Marty Makary: The Time Has Come to Move Most Drugs to Over-the-Counter Status

In an interview with CNBC on Wednesday, Food and Drug Administration Commissioner Marty Makary declared that most medications should be available over the counter unless they are unsafe, addictive, or require medical monitoring.

Makary outlined plans for the agency to pursue regulatory changes this year to allow more prescription medicines to transition to over-the-counter status—a move 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.

The FDA is currently reviewing “basic, safe” prescription drugs—including nausea medications and vaginal estrogen products used to treat menopausal symptoms such as dryness and pain—for potential over-the-counter status.

Makary described the initiative as part of a broader effort aligned with recent legislative changes passed in November. The legislation streamlines the process for prescription-to-over-the-counter transitions, creating full, conditional, and partial “switch” pathways.

He argued that expanding OTC access would bypass insurers and pharmacy benefit managers, cutting out rebate-driven pricing structures that obscure drug costs. Makary also contended that such changes could increase price transparency and potentially lower patients’ out-of-pocket expenses.

However, the Association for Accessible Medicines, which represents generic drug manufacturers and distributors, warned that shifting many prescription drugs to nonprescription status might 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—potentially making certain treatments less affordable than low-cost generic prescriptions covered under insurance.

Makary emphasized a fundamental shift in philosophy: “We have to trust people to make their decisions. We’ve got to get away from this paternalistic mindset.”