FDA announced Tuesday a new initiative to establish innovative approaches to increase access to a wider selection of nonprescription drug products for consumers.
FDA announced Tuesday a new initiative to establish innovative approaches to increase access to a wider selection of nonprescription drug products for consumers. The goal, said FDA Commissioner Scott Gottlieb, MD, is to empower consumers “to self-treat common conditions and potentially some chronic conditions.” Gottlieb noted that not all prescription medications “can or should be available directly to consumers,” but certain types of drugs “are appropriate for nonprescription use if we are able to ensure access to resources that will help patients determine if the medicine is right for them.” Approaches being considered for the innovative pathway include applying innovative solutions such as digital health technologies that would support consumers in properly and safely self-selecting and using certain medications. While nonprescription drugs are currently marketed under the OTC Monograph Process or the New Drug Application (NDA), new draft guidance from FDA, “Innovative Approaches for Nonprescription Drug Products,” applies to drugs under the NDA process and would expand the NDA pathway to include therapeutic indications that have not previously been available for use without a prescription, Gottlieb said. The draft guidance also discusses two approaches for demonstrating safety and effectiveness that could be useful in cases where the “Drug Facts Labeling” (DFL) by itself is not enough to ensure that the drug product can be used safely and effectively. The first approach involves the development of labeling in addition to the DFL, while the second is the implementation of additional conditions so consumers can appropriately self-select and use the product. “But it’s important we’re clear that we are not proposing a change in the evidentiary standard needed for a product to be approved by the FDA as nonprescription,” Gottlieb stressed. “As we move into making this a reality, the FDA will ensure that products considered under this framework receive a robust scientific review to ensure they can be used safely by patients.”