I 

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. 

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’’. 

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 awareness. 

Sec. 5. Improving EHR systems to improve the use of pharmacogenomic information. 

Sec. 6. Increased authorization for pharmacogenomics implementation research. 

Sec. 7. Definition. 

1 SEC. 3. NATIONAL ACTION PLAN FOR ADVERSE DRUG 

2 EVENT PREVENTION. 

3 The Secretary of Health and Human Services shall— 

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

5 enactment of this Act, in coordination with the 

6 heads of other relevant Federal departments and 

7 agencies including the Director of the National 

8 Human Genome Research Institute, and in consulta9 tion with the Director of the Eunice Kennedy Shriv10 er National Institute of Child Health and Human 

11 Development, the Director of the National Center 

12 for Biotechnology Information, and the Director of 

13 the National Library of Medicine, submit a report to 

14 the Congress on— 

15 (A) the implementation of the National Ac16 tion Plan for Adverse Drug Event Prevention of 

17 the Department of Health and Human Services; 

18 and 

19 (B) the progress in meeting the target ap20 proved by the Federal Interagency Steering 


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1 Committee for Adverse Drug Events for a 10- 

2 percent reduction for— 

3 (i) the rate of adverse drug events 

4 from anticoagulants among United States 

5 inpatient stays; 

6 (ii) the rate of adverse drug events 

7 from hypoglycemic agents among United 

8 States inpatient stays; 

9 (iii) the rate of adverse drug events 

10 from opioid analgesics among United 

11 States inpatient stays; 

12 (iv) the rate of visits to United States 

13 hospital emergency departments for ad14 verse drug events associated with injury 

15 from oral anticoagulants; 

16 (v) the rate of visits to United States 

17 hospital emergency departments for ad18 verse drug events associated with injury 

19 from insulin; and 

20 (vi) the rate of visits to United States 

21 hospital emergency departments for ad22 verse drug events associated with thera23 peutic use of opioid analgesics; 

24 (2) convene the Federal Interagency Steering 

25 Committee for Adverse Drug Events to update the 


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1 National Action Plan for Adverse Drug Event Pre2 vention; and 

3 (3) require such Committee, in updating the 

4 National Action Plan for Adverse Drug Event Pre5 vention— 

6 (A) to consider advances in scientific un7 derstanding and technology pertaining to drug8 gene-drug interactions, clinical outcomes, health 

9 care utilization, and the decreasing cost of ge10 netic testing; 

11 (B) to assess the role of pharmacogenetics 

12 testing combined with clinical decision support 

13 as an evidence-based prevention tool; and 

14 (C) to evaluate operating characteristics 

15 for Federal adverse drug event surveillance sys16 tems and expand capabilities to identify genetic 

17 associations in adverse events. 

18 SEC. 4. ADVERSE DRUG EVENT AND PHARMACOGENOMIC 

19 TESTING AWARENESS. 

20 Part P of title III of the Public Health Service Act 

21 (42 U.S.C. 280g et seq.) is amended by adding at the end 

22 the following: 

23 ‘‘SEC. 399V–7. ADVERSE DRUG EVENT AND 

24 PHARMACOGENOMIC TESTING AWARENESS. 

25 ‘‘(a) PUBLIC EDUCATION CAMPAIGN.— 


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1 ‘‘(1) IN GENERAL.—The Secretary, acting 

2 through the Director of the National Human Ge3 nome Research Institute, in consultation with the 

4 Director of the Eunice Kennedy Shriver National In5 stitute of Child Health and Human Development, 

6 the Director of the National Center for Bio7 technology Information, and the Director of the Na8 tional Library of Medicine, shall conduct a national 

9 evidence-based education campaign to increase the 

10 public’s awareness regarding— 

11 ‘‘(A) the prevalence of adverse drug events 

12 and adverse drug reactions; 

13 ‘‘(B) specific risk factors that increase an 

14 individual’s likelihood of experiencing an ad15 verse drug event or adverse drug reaction; 

16 ‘‘(C) basic information about 

17 pharmacogenomic testing and how its use, in18 cluding incorporation in comprehensive medica19 tion management, may prevent adverse drug re20 actions in certain clinical situations; 

21 ‘‘(D) the role of health care providers in 

22 performing pharmacogenomic testing, inter23 preting the results of such testing, and adjust24 ing medications based on such results; 


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1 ‘‘(E) the availability of pharmacogenomic 

2 testing; 

3 ‘‘(F) comprehensive medication manage4 ment; and 

5 ‘‘(G) how the benefits of an individual’s 

6 pharmacogenomic test results might change or 

7 be relevant over time. 

