S.2529

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

The bill amends the Federal Food, Drug, and Cosmetic Act to enhance the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches. It mandates the Secretary of Health and Human Services to issue guidance on the process and standards for approving such applications, especially for prescription drugs with well-established safety profiles. The guidance must include evidentiary expectations, procedures for requesting meetings, and recommendations for incorporating mechanisms like mobile applications and decision aids.