06/21/2012

Judge's wooden gavel with old books and paper with word 'law' in background.

On Wednesday, June 20, the U.S. House of Representatives passed comprehensive legislation, the Food and Drug Administration Safety and Innovation Act. Advocates will recall that companion legislation had previously passed the Senate including provisions that would establish national best practices for retail and other pharmacies to use in providing accessible prescription drug labeling to their customers with vision loss. Once these best practices are promulgated, a Government Accountability Office (GAO) study will assess the extent to which pharmacies are employing such best practices and improving access. Once enacted, these provisions will serve as a valuable supplement to existing requirements under the Americans with Disabilities Act and other federal and state laws imposing obligations on pharmacies to ensure effective communication and barrier removal for people with disabilities.

While the House bill had not included the drug label provisions in prior versions, the version of the bill brought to the House floor yesterday did contain them, along with a variety of other changes reflecting the informal, behind the scenes, negotiations by House and Senate staff and Members to reconcile the differences between the House and Senate approaches. This is a good illustration of how Congress may forgo the formality of conference committee proceedings in favor of a more streamlined, but arguably less transparent, legislative process. Such a streamlined process reflects the overwhelmingly bipartisan commitment in both houses of Congress to act by September 30 of this year to enact the vast array of complex policy issues addressed by the legislation.

The President is expected to sign the bill once yesterday's House-passed version is formally endorsed by the Senate; action in the Senate is anticipated within the next ten days. Congratulations to all advocates and organizations who have contributed to this effort and worked so hard to bring much-needed attention to the significant public health challenge of inaccessible prescription drug labeling.

See also: Senate Passes Accessible Drug Label Bill

Gavel photo courtesy of Shutterstock.

Author Mark Richert
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