'The Fall of FDA Review' by Daniel G. Aaron in (2023) Yale Journal of Health Policy, Law, and Ethics comments
The U.S. Food and Drug Administration is in crisis. Contaminated baby formula is only the latest of a series of scandals that have catapulted FDA into the public spotlight. FDA can hardly go a single day without an investigation, news scoop, or scholarly critique of the agency’s work. FDA regulates 25% of the U.S. economy, yet 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, 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. U.S. life expectancy fell by 2 years between 2018 and 2020, in part due to FDA-regulated products. What can explain this extreme abdication of regulatory authority that is leaving the American public unsafe and unprotected?
Until now, the siloed nature of FDA law has prevented a meaningful analysis of premarket review as a legal regime. This article offers the first cross-disciplinary critique of premarket review across five FDA product areas. Leveraging regulatory history, medical science, epidemiology, and law, I argue that premarket review is faltering and aim to explain why. 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, I propose a suite of structural solutions to build a revitalized FDA: one that is dutifully empowered, inside and out, to safeguard the public health.
