Text: H.R.5198 — 116th Congress (2019-2020)All Information (Except Text)

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Introduced in House (11/20/2019)

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5198 Introduced in House (IH)]


  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.



                           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 


                                 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,


    This Act may be cited as the ``Patients' Right to Know Their 
Medication Act of 2019''.


    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.).


    (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 505F 
(21 U.S.C. 355g) the following:


    ``(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 
    ``(b) Content.--The regulations promulgated under subsection (a) 
shall require that the patient medication information with respect to a 
            ``(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 promotional 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 
                    ``(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 
                    ``(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
            ``(3) 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 of printed 
        patient medication information to accommodate prescriptions 
        dispensed therefrom.
    ``(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.''.
    (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 
    ``(ee) If it is a drug subject to section 503(b)(1) and patient 
medication information is not provided in accordance with section