Summary
# Patients' Right to Know Their Medication Act of 2023
## WHAT THIS BILL DOES
This bill requires the federal government to create and enforce rules about patient medication information that must be printed on prescription drug labels. Drug manufacturers would have to include this information in a standard, patient-friendly paper format with every prescription they dispense.
## WHO IT AFFECTS
* Patients who receive prescription medications
* Prescription drug manufacturers
* Pharmacies and other places that dispense prescription drugs
* The Food and Drug Administration (the federal agency that approves medications)
## KEY PROVISIONS
* The Food and Drug Administration must write regulations within 1 year of this law passing that set requirements for patient medication information on prescription drug labels, including how it should be written, what it should look like, what color it should be, and how it should be shared (Sec. 3(a))
* Patient medication information must include the drug's name and code number, what the drug is used for, how to use it properly, possible side effects, dangerous interactions with other drugs or foods, and the manufacturer's phone number (Sec. 3(b))
* Patient medication information must be printed and given to patients with every prescription in a standard format using clear language and pictures when helpful, and it must not be written like an advertisement (Sec. 3(b))
* Regulations must require updates to patient medication information as new drugs and new safety information become available (Sec. 3(c))
* Prescription drugs that do not include this printed patient information would be considered misbranded, which is illegal (Sec. 502)
## WHAT CHANGES
Drug manufacturers would be required to print patient medication information in a standardized, single-page format and include it with every prescription dispensed. This requirement did not exist before in the law. The Food and Drug Administration would have to create specific rules about what information to include, how it should look and read, and how to update it over time.
## IMPORTANT DEFINITIONS
* **Prescription drugs**: Medications that require a doctor's order to obtain (explicitly referenced as "drugs subject to section 503(b)(1)")
* **Patient medication information**: Written information about a drug given to patients that explains how to use it safely and what side effects might happen
* **Misbranded**: When a drug product does not follow federal labeling requirements, making it illegal to sell
## EFFECTIVE DATE
Not specified in bill text
I
118TH CONGRESS
1ST SESSION H. R. 1173
To amend the Federal Food, Drug, and Cosmetic Act regarding the patient
medication information required to be included in the labeling of prescrip-
tion drugs, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 24, 2023
Mr. CARTER
of Georgia (for himself, Mr. GOLDEN
of Maine, Mr.
WESTERMAN, and Mr. RUPPERSBERGER) 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 regard-
ing 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 Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Patients’ Right to
4
Know Their Medication Act of 2023’’.
5
SEC. 2. FINDINGS.
6
Congress finds the following:
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•HR 1173 IH
(1) Prescription medications are important to
1
the health and well-being of the American public.
2
(2) According to the Centers for Disease Con-
3
trol and Prevention (CDC), 48.9 percent of Ameri-
4
cans used at least one prescription drug in the past
5
30 days.
6
(3) The utilization of prescription drugs can
7
subject patients to adverse drug events; therefore,
8
patient safety is of the utmost importance.
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(4) Studies indicate that paper format patient
10
medication information (PMI) can help protect pa-
11
tients and prevent the majority of costly adverse
12
drug events.
13
(5) In addition to bolstering patient safety, the
14
mandatory use of a standardized PMI provided to
15
all patients in nonhospital settings could reduce
16
costs associated with emergency room visits and hos-
17
pital admissions related to adverse drug events by
18
$14.6 to $26.2 billion dollars annually.
19
(6) Many patients cannot access electronic
20
versions of PMI, thereby necessitating a paper op-
21
tion.
22
(7) The Government Accountability Office
23
found that relying on electronic labeling as a com-
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•HR 1173 IH
plete substitute for paper labeling could adversely
1
impact public health.
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(8) A congressionally mandated paper PMI is
3
needed because no standardized PMI in a single
4
page, paper copy, proven patient-friendly format is
5
currently available to patients or required by the
6
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
7
301 et seq.).
8
SEC. 3. PATIENT MEDICATION INFORMATION FOR PRE-
9
SCRIPTION DRUGS.
10
(a) IN GENERAL.—Chapter V of the Federal Food,
11
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
12
ed by inserting after section 505G (21 U.S.C. 355h) the
13
following:
14
‘‘SEC. 505H. PATIENT MEDICATION INFORMATION FOR PRE-
15
SCRIPTION DRUGS.