8 ‘‘(2) CONSIDERATION OF ADVICE OF STAKE9 HOLDER EXPERTS.—The education campaign under 

10 paragraph (1) shall take into consideration the ad11 vice of stakeholder expects, such as those special12 izing in medical genetics and pharmacogenetics and 

13 collaborative communities focused on 

14 pharmacogenomics. 

15 ‘‘(3) MEDIA CAMPAIGN.—In conducting the 

16 education campaign under paragraph (1), the Sec17 retary, after considering the advice of stakeholder 

18 experts pursuant to paragraph (2), may award 

19 grants or contracts to entities to establish national 

20 multimedia campaigns that may include advertising 

21 through television, radio, print media, billboards, 

22 posters, all forms of existing and especially emerging 

23 social networking media, other Internet media, and 

24 any other medium determined appropriate by the 

25 Secretary. 


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1 ‘‘(4) RURAL REGIONS, HEALTH PROFESSIONAL

2 SHORTAGE AREAS, AND UNDERSERVED COMMU3 NITIES.—The Secretary shall ensure that the edu4 cation campaign under paragraph (1)— 

5 ‘‘(A) reaches rural and medically under6 served communities (as defined in section 799); 

7 and 

8 ‘‘(B) includes the involvement of commu9 nity health centers, community pharmacies, and 

10 other local health clinics. 

11 ‘‘(b) HEALTH CARE PROFESSIONAL EDUCATION

12 CAMPAIGN.— 

13 ‘‘(1) IN GENERAL.—The Secretary, acting 

14 through the Director of the National Human Ge15 nome Research Institute, in consultation with the 

16 Director of the Eunice Kennedy Shriver National In17 stitute of Child Health and Human Development, 

18 the Director of the National Center for Bio19 technology Information, the Director of the National 

20 Library of Medicine, and the Administrator of the 

21 Health Resources and Services Administration, shall 

22 establish a national health education program for 

23 health care providers and health care leaders, includ24 ing administrators, pharmacists, nurse practitioners, 

25 physicians’ assistants, physician medical geneticists, 


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1 laboratory medical geneticists, genetic counselors, 

2 medical educators, and the faculty of schools of med3 icine and other schools of health professions, on the 

4 following: 

5 ‘‘(A) Pharmacogenomic testing and the ex6 tent of its ability to prevent adverse drug reac7 tions. 

8 ‘‘(B) Pharmacogenomic testing, drug inter9 action alerting systems, when to refer to or con10 sult with a genetics provider, and the standards 

11 of care for patients who are suspected or known 

12 to have a genetic variant that is known to im13 pact drug metabolism. 

14 ‘‘(C) Evidence-based information that 

15 would encourage individuals and their health 

16 care professionals to consider pharmacogenomic 

17 testing as part of their health care plan to the 

18 extent appropriate. 

19 ‘‘(D) The role of medical professionals who 

20 specialize in genetics and genomics. 

21 ‘‘(E) How to incorporate 

22 pharmacogenomics into comprehensive medica23 tion management. 

24 ‘‘(2) GRANTS.— 


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1 ‘‘(A) AWARD.—In carrying out the na2 tional health education program under this sub3 section, the Secretary, acting through the Di4 rector of the National Human Genome Re5 search Institute, may award grants to nonprofit 

6 organizations to carry out educational activities 

7 with respect to the topics listed in subpara8 graphs (A) through (D) of paragraph (1). 

9 ‘‘(B) USE OF FUNDS.—A grant under sub10 paragraph (A) may be used to support one or 

11 more of the following activities: 

12 ‘‘(i) Increasing the knowledge and 

13 awareness of health care providers and 

14 health care leaders about 

15 pharmacogenomic testing and drug inter16 actions. 

