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

This bill (S 2529) clarifies the process for switching prescription drugs to over-the-counter (OTC) status. It requires the FDA to hold meetings with drug manufacturers to develop application plans, issue new guidance within 18 months on evidence standards (including how to use medical literature and demonstrate consumer understanding), and create a public stakeholder engagement plan. The bill directly affects drug manufacturers seeking to switch products and the FDA’s review process. Key provisions define "full" (same use conditions) and "partial" (limited conditions) switches and set clear expectations for supporting evidence, aiming to make the approval process more predictable.