[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2214 Introduced in Senate (IS)]

<DOC>






114th CONGRESS
  1st Session
                                S. 2214

 To amend the Federal Food, Drug, and Cosmetic Act to require patient 
 medication information to be provided with certain prescription drugs.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 28, 2015

Mrs. Gillibrand (for herself, Ms. Warren, Ms. Stabenow, Mr. Brown, and 
Mr. Blumenthal) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to require patient 
 medication information to be provided with certain prescription drugs.

    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 ``Cody Miller Patient Medication 
Information Act''.

SEC. 2. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION DRUGS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 505E the following:

``SEC. 505F. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION DRUGS.

    ``(a) In General.--Not later than 2 years after the date of 
enactment of this section, the Secretary shall issue final regulations 
regarding the authorship, content, format, and dissemination 
requirements for patient medication information for drugs subject to 
section 503(b)(1).
    ``(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 based on the professional labeling 
        approved by the Secretary; and
            ``(2) include standard, nontechnical, understandable, plain 
        language that is not promotional in tone or content, and 
        contain at least--
                    ``(A) the established name of the drug or the 
                proper name of the biological product, as applicable;
                    ``(B) drug uses;
                    ``(C) general directions for proper use;
                    ``(D) contraindications, 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 groups 
                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) when a patient should contact his or her 
                health care professional;
                    ``(G) instructions not to share medications, and, 
                if any exist, key storage requirements, and 
                recommendations relating to proper disposal of any 
                unused portion of the drug;
                    ``(H) known clinically important interactions with 
                other drugs and substances; and
                    ``(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, 
                pediatric, geriatric, racial and ethnic minority 
                groups, and other subpopulations.
    ``(c) Timeliness, Consistency, and Accuracy.--The regulations 
promulgated under subsection (a) shall include standards relating to 
how the Secretary--
            ``(1) shall perform timely reviews and updates of patient 
        medication information as new drugs and new information become 
        available;
            ``(2) may perform, when appropriate, updates to help 
        communicate information that is shared by similar drug products 
        or drugs within classes of medications in order to avoid 
        patient confusion and harm; and
            ``(3) shall develop a process, including consumer testing, 
        to assess the quality and effectiveness of patient medication 
        information in ensuring that patient medication information 
        developed in accordance with this section promotes patient 
        understanding and safe and effective medication use.
    ``(d) Electronic Repository.--The regulations promulgated under 
subsection (a) shall provide for the development of a publicly 
accessible electronic repository for all patient medication information 
documents and content to facilitate the availability of patient 
medication information.''.

SEC. 3. ENFORCEMENT AND DISSEMINATION.

    (a) Enforcement.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(dd) If it is a drug subject to section 503(b)(1) and patient 
medical information described in section 505F is not provided, as 
required under section 503(b)(1).''.
    (b) Dissemination.--Section 503(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353) is amended by inserting ``Under the 
circumstances determined by the Secretary through regulation or 
guidance, a drug dispensed in accordance with this paragraph shall be 
accompanied by the patient medication information for such drug 
developed in accordance with section 505F'' after ``by the 
pharmacist.''.
                                 <all>