FDA chief Marty Makary says ‘everything should be over the counter’ unless drug is unsafe or addictive

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 – doubling down on a push that some in the pharmaceutical industry have questioned. 

In an interview Wednesday in Washington, D.C., Makary said the FDA aims to make changes this year that allow more companies to offer their prescription medicines over the counter, or OTC. He noted that 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. 

“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 long considered making some prescription drugs available OTC to improve accessibility, reduce health-care costs and help patients stay on their medications. For example, patients wouldn’t have to take time off work to see a doctor for a prescription or could refill a drug without delay.

Congress boosted the effort through legislation in November that streamlines the regulatory process for prescription-to-OTC transitions, including full, conditional and partial “switch” pathways.

Makary framed the FDA’s latest push to expand OTC access as another way to lower drug costs, a key priority of the Trump administration. 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.

He also said selling drugs over the counter promotes transparency that “keeps prices in check.” In some cases, Makary said 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 that argument. Most OTC drugs are not covered by insurance, meaning their prices could eclipse those of generic prescription medicines and potentially make them less affordable for patients who rely on coverage. 

In comments to the FDA earlier this month, the Association for Accessible Medicines argued that “the shift of many prescription drugs to nonprescription status could actually increase costs to patients, thereby decreasing patient access to treatments.” That organization represents manufacturers and distributors of generic prescription medicines. 

The FDA also doesn’t have the authority to regulate drug prices. In its own comments this month, PhRMA said the agency must respect “the core principle that pricing considerations may not factor into FDA regulatory decision-making.”

The Pharmaceutical Research and Manufacturers of America added 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. 

In its own comment this month, AstraZeneca said several previous attempts to transition cholesterol-cutting statins to OTC status have been “unsuccessful, with consumers consistently having difficulty making proper self-selection decisions.” 

Meanwhile, Makary told CNBC on Wednesday that “we have to trust people to make their decisions. We’ve got to get away from this paternalistic mindset.”

The FDA removed the longtime director of the office of over-the-counter drugs, Theresa Michele, from her position in December, STAT news reported at the time.