No official summary available for this bill.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7848 Introduced in House (IH)]
<DOC>
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.
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 of 2024''.
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 education for
health care professionals.
Sec. 5. Improving EHR systems to improve the use of pharmacogenomic
information.
SEC. 3. NATIONAL ACTION PLAN FOR ADVERSE DRUG EVENT PREVENTION.
The Secretary of Health and Human Services (in this Act referred to
as the ``Secretary'') 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, submit a report to the
Congress on the implementation of the National Action Plan for
Adverse Drug Event Prevention of the Department of Health and
Human Services, including on the progress in meeting the target
outcomes approved by the Federal Interagency Steering Committee
for Adverse Drug Events;
(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
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 systems 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 administrators, primary and specialty
care physicians, pharmacists, nurse practitioners, physician
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:
(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 standards 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 encourage
individuals and their health care professionals to consider
pharmacogenomic testing as part of their health care plan to
the extent appropriate.
(4) The role of medical professionals who specialize in
genetics and genomics.
(5) How to incorporate pharmacogenomics into comprehensive
medication management.
(6) The importance of reporting information about known and
relevant pharmacogenomic information 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 care physicians, pharmacists,
nurse practitioners, physician 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 medication order is completed
and acted upon during computerized provider order entry, interventions
might 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) 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
(B) not less than biannually, update such guidance
to incorporate pharmacogenomic information from--
(i) new or updated drug labels; and
(ii) newly established peer-reviewed
professional guidelines on drug-gene
associations.
(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 development of electronic health record systems
that allow for adverse drug event information to be directly reported
to the FDA Adverse Event Reporting System.
(d) Updating FAERS; Patient-Friendly Reporting.--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 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 offices, 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 enactment of
this Act, report to the Congress on the progress made in
implementing paragraphs (1) and (2).
(e) GAO Study and Recommendations on Inclusion 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.
(f) Report 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 a report 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 such report to the Congress.
(2) Consideration of needed advancements.--As part of the
report under paragraph (1), the Secretary shall consider what
advancements are needed in electronic health record systems to
capture information about the laboratory and the test used as
part of pharmacogenomic testing.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line