I 
116TH CONGRESS 
1ST SESSION H. R. 5198 
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 
NOVEMBER 20, 2019 
Mr. GOLDEN (for himself and Mr. CARTER of Georgia) 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-
tives 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 2019’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
VerDate Sep 11 2014 
23:09 Nov 29, 2019
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H5198.IH
H5198
kjohnson on DSK79L0C42 with BILLS
(1) Prescription medications are important to 
the health and well-being of the American public. 
(2) According to the Centers for Disease Con-
trol and Prevention (CDC), 48.9 percent of Ameri-
cans 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 pa-
tients 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 hos-
pital 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 op-
tion. 
(7) The Government Accountability Office 
found that relying on electronic labeling as a com-
VerDate Sep 11 2014 
23:09 Nov 29, 2019
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H5198.IH
H5198
kjohnson on DSK79L0C42 with BILLS
plete 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 PRE-
SCRIPTION DRUGS. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 505F (21 U.S.C. 355g) the 
following: 
‘‘SEC. 505G. PATIENT MEDICATION INFORMATION FOR PRE-
SCRIPTION DRUGS. 
‘‘(a) IN GENERAL.—The Secretary shall issue regula-
tions on the patient medication information that is re-
quired to be in the printed labeling of drugs subject to 
section 503(b)(1), including regulations regarding the au-
thorship, content, format, color, printing, and dissemina-
tion 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. 
VerDate Sep 11 2014 
23:09 Nov 29, 2019
Jkt 099200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5198.IH
H5198
kjohnson on DSK79L0C42 with BILLS
‘‘(b) CONTENT.—The regulations promulgated under 
subsection (a) shall require that the patient medication in-
formation with respect to a drug— 
‘‘(1) be scientifically accurate, include relevant 
patient safety information, and be approved by the 
Secretary; 
‘‘(2) include understandable plain language, 
and include graphics and pictures when applicable, 
and be provided in a consistent, standardized format 
and color for all drug products, and not be pro-
motional in tone or content, and 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, pre-
cautions, the most frequently occurring adverse 
reactions, and adverse reactions that are impor-
tant for other reasons (such as because they are 
serious), especially with respect to certain sub-
populations such as children, pregnant women, 
and the elderly; 
VerDate Sep 11 2014 
23:09 Nov 29, 2019
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5198.IH
H5198
kjohnson on DSK79L0C42 with BILLS