FDA to Weigh Switching More Prescription Drugs to Over Counter

The FDA is planning to call on the health-care industry and consumers to provide information on the benefits of switching a prescription drug to over-the-counter, the agency’s drug chief said Tuesday.

“What we want people to do is focus on the benefit that we can provide to society by that switch,” George Tidmarsh, director of the Center for Drug Evaluation and Research, said at a regulatory conference held by the Consumer Healthcare Products Association.

“I encourage industry to really focus, in the broadest way, on the benefit of the switch,” Tidmarsh added. “Not just the specifics of that, but the impact broadly in the health-care system.”

The agency will announce the request for information in the Federal Register, the drug chief said.

Switching a prescription drug to over-the-counter is a highly regulated process that widens the range of medicines available to consumers.

An important difference between a prescription drug application and a nonprescription drug application is that consumer behavior studies are often needed to demonstrate that consumers can use the nonprescription drug product safely and effectively without the supervision of a health provider, according to the agency.

The FDA in December 2024 finalized a rule that outlined industry provisions for the marketing of nonprescription drugs with an additional condition for nonprescription use.

The products can be marketed without a prescription if a manufacturer implements an additional condition to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a licensed practitioner.