Board to Lead Effort to Develop Guidance on Accessible Drug Labels

July 13, 2012; updated September 7, 2012


pill bottleThe Access Board will lead an effort to develop guidance on making prescription drug labels accessible to people with vision impairments under an act signed into law by President Obama this week. The "Food and Drug Administration Safety and Innovation Act" includes measures to promote drug safety and to improve FDA procedures for reviewing new medicines and medical devices.

A provision of the act (§904) authorizes the Board to convene a stakeholder working group to develop best practices for making information on prescription drug container labels accessible to people who are blind or visually impaired. This group, which will include equal representation from advocacy organizations and from industry, will develop best practices for pharmacies on providing independent access to prescription drug container labels. The working group will explore various alternatives, including braille, large print labels, and various auditory technologies such as “talking bottles” and radio frequency identification tags. The group’s recommendations, which are to be developed within one year, will be advisory only, not mandatory, and will not have the force of guidelines or standards.

The law also calls upon the National Council on Disability to conduct an informational and educational campaign in cooperation with the stakeholder working group to inform the public, including people with disabilities and pharmacists, of the best practices. The Government Accountability Office will undertake a review at a later date to assess the extent to which pharmacies are following the best practices and to what extent barriers to information on prescription drug container labels remain.

For further information, contact Susan Crawford at This email address is being protected from spambots. You need JavaScript enabled to view it. , (202) 272-0029 (v), or (202) 272-0082 (TTY). Those interested in this initiative can sign up to receive further updates.

 

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Section 904 of the Food and Drug Administration Safety and Innovation Act

§904. ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG CONTAINER LABELS BY VISUALLY-IMPAIRED AND BLIND CONSUMERS.

(a) Establishment of Working Group-

(1) IN GENERAL- The Architectural and Transportation Barriers Compliance Board (referred to in this section as the `Access Board') shall convene a stakeholder working group (referred to in this section as the `working group') to develop best practices on access to information on prescription drug container labels for individuals who are blind or visually impaired.


(2) MEMBERS- The working group shall be comprised of representatives of national organizations representing blind and visually-impaired individuals, national organizations representing the elderly, and industry groups representing stakeholders, including retail, mail order, and independent community pharmacies, who would be impacted by such best practices. Representation within the working group shall be divided equally between consumer and industry advocates.


(3) BEST PRACTICES-


(A) IN GENERAL- The working group shall develop, not later than 1 year after the date of the enactment of this Act, best practices for pharmacies to ensure that blind and visually-impaired individuals have safe, consistent, reliable, and independent access to the information on prescription drug container labels.


(B) PUBLIC AVAILABILITY- The best practices developed under subparagraph (A) may be made publicly available, including through the Internet websites of the working group participant organizations, and through other means, in a manner that provides access to interested individuals, including individuals with disabilities.


(C) LIMITATIONS- The best practices developed under subparagraph (A) shall not be construed as accessibility guidelines or standards of the Access Board, and shall not confer any rights or impose any obligations on working group participants or other persons. Nothing in this section shall be construed to limit or condition any right, obligation, or remedy available under the Americans with Disabilities Act of 1990 (42 U.S.C. 12101 et seq.) or any other Federal or State law requiring effective communication, barrier removal, or nondiscrimination on the basis of disability.


(4) CONSIDERATIONS- In developing and issuing the best practices under paragraph (3)(A), the working group shall consider--


(A) the use of--


(i) Braille;


(ii) auditory means, such as--


(I) `talking bottles' that provide audible container label information;


(II) digital voice recorders attached to the prescription drug container; and


(III) radio frequency identification tags;


(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; and


(iv) other relevant alternatives as determined by the working group;


(B) whether there are technical, financial, manpower, or other factors unique to pharmacies with 20 or fewer retail locations which may pose significant challenges to the adoption of the best practices; and


(C) such other factors as the working group determines to be appropriate.


(5) INFORMATION CAMPAIGN- Upon completion of development of the best practices under subsection (a)(3), the National Council on Disability, in consultation with the working group, shall conduct an informational and educational campaign designed to inform individuals with disabilities, pharmacists, and the public about such best practices.


(6) FACA WAIVER- The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the working group.


(b) GAO Study-


(1) IN GENERAL- Beginning 18 months after the completion of the development of best practices under subsection (a)(3)(A), the Comptroller General of the United States shall conduct a review of the extent to which pharmacies are utilizing such best practices, and the extent to which barriers to accessible information on prescription drug container labels for blind and visually-impaired individuals continue.


(2) REPORT- Not later than September 30, 2016, the Comptroller General of the United States shall submit to Congress a report on the review conducted under paragraph (1). Such report shall include recommendations about how best to reduce the barriers experienced by blind and visually-impaired individuals to independently accessing information on prescription drug container labels.


(c) Definitions- In this section--


(1) the term `pharmacy' includes a pharmacy that receives prescriptions and dispenses prescription drugs through an Internet website or by mail;


(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)); and


(3) the term `prescription drug container label' means the label with the directions for use that is affixed to the prescription drug container by the pharmacist and dispensed to the consumer.