I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prescription Drug La5 beling Promotion Act of 2012’’. 


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1 SEC. 2. ACCESSIBILITY OF INFORMATION IN PRESCRIP2 TION DRUG LABELING BY VISUALLY-IM3 PAIRED AND BLIND CONSUMERS. 

4 (a) ESTABLISHMENT OF WORKING GROUP.— 

5 (1) IN GENERAL.—The Secretary of Health and 

6 Human Services (in this section referred to as the 

7 ‘‘Secretary’’) shall establish a working group (in this 

8 section referred to as the ‘‘working group’’) to de9 velop and promulgate guidance constituting best 

10 practices on access to prescription drug labeling for 

11 the visually impaired. 

12 (2) MEMBERS.—The working group shall in13 clude representatives of national organizations rep14 resenting blind and visually impaired individuals, na15 tional organizations representing the elderly, and in16 dustry groups representing stakeholders, including 

17 pharmacists, who would be impacted by such best 

18 practices. Representation within the working group 

19 shall be divided equally between consumer and in20 dustry advocates. 

21 (3) GUIDANCE ON BEST PRACTICES.—The 

22 working group shall promulgate, not later than 1 

23 year after the date of the enactment of this Act, 

24 guidance on best practices for pharmacies to ensure 

25 that blind and visually impaired individuals have 

26 safe, consistent, reliable, and independent access to 


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1 the information in the labeling of prescription drugs. 

2 Such guidance shall be made available through pub3 lication in the Federal Register and posting on the 

4 Web site of the Food and Drug Administration. 

5 (4) CONSIDERATIONS.—In developing and pro6 mulgating such guidance on best practices, the 

7 working group shall consider— 

8 (A) the use of— 

9 (i) Braille; 

10 (ii) auditory means, such as— 

11 (I) ‘‘talking bottles’’ that provide 

12 audible label information; 

13 (II) digital voice recorders at14 tached to the prescription drug con15 tainer; and 

16 (III) radio frequency identifica17 tion (RFID) tags; and 

18 (iii) enhanced visual means, such as— 

19 (I) large font labels or large font 

20 ‘‘duplicate’’ labels that are affixed or 

21 matched to a prescription drug con22 tainer; 

23 (II) high-contrast printing; and 

24 (III) sans-serf font; 


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1 (B) whether there are technical, financial, 

2 manpower, or other factors unique to phar3 macies with 20 or fewer retail locations which 

4 may fundamentally impact the ability of such 

5 pharmacies to implement the best practices; 

6 and 

7 (C) such other factors as the working 

8 group determines to be appropriate. 

9 (5) INFORMATION CAMPAIGN.—Upon the pro10 mulgation of the guidance on best practices, the 

11 Commissioner of Food and Drugs, in consultation 

12 with the working group, shall conduct an informa13 tional and educational program designed to inform 

14 the public and pharmacists about such guidance and 

15 practices. 

16 (6) FACA WAIVER.—The Federal Advisory 

17 Committee Act shall not apply to the working group. 

18 (b) GAO STUDY.— 

19 (1) IN GENERAL.—Beginning 18 months after 

20 the publication of the guidance on best practices 

21 under subsection (a), the Comptroller General of the 

22 United States shall conduct a review of such guid23 ance, the extent to which pharmacies are complying 

24 with such best practices, and the extent to which 


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1 barriers to accessible prescription drug labeling for 

2 blind and visually-impaired individuals continue. 

3 (2) REPORT.—Not later than September 30, 

4 2016, the Comptroller General shall submit to Con5 gress a report on the review conducted under para6 graph (1). Such report shall include recommenda7 tions for how best to reduce the barriers blind and 

8 visually-impaired individuals have to access prescrip9 tion drug labeling. 

10 (c) DEFINITIONS.—In this section: 

11 (1) The term ‘‘pharmacy’’ includes a pharmacy 

12 that receives prescriptions, and dispenses prescrip13 tion drugs, through an Internet Web site. 

14 (2) The term ‘‘prescription drug’’ means a drug 

15 subject to section 503(b)(1) of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)). 

Æ 


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