FDA May Extend NDA Pathway to Increase Access to Nonprescription Drugs

The FDA proposes to extend the new drug application pathway to include therapeutic indications that have not previously been available for nonprescription drugs, Commissioner Scott Gottlieb said in announcing a new draft guidance on the initiative.

Drug sponsors may be able to make medicines available without a prescription by developing labels beyond the required drug facts labeling or by requiring customers to meet certain conditions — possibly using mobile apps or interactive video displays, the agency said.

Gottlieb stressed that the agency is “not proposing a change in the evidentiary standard needed for a product to be approved by the FDA as nonprescription.”