[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6514 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 6514

  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 HOUSE OF REPRESENTATIVES

                           September 21, 2012

  Mr. Gibson introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 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) Submission of PMI.--
            ``(1) Submission of pmi for approval.--The regulations 
        promulgated under subsection (a) shall--
                    ``(A) with respect to any drug for which an 
                application is submitted under subsection (b) or (j) of 
                section 505 of this Act, or under subsection (a) or (k) 
                of section 351 of the Public Health Service Act, on or 
                after the date that is 18 months after the date of the 
                enactment of the Cody Miller initiative for Safer 
                Prescriptions Act--
                            ``(i) require the sponsor of the drug to 
                        submit PMI for the drug as part of such 
                        application; and
                            ``(ii) provide for approval or disapproval 
                        of the PMI as part of the process for approving 
                        or disapproving the application; and
                    ``(B) with respect to any other drug lawfully 
                marketed in the United States--
                            ``(i) require the sponsor of the drug to 
                        submit PMI for the drug to the Secretary; and
                            ``(ii) provide for approval or disapproval 
                        of the PMI.
            ``(2) Identical pmi for generic drugs.--The regulations 
        promulgated under subsection (a) shall require the PMI for a 
        drug subject to an abbreviated new drug application under 
        section 505(j) to be identical to the PMI for the listed drug 
        (as such term is used in section 505(j)), except for excluding 
        any portion of the PMI for the listed drug that is protected by 
        patent or by an exclusivity period under this Act.
    ``(e) Electronic Repository.--
            ``(1) In general.--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.
            ``(2) Effect of submission.--If the sponsor of a drug 
        submits PMI to such electronic registry, the sponsor is deemed, 
        subject to the deadlines specified in subsection (d)(1), to 
        have submitted the PMI for purposes of subsection (d)(1).''.

SEC. 3. PUBLICATION ON INTERNET WEB SITE.

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