“A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.”
No CRS summary available for this bill.
This section amends section 505(b) of the Federal Food, Drug, and Cosmetic Act to establish procedures to increase clarity and predictability in FDA review of applications for Rx-to-nonprescription switches (i.e., approval of an application or supplement by the holder of an approved prescription drug application to market the drug as nonprescription, including full switches under the same or additional conditions of use or partial switches for certain conditions only). Specifically, the section: (1) authorizes pre-application meetings between FDA and sponsors to develop plans addressing public health risks, necessary evidence and studies, and application format and content, with meetings documented in minutes; (2) directs FDA to issue guidance within 18 months of enactment describing use of existing data (e.g., literature, prior findings, human experience), meeting procedures, evidentiary standards for consumer self-selection and label comprehension, and additional tools (e.g., mobile apps, decision aids); (3) requires FDA, within one year of enactment, to publish a stakeholder engagement plan for identifying promising prescription drug candidates for switches; and (4) clarifies that the provision does not affect FDA authority over OTC monograph drugs or authorize disclosure of confidential information. The section further requires the Government Accountability Office, within one year of enactment, to report to specified congressional committees on Rx-to-nonprescription switches approved from October 1, 2022, including approval numbers and timelines (overall and for partial switches with additional conditions), barriers to review, FDA stakeholder engagement, and opportunities for collaboration with CMS on claims data analysis.