Food and Drug Administration Commissioner Marty Makary told CNBC that he believes “everything should be over the counter” unless a drug is unsafe, addictive or requires monitoring. He added that the FDA aims to make changes this year that allow more companies to offer their prescription medicines over the counter, or OTC. He also noted the agency is going through “the proper regulatory processes” to update OTC monographs – the rulebooks that determine which drugs can be sold without a prescription.
Makary said the FDA is looking at “basic, safe” prescription drugs like nausea medications and vaginal estrogen, which is used to treat menopausal symptoms like dryness and pain.
“In my opinion, everything should be over the counter and not requiring a prescription, unless it’s unsafe, unless you need laboratory tests to monitor how it’s being received by your body, or if it could be used for some nefarious purpose or it’s addictive,” Makary told CNBC after the PhRMA Forum, a one-day event organized by the pharmaceutical industry’s largest lobbying group.
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“If it doesn’t meet those criteria, why shouldn’t a drug be over the counter? So we should be asking, why not? Instead of, ‘Oh, you want to move over the counter, you got to go through a long, tedious process,” he added.
The FDA has been considering making some prescription drugs OTC for a long time, in order to improve accessibility, reduce health-care costs and help patients stay on their medications. This effort was boosted in legislation by Congress in November 2025, that streamlines the regulatory process for prescription-to-OTC transitions, including full, conditional and partial “switch” pathways.
Makary positions the efforts to expand OTC access as a way to lower drug costs. He argued that placing medications directly on store shelves would bypass insurers and pharmacy benefit managers, eliminating the rebate-driven system that often obscures a drug’s true price.
Makary also said selling drugs over the counter promotes transparency that “keeps prices in check.” He also said that in some cases, cash prices for OTC medicines are lower than patients’ copays for prescription drugs “when there’s a money game going on behind the pharmacy counter,” with employers and insurers sharing the cost.
Some in the pharmaceutical industry have pushed back on the argument. The Association for Accessible Medicines said that “the shift of many prescription drugs to nonprescription status could actually increase costs to patients, thereby decreasing patient access to treatments.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) said that the FDA should not attempt to transition any prescription drugs to OTC without first consulting manufacturers. But the group emphasized that it supports the FDA’s effort to expand access to crucial medicines.