A
federal agency offered no clear guidance on approved legislation that could
eliminate requirements for paper labeling to be included with pharmaceuticals.
The US General Accounting Office (GAO) said it found "no consensus among
stakeholders on the advantages and disadvantages of eliminating paper labeling
and relying instead on electronic labeling as a complete substitute."
The
GAO report follows approval of the Safeguarding America's Pharmaceuticals Act
of 2013 -- H.R. 1919 -- by the House of Representatives, and the Drug Supply
Chain Security Act -- S. 957 -- by the Senate. A committee will reconcile the
differences in the two bills. The Senate version did not include the paper
labeling language.
GAO
reported that drug industry stakeholders said an advantage of electronic
labeling provides physicians, pharmacists and patients with the most current
drug information in a more user-friendly format, which would positively impact
public health. Yet relying on electronic labeling as a complete substitute for
paper labeling could adversely impact public health by limiting the
availability of drug labeling for some physicians, pharmacists, and patients by
requiring them to access drug labeling through a medium with which they might
be uncomfortable, that they might find inconvenient, or that might be
unavailable.
"Relying
on electronic drug labeling as a complete substitute for paper drug labeling
would require amending or reviewing relevant federal regulations and shift some
responsibilities from drug manufacturers to pharmacies," GAO stated.
"Additionally, drug manufacturers currently provide pharmacies with a
supply of paper labeling for patients. However, stakeholders said that if
patients want to continue receiving drug labeling in paper form and pharmacies
are expected to print drug labeling for distribution, it would shift the costs
of printing to the pharmacies." In 2011, retail pharmacies filled
approximately 3.8 billion prescriptions for drugs, the report added.
Officials
from paper industry states objected to the paper label
exemption
saying it would harm the industry and mills that employ thousands of workers.
