‘‘(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 In-
stitute of Child Health and Human Development, the Di-
rector of the National Center for Biotechnology Informa-
tion, the Director of the National Library of Medicine, the 
Administrator of the Centers for Medicare & Medicaid 
Services, and relevant stakeholders with expertise in devel-
oping quality measures of label and peer-reviewed profes-
sional 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 de-
cisions 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 Secu-
rity Act receiving a pharmacogenetic test, as rec-
ommended in alignment with a drug product’s label 
or peer-reviewed professional guidelines; and 
VerDate Sep 11 2014 
00:31 Mar 05, 2022
Jkt 029200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H6875.IH
H6875
kjohnson on DSK79L0C42PROD with BILLS
‘‘(4) the number or percentage of changes, be-
ginning one year after the date of enactment of this 
section, in medication management as a result of in-
corporating information from pharmacogenomic test-
ing. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) ADVERSE DRUG EVENT.—The term ‘ad-
verse 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 hu-
mans 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 appro-
priated $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 
VerDate Sep 11 2014 
00:31 Mar 05, 2022
Jkt 029200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H6875.IH
H6875
kjohnson on DSK79L0C42PROD with BILLS
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 informa-
tion technology, including for electronic prescribing sys-
tems and real-time pharmacy benefit checks, such that be-
fore a medication order is completed and acted upon dur-
ing computerized provider order entry, interventions must 
automatically indicate to a user— 
(1) when pharmacogenomic testing is appro-
priate based on a drug product’s label or peer-re-
viewed professional guidelines; and 
(2) drug-gene and drug-drug-gene associations, 
established by a drug product’s label or peer-re-
viewed 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 pro-
gram 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 Cos-
metic Act (21 U.S.C. 301 et seq.) and other applicable 
statutory authorities to— 
VerDate Sep 11 2014 
00:31 Mar 05, 2022
Jkt 029200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H6875.IH
H6875
kjohnson on DSK79L0C42PROD with BILLS
(1) ensure that drug-gene interaction alerting 
systems are continuously updated to incorporate in-
formation 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 ad-
verse drug event is caused by pharmacogenetic inter-
actions to the FDA Adverse Event Reporting Sys-
tem directly through the use of the health care pro-
vider’s electronic health record system. 
(c) UPDATING FAERS; PATIENT-FRIENDLY RE-
PORTING.—The Secretary, acting through the Commis-
sioner 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 
VerDate Sep 11 2014 
00:31 Mar 05, 2022
Jkt 029200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H6875.IH
H6875
kjohnson on DSK79L0C42PROD with BILLS