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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3212 Introduced in Senate (IS)]

112th CONGRESS
  2d Session
                                S. 3212

  To require the Secretary of Health and Human Services to promulgate 
      regulations regarding the authorship, content, format, and 
  dissemination of Patient Medication Information to ensure patients 
      receive consistent and high-quality information about their 
   prescription medications and are aware of the potential risks and 
                 benefits of prescription medications.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              May 22, 2012

Mrs. Gillibrand introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
  To require the Secretary of Health and Human Services to promulgate 
      regulations regarding the authorship, content, format, and 
  dissemination of Patient Medication Information to ensure patients 
      receive consistent and high-quality information about their 
   prescription medications and are aware of the potential risks and 
                 benefits of prescription medications.

    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 Initiative for Safer 
Prescriptions 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 505D the following:

``SEC. 505E. 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 regulations 
regarding the authorship, content, format, and dissemination 
requirements for patient medication information (referred to in this 
section as `PMI') for drugs subject to section 503(b)(1).
    ``(b) Content.--The regulations promulgated under subsection (a) 
shall require that the PMI with respect to a drug--
            ``(1) be scientifically accurate and based on the 
        professional labeling approved by the Secretary and 
        authoritative, peer-reviewed literature; and
            ``(2) includes nontechnical, understandable, plain language 
        that is not promotional in tone or content, and contains at 
        least--
                    ``(A) the established name of drug, including the 
                established name of such drug as a listed drug (as 
                described in section 505(j)(2)(A)) and as a drug that 
                is the subject of an approved abbreviated new drug 
                application under section 505(j) or of an approved 
                license for a biological product submitted under 
                section 351(k) of the Public Health Service Act, if 
                applicable;
                    ``(B) drug uses and clinical benefits;
                    ``(C) general directions for proper use;
                    ``(D) contraindications, common side effects, and 
                most serious risks of the drug, 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; and
                    ``(H) known clinically important interactions with 
                other drugs and substances.
    ``(c) Timeliness, Consistency, and Accuracy.--The regulations 
promulgated under subsection (a) shall include standards related to--
            ``(1) performing timely updates of drug information as new 
        drugs and new information becomes available;
            ``(2) ensuring that common information is applied 
        consistently and simultaneously across similar drug products 
        and for drugs within classes of medications in order to avoid 
        patient confusion and harm; and
            ``(3) developing a process, including consumer testing, to 
        assess the quality and effectiveness of PMI in ensuring that 
        PMI 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 PMI documents and content to 
facilitate the availability of PMI.''.

SEC. 3. PUBLICATION ON INTERNET WEBSITE.

    The Secretary of Health and Human Services shall publish on the 
Internet website of the Food and Drug Administration a link to the 
Daily Med website (http://dailymed.nlm.nih.gov/dailymed) (or any 
successor website).
                                 <all>
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