Most medications should be available over the counter (OTC) unless they are unsafe, addictive, or require medical monitoring, Food and Drug Administration Commissioner Marty Makary said in an interview with CNBC on Wednesday.
Makary said the FDA plans to pursue regulatory changes this year to allow more companies to transition prescription medicines to OTC status — a sweeping vision that is drawing scrutiny from segments of the pharmaceutical industry.
"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 said following the PhRMA Forum, an event organized by the Pharmaceutical Research and Manufacturers of America.
He added, "If it doesn't meet those criteria, why shouldn't a drug be over the counter? So we should be asking, why not?"
Makary said the agency is currently working through formal regulatory processes to update OTC monographs — the rulebooks that determine which drugs can be sold without a prescription.
He indicated the FDA is reviewing "basic, safe" prescription drugs — including nausea medications and vaginal estrogen products used to treat menopausal symptoms such as dryness and pain.
The FDA has long explored shifting certain prescription drugs to OTC status as a way to improve access, lower healthcare costs, and help patients remain adherent to medications.
Congress bolstered those efforts with legislation passed in November that streamlines the process for prescription-to-OTC transitions, creating full, conditional, and partial "switch" pathways.
Makary framed the latest push as part of a broader effort aligned with the Trump administration's focus on lowering drug costs. He argued that placing more medications directly on store shelves would bypass insurers and pharmacy benefit managers, cutting out rebate-driven pricing structures that can obscure a drug's actual cost.
He also contended that OTC availability can increase price transparency and, in some cases, lower out-of-pocket expenses.
Makary said some OTC medicines already carry lower cash prices than patients' copays for prescription drugs, describing what he called "a money game going on behind the pharmacy counter."
However, some pharmaceutical groups have cautioned that expanding OTC access could have unintended consequences.
The Association for Accessible Medicines, which represents generic drug manufacturers and distributors, told the FDA earlier this month that shifting many prescription drugs to nonprescription status could raise costs for patients if insurance no longer covers those medicines.
Most OTC drugs are not reimbursed by insurance, meaning patients may pay the full retail price. Critics argue that could make certain treatments less affordable than low-cost generic prescriptions covered under insurance plans.
Makary signaled that the agency's approach reflects a broader philosophical shift.
"We have to trust people to make their decisions," he said. "We've got to get away from this paternalistic mindset."
Brian Freeman ✉
Brian Freeman, a Newsmax writer based in Israel, has more than three decades writing and editing about culture and politics for newspapers, online and television.
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