(A) to consider advances in scientific un-
derstanding 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 sys-
tems 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 administra-
tors, primary and specialty care physicians, pharmacists, 
nurse practitioners, physician assistants, physician med-
ical geneticists, laboratory medical geneticists, genetic 
counselors, medical educators, and the faculty of schools 
of medicine and other schools of health professions, on the 
following: 
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(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 stand-
ards 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 en-
courage individuals and their health care profes-
sionals to consider pharmacogenomic testing as part 
of their health care plan to the extent appropriate. 
(4) The role of medical professionals who spe-
cialize in genetics and genomics. 
(5) How to incorporate pharmacogenomics into 
comprehensive medication management. 
(6) The importance of reporting information 
about known and relevant pharmacogenomic infor-
mation 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 
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care physicians, pharmacists, nurse practitioners, physi-
cian 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 medica-
tion order is completed and acted upon during computer-
ized provider order entry, interventions might automati-
cally 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) 
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 
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(B) not less than biannually, update such 
guidance to incorporate pharmacogenomic infor-
mation from— 
(i) new or updated drug labels; and 
(ii) newly established peer-reviewed 
professional guidelines on drug-gene asso-
ciations. 
(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 develop-
ment of electronic health record systems that allow for ad-
verse drug event information to be directly reported to the 
FDA Adverse Event Reporting System. 
(d) UPDATING FAERS; PATIENT-FRIENDLY RE-
PORTING.—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 
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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 of-
fices, 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 en-
actment of this Act, report to the Congress on the 
progress made in implementing paragraphs (1) and 
(2). 
(e) GAO STUDY AND RECOMMENDATIONS ON INCLU-
SION 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. 
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