FDA Push to Move More Drugs to OTC Status
FDA is touting upcoming actions to encourage moving more medications from prescription-only status to over-the-counter (OTC) availability, a shift the agency says could lower drug prices, reduce unnecessary emergency room visits, and streamline access to common treatments. In an interview with The Daily Wire, FDA commissioner Marty Makary said the effort is aimed at dismantling what he described as an outdated regulatory framework that no longer reflects how many Americans use and understand medications.
Makary argued that most widely used drugs already meet basic safety standards and questioned why patients must still obtain prescriptions for many of them. While physicians would retain the ability to prescribe medications that are also sold over the counter, he said the existing system has failed in several areas, citing the overprescribing of opioids and antibiotics as examples.
Makary said FDA plans to formalize clear criteria for determining which drugs are appropriate for nonprescription use. Those standards would focus on medications with strong safety profiles, low or no abuse potential, no requirement for routine laboratory monitoring, and limited risk of misuse. Among the drugs he cited as potential candidates for broader over-the-counter availability was naloxone, commonly known by the brand name Narcan, as well as certain anti-nausea medications.
The over-the-counter drug push was codified late last year in a spending bill (H.R. 5371) that included the “Over-the-Counter Monograph Drug User Fee Amendments,” which reauthorized FDA’s OTC monograph user fee program and included provisions that pertain to prescription to OTC drug switches (see Hogan Lovells summary).
The law further requires FDA to issue a guidance “to increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs under this section, including in the case of applications for an Rx-to-nonprescription switch, especially with respect to prescription drugs with well-established safety profiles for which an applicant may seek approval for nonprescription use.” In addition, FDA must – by November – further develop a plan “to engage stakeholders on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates” for an OTC switch.
According to Makary, expanded over-the-counter access could also bring down costs by increasing price transparency. When drugs are sold directly on store shelves, he said, consumers can see prices upfront, which creates competitive pressure and keeps costs in check. The shift could also reduce the influence of pharmacy benefit managers, which negotiate drug prices behind the scenes and often leave employers and health plans paying far more than patients realize.