Unpacking the FDA’s Sweeping Proposal to Move All Drugs to OTC

The FDA Commissioner Marty Makary, MD, MPH, and his recent declaration that all prescription drugs should default to over-the-counter (OTC) status—unless proven unsafe or addictive—have shaken up the pharmacy profession. It’s now raising urgent questions about patient safety, drug access, and who ultimately controls medication policy in the US.

On the latest episode of the Over the Counter podcast, Mark Garofoli, PharmD, BCGP, CPE, CTTS, clinical assistant professor and director of experiential learning at the West Virginia University School of Pharmacy, dissects what this sweeping proposal actually means for pharmacists and their patients.

He doesn’t mince words when examining the commissioner’s framing. He points out a core logical tension: If a drug is truly unsafe, it shouldn't be prescription-only in the first place—it arguably shouldn't be on the market at all.

The conversation moves quickly into the financial realities patients would face. A drug moving from prescription to OTC status can mean trading a modest insurance copay for a significantly higher out-of-pocket cost—a shift that complicates the pharmacist's counseling role considerably.

He also explores specific drug classes frequently floated as OTC candidates, weighing the genuine access benefits against serious safety concerns around narrow therapeutic windows and misuse potential. The discussion broadens to examine a “pharmacist-only” or “behind-the-counter” drug classification already used in countries like the UK and Australia—a middle-ground model that could expand access while preserving a professional checkpoint.

Garofoli’s verdict is measured, but pointed, and well worth hearing for any pharmacy professional trying to make sense of where this conversation is actually headed.

Stay tuned for weekly podcast episodes of Over the Counter powered by Drug Topics. Check out our most recent episode with William A. Bryson, PharmD, who joined this past week for a bonus installment centered around the celebration of Diabetes Alert Day on March 24.

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