America is in the midst of a pharmacy crisis, and the Food and Drug Administration could make it much worse. Hundreds of pharmacies closed in the first few months of 2025, and major pharmacy chains have plans to close hundreds more locations in 2026. Now, as millions of Americans face expanding pharmacy deserts, the FDA is proposing a prescription drug labeling overhaul that could deliver the final blow to struggling community pharmacies, especially ones that serve as lifelines in underserved areas.
The FDA’s proposed overhaul of prescription drug labeling — pushing a one-page, FDA-approved “Patient Medication Information” handout from the pharmacy instead of manufacturer-printed information inserts with every dispensed prescription — is being pitched as a win for clarity and safety. Beneath the surface, this one-size-fits-all regulation is a regulatory time bomb, one that shifts burdens from drug manufacturers to community pharmacies, and fails to implement the design and format that will best serve patients in individual communities.
A new legal analysis, “Burdens Without Benefits,” exposes the flaws of the proposed rule. While the FDA touts increased transparency and improved patient understanding, the agency’s data reveal a plan built on shaky assumptions, hidden liabilities and massive costs for pharmacies, especially the small, independent ones already stretched thin.
Perhaps most troubling is how the rule shifts responsibility from those who profit most to those who can least afford it. Currently, drug manufacturers bear primary responsibility for PMI. The new rule transfers the burden of providing PMI to patients to community pharmacies, who will bear the financial, logistical and legal risks of complying with this FDA requirement while manufacturers see their obligations reduced.
Estimates show that pharmacies will spend 71.1 million labor hours complying with the new PMI distribution requirement, on top of existing workloads. That’s $1.6 billion yearly in added costs — mostly in printing, supplies and pharmacy technician time. The FDA dismisses these burdens as insignificant, claiming they merely replace existing practices. That’s not true. Many struggling independent pharmacies cannot absorb such costs, unlike pharmaceutical companies, which are currently responsible for PMI inserts and guides.
Consider the mathematics of survival: A typical independent pharmacy fills about 200 prescriptions daily. Under the new rule, each prescription generates additional printing or technology costs, labor time and potential legal liability. For pharmacies operating on razor-thin margins — many independent “mom and pop” shops report net pharmacy profit of less than 1-3 percent and average gross profit margin at just 22 percent — these seemingly small per-prescription costs quickly become serious threats.
The rule also sets the stage for a shift to digital distribution of PMI sheets, particularly because many pharmacies won’t be able to cover the costs of printing. This creates a cruel irony. Rural and underserved areas, where pharmacy deserts are expanding fastest, often lack reliable internet access, making electronic distribution impractical for patients who need it most.
Worse still, the FDA’s benefit projections are wildly speculative. The agency claims the rule will save patients time because they won’t have to search online or wade through complex handouts. That “time saved” is then converted into economic value. But there’s no evidence that digital medication information improves patient comprehension, adherence or safety. In fact, one study found that well-designed, printed medication guides are still preferred by patients. In fact, one could argue they could be more effective than digital alternatives, especially for older adults and those without reliable internet access. If printed PMI falls by the wayside due to new costs for pharmacies, patients could be forced to use only less effective digital PMI.
This represents a fundamental shift: privatizing profits while socializing compliance costs. As independent pharmacies continue to close at alarming rates, this regulatory burden-shifting accelerates the very problem it is meant to solve.
As America grapples with expanding pharmacy deserts, policymakers face a choice: continue pursuing regulations that sound good in theory but devastate pharmacies in practice, or craft solutions that strengthen the pharmacy infrastructure patients depend on.
Patient safety demands better than this. A genuinely patient-centered approach would preserve the strengths of current printed literature while improving the format and reducing length, keeping the burden on large for-profit conglomerates, and addressing the root causes of pharmacy closures — PBM abuses, reimbursement cuts and regulatory burden — rather than adding compliance costs.
If the FDA proceeds without addressing these fundamental flaws, patients may not gain a clearer understanding of their medications, but they might lose access to the pharmacies they rely on. The prescription for better patient information shouldn’t kill the pharmacies that serve them.