The provision blocks the FDA’s proposal, which would allow pharmaceutical companies to only distribute prescribing information electronically instead of using traditional paper inserts.
Washington, D.C. - An amendment authored by U.S. Senator Susan Collins to continue to preserve prescription paper inserts and protect rural Americans was included in the fiscal year (FY) 2019 Appropriations Minibus.
Senator Collins’ provision would block the Food and Drug Administration’s (FDA) proposed e-labeling rule for prescribing information that would have allowed pharmaceutical companies to only distribute prescribing information electronically instead of using traditional paper inserts. The FY19 Appropriations Minibus recently passed the Senate by an overwhelming majority of 85 to 15 and will now be considered by the U.S. House of Representatives.
“The FDA’s proposed rule regarding the electronic distribution of prescribing information instead of paper would not only have an adverse effect on patient safety, but would also be acutely felt by Americans in rural states like Maine who may not have reliable access to broadband,” said Senator Collins. “This provision, which has garnered support from both sides of the aisle, will ensure that pharmacists and consumers have convenient access to the information they need.”
Allowing companies to only provide an electronic copy of the pharmaceutical insert would limit the accessibility of this information for both pharmacists and consumers. In addition, this misguided rule would negatively affect seniors, 90 percent of whom take at least one prescription drug in any given month.
The FDA’s proposed rule would also have adverse consequences for Maine’s forest products industry. The Twin Rivers paper mill in Madawaska has long been successful in producing pharmaceutical information inserts.
Senator Collins secured similar provisions in the fiscal year 2016 omnibus bill as well as the fiscal years 2017 and 2018 agriculture funding bills. In December 2014, Senator Collins sent a letter to then-FDA Commissioner Dr. Margaret Hamburg, urging her to withdraw the proposed rule.