I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Right Drug Dose Now 

5 Act of 2024’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents of this Act is as follows: 


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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. 

1 SEC. 3. NATIONAL ACTION PLAN FOR ADVERSE DRUG 

2 EVENT PREVENTION. 

3 The Secretary of Health and Human Services (in this 

4 Act referred to as the ‘‘Secretary’’) shall— 

5 (1) not later than 180 days after the date of 

6 enactment of this Act, in coordination with the 

7 heads of other relevant Federal departments and 

8 agencies, submit a report to the Congress on the im9 plementation of the National Action Plan for Ad10 verse Drug Event Prevention of the Department of 

11 Health and Human Services, including on the 

12 progress in meeting the target outcomes approved by 

13 the Federal Interagency Steering Committee for Ad14 verse Drug Events; 

15 (2) convene the Federal Interagency Steering 

16 Committee for Adverse Drug Events to update the 

17 National Action Plan for Adverse Drug Event Pre18 vention; and 

19 (3) require such Committee, in updating the 

20 National Action Plan for Adverse Drug Event Pre21 vention— 


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1 (A) to consider advances in scientific un2 derstanding and technology pertaining to drug3 gene interactions (including interactions among 

4 multiple drugs and genes), clinical outcomes, 

5 health care utilization, and the decreasing cost 

6 of genetic testing; 

7 (B) to assess the role of pharmacogenetics 

8 testing combined with clinical decision support 

9 as an evidence-based prevention tool; and 

10 (C) to evaluate operating characteristics 

11 for Federal adverse drug event monitoring sys12 tems and expand capabilities to identify genetic 

13 associations in adverse events. 

14 SEC. 4. ADVERSE DRUG EVENT AND PHARMACOGENOMIC 

15 TESTING EDUCATION FOR HEALTH CARE 

16 PROFESSIONALS. 

17 The Secretary shall issue guidance for health care 

18 providers and health care leaders, including administra19 tors, primary and specialty care physicians, pharmacists, 

20 nurse practitioners, physician assistants, physician med21 ical geneticists, laboratory medical geneticists, genetic 

22 counselors, medical educators, and the faculty of schools 

23 of medicine and other schools of health professions, on the 

24 following: 


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1 (1) Pharmacogenomic testing and the extent of 

2 its ability to prevent adverse drug reactions. 

3 (2) Pharmacogenomic testing, drug interaction 

4 alerting systems, when to refer to or consult with a 

5 genetics provider, and the applicable Federal stand6 ards of care for patients who are suspected or known 

7 to have a genetic variant that is known to impact 

8 drug metabolism or adverse reactions. 

9 (3) Evidence-based information that would en10 courage individuals and their health care profes11 sionals to consider pharmacogenomic testing as part 

12 of their health care plan to the extent appropriate. 

13 (4) The role of medical professionals who spe14 cialize in genetics and genomics. 

15 (5) How to incorporate pharmacogenomics into 

16 comprehensive medication management. 

17 (6) The importance of reporting information 

18 about known and relevant pharmacogenomic infor19 mation when reporting adverse drug events to the 

20 FDA Adverse Event Reporting System. 

21 SEC. 5. IMPROVING EHR SYSTEMS TO IMPROVE THE USE 

22 OF PHARMACOGENOMIC INFORMATION. 

23 (a) CERTIFICATION CRITERIA.—The Secretary shall 

24 provide guidance for health care providers and health care 

25 leaders, including administrators, primary and specialty 


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1 care physicians, pharmacists, nurse practitioners, physi2 cian assistants, physician medical geneticists, laboratory 

3 medical geneticists, genetic counselors, medical educators, 

4 and the faculty of schools of medicine and other schools 

5 of health professions, on health information technologies, 

6 including for electronic prescribing systems and real-time 

7 pharmacy benefit checks, regarding how, before a medica8 tion order is completed and acted upon during computer9 ized provider order entry, interventions might automati10 cally indicate to a user— 

11 (1) when pharmacogenomic testing is appro12 priate based on a drug product’s label or peer-re13 viewed professional guidelines; and 

14 (2) drug-gene and drug-drug-gene associations, 

15 established by a drug product’s label or peer-re16 viewed professional guidelines, based on a patient’s 

17 medication list, medication allergy list, and results 

18 from pharmacogenomic testing. 

19 (b) GUIDANCE ON DRUG-GENE INTERACTION

20 ALERTING SYSTEMS.— 

21 (1) ISSUANCE AND UPDATES.—The Secretary 

22 shall— 

23 (A) issue routine guidance on drug-gene 

24 interaction alerting systems in electronic health 

25 records; and 


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1 (B) not less than biannually, update such 

2 guidance to incorporate pharmacogenomic infor3 mation from— 

4 (i) new or updated drug labels; and 

5 (ii) newly established peer-reviewed 

6 professional guidelines on drug-gene asso7 ciations. 

8 (2) RULE OF CONSTRUCTION.—Nothing in 

9 paragraph (1) shall be construed as prohibiting an 

10 entity from updating the results of 

11 pharmacogenomic testing, or alerting the provider, if 

12 a medication is contraindicated by the results of 

13 pharmacogenomic testing. 

14 (c) REDUCING ADVERSE DRUG EVENTS REPORTING

15 BURDENS.—The Secretary shall encourage the develop16 ment of electronic health record systems that allow for ad17 verse drug event information to be directly reported to the 

18 FDA Adverse Event Reporting System. 

19 (d) UPDATING FAERS; PATIENT-FRIENDLY RE20 PORTING.—The Secretary shall— 

21 (1) update the FDA Adverse Event Reporting 

22 System, including to— 

23 (A) create an optional selection tool that 

24 allows individuals to report whether an adverse 


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1 drug event is associated with a drug-gene or 

2 drug-drug-gene interaction; and 

3 (B) accept information directly from health 

4 care providers’ electronic health record systems; 

5 (2) work with relevant Federal agencies and of6 fices, and stakeholders, to create patient-friendly 

7 electronic options for reporting adverse drug events 

8 such as submission through an optional designated 

9 mobile device application or mobile device messaging 

10 application; and 

11 (3) not later than 1 year after the date of en12 actment of this Act, report to the Congress on the 

13 progress made in implementing paragraphs (1) and 

14 (2). 

15 (e) GAO STUDY AND RECOMMENDATIONS ON INCLU16 SION OF INFORMATION ON DRUG-GENE INTERACTIONS

17 ON DRUG LABELS.—Not later than 180 days after the 

18 date of enactment of this Act, the Comptroller General 

19 of the United States shall— 

20 (1) study, and formulate recommendations on, 

21 how the Food and Drug Administration can include 

22 and update information on drug-gene interactions on 

23 drug labels; and 

24 (2) submit recommendations to the relevant 

25 committees of jurisdiction. 


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1 (f) REPORT ON ADDITIONAL IMPROVEMENTS TO

2 ELECTRONIC HEALTH RECORD SYSTEMS.— 

3 (1) IN GENERAL.—Not later than 180 days 

4 after the date of enactment of this Act, the Sec5 retary shall— 

6 (A) complete a report on additional im7 provements to electronic health record systems 

8 that are needed to further the development of 

9 real world evidence (as defined in section 505F 

10 of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 355g)) in pharmacogenomics; and 

12 (B) submit such report to the Congress. 

13 (2) CONSIDERATION OF NEEDED ADVANCE14 MENTS.—As part of the report under paragraph (1), 

15 the Secretary shall consider what advancements are 

16 needed in electronic health record systems to capture 

17 information about the laboratory and the test used 

18 as part of pharmacogenomic testing. 

Æ 


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