ENHANCING OTC MONOGRAPH DRUG REGULATION THROUGH USER FEE PROGRAM

Abstract

Food and Drug Administration (FDA) has introduced a distinctive regulatory program known as Over-the-Counter Monograph Drug User Fee Program (OMUFA) to improve the efficacy and security of over-the-counter (OTC) medications made available to consumers. The program, which represents a pivotal shift in the regulatory landscape, aims to address the challenges associated with the oversight of OTC monograph drugs. The OMUFA's primary objective is to expedite the review and approval process of OTC monograph drugs while maintaining stringent safety standards. By imposing user fees on manufacturers and sponsors seeking to bring new OTC products to market or seeking updates for existing ones, the program is designed to support the FDA's ability to allocate additional resources for timely reviews and assessments. This work delves into the key components and mechanics of the OMUFA, such as the user fee structure, types of submissions covered, and the corresponding performance goals established for the FDA. While acknowledging the benefits of the OMUFA, this work also discusses potential challenges and concerns raised by industry stakeholders and consumer advocacy groups. This critical regulatory initiative has the potential to facilitate further research and discussions on optimizing drug safety and access within the OTC market through required modifications and initiatives.