More medications should be available without a prescription
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 needs to be monitored – a move that some in the pharmaceutical industry have questioned.
In an interview Wednesday in Washington, D.C., Makary said the FDA wants to make changes this year that will allow more companies to offer their prescription drugs over-the-counter (OTC). He noted that the agency is going through “the appropriate regulatory processes” to update OTC monographs – the sets of rules that determine which drugs can be sold without a prescription.
Makary said the FDA is reviewing “simple, safe” 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 is unsafe, unless you need lab testing to monitor how it is absorbed into your body, or if it could be used for a nefarious purpose or is addictive,” Makary told CNBC after the PhRMA forum, a day-long event organized by the pharmaceutical industry’s largest lobbying group.
“If it doesn’t meet those criteria, then why shouldn’t a drug be over-the-counter? So we should ask ourselves, why not? Instead of saying, ‘Oh, if you want to go over-the-counter, you have to go through a long, drawn-out process,'” he added.
Marty Makary, U.S. President Donald Trump’s nominee for commissioner of the U.S. Food and Drug Administration (FDA), testifies before a Senate Health, Education, Labor and Pensions (HELP) Committee confirmation hearing on Capitol Hill in Washington, DC, USA, March 6, 2025.
Kent Nishimura | Reuters
The FDA has long considered allowing some prescription drugs to be marketed over the counter 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 to get a prescription or be able to refill a medication without delay.
Congress stepped up efforts in November with legislation streamlining the regulatory process for transitioning from prescription to over-the-counter drugs, including full, conditional and partial “switching pathways.”
Makary called the FDA’s recent push to expand OTC access another way to reduce drug costs, a key priority of the Trump administration. He argued that placing drugs directly on store shelves would bypass insurers and benefit managers at pharmacies and eliminate the rebate-driven system that often obscures a drug’s true price.
He also said that selling medicines over the counter promotes transparency that “keeps prices under control.” In some cases, Makary said, cash prices for over-the-counter drugs are lower than patients’ co-pays for prescription drugs “when there’s a money game going on behind the pharmacy counter,” with employers and insurers sharing the cost.
Pharma questions OTC push
Some in the pharmaceutical industry have rejected that argument. Most over-the-counter drugs are uninsured, meaning their prices could exceed the prices of generic prescription drugs and potentially make them less affordable for patients who rely on insurance.
In comments to the FDA earlier this month, the Association for Accessible Medicines argued that “moving many prescription drugs to nonprescription status could actually increase costs for patients and thereby reduce patients’ access to treatments.” 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 core principle that price considerations must not be taken into account in FDA’s regulatory decision-making.”
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The Pharmaceutical Research and Manufacturers of America added that the FDA should not attempt to switch prescription drugs to over-the-counter drugs without first consulting with manufacturers. However, the group stressed that it supports the FDA’s efforts to expand access to important medicines.
In his own commentary this month: AstraZeneca said several previous attempts to switch cholesterol-lowering statins to OTC status “have been unsuccessful as consumers have consistently struggled to make proper self-selection decisions.”
Meanwhile, Makary told CNBC on Wednesday: “We need to trust people to make their decisions. We need to get away from this paternalistic mindset.”
The FDA fired longtime over-the-counter drug chief Theresa Michele in December, STAT News reported at the time.
