[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5133 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 5133
To amend the Federal Food, Drug, and Cosmetic Act regarding the patient
medication information required to be included in the labeling of
prescription drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 4, 2025
Mr. Bentz (for himself and Mr. Golden of Maine) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act regarding the patient
medication information required to be included in the labeling of
prescription drugs, 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 ``Patients' Right to Know Their
Medication Act of 2025''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Prescription medications are important to the health
and well-being of the American public.
(2) According to the Centers for Disease Control and
Prevention (CDC), 48.9 percent of Americans used at least one
prescription drug in the past 30 days.
(3) The utilization of prescription drugs can subject
patients to adverse drug events; therefore, patient safety is
of the utmost importance.
(4) Studies indicate that paper format patient medication
information (PMI) can help protect patients and prevent the
majority of costly adverse drug events.
(5) In addition to bolstering patient safety, the mandatory
use of a standardized PMI provided to all patients in
nonhospital settings could reduce costs associated with
emergency room visits and hospital admissions related to
adverse drug events by $14.6 to $26.2 billion dollars annually.
(6) Many patients cannot access electronic versions of PMI,
thereby necessitating a paper option.
(7) The Government Accountability Office found that relying
on electronic labeling as a complete substitute for paper
labeling could adversely impact public health.
(8) A congressionally mandated paper PMI is needed because
no standardized PMI in a single page, paper copy, proven
patient-friendly format is currently available to patients or
required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
SEC. 3. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION DRUGS.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505G
(21 U.S.C. 355h) the following:
``SEC. 505H. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION DRUGS.
``(a) In General.--The Secretary shall issue regulations on the
patient medication information that is required to be in the printed
labeling of drugs subject to section 503(b)(1), including regulations
regarding the authorship, content, format, color, printing, and
dissemination requirements for such patient medication information. The
Secretary shall issue final regulations pursuant to the preceding
sentence not later than 1 year after the date of enactment of this
section.
``(b) Content.--The regulations promulgated under subsection (a)
shall require that the patient medication information with respect to a
drug--
``(1) be scientifically accurate, include relevant patient
safety information, and be approved by the Secretary;
``(2) be developed by manufacturers applying for approval
of a drug under this section and approved as part of such
application by the Secretary;
``(3) with respect to the language used and format--
``(A) utilize understandable plain language and
include graphics and pictures when applicable;
``(B) be provided in a consistent, standardized
format, minimum font size, and color for all drug
products;
``(C) be supplied by such manufacturer in printed
form on paper with processes and verifications that are
consistent with Current Good Manufacturing Practice;
and
``(D) not be promotional in tone or content;
``(4) contain at least--
``(A) the established name of the drug (or, if the
drug is a biological product, the proper name of the
biological product) and the national drug code for the
drug;
``(B) indications for use approved by the Food and
Drug Administration;
``(C) general directions for proper use;
``(D) contraindications, warnings, precautions, the
most frequently occurring adverse reactions, and
adverse reactions that are important for other reasons
(such as because they are serious), especially with
respect to certain subpopulations such as children,
pregnant women, and the elderly;
``(E) measures patients may be able to take, if
any, to reduce the side effects and risks of the drug;
``(F) information about when a patient should
contact his or her health care professional;
``(G) instructions not to share medications, and,
if applicable, key storage requirements and
recommendations relating to proper disposal of any
unused portion of the drug;
``(H) known clinically important interactions with
other drugs, food, and other substances;
``(I) a statement of whether sufficient data are
available concerning the use of the drug in specified
subpopulations, such as women, pregnant women,
lactating women, women and men of reproductive age, and
pediatric, geriatric, racial, and ethnic minority
groups;
``(J) the name of the manufacturer and a toll-free
telephone number for consumers to contact the
manufacturer of the drug; and
``(K) a current link to Form FDA 3500B for
voluntary reporting for consumers of adverse events,
product problems, and product use errors (or any
successor form); and
``(5) be provided to a patient or agent of a patient in a
printed format with each prescription dispensed, such that a
drug labeled for distribution shall be accompanied by printed
labeling physically on or within the packaging from which the
drug is to be dispensed, in an adequate supply.
``(c) Timeliness, Consistency, Accuracy, and Effectiveness.--The
regulations promulgated under subsection (a) shall--
``(1) provide for timely reviews, approvals, and updates of
patient medication information as new drugs and new information
become available;
``(2) provide for updates, when appropriate, to help
communicate information that is shared by similar products or
drugs within classes of medication to avoid patient confusion
and harm;
``(3) include specifications for language, graphics,
format, color, and pictures required by subsection (b)(2), to
be developed based upon documented patient research with one or
more actual drug products that demonstrates improved patient
learning and understanding of safe and effective medication
use; and
``(4) be based on a demonstrated causal connection between
the enhanced patient medication information required by the
regulations and improved patient medication adherence and
compliance for the purpose of reducing the cost of health care
and improving desired medical outcomes.
``(d) Adequate Supply.--For purposes of this section, the term
`adequate supply' means, with respect to the provision of patient
medication information, that the number of printed patient medical
information is adequate for the distribution of one printed patient
medical information per prescription in the case of packaging that
contains a bulk amount of prescription drug units intended to supply
multiple prescriptions.''.
(b) Misbranding Offense.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
``(hh) If it is a drug subject to section 503(b)(1) and patient
medication information is not provided in accordance with section
505H.''.
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