17 ‘‘(ii) Increasing the number of health 

18 professional schools that incorporate 

19 pharmacogenomic curricula in classroom 

20 instruction. 

21 ‘‘(iii) Increasing the ability of health 

22 care providers to note and respond to the 

23 impact of gender, ethnicity, age, and other 

24 relevant characteristics on drug metabo25 lism. 


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1 ‘‘(iv) Developing principles, practices, 

2 and curriculum instruction that prepare 

3 medical, nursing, pharmacy, and other 

4 health professions students to effectively 

5 apply knowledge and skills needed to rec6 ognize— 

7 ‘‘(I) when a patient is eligible for 

8 pharmacogenomic testing, including 

9 as part of comprehensive medication 

10 management when appropriate, and in 

11 accordance with the patient’s health 

12 care team, a drug product’s label, and 

13 professional clinical guidelines; and 

14 ‘‘(II) how to appropriately use 

15 the test results to adjust a prescrip16 tion or otherwise change a patient’s 

17 health care plan. 

18 ‘‘(v) Providing opportunities for prac19 ticing health care professionals to receive 

20 pharmacogenomics training and education 

21 through a variety of modalities including 

22 in-person, electronic media, professional 

23 meetings and conferences, and social 

24 media. 


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1 ‘‘(c) REPORTING.—At least every three years, the 

2 Secretary, acting through the Director of the National 

3 Human Genome Research Institute, in consultation with 

4 the Director of the Eunice Kennedy Shriver National In5 stitute of Child Health and Human Development, the Di6 rector of the National Center for Biotechnology Informa7 tion, the Director of the National Library of Medicine, the 

8 Administrator of the Centers for Medicare & Medicaid 

9 Services, and relevant stakeholders with expertise in devel10 oping quality measures of label and peer-reviewed profes11 sional guidelines on drug-gene interactions, shall publish 

12 data on— 

13 ‘‘(1) the public’s awareness regarding adverse 

14 drug events and pharmacogenomic testing; 

15 ‘‘(2) the number or percentage of individuals 

16 utilizing information to inform their health care de17 cisions regarding prescription medications and 

18 pharmacogenomic testing; 

19 ‘‘(3) the change in the number or percentage of 

20 individuals enrolled in a prescription drug plan 

21 under part D of the title XVIII of the Social Secu22 rity Act receiving a pharmacogenetic test, as rec23 ommended in alignment with a drug product’s label 

24 or peer-reviewed professional guidelines; and 


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1 ‘‘(4) the number or percentage of changes, be2 ginning one year after the date of enactment of this 

3 section, in medication management as a result of in4 corporating information from pharmacogenomic test5 ing. 

6 ‘‘(d) DEFINITIONS.—In this section: 

7 ‘‘(1) ADVERSE DRUG EVENT.—The term ‘ad8 verse drug event’ means an injury resulting from 

9 any medical intervention with a drug. 

10 ‘‘(2) ADVERSE DRUG REACTION.—The term 

11 ‘adverse drug reaction’ means a response to a drug 

12 that— 

13 ‘‘(A) is noxious and unintended; and 

14 ‘‘(B) occurs at doses normally used in hu15 mans for prophylaxis, diagnosis, or therapy of 

16 disease or for the modification of physiologic 

17 function. 

18 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 

19 carry out this section, there is authorized to be appro20 priated $50,000,000 for each of fiscal years 2022 through 

21 2027.’’. 

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

23 OF PHARMACOGENOMIC INFORMATION. 

24 (a) CERTIFICATION CRITERIA.—The Secretary of 

25 Health and Human Services (in this section referred to 


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1 as the ‘‘Secretary’’) shall adopt pursuant to subtitle A of 

2 title XXX of the Public Health Service Act (42 U.S.C. 

3 300jj–11 et seq.) certification criteria for health informa4 tion technology, including for electronic prescribing sys5 tems and real-time pharmacy benefit checks, such that be6 fore a medication order is completed and acted upon dur7 ing computerized provider order entry, interventions must 

8 automatically indicate to a user— 

9 (1) when pharmacogenomic testing is appro10 priate based on a drug product’s label or peer-re11 viewed professional guidelines; and 

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

13 established by a drug product’s label or peer-re14 viewed professional guidelines, based on a patient’s 

15 medication list, medication allergy list, and results 

16 from pharmacogenomic testing. 

