U.S. Sen. Susan Collins’ (R-ME) amendment to retain paper inserts in customer prescription packages received approval from the U.S. Senate as part of the $154.2-billion fiscal year 2019 spending package to fund the federal Departments of Interior, Treasury, Agriculture, Transportation, Housing and Urban Development, and the Environmental Protection Agency.
The FY 2019 appropriations minibus, H.R. 6147, which the Senate passed 92-6 on Aug. 31, includes a Senate amendment Sen. Collins introduced in late July to block the Food and Drug Administration’s (FDA) proposed e-labeling rule.
The FDA’s proposed rule would allow pharmaceutical companies to distribute prescribing information electronically rather than using paper inserts.
“The FDA’s proposed rule … would not only have an adverse effect on patient safety,” Sen. Collins said, “but would also be acutely felt by Americans in rural states like Maine who may not have reliable access to broadband.”
The U.S. House of Representatives is set to debate H.R. 6147 next week.
Sen. Collins said that her amendment, “which has garnered support from both sides of the aisle, will ensure that pharmacists and consumers have convenient access to the information they need.”
Providing only electronic copies of the pharmaceutical inserts would limit access to the information for many of America’s senior citizens, 90 percent of whom take at least one prescription drug a month, according to a statement from Sen. Collins’ office.
The senator also thinks the FDA’s proposed e-labeling rule would negatively impact her home state’s forest products industry, which includes paper mills that produce such pharmaceutical information inserts.
Sen. Collins secured provisions similar to her current amendment in the FY 2016 omnibus spending bill, and in agriculture funding bills for FY 2017 and FY 2018, according to her staff.