WASHINGTON, D.C.—U.S. Senator Susan Collins, a senior member of the Appropriations Committee, authored and successfully secured an important provision that would continue to protect prescription paper inserts in the fiscal year 2019 agriculture and nutrition programs funding bill. The provision would block the Food and Drug Administration’s (FDA) proposed e-labeling rule for prescribing information, which would be acutely felt by rural Americans. The bipartisan bill was favorably reported out of committee and is now available for consideration before the full Senate.
“The FDA’s proposed rule to allow pharmaceutical companies to only distribute prescribing information electronically for physicians, pharmacists, and other health care professionals instead of using traditional paper inserts is deeply flawed. Prescription paper inserts provide critical information to pharmacists who administer life-saving drugs and to patients who are prescribed them,” said Senator Collins. “Allowing companies to only provide an electronic copy of the pharmaceutical insert would limit the accessibility of this information for both pharmacists and consumers, particularly those in rural states like Maine. In addition, this misguided rule would negatively affect seniors in particular, 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, for instance, has long been successful in producing pharmaceutical information inserts.”
“I am pleased that the Appropriations Committee has once again advanced this important bipartisan provision to block the FDA’s proposed rule, and I will strongly urge my colleagues on both sides of the aisle to support it when the bill comes before the full Senate for a vote.”
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 FDA Commissioner Dr. Margaret Hamburg, urging her to withdraw the proposed rule.