Opportunities and Challenges for Advancing Non-Prescription Medicines

FDA officials are proposing new rules, beefing up regulatory resources, and promoting digital technologies to support the development and marketing of safe and innovative over-the-counter (OTC) therapies. The agency and manufacturers continue to hope that Congress will approve legislation authorizing new user fees to modernize the OTC monograph review program, a plan that has been high on the legislative agenda for several years. But even without final agreement on that reform initiative, officials at the Center for Drug Evaluation and Research (CDER) expect to establish an expanded review office for nonprescription drugs as part of a broader reorganization of the Office of New Drugs (OND). In addition, the revamped office will better manage new drug applications (NDAs) for non-prescription medicines, including the new Nonprescription Safe Use Regulatory Expansion (NSURE) initiative to facilitate switches of prescription therapies to nonprescription status. “OTC monograph reform remains a top priority for the agency,” stated FDA Chief of Staff Lauren Silvis at the recent meeting of the Consumer Health Products Association (CHPA). She described agency plans to facilitate prescription-to-OTC switches to increase consumer access to medicines that can be used safely without a prescription. Draft guidance issued in 2018 should encourage manufacturers to provide additional information on proper product use than what is found in the approved drug facts label (DFL). CDER also is working to finalize a proposed rule for developing and marketing OTC sunscreens, an issue that has raised a host of issues relevant to ensuring safe and proper use of these widely available products. FDA seeks additional data to document the safety of ingredients commonly used in sunscreens that can be absorbed in ways to possibly have systemic effects on the body.