Washington, D.C. (September 9, 2024) – Healthcare experts are sounding the alarm on a new Food and Drug Administration (FDA) proposed rule standardizing prescription medication information (PMI). Currently, PMI – the printed information that accompanies prescription drugs – is not standardized and is hard to understand.
While PMI needs to be standardized, the proposed rule does not consider cognitively backed research while designing the format and also incentivizes transitioning from printed PMI to digital. Healthcare experts agree that the proposed rule will hurt patients and burden already struggling community pharmacies.
Here’s what health experts are saying about the FDA rule:
Dr. John Whyte, former U.S. Food & Drug Administration (FDA) Director of Professional Affairs and Stakeholder Engagement, Center for Drug Evaluation and Research:
“For many people, a printed format simply works better at conveying information, which is why it makes little sense that the FDA would rip life-saving printed information from patients’ hands. At a time of rampant misinformation for which the FDA expressed an explicit priority to combat, the FDA should be making it easier for patients to learn about their medications, not harder.” – The Hill
Mark Grant, MD, Associate Director of Addiction Services, CODAC Health, Recovery & Wellness:
“If enacted, the FDA’s proposed rule would be a dangerous change for anyone who lacks broadband access…Anyone living in an area without broadband access would suddenly be unable to access the information they need to take their medication safely” – The Well News
RetireSafe CEO Mark Gibbons:
“I’ve seen it myself: my mother depends on prescription medications and sometimes forgets what her pharmacist or doctor tells her about her medications…I’m grateful to be able to help my mom, but not all seniors have a support system…The FDA’s proposed rule does nothing to ensure that the standardized format is shown to be understandable, clear, or accessible” – El Periodico U.S.A. (translated)
North Carolina State Representative and retired pharmacistWayne Sasser (R-NC-67), and State Senator and retired nurse Gale Adcock (D-NC-41):
“Not only would digital PMI disproportionately affect rural communities without reliable access to the internet and our seniors who have a hard time using technology — it would also be an unnecessary cybersecurity risk.” – InsideSources
Congress can heed the warnings of these health experts by passing the Patients’ Right to Know Their Medication Act (H.R. 1173), bipartisan legislation that would ensure that all patients receive printed, effective PMI at the pharmacy.
The Pharmaceutical Printed Literature Association
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.