Food and Drug Administration Commissioner Marty McCulley told CNBC that he believes “everything should be over-the-counter” unless it’s unsafe, addictive or requires monitoring, adding to a push that some in the pharmaceutical industry have questioned.
McCurry said in an interview Wednesday in Washington, D.C., that the FDA aims to make changes this year that would allow more companies to make prescription drugs available over-the-counter (OTC). He said the agency is updating the OTC monograph, the rulebook that determines which medicines can be sold without a prescription, through “appropriate regulatory processes.”
McCurry said the FDA is considering “basic and safe” prescription drugs such as anti-nausea drugs and vaginal estrogens used to treat menopausal symptoms such as dryness and pain.
“In my opinion, unless it’s dangerous, everything should be sold over the counter and don’t require a prescription, unless there’s a clinical test to monitor how it’s being received by the body, or whether it could be used for some nefarious purpose, or whether it’s addictive,” McCurry told CNBC after the PhRMA Forum, a one-day event hosted by the pharmaceutical industry’s largest lobbying group.
“If it doesn’t meet those criteria, why shouldn’t the drug be sold over-the-counter? So we should be asking why not, instead of, ‘Oh, we want to sell it over-the-counter, but we have to go through a long, tedious process,'” he added.
Marty McCulley, President Donald Trump’s nominee for head of the U.S. Food and Drug Administration (FDA), testifies during the confirmation hearing of the Senate Committee on Health, Education, Labor, and Pensions (HELP) at the Capitol in Washington, DC, on March 6, 2025.
Kent Nishimura | Reuters
The FDA has long considered making some prescription drugs available over-the-counter to improve access, reduce health care costs, and help patients stick to their medications. For example, patients no longer have to take time off from work to see a doctor to get their prescriptions filled, and they can refill their medications without delay.
Congress backed this effort in November through legislation that would streamline the regulatory process for prescription-to-OTC transitions, including full, conditional, and partial “switch” pathways.
McCurry framed the FDA’s recent efforts to expand OTC access as another way to reduce drug costs, a key priority of the Trump administration. He argued that putting drugs directly on store shelves would bypass insurance companies and pharmacy benefit managers and eliminate the rebate-driven system that often obscures a drug’s true price.
He also said over-the-counter sales of medicines promote transparency that “keeps prices in check.” McCurry said the cash price for OTC drugs can be lower than a patient’s out-of-pocket cost for a prescription drug “if there’s a money game going on behind the pharmacy counter” where employers and insurance companies split the cost.
Pharmaceutical companies have doubts about OTC push
Some in the pharmaceutical industry reject this argument. Because most OTC drugs are not covered by insurance, their prices can exceed those of generic prescription drugs, making them less expensive for patients who rely on insurance.
The Accessible Medicines Association argued in comments to the FDA earlier this month that “the transition of many prescription drugs to nonprescription drug status could actually increase costs for patients, thereby reducing patient access to treatment.” This organization represents manufacturers and distributors of generic prescription drugs.
The FDA also has no authority to regulate drug prices. In its own comments this month, PhRMA said the agency must respect “the fundamental principle that pricing considerations do not factor into FDA’s regulatory decision-making.”
PhRMA added that the FDA should not attempt to move prescription drugs to OTC without first consulting with the manufacturer. But the group emphasized that it supports the FDA’s efforts to expand access to critical medicines.
In my own comments this month, AstraZeneca He said several previous attempts to move cholesterol-lowering statins into over-the-counter products “have consistently been difficult for consumers to make appropriate self-selection decisions and have failed.”
Meanwhile, McCurry told CNBC on Wednesday: “We have to trust people to make decisions. We have to move away from this paternalistic mindset.”
The FDA fired Teresa Michele, the agency’s longtime head of over-the-counter pharmacy, in December, STAT News reported at the time.
