S. 2529 aims to streamline and clarify how pharmaceutical companies can apply to convert prescription drugs to over-the-counter medications. The bill requires the Food and Drug Administration (FDA) to issue detailed guidance within 18 months explaining the standards and evidence needed for these applications, including how companies can use existing safety data and medical literature to support their requests. Companies can now request formal meetings with the FDA to develop application plans, with documented recommendations to improve predictability. Within one year, the FDA must also publish a public plan for engaging stakeholders to identify prescription drugs that could be good candidates for conversion to nonprescription status. Additionally, the Government Accountability Office must report within one year on recent switch approvals, timelines, barriers to review, and potential opportunities for collaboration between federal agencies—though no specific funding is allocated in the bill text.
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