I 112th CONGRESS 2d Session H. R. 4087 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.

1.

Short title

This Act may be cited as the Prescription Drug Labeling Promotion Act of 2012.

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)).