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Access Board to Lead Effort to Develop Guidance on Accessible Drug Labels

July 13, 2012

The U.S. 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 (Section 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 Marsha Mazz at mazz@access-board.gov, (202) 272-0020 (v), or (202) 272-0076 (TTY). Those interested in this initiative can sign up to receive further updates.

News source: U.S. Access Board


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