The Fall of FDA Review

Abstract

The U.S. Food and Drug Administration (FDA) is in crisis. FDA can hardly go a single day without an investigation, negative news story, or scholarly critique of the agency’s work. We have increasingly entrusted FDA—today, to the tune of 25% of the U.S. economy—with vetting the products we put in and on our bodies. But the array of problems facing the agency raises questions about whether it is equipped to succeed in the 21st century.

FDA’s core function is to oversee a special legal regime called “premarket review.” Congress has prohibited all marketing of certain types of products (like drugs) until FDA reviews and approves an application from the manufacturer. This system allows consumers to depend on the foods they ingest, the pills they swallow, and the health care they receive—in theory. But critics have documented how FDA review failures have produced, or contributed to, public health crises, including those related to opioids, e-cigarettes, trans fats, sugar, and, most recently, the COVID-19 pandemic.

Leveraging five FDA product areas, this Article argues that premarket review is faltering. The reasons vary somewhat across FDA’s regulatory regimes. However, the bottom line is the same: longstanding efforts to undermine FDA governance by corporations and financial power writ large. Corporate deregulatory efforts have operated through courts, Congress, the President, and the agency’s leadership itself. In some cases, premarket review has been so hollowed out that all that remains is the illusion of regulation, nothing more. These developments reflect the ascendancy of neoliberalism, a system in which core social guarantees devolve to decisions by individual consumers.

We need not accept this state of affairs. Learning from the mechanisms behind premarket review’s erosion, this Article proposes a suite of structural solutions to build a revitalized FDA: one that is dutifully empowered, inside and out, to safeguard the public health.

Keywords: FDA, Public Health, Administrative Law, Premarket Review, Drugs, Devices, Tobacco, Food Additives, Tests, Mortality, COVID-19