FY 2016 Omnibus Signed into Law Includes Provision Authored by Senator Collins Blocking E-Labeling of Prescription Drugs
WASHINGTON, D.C. – The fiscal year 2016 omnibus that was recently signed into law includes a provision authored by Senator Susan Collins that would block the Food and Drug Administration’s (FDA) proposed E-labeling rule for prescribing information, which would be acutely felt by rural Americans in Maine and across our country. This provision will protect paper inserts that are important tools for our pharmacists and health care professionals in charge of administering life-saving medications to our hardworking families and seniors.
Senator Collins had serious concerns regarding the FDA’s proposed rule on Electronic Prescribing Information and its implication for seniors and rural communities. The proposed rule by the FDA would have allowed pharmaceutical companies to only electronically distribute prescribing information for physicians, pharmacists, and other health care professionals instead of using traditional paper inserts. In December 2014, Senator Collins sent a letter to FDA Commissioner Dr. Margaret Hamburg, urging her to withdraw the proposed rule. That letter can be viewed here.
“Pharmaceutical 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 certain consumers. This misguided rule would have negatively affected seniors in particular, 90 percent of whom take at least one prescription drug in any given month. The FDA’s rule would have also had adverse consequences for Maine’s forest products industry. The Twin Rivers paper mill in Madawaska, for instance, is thriving due to its focus on producing pharmaceutical information inserts.”