WASHINGTON, D.C. — An amendment authored by U.S. Sen. Susan Collins, R-Maine, to continue to preserve prescription paper inserts and protect rural Americans was included in the fiscal year (FY) 2019 Appropriations Minibus.
The provision would block the Food and Drug Administration’s proposal to eliminate paper prescribing information inserts from pharmaceuticals, allowing drug companies only to distribute prescribing information electronically
The FY19 Appropriations Minibus recently passed the Senate by an overwhelming majority of 85 to 15.
“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 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.”
The senator contended that allowing companies to provide only an electronic copy of the pharmaceutical insert would limit the accessibility of this information for both pharmacists and consumers. The 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 senator indicated; the Twin Rivers paper mill in Madawaska has long been successful in producing pharmaceutical information inserts.
In December 2014, Collins wrote to then-FDA Commissioner Dr. Margaret Hamburg, urging her to withdraw the proposed rule.
The appropriations package now faces the U.S. House of Representatives.
