[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4087 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 4087

 To provide for the development and dissemination of best practices to 
   ensure that visually-impaired and blind individuals in the United 
 States have safe, consistent, reliable, and independent access to the 
               information in prescription drug labeling.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 24, 2012

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

_______________________________________________________________________

                                 A BILL


 
 To provide for the development and dissemination of best practices to 
   ensure that visually-impaired and blind individuals in the United 
 States have safe, consistent, reliable, and independent access to the 
               information in prescription drug labeling.

    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 ``Prescription Drug Labeling Promotion 
Act of 2012''.

SEC. 2. ACCESSIBILITY OF INFORMATION IN PRESCRIPTION DRUG LABELING BY 
              VISUALLY-IMPAIRED AND BLIND CONSUMERS.

    (a) Establishment of Working Group.--
            (1) In general.--The Secretary of Health and Human Services 
        (in this section referred to as the ``Secretary'') shall 
        establish a working group (in this section referred to as the 
        ``working group'') to develop and promulgate guidance 
        constituting best practices on access to prescription drug 
        labeling for the visually impaired.
            (2) Members.--The working group shall include 
        representatives of national organizations representing blind 
        and visually impaired individuals, national organizations 
        representing the elderly, and industry groups representing 
        stakeholders, including pharmacists, who would be impacted by 
        such best practices. Representation within the working group 
        shall be divided equally between consumer and industry 
        advocates.
            (3) Guidance on best practices.--The working group shall 
        promulgate, not later than 1 year after the date of the 
        enactment of this Act, guidance on best practices for 
        pharmacies to ensure that blind and visually impaired 
        individuals have safe, consistent, reliable, and independent 
        access to the information in the labeling of prescription 
        drugs. Such guidance shall be made available through 
        publication in the Federal Register and posting on the Web site 
        of the Food and Drug Administration.
            (4) Considerations.--In developing and promulgating such 
        guidance on best practices, the working group shall consider--
                    (A) the use of--
                            (i) Braille;
                            (ii) auditory means, such as--
                                    (I) ``talking bottles'' that 
                                provide audible label information;
                                    (II) digital voice recorders 
                                attached to the prescription drug 
                                container; and
                                    (III) radio frequency 
                                identification (RFID) tags; and
                            (iii) enhanced visual means, such as--
                                    (I) large font labels or large font 
                                ``duplicate'' labels that are affixed 
                                or matched to a prescription drug 
                                container;
                                    (II) high-contrast printing; and
                                    (III) sans-serf font;
                    (B) whether there are technical, financial, 
                manpower, or other factors unique to pharmacies with 20 
                or fewer retail locations which may fundamentally 
                impact the ability of such pharmacies to implement the 
                best practices; and
                    (C) such other factors as the working group 
                determines to be appropriate.
            (5) Information campaign.--Upon the promulgation of the 
        guidance on best practices, the Commissioner of Food and Drugs, 
        in consultation with the working group, shall conduct an 
        informational and educational program designed to inform the 
        public and pharmacists about such guidance and practices.
            (6) FACA waiver.--The Federal Advisory Committee Act shall 
        not apply to the working group.
    (b) GAO Study.--
            (1) In general.--Beginning 18 months after the publication 
        of the guidance on best practices under subsection (a), the 
        Comptroller General of the United States shall conduct a review 
        of such guidance, the extent to which pharmacies are complying 
        with such best practices, and the extent to which barriers to 
        accessible prescription drug labeling for blind and visually-
        impaired individuals continue.
            (2) Report.--Not later than September 30, 2016, the 
        Comptroller General shall submit to Congress a report on the 
        review conducted under paragraph (1). Such report shall include 
        recommendations for how best to reduce the barriers blind and 
        visually-impaired individuals have to access prescription drug 
        labeling.
    (c) Definitions.--In this section:
            (1) The term ``pharmacy'' includes a pharmacy that receives 
        prescriptions, and dispenses prescription drugs, through an 
        Internet Web site.
            (2) The term ``prescription drug'' means a drug subject to 
        section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 353(b)(1)).
                                 <all>