The End of FDA Exceptionalism? Dissecting Deference to the FDA in Drug Disputes

by Anjali Deshmukh*

Volume 46 Issue 3

The full text of this article may be downloaded by clicking on the PDF link.

On April 7, 2023, a federal judge issued a nationwide stay on the United States Food and Drug Administration (FDA) approval of the abortifacient medication mifepristone. It was instantly a landmark case, decried as the first time in over one-hundred years that a federal court nullified an FDA drug approval. A few hours later, a second federal district court enjoined FDA restrictions on mifepristone. Two federal courts substantively evaluating FDA drug approval data in one day is unprecedented. It begs the question: will courts overturn FDA drug approvals again?

Conventional wisdom says no. Abortion exceptionalism, the trend of legislatures and courts subjecting abortion to unique and burdensome rules, suggests that aggressive judicial review of FDA approvals in non-abortion contexts will continue to be limited. Yet this Article analyzes pharmaceutical litigation involving the FDA across the last decade to offer an alternative narrative on whether and when challenges to FDA drug determinations might occur. Between 2019 and 2023, courts have overturned multiple longstanding FDA policies by challenging science-based policy decisions. Viewed in this light, the mifepristone cases could be one piece of a concerning emerging trend. This Article also explores why litigants have been more successful than usual. It argues that the emerging new norm of scrutinizing science-based policy choices may also be connected to growing public skepticism of the FDA in the wake of multiple concurrent pharmaceutical-approval crises including COVID-19 treatments, opioids, and the controversial Alzheimer’s drug aducanumab. Judicial deference to agencies has also been declining for decades. After the 2023 Supreme Court Term, longstanding FDA policies deciding drug approvals might be successfully challenged more often. While there are other reasons to suspect that challenges to FDA drug approval decisions may not increase, it is more important than ever to restore trust in the FDA and consider where judicial review of pharmaceutical determinations is beneficial.

* Assistant Professor of Law at Georgia State University College of Law and Adjunct Assistant Professor of Pediatrics at Emory School of Medicine. Early drafts of this piece were selected for the 2023 Wiet Life Science Law Scholars Workshop at Loyola University Chicago School of Law, the 2023 Program on Regulation, Therapeutics, and Law Works in Progress Workshop, the 2023 Third Annual Asian American Pacific Islander and Middle Eastern and North African Women in The Legal Academy Workshop, New Voices in Administrative Law at AALS 2024 Annual Meeting, Faculty Exchange Presentation at the University of South Carolina (March 2024), and the 2024 Administrative Law Roundtable at Notre Dame School of Law. For their helpful comments and discussion on this piece, I am deeply grateful to Daniel Aaron, Nick Bednar, Jack Beerman, Anya Bernstein, Emily Bremer, Nathan Cortez, Doron Dorfman, Catherine Baylin Duryea, Wendy Epstein, Leah Fowler, Erin Fuse-Brown, Sara Gerke, Lewis Grossman, Yaniv Heled, Kristen Hickman, Cynthia Ho, Aaron Kesselheim, Tim Lytton, Richard Murphy, Jordan Paradise, Nick Parrillo, Laura Pedraza-Farina, Shalini Bhargava Ray, Christopher Robinson, Rachel Sachs, Josh Sarnoff, Catherine Sharkey, Noah Smith-Drelich, Jennifer Wagner, Mellissa Wasserman, Leslie Wolf, and Patricia Zettler, amongst many others. Thank you Joey Shafritz, Addie Morgan, and Todd Stephenson for research assistance and Dan Quiggin, Ph.D. for statistical support. All mistakes are my own.