Press Release : PPLA
Washington, DC (January 18, 2024) – Today, the Pharmaceutical Printed Literature Association (PPLA) is joining a bipartisan group of lawmakers from both houses of Congress in urging the Food and Drug Administration (FDA) to revise its proposed rule “Medication Guides: Patient Medication Information.” PPLA and these lawmakers are concerned that the rule, while taking necessary steps to standardize patient medication information (PMI), fails to incorporate cognitively accessible formatting and would promote a digital PMI format that many patients would struggle to access.
Last month, U.S. Senators Tammy Baldwin (D-WI), Mike Braun (R-IN), Angus King (I-ME) and Shelley Moore Capito (R-WV) in the Senate and Representatives Buddy Carter (R-GA), Jared Golden (D-ME), Bruce Westerman (R-AR), C.A. Dutch Ruppersburger (D-MD), Jeff Van Drew (R-NJ), Yvette Clark (D-NY), Ben Cline (R-VA), David Trone (D-MD), and Chellie Pingree (D-ME) in the House of Representatives sent letters to FDA Commissioner Robert Califf highlighting how pushing PMI onto a digital platform, while neglecting to update its formatting to be comprehensible, increases the risk that patients will go without crucial details about their prescriptions and puts patient health at risk.
“Printed patient medication information, when provided at the point-of-care in an understandable format, is a powerful educational tool that ensures every patient fully understands their medications and how to take them,” said PPLA Board President Dave Joesten. “By pushing this information onto a digital platform, the FDA’s rule would put this information out of reach for many communities, particularly the elderly and rural Americans, and create undue burdens for pharmacists who will have to print PMI themselves upon request. We’re grateful that Senators Baldwin, Braun, Capito, and King as well as Representatives Carter, Golden, Westerman, Ruppersburger, Van Drew, Clark, Cline, Trone, and Pingree are speaking out against this dangerous proposal, and we join them in urging the FDA to reverse course, protect patient access to life-saving medication information, and update PMI formatting for patient comprehension.”
“When patients have access to easy-to-understand, printed information, they have better health outcomes. I am urging the FDA to honor this idea and consider changes to the Medication Guides: Patient Medication Information rule that will provide patients with written prescription drug information that is clear, concise, accessible, and useful,” said Senator Tammy Baldwin (D-WI).
“Hoosiers need to have easy access to all their medical information, and the FDA should facilitate simple prescription drug information for patients,” said Senator Mike Braun (R-IN).
“When I practiced pharmacy, I always made sure that my patients knew the impacts their prescriptions would have on their health. Ensuring that patient medical information is available on paper, at the point of sale, will help patients, pharmacists, and drug manufacturers maintain the highest quality health care for all. You shouldn’t need a medical degree or even a strong internet connection to know that you’re taking your medications safely and correctly,” said Congressman Buddy Carter (R-GA).
“Mainers shouldn’t have to go out of their way to access information about their medications. Making patients search online for necessary information is a needless barrier that makes it harder for Mainers, particularly older Mainers, and people without reliable internet access, to make informed health care decisions. Guaranteeing printed information will ensure Mainers can comfortably use their medications,” said Congressman Jared Golden (D-ME).
The Pharmaceutical Printed Literature Association
The Pharmaceutical Printed Literature Association is a trade group representing printers of regulated pharmaceutical information, including packaging inserts, medication guides, and patient package inserts as well as other label packaging such as folding cartons and pressure-sensitive labels. Material and technology suppliers are also part of the PPLA.
Chartered in 2001, the PPLA serves as the voice for our members, advocating for patient safety and risk communication by fighting to keep information on paper and readily accessible for patients and caregivers. This information helps drive the patient involvement model of health care, helping patients get the maximum benefits from the powerful drugs they take while minimizing risk.
For more information about PPLA, click here.