) Increasing the ability of health 
                        care providers to note and respond to the 
                        impact of gender, ethnicity, age, and other 
                        relevant characteristics on drug metabolism.
                            ``(iv) Developing principles, practices, 
                        and curriculum instruction that prepare 
                        medical, nursing, pharmacy, and other health 
                        professions students to effectively apply 
                        knowledge and skills needed to recognize--
                                    ``(I) when a patient is eligible 
                                for pharmacogenomic testing, including 
                                as part of comprehensive medication 
                                management when appropriate, and in 
                                accordance with the patient's health 
                                care team, a drug product's label, and 
                                professional clinical guidelines; and
                                    ``(II) how to appropriately use the 
                                test results to adjust a prescription 
                                or otherwise change a patient's health 
                                care plan.
                            ``(v) Providing opportunities for 
                        practicing health care professionals to receive 
                        pharmacogenomics training and education through 
                        a variety of modalities including in-person, 
                        electronic media, professional meetings and 
                        conferences, and social media.
    ``(c) Reporting.--At least every three years, the Secretary, acting 
through the Director of the National Human Genome Research Institute, 
in consultation with the Director of the Eunice Kennedy Shriver 
National Institute of Child Health and Human Development, the Director 
of the National Center for Biotechnology Information, the Director of 
the National Library of Medicine, the Administrator of the Centers for 
Medicare & Medicaid Services, and relevant stakeholders with expertise 
in developing quality measures of label and peer-reviewed professional 
guidelines on drug-gene interactions, shall publish data on--
            ``(1) the public's awareness regarding adverse drug events 
        and pharmacogenomic testing;
            ``(2) the number or percentage of individuals utilizing 
        information to inform their health care decisions regarding 
        prescription medications and pharmacogenomic testing;
            ``(3) the change in the number or percentage of individuals 
        enrolled in a prescription drug plan under part D of the title 
        XVIII of the Social Security Act receiving a pharmacogenetic 
        test, as recommended in alignment with a drug product's label 
        or peer-reviewed professional guidelines; and
            ``(4) the number or percentage of changes, beginning one 
        year after the date of enactment of this section, in medication 
        management as a result of incorporating information from 
        pharmacogenomic testing.
    ``(d) Definitions.--In this section:
            ``(1) Adverse drug event.--The term `adverse drug event' 
        means an injury resulting from any medical intervention with a 
        drug.
            ``(2) Adverse drug reaction.--The term `adverse drug 
        reaction' means a response to a drug that--
                    ``(A) is noxious and unintended; and
                    ``(B) occurs at doses normally used in humans for 
                prophylaxis, diagnosis, or therapy of disease or for 
                the modification of physiologic function.
    ``(e) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $50,000,000 for each of fiscal 
years 2022 through 2027.''.

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

    (a) Certification Criteria.--The Secretary of Health and Human 
Services (in this section referred to as the ``Secretary'') shall adopt 
pursuant to subtitle A of title XXX of the Public Health Service Act 
(42 U.S.C. 300jj-11 et seq.) certification criteria for health 
information technology, including for electronic prescribing systems 
and real-time pharmacy benefit checks, such that before a medication 
order is completed and acted upon during computerized provider order 
entry, interventions must 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) Reporting and Association of Adverse Drug Events.--The 
Secretary, in consultation with the Commissioner of Food and Drugs, 
shall carry out a program to improve the reporting of adverse drug 
events and the association, if any, of such events to a patient's 
genetic status. As part of the program, the Secretary shall issue 
regulations pursuant to the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) and other applicable statutory authorities to--
            (1) ensure that drug-gene interaction alerting systems are 
        continuously updated to incorporate information from new or 
        updated drug labels with pharmacogenomic information and newly 
        established peer-reviewed professional guidelines on drug-gene 
        associations;
            (2) facilitate the reporting of adverse drug events to the 
        FDA Adverse Event Reporting System directly through the use of 
        the health care provider's electronic health record system; and
            (3) allow for the reporting of whether an adverse drug 
        event is caused by pharmacogenetic interactions to the FDA 
        Adverse Event Reporting System directly through the use of the 
        health care provider's electronic health record system.
    (c) Updating FAERS; Patient-Friendly Reporting.--The Secretary, 
acting through the Commissioner of Food and Drugs, shall--
            (1) update the FDA Adverse Event Reporting System, 
        including to--
                    (A) accept information directly from health care 
                providers' electronic health record systems;
                    (B) improve the collection of real world evidence 
                (as defined in section 505F of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 355g)); and
                    (C) create a selection tool that allows individuals 
                to report whether an adverse drug event is associated 
                with a drug-gene interaction;
            (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 a 
        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).
    (d) Assessment 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 an assessment 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 a report to the Congress on the findings 
                on the assessment.
            (2) Consideration of needed advancements.--As part of the 
        assessment under paragraph (1), the Secretary shall consider 
        what advancements are needed to capture information about the 
        laboratory and the test used as part of pharmacogenomic 
        testing.

SEC. 6. INCREASED AUTHORIZATION FOR PHARMACOGENOMICS IMPLEMENTATION 
              RESEARCH.

    There is authorized to be appropriated to the National Institutes 
of Health $7,000,000 for each of fiscal years 2022 through 2025 for the 
conduct, support, and maintenance of pharmacogenomics implementation 
research through the Genomic Community Resources program.

SEC. 7. DEFINITIONS.

    In this Act:
            (1) The term ``adverse drug event'' means an injury 
        resulting from any medical intervention with a drug.
            (2) The term ``comprehensive medication management'' means 
        medication management pursuant to a standard of care that 
        ensures each patient's medications are individually assessed to 
        determine that each medication is appropriate for the patient, 
        effective for the medical condition, and safe given the 
        comorbidities and other medications being taken and able to be 
        taken by the patient as intended.
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