Bold claim: the FDA should make nearly every drug available without a prescription unless there are clear safety, addictive, or monitoring concerns, and this is stirring a major debate over how we access medicines. Now, FDA Commissioner Marty Makary has told CNBC that essentially everything should be OTC unless a drug is unsafe, habit-forming, or requires ongoing lab checks. He’s reinforcing a push to broaden nonprescription options, a stance that some in the pharma industry question and scrutinize.
In a Washington, D.C. interview, Makary explained that the agency plans to move forward this year with changes that would let more prescription medicines be sold over the counter. The FDA is currently engaging in the appropriate regulatory steps to update OTC monographs—the rulebooks that decide which drugs can be sold without a prescription.
He highlighted everyday, “basic, safe” prescription products as targets for OTC status, such as nausea remedies and vaginal estrogen used for menopausal symptoms like dryness and discomfort. Makary framed the argument simply: if a drug isn’t unsafe, doesn’t require lab monitoring, and isn’t prone to misuse or addiction, why shouldn’t it be OTC? He added that the alternative is a lengthy, burdensome process to move a drug over the counter.
The image of Makary, who was President Trump’s nominee for FDA commissioner, surfaced at a confirmation hearing on Capitol Hill in March 2025. After a subsequent appearance at the PhRMA Forum—a major industry lobbying event—he reiterated the goal of expanding OTC access as a way to lower drug costs.
Historically, the FDA has contemplated OTC transitions to improve access, cut healthcare costs, and simplify adherence. Moving a prescription to OTC can spare patients the need to visit a clinician for a new prescription or wait for refills. In November, Congress passed legislation designed to streamline this transition process, including full, conditional, and partial “switch” pathways.
Makary presented the OTC push as another mechanism to reduce drug costs. He argued that placing medicines on store shelves could bypass some middlemen like insurers and pharmacy benefit managers, potentially cutting the often opaque rebate-driven pricing structure. In his view, OTC sales could bring greater price transparency, sometimes resulting in cash prices that undercut prescription copays when the pharmacy pricing ecosystem is complex.
Pharmaceutical industry voices, however, push back. Critics note that most OTC drugs aren’t covered by insurance, so their prices can exceed those of inexpensive generics once patients aren’t sharing costs through coverage. In a recent FDA submission, the Association for Accessible Medicines warned that moving many prescriptions to nonprescription could raise out-of-pocket costs for patients and limit access to necessary treatments. This group represents manufacturers and distributors of generic meds.
PhRMA echoed similar cautions, emphasizing that the FDA should not let pricing concerns dictate regulatory decisions and that any transition to OTC should involve collaboration with drug makers. AstraZeneca also weighed in, noting past attempts to switch cholesterol-lowering statins to OTC status have struggled because consumers often misjudge self-selection.
Makary told CNBC that trust in individual choice is essential and that the era of paternalistic constraints should end. He has signaled a broader philosophy: empower consumers to decide, with appropriate safeguards in place.
On the broader regulatory front, the FDA has already seen personnel shifts related to the OTC office, with reports indicating leadership changes in late 2024. These moves come as the agency continues to navigate how best to balance access, affordability, and safety in a rapidly evolving pharmaceutical landscape.
