FDA chief says most prescription drugs should be sold over the counter

By HPN Staff

Food and Drug Administration Commissioner Marty Makary is calling for a sweeping expansion of over-the-counter drugs, arguing that most medications should not require a prescription unless there is a clear safety risk.

Makary said in an interview that prescription drugs should be over the counter unless the drug is unsafe or requires monitoring.

"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 in the interview. 

The comments signal a potential shift in federal drug policy under President Donald Trump, whose administration has emphasized price transparency and market competition as part of its broader health care agenda.

Why it matters

The changes, Makary added, are part of the Trump administration’s overall push to lower drug costs, ultimately putting patients in control of their care. By allowing more medicines to be sold without prescriptions, patients could avoid additional doctor visits and potentially reduce some insurance-related costs, he said. 

Makary also argued that such a move would remove insurers and pharmacy benefit managers from the transaction, a system that has drawn bipartisan scrutiny over pricing practices and rebate structures.

The pharmaceutical industry has expressed reservations. In comments submitted to the FDA in response to a recent request for information on increasing access to nonprescription drugs, the Pharmaceutical Research and Manufacturers of America said decisions to switch drugs from prescription to over-the-counter status must remain grounded in safety and effectiveness standards. The group added that “pricing considerations may not factor into FDA regulatory decision-making.” 

The Association for Accessible Medicines also notes that most over-the-counter drugs are not covered by insurance, raising concerns that some patients could face higher out-of-pocket costs if commonly used prescription drugs lose coverage.

The bigger picture

Congress passed legislation last year designed to streamline the regulatory process for certain prescription drugs to transition to over-the-counter status. Historically, such switches require additional data demonstrating that consumers can safely use a drug without physician supervision, including studies on labeling comprehension and actual use.

The FDA oversees the prescription-to-over-the-counter switch process, approving drugs for nonprescription sale only when it determines that prescription status is no longer necessary to protect public health.

Makary’s comments and these regulatory updates highlight an ongoing debate over how to expand access to medications while maintaining safety. Policymakers and drug manufacturers alike are weighing the potential for lower costs and increased consumer control against the need for appropriate oversight, a tension that will likely shape future changes to the traditional prescription model.