FDA Commissioner Marty Makary said that all drugs should be available over the counter unless they are unsafe, addictive, or require monitoring [1].

This proposal represents a potential shift in how the U.S. government regulates medication access. By reducing the number of drugs requiring a prescription, the FDA could lower barriers to care and decrease the burden on healthcare providers for routine monitoring.

During a Feb. 18 interview with CNBC, Makary said he has a philosophy of accessibility for the agency [1]. He said, "Everything should be over the counter unless a drug is unsafe or addictive" [1]. The commissioner said that the current system often restricts access to medications that do not pose significant risks to the general public.

Makary said that shifting safe drugs to over-the-counter status would increase patient access and reduce the necessity for frequent prescriptions [4]. This approach focuses on the inherent safety profile of the medication rather than traditional regulatory categories.

While advocating for broader access, Makary said that safety remains the primary concern [4]. He said, "We should make more prescription drugs available over the counter, but safety must be ensured" [4]. The FDA's goal would be to identify medications that can be safely self-administered without the oversight of a physician.

Under this framework, drugs that are highly addictive or those that require regular clinical monitoring to prevent toxicity would remain prescription-only [1]. The agency would need to evaluate which existing prescription medications meet these safety criteria before changing their classification [4].

“Everything should be over the counter unless a drug is unsafe or addictive.”

A widespread shift toward over-the-counter availability would likely disrupt the pharmaceutical supply chain and the primary care model. While it could reduce costs and wait times for patients, it shifts the responsibility of risk assessment from licensed clinicians to the consumers themselves.