16
‘‘(a) IN GENERAL.—The Secretary shall issue regula-
17
tions on the patient medication information that is re-
18
quired to be in the printed labeling of drugs subject to
19
section 503(b)(1), including regulations regarding the au-
20
thorship, content, format, color, printing, and dissemina-
21
tion requirements for such patient medication information.
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The Secretary shall issue final regulations pursuant to the
23
preceding sentence not later than 1 year after the date
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of enactment of this section.
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‘‘(b) CONTENT.—The regulations promulgated under
1
subsection (a) shall require that the patient medication in-
2
formation with respect to a drug—
3
‘‘(1) be scientifically accurate, include relevant
4
patient safety information, and be approved by the
5
Secretary;
6
‘‘(2) include understandable plain language,
7
and include graphics and pictures when applicable,
8
and be provided in a consistent, standardized format
9
and color for all drug products, and not be pro-
10
motional in tone or content, and contain at least—
11
‘‘(A) the established name of the drug (or,
12
if the drug is a biological product, the proper
13
name of the biological product) and the national
14
drug code for the drug;
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‘‘(B) indications for use approved by the
16
Food and Drug Administration;
17
‘‘(C) general directions for proper use;
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‘‘(D) contraindications, warnings, pre-
19
cautions, the most frequently occurring adverse
20
reactions, and adverse reactions that are impor-
21
tant for other reasons (such as because they are
22
serious), especially with respect to certain sub-
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populations such as children, pregnant women,
24
and the elderly;
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‘‘(E) measures patients may be able to
1
take, if any, to reduce the side effects and risks
2
of the drug;
3
‘‘(F) information about when a patient
4
should contact his or her health care profes-
5
sional;
6
‘‘(G) instructions not to share medications,
7
and, if applicable, key storage requirements and
8
recommendations relating to proper disposal of
9
any unused portion of the drug;
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‘‘(H) known clinically important inter-
11
actions with other drugs, food, and other sub-
12
stances;
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‘‘(I) a statement of whether sufficient data
14
are available concerning the use of the drug in
15
specified subpopulations, such as women, preg-
16
nant women, lactating women, women and men
17
of reproductive age, and pediatric, geriatric, ra-
18
cial, and ethnic minority groups;
19
‘‘(J) the name of the manufacturer and a
20
toll-free telephone number for consumers to
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contact the manufacturer of the drug; and
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‘‘(K) a current link to Form FDA 3500B
23
for voluntary reporting for consumers of ad-
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•HR 1173 IH
verse events, product problems, and product use
1
errors (or any successor form); and
2
‘‘(3) be provided to a patient or agent of a pa-
3
tient in a printed format with each prescription dis-
4
pensed, such that a drug labeled for distribution
5
shall be accompanied by printed labeling physically
6
on or within the packaging from which the drug is
7
to be dispensed, in an adequate supply of printed
8
patient medication information to accommodate pre-
9
scriptions dispensed therefrom.
10
‘‘(c) TIMELINESS, CONSISTENCY, ACCURACY, AND
11
EFFECTIVENESS.—The regulations promulgated under
12
subsection (a) shall—
13
‘‘(1) provide for timely reviews, approvals, and
14
updates of patient medication information as new
15
drugs and new information become available;
16
‘‘(2) provide for updates when appropriate to
17
help communicate information that is shared by
18
similar products or drugs within classes of medica-
19
tion to avoid patient confusion and harm;
20
‘‘(3) include specifications for language, graph-
21
ics, format, color, and pictures required by sub-
22
section (b)(2), to be developed based upon docu-
23
mented patient research with one or more actual
24
drug products that demonstrates improved patient
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•HR 1173 IH
learning and understanding of safe and effective
1
medication use; and
2
‘‘(4) be based on a demonstrated causal connec-
3
tion between the enhanced patient medication infor-
4
mation required by the regulations and improved pa-
5
tient medication adherence and compliance for the
6
purpose of reducing the cost of health care and im-
7
proving desired medical outcomes.’’.
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(b) MISBRANDING OFFENSE.—Section 502 of the
9
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352)
10
is amended by adding at the end the following:
11
‘‘(gg) If it is a drug subject to section 503(b)(1) and
12
patient medication information is not provided in accord-
13
ance with section 505H.’’.
14
Æ
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