FDA’s Stance on OTC Drugs Raises Complex Patient Safety Questions

As the FDA continues to reshape how Americans access medications, a sweeping proposal to make most drugs available over the counter (OTC) by default is sparking debate across the pharmacy profession.

The idea, according to FDA Commissioner Marty Makary, MD, MPH, is that “everything should be OTC” unless proven unsafe or addictive.¹ This may sound straightforward and optimistic, but for pharmacists, the implications run far deeper.

“The question is, where does the action actually go?” Mark Garofoli, PharmD, BCGP, CPE, CTTS, clinical assistant professor and director of experiential learning at West Virginia University School of Pharmacy, told Drug Topics. “This statement makes a lot of people stop and think: How do we organize our health care system overall and [provide] access to medications?”

In part one of our interview, Garofoli dissects the FDA commissioner’s bold default-to-OTC stance, probing the fine print behind safety and whether new thresholds effectively describe what already defines a prescription medication. He raises pointed questions about the practical and pharmacological implications of such sweeping language, noting that medications flagged for misuse, abuse, or diversion potential present challenges that a simple OTC reclassification cannot easily resolve.

Rather than offering a clean yes or no answer, Garofoli invites pharmacists and policymakers to engage with the harder questions lurking beneath the surface: What do our drug categories actually mean? How should the regulatory framework evolve? What role should pharmacists play as the boundaries between prescription and OTC access continue to shift?

For pharmacy professionals watching these policy developments unfold in real time, Garofoli provides a grounded, clinically informed perspective on one of the more consequential—and complicated—regulatory debates to hit the industry in recent years.

READ MORE: OTC Resource Center

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REFERENCE

Constantino AK. FDA chief Marty Makary says ‘everything should be over the counter’ unless drug is unsafe or addictive. CNBC. February 18, 2026. Accessed March 20, 2026. https://www.cnbc.com/2026/02/18/fda-chief-marty-makary-more-drugs-should-be-over-the-counter.html