28 Apr Health Care, Environmental Stakeholders Praise Introduction of E-Labeling Legislation
FOR IMMEDIATE RELEASE: April 28, 2022
Bill aims to modernize access to prescribing information
WASHINGTON – Today, the Alliance to Modernize Prescribing Information (AMPI) praised the introduction of H.R. 7559, the Prescription Information Modernization Act, by U.S. Representatives Mikie Sherrill (NJ-11) and John Curtis (UT-03). The legislation authorizes the Food and Drug Administration (FDA) to advance a 2014 proposed rule that would allow for prescribing information (PI), information provided by drug manufacturers to prescribers and pharmacists describing the safe and effective use of a drug, to be transmitted electronically. Since the FDA first proposed the rule to modernize PI, the appropriations process in Congress has been used to stop its implementation.
Currently, PI is provided to prescribers and pharmacists as a bulky paper attachment and is separate from the information provided to patients. On average, PI is 30 pages long. Developing, printing, and delivering updates to paper PI through the supply chain takes on average 8 to 12 months, meaning that the information providers receive is outdated by the time they receive the paper version.
“The current guidelines for transmitting prescribing information have been in place since 1962,” said Richard Carbo, AMPI spokesperson. “Electronic PI ensures that the most up-to-date information about a drug is available for prescribers and pharmacists to make informed decisions for their patients. As health care providers have come to rely on electronic means of accessing PI, the printed PI is routinely discarded, resulting in the waste of billions of sheets of paper. Our coalition supports this commonsense, bipartisan legislation because it is in the best interest of the environment, health care providers, and—most importantly—patient safety.”
The bipartisan legislation is cosponsored by U.S. Reps. Tom O’Halleran and Markwayne Mullin.
A broad coalition of stakeholders support the Prescription Information Modernization Act, including the American Pharmacists Association (APhA), AbbVie, Allergy & Asthma Network, AmerisourceBergen, Amgen, Association for Accessible Medicines (AAM), Beyond Type 1, Biotechnology Innovation Organization, Bio NJ, Bristol Myers Squibb, Boomer Esiason Foundation, Eli Lilly and Company, Fresenius Kabi, Healthcare Distribution Alliance (HDA), HealthCare Institute of New Jersey (HINJ), Johnson & Johnson, LUNGevity Foundation, Lupin, McKesson, Merk, National Grange, New York BIO, North Carolina Biosciences Organization, Pfizer, Teva, Viatris, Zero Cancer, BioUtah, Georgia Bio, Texas Healthcare and Biosciences Institute (THBI), Maryland Tech Council.
To view the press release from Reps. Sherrill and Curtis, please click here.
AMPI is a group of stakeholders committed to the modernization of pharmaceutical labeling information to improve patient safety. Learn more: www.modernizeprescribinginfo.com.