17 (b) REPORTING AND ASSOCIATION OF ADVERSE

18 DRUG EVENTS.—The Secretary, in consultation with the 

19 Commissioner of Food and Drugs, shall carry out a pro20 gram to improve the reporting of adverse drug events and 

21 the association, if any, of such events to a patient’s genetic 

22 status. As part of the program, the Secretary shall issue 

23 regulations pursuant to the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 301 et seq.) and other applicable 

25 statutory authorities to— 


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1 (1) ensure that drug-gene interaction alerting 

2 systems are continuously updated to incorporate in3 formation from new or updated drug labels with 

4 pharmacogenomic information and newly established 

5 peer-reviewed professional guidelines on drug-gene 

6 associations; 

7 (2) facilitate the reporting of adverse drug 

8 events to the FDA Adverse Event Reporting System 

9 directly through the use of the health care provider’s 

10 electronic health record system; and 

11 (3) allow for the reporting of whether an ad12 verse drug event is caused by pharmacogenetic inter13 actions to the FDA Adverse Event Reporting Sys14 tem directly through the use of the health care pro15 vider’s electronic health record system. 

16 (c) UPDATING FAERS; PATIENT-FRIENDLY RE17 PORTING.—The Secretary, acting through the Commis18 sioner of Food and Drugs, shall— 

19 (1) update the FDA Adverse Event Reporting 

20 System, including to— 

21 (A) accept information directly from health 

22 care providers’ electronic health record systems; 

23 (B) improve the collection of real world 

24 evidence (as defined in section 505F of the 


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1 Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 355g)); and 

3 (C) create a selection tool that allows indi4 viduals to report whether an adverse drug event 

5 is associated with a drug-gene interaction; 

6 (2) work with relevant Federal agencies and of7 fices, and stakeholders, to create patient-friendly 

8 electronic options for reporting adverse drug events 

9 such as submission through a designated mobile de10 vice application or mobile device messaging applica11 tion; and 

12 (3) not later than 1 year after the date of en13 actment of this Act, report to the Congress on the 

14 progress made in implementing paragraphs (1) and 

15 (2). 

16 (d) ASSESSMENT ON ADDITIONAL IMPROVEMENTS

17 TO ELECTRONIC HEALTH RECORD SYSTEMS.— 

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

19 after the date of enactment of this Act, the Sec20 retary shall— 

21 (A) complete an assessment on additional 

22 improvements to electronic health record sys23 tems that are needed to further the develop24 ment of real world evidence (as defined in sec25 tion 505F of the Federal Food, Drug, and CosVerDate Sep 11 2014 00:31 Mar 05, 2022 Jkt 029200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H6875.IH H6875

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1 metic Act (21 U.S.C. 355g)) in 

2 pharmacogenomics; and 

3 (B) submit a report to the Congress on the 

4 findings on the assessment. 

5 (2) CONSIDERATION OF NEEDED ADVANCE6 MENTS.—As part of the assessment under para7 graph (1), the Secretary shall consider what ad8 vancements are needed to capture information about 

9 the laboratory and the test used as part of 

10 pharmacogenomic testing. 

11 SEC. 6. INCREASED AUTHORIZATION FOR 

12 PHARMACOGENOMICS IMPLEMENTATION RE13 SEARCH. 

14 There is authorized to be appropriated to the Na15 tional Institutes of Health $7,000,000 for each of fiscal 

16 years 2022 through 2025 for the conduct, support, and 

17 maintenance of pharmacogenomics implementation re18 search through the Genomic Community Resources pro19 gram. 

20 SEC. 7. DEFINITIONS. 

21 In this Act: 

22 (1) The term ‘‘adverse drug event’’ means an 

23 injury resulting from any medical intervention with 

24 a drug. 


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1 (2) The term ‘‘comprehensive medication man2 agement’’ means medication management pursuant 

3 to a standard of care that ensures each patient’s 

4 medications are individually assessed to determine 

5 that each medication is appropriate for the patient, 

6 effective for the medical condition, and safe given 

7 the comorbidities and other medications being taken 

8 and able to be taken by the patient as intended. 

Æ 


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