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 bet that some in the pharmaceutical industry have questioned.
In an interview Wednesday in Washington, D.C., Makary said the FDA intends to make changes this year that will allow more companies to offer their prescription drugs over the counter, or OTC. He noted that the agency is going through “the appropriate regulatory processes” to update over-the-counter monographs (the rule books that determine which drugs can be sold without a prescription).
Makary said the FDA is looking at “safe, basic” prescription medications, such as anti-nausea medications and vaginal estrogen, which is used to treat menopausal symptoms such as dryness and pain.
“In my opinion, everything should be over-the-counter and not require a prescription, unless it's unsafe, unless you need lab testing to monitor how your body receives it, or whether it could be used for some nefarious purpose or is 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 ask ourselves, why not? Instead of, 'Oh, if you want to go over-the-counter, you have to go through a long and tedious process,'” he added.
Marty Makary, US President Donald Trump's nominee to be commissioner of the Food and Drug Administration (FDA), testifies before a Senate Health, Education, Labor and Pensions (HELP) Committee confirmation hearing on Capitol Hill in Washington, DC, US, on March 6, 2025.
Kent Nishimura | Reuters
The FDA has long considered making some prescription drugs available without a prescription to improve accessibility, reduce health care costs, and help patients continue taking their medications. For example, patients would not have to take time off work to see a doctor for a prescription or could refill a medication without delay.
In November, Congress boosted the effort through legislation that streamlines the regulatory process for transitions from prescription drugs to over-the-counter drugs, including full, conditional, and partial “switching” pathways.
Makary framed the FDA's latest push to expand access to over-the-counter drugs 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 insurers and pharmacy benefit managers, eliminating the rebate-based system that often obscures the true price of a drug.
He also said selling drugs without a prescription promotes transparency that “keeps prices in check.” In some cases, Makary said cash prices for over-the-counter drugs are lower than patients' co-pays for prescription drugs “when there is a money game behind the pharmacy counter,” with employers and insurers sharing the cost.
The pharmaceutical industry questions the push for over-the-counter medications
Some in the pharmaceutical industry have rejected that argument. Most over-the-counter medications are not covered by insurance, meaning their prices could dwarf those of generic prescription drugs 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 over-the-counter status could actually increase costs for patients, thereby decreasing patient access to treatments.” That 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 cannot influence FDA's regulatory decision-making.”
Pharmaceutical Research and Manufacturers of America added that the FDA should not attempt to transition any prescription drugs to over-the-counter without first consulting the manufacturers. But the group emphasized that it supports the FDA's effort to expand access to crucial drugs.
In his own commentary this month, AstraZeneca He said several previous attempts to transition cholesterol-lowering statins to over-the-counter status have been “unsuccessful, and consumers have consistently had difficulty making appropriate self-selection decisions.”
Meanwhile, Makary told CNBC on Wednesday that “we have to trust people to make their decisions. We have to move away from this paternalistic mentality.”
The FDA removed the former director of the OTC Drug Office, Theresa Michele, from her position in December, STAT News reported at the time.
