Opening the FDA Black Box

The US Food and Drug Administration (FDA) is sometimes described as the most powerful regulatory agency in the world, its decisions affecting billions of both lives and dollars. The agency has this distinction not just because of its legislative mandate or governmental role but in part because of its reputation.¹ This reputation has been shaped by how it makes its decisions, by its “conceptual power” in the language and methodologic standards it uses for drug and device approval, and by its ability to gain legitimacy among multiple audiences via a combination of scientific rigor and flexibility.¹