Bill > S2529

This bill aims to improve the process for converting prescription (Rx) drugs to nonprescription (over-the-counter or OTC) drugs by establishing clearer guidelines and procedures. The legislation allows drug manufacturers to request meetings with the Food and Drug Administration (FDA) to discuss their plans for switching a drug from prescription to nonprescription status, with the goal of addressing potential public health risks and determining the evidence needed for approval. Within 18 months, the FDA must issue guidance that explains how various sources of information (such as medical literature, previous safety findings, and human experience) can support these switch applications. The bill defines two types of switches: a full switch, where a drug becomes available without a prescription under the same or slightly modified conditions, and a partial switch, where the drug is nonprescription only under specific conditions. The legislation also requires the Government Accountability Office (GAO) to submit a report evaluating the Rx-to-nonprescription switch process, including the number of approved applications, average approval times, potential barriers, and opportunities for collaboration between different health agencies. Importantly, the bill does not modify the FDA's existing authority over OTC drug regulations and protects confidential commercial information.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/2529/all-info