Public Controversy and Community Voices: A Culture-Centered Examination of the Federal Drug Administration's Approval of BiDil from the Perspective of African American-Led Organizations.

Abstract

The study examines how African American-led organizations leveraged BiDil (hydralazine-isosorbide dinitrate, HYD/ISDN)'s promotional messaging to highlight broader structural barriers in healthcare following the FDA's approval of the drug as the first race-based heart failure treatment for African Americans. Using a textual analysis guided by the culture-centered approach (CCA), this study analyzes advocacy narratives from organizations such as the National Association for the Advancement of Colored People (NAACP) and the Association of Black Cardiologists (ABC) to explore how promotional messaging extends beyond HYD/ISDN to expose deeper economic, systemic, and ethical challenges in US healthcare. The findings reveal three major themes: (1) Framing HYD/ISDN as a Milestone in Racial Health Equity, (2) Addressing Historical Mistrust Through Advocacy and Medical-Cultural Innovation, and (3) Structural and Economic Barriers in Healthcare Access. These themes illustrate how HYD/ISDN's approval was both a symbol of racial progress and a point of contention, reinforcing debates about racialized medicine, affordability, and systemic bias in clinical research. The study concludes that while HYD/ISDN's promotional messaging helped raise awareness of racial health disparities, true health equity requires structural reforms in drug accessibility, research participation, and culturally centered care.