Washington, DC (September 25, 2025) – Today, the Pharmaceutical Printed Literature Association (PPLA) announced the release of “Burdens Without Benefits: A Critical Analysis of the FDA’s Proposed Changes to Prescription Drug Labeling,” prepared by the healthcare attorneys at Brown & Fortunato.
The report finds that the Food and Drug Administration’s (FDA) planned overhaul of prescription drug labeling would impose billions in hidden costs and regulatory liabilities on America’s community pharmacies – with little demonstrated benefit for patients.
“In our analysis, the FDA’s one-size-fits-all labeling rule doesn’t just miss the mark – it actively undermines the critical role of pharmacists and endangers patient comprehension,” said Dave Joesten, Board Chairman of PPLA. “The agency’s own estimates ignore the severe printing, labor, and compliance costs, and substitute hope for evidence. Before the FDA moves forward, policymakers must understand the real-world consequences for pharmacies and the communities they serve.”
“Like many other administrative rule revisions that the FDA issues, its proposed overhaul of prescription drug labeling may look good on paper, but it saddles pharmacies—and especially smaller community pharmacies—with liabilities that have simply not been considered by agency analysts,” said Jeffrey S. Baird, Esq., Brown & Fortunato.
The White Paper reveals that the new requirements would increase operational costs for independent pharmacies, exacerbate regulatory risks related to patient privacy, and risk widening health disparities for patients lacking reliable internet access. The authors call on regulators to halt implementation and work closely with stakeholders to develop proposals that are grounded in evidence and support – not burden – front-line pharmacists.
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.