FDA Chief Makary Pushes OTC Drug Expansion, Addresses GLP-1 Compounding and China Competition

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. The FDA aims to make changes this year that allow more companies to offer their prescription medicines over the counter, or OTC.

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. 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.

"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 said. "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.'"

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. 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 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.

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.

On compounded GLP-1 drugs, Makary said the FDA is "serious" about cracking down on unlawful, mass compounding of GLP-1s. This comes on the heels of the FDA announcing plans to take action against telehealth company Hims & Hers, which has been mass marketing compounded versions of Novo Nordisk's Wegovy pill and injections. The FDA said it plans to restrict GLP-1 ingredients used in non-approved compounded drugs, citing concerns over quality, safety and potential violations of federal law.

Makary said branded drug manufacturers go through the FDA process "properly" by conducting clinical trials that demonstrate the benefit of a product. The agency also regulates the marketing claims for those drugs, such as requiring that ads reflect side effects. But Makary said, "Sometimes, what we've seen are companies that are violating those regulations." The FDA is "directly talking to these companies and saying, you have to play by the rules," he added.

When asked if 2026 could be the end of illegal mass compounding of GLP-1s, Makary said, "I hope so." The FDA is seeing more companies get their active pharmaceutical ingredients from Novo Nordisk and Eli Lilly, "and that system has a path of working." "If [Novo and Lilly] are providing APIs and the compounding meets the regulation, then the more competition, the better," he said.

Regarding Moderna's experimental mRNA flu shot, the FDA agreed to review the application, reversing the agency's earlier decision to refuse to accept it. The FDA is now slated to decide whether to approve the flu shot on Aug. 5. Makary said the FDA's guidance to Moderna on its jab "was pretty clear." The agency recommended that the group of participants ages 65 and up in the study who didn't take Moderna's shot receive the "standard of care, not the substandard of care" as a comparison product. The FDA's previous feedback expressed a preference for Moderna to use a higher-dose vaccine for older adults as a comparator in the trial.

Moderna has disputed that reasoning, noting that FDA rules and guidance does not actually require trials to use the most advanced or highest-dose vaccine as a comparator in clinical studies. The company has also said it is inconsistent with the FDA's prior written communication about the trial design, even before the study began, where the agency said using the standard flu shot would be "acceptable."

When asked about his stance on mRNA technology, Makary said he's "hopeful and optimistic" about the platform but would also "like to see the data." "We're not going to get ahead of the game," he said. "We're going to basically say, we'd like to see the data, how far mRNA technology can be applied is a question where we'd love to see it applied, as far as it can be applied, but it's got to meet our scientific standards, so we'll see what it gets with cancer, with other infectious diseases. ..."

Makary also warned that the U.S. is falling behind China in early-stage drug development and called for reforms to streamline how new treatments enter clinical trials. China's biotech sector has expanded rapidly in recent years, fueled by heavy state investment, deep talent pools and faster regulatory timelines. U.S. policymakers have faced mounting pressure to boost domestic innovation rather than attempt to stymie it in China.

"We walked into a mess," Makary said, referring to the gap between the U.S. and China in phase one trials conducted in 2024. Makary pointed to three key bottlenecks: hospital contracting, ethics reviews and approvals, and the process for submitting Investigational New Drug (IND) applications that allow companies to begin human testing.