A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.

The bill would create a formal, clearer pathway for converting prescription drugs to nonprescription (OTC) status. It adds a new subsection to the Food and Drug Administration’s (FDA) review authority (505(b)) that allows applicants to request pre-submission meetings with the agency to discuss their plan, risks, necessary evidence, study designs, and the format of their application. It also requires FDA to issue guidance within 18 months that explains how evidence may be used (including literature, prior safety/efficacy findings, and other data), how meetings should be requested and documented, evidentiary expectations for approval, and how nontraditional information tools (like mobile apps or decision aids) can be incorporated into the submission. The bill also mandates a stakeholder-engagement plan to identify potential Rx-to-nonprescription switch candidates and creates a detailed GAO evaluation of past and future processes, including timelines, barriers, stakeholder engagement, and potential payer data collaboration. Importantly, the bill preserves existing FDA authority over OTC monographs and confidentiality protections.