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 prescription 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 regarding the patient medication information required to be 

included in the labeling of prescription drugs, and for 

other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Patients’ Right to 

5 Know Their Medication Act of 2019’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) Prescription medications are important to 

2 the health and well-being of the American public. 

3 (2) According to the Centers for Disease Con4 trol and Prevention (CDC), 48.9 percent of Ameri5 cans used at least one prescription drug in the past 

6 30 days. 

7 (3) The utilization of prescription drugs can 

8 subject patients to adverse drug events; therefore, 

9 patient safety is of the utmost importance. 

10 (4) Studies indicate that paper format patient 

11 medication information (PMI) can help protect pa12 tients and prevent the majority of costly adverse 

13 drug events. 

14 (5) In addition to bolstering patient safety, the 

15 mandatory use of a standardized PMI provided to 

16 all patients in nonhospital settings could reduce 

17 costs associated with emergency room visits and hos18 pital admissions related to adverse drug events by 

19 $14.6 to $26.2 billion dollars annually. 

20 (6) Many patients cannot access electronic 

21 versions of PMI, thereby necessitating a paper op22 tion. 

23 (7) The Government Accountability Office 

24 found that relying on electronic labeling as a comVerDate Sep 11 2014 23:09 Nov 29, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5198.IH H5198

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1 plete substitute for paper labeling could adversely 

2 impact public health. 

3 (8) A congressionally mandated paper PMI is 

4 needed because no standardized PMI in a single 

5 page, paper copy, proven patient-friendly format is 

6 currently available to patients or required by the 

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 301 et seq.). 

9 SEC. 3. PATIENT MEDICATION INFORMATION FOR PRE10 SCRIPTION DRUGS. 

11 (a) IN GENERAL.—Chapter V of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend13 ed by inserting after section 505F (21 U.S.C. 355g) the 

14 following: 

15 ‘‘SEC. 505G. PATIENT MEDICATION INFORMATION FOR PRE16 SCRIPTION DRUGS. 

17 ‘‘(a) IN GENERAL.—The Secretary shall issue regula18 tions on the patient medication information that is re19 quired to be in the printed labeling of drugs subject to 

20 section 503(b)(1), including regulations regarding the au21 thorship, content, format, color, printing, and dissemina22 tion requirements for such patient medication information. 

23 The Secretary shall issue final regulations pursuant to the 

24 preceding sentence not later than 1 year after the date 

25 of enactment of this section. 


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1 ‘‘(b) CONTENT.—The regulations promulgated under 

2 subsection (a) shall require that the patient medication in3 formation with respect to a drug— 

4 ‘‘(1) be scientifically accurate, include relevant 

5 patient safety information, and be approved by the 

6 Secretary; 

7 ‘‘(2) include understandable plain language, 

8 and include graphics and pictures when applicable, 

9 and be provided in a consistent, standardized format 

10 and color for all drug products, and not be pro11 motional in tone or content, and contain at least— 

12 ‘‘(A) the established name of the drug (or, 

13 if the drug is a biological product, the proper 

14 name of the biological product) and the national 

15 drug code for the drug; 

16 ‘‘(B) indications for use approved by the 

17 Food and Drug Administration; 

18 ‘‘(C) general directions for proper use; 

19 ‘‘(D) contraindications, warnings, pre20 cautions, the most frequently occurring adverse 

21 reactions, and adverse reactions that are impor22 tant for other reasons (such as because they are 

23 serious), especially with respect to certain sub24 populations such as children, pregnant women, 

25 and the elderly; 


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1 ‘‘(E) measures patients may be able to 

2 take, if any, to reduce the side effects and risks 

3 of the drug; 

4 ‘‘(F) information about when a patient 

5 should contact his or her health care profes6 sional; 

7 ‘‘(G) instructions not to share medications, 

8 and, if applicable, key storage requirements and 

9 recommendations relating to proper disposal of 

10 any unused portion of the drug; 

11 ‘‘(H) known clinically important inter12 actions with other drugs, food, and other sub13 stances; 

14 ‘‘(I) a statement of whether sufficient data 

15 are available concerning the use of the drug in 

16 specified subpopulations, such as women, preg17 nant women, lactating women, women and men 

18 of reproductive age, and pediatric, geriatric, ra19 cial, and ethnic minority groups; 

20 ‘‘(J) the name of the manufacturer and a 

21 toll-free telephone number for consumers to 

22 contact the manufacturer of the drug; and 

23 ‘‘(K) a current link to Form FDA 3500B 

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1 verse events, product problems, and product use 

2 errors (or any successor form); and 

3 ‘‘(3) be provided to a patient or agent of a pa4 tient in a printed format with each prescription dis5 pensed, such that a drug labeled for distribution 

6 shall be accompanied by printed labeling physically 

7 on or within the packaging from which the drug is 

8 to be dispensed, in an adequate supply of printed 

9 patient medication information to accommodate pre10 scriptions dispensed therefrom. 

11 ‘‘(c) TIMELINESS, CONSISTENCY, ACCURACY, AND

12 EFFECTIVENESS.—The regulations promulgated under 

13 subsection (a) shall— 

14 ‘‘(1) provide for timely reviews, approvals, and 

15 updates of patient medication information as new 

16 drugs and new information become available; 

17 ‘‘(2) provide for updates when appropriate to 

18 help communicate information that is shared by 

19 similar products or drugs within classes of medica20 tion to avoid patient confusion and harm; 

21 ‘‘(3) include specifications for language, graph22 ics, format, color, and pictures required by sub23 section (b)(2), to be developed based upon docu24 mented patient research with one or more actual 

25 drug products that demonstrates improved patient 


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1 learning and understanding of safe and effective 

2 medication use; and 

3 ‘‘(4) be based on a demonstrated causal connec4 tion between the enhanced patient medication infor5 mation required by the regulations and improved pa6 tient medication adherence and compliance for the 

7 purpose of reducing the cost of health care and im8 proving desired medical outcomes.’’. 

9 (b) MISBRANDING OFFENSE.—Section 502 of the 

10 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) 

11 is amended by adding at the end the following: 

12 ‘‘(ee) If it is a drug subject to section 503(b)(1) and 

13 patient medication information is not provided in accord14 ance with section 505G.’’. 

Æ 


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