3 Reasons Why a Proposed FDA Rule Would Endanger American Health and Safety

Washington, DC (March 15, 2024) – In response to the U.S. Food and Drug Administration’s (FDA) proposed rule that would lower access to printed Patient Medication Information (PMI), the Pharmaceutical Printed Literature Association (PPLA) is calling attention to the numerous ways the rule will undermine PMI, the life-saving information dispensed with prescriptions at the pharmacy.

1. With this rule, the FDA attempted to improve PMI in order to mitigate medication non-adherence. However, the FDA failed to study, consider or implement scientifically-tested design.
2. The FDA also failed to safeguard printed PMI, which is the safest, most effective format. Instead, the rule would shift PMI to the digital format, which limits access for rural and low-income Americans without consistent broadband access and only provides printed PMI if asked for.
3. Because printed PMI would still need to be provided if asked for, the rule would force pharmacies, not drug manufacturers, to be responsible for the cost and labor of printing PMI. This will increase pharmacist workloads by 71.7 million hours, the equivalent of 35,858 full-time pharmacy technicians, and cost over $1.6 billion a year. Smaller independent pharmacies, which account for 34% of total pharmacies in the United States, will face severe economic repercussions.
4. As the FDA continues to consider the rule after it held a public comment period last year, Congress must pass the bipartisan Patients’ Right to Know Their Medication Act (H.R. 1173), which would standardize PMI based on a scientifically-tested design and guarantee drug manufacturers print PMI for every American.

About 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.