Regulatory Frameworks, Licensing Requirements, and Drug Accessibility: Challenges in Puerto Rico Related to Innovative Treatments for Chronic Depression

Abstract

This study examined how licensing requirements, certifications, and regulatory frameworks influence drug pricing and access to innovative treatments in Puerto Rico, using TRANQUI-Spray (a fictitious name used for confidentiality purposes), a Risk Evaluation and Mitigation Strategy (REMS)-mandated, controlled-substance nasal spray for treatment-resistant depression as the central case study. The research analyzed how intellectual-property protections and complex approval pathways shape market dynamics, limit competition, and contribute to high medication costs. It also evaluated how FDA and DEA regulations, REMS infrastructure, and clinical certification requirements restrict the availability of novel therapies for chronic diseases. Through a qualitative approach, the study identified structural barriers to equitable access and highlighted opportunities for regulatory simplification, expanded REMS-certified capacity, and improved policy alignment. Findings underscore the need for streamlined processes that reduce administrative burden, support generic entry, and enhance affordability, ultimately promoting better health outcomes and strengthening Puerto Rico’s healthcare system.