The Supreme Court on June 28, 2024 put the final nail in the coffin of so-called "Chevron deference," a key judicial doctrine that has governed, or strongly influenced, the outcomes of thousands of lawsuits against federal government agencies since 1984 when the Court issued its decision in Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 (1984). 

Chevron gave tremendous power to executive branch agencies, including the Food and Drug Administration (FDA), to interpret the statutes they administer, by severely limiting the ability of the courts to overturn agency interpretations of statutory provisions that were deemed “ambiguous.”  

Countless lawsuits brought against FDA by companies in the pharmaceutical, medical device, dietary supplement and other regulated industries have summarily failed due to the courts' application of Chevron deference over the past four decades, but under the Court's new decision in Loper-Bright Enterprises v. Raimondo, FDA and other agencies will no longer be able to simply invoke statutory “ambiguity” and “deference” and expect to win the case.

Rather, when initially making regulatory policy and individual regulatory decisions, FDA and other agencies will now have to more carefully square their actions with relevant statutory authority(ies), and importantly, federal courts are now freed to perform “their inde­pendent judgment in deciding whether an agency has acted within its statutory authority, as the [Administrative Procedure Act] APA requires….[and] courts need not and un­der the APA may not defer to an agency interpretation of the law simply because a statute is ambiguous."

The law of APA litigation, and the history of Chevron deference (and its numerous judicial variants and offshoots) is far too complex to discuss in detail in this post, and indeed entire law school courses are devoted to the topic. Suffice to say, however, that the complexity of this area of law arises in part from numerous agencies' implementations of, and judicial decisions involving, tremendously complex and ever-changing regulatory agency statutes (including the Food, Drug and Cosmetic Act (FDCA)), many of which were written by Congress in ways that are inscrutable to ordinary readers of the English language.  

But importantly, the very notion of judicial deference to executive branch agencies implicates fundamental Constitutional questions of the proper separation of powers between and among the three branches of government. As Justice Thomas states in his concurring opinion in Loper-Bright, “Chevron was thus a fundamental disruption of our separation of powers. It improperly strips courts of judicial power by simultaneously increasing the power of executive agencies. By overruling Chevron, we re­store this aspect of our separation of powers.”

So, what does this mean for FDA-regulated entities?  The detailed answers will emerge over time, but in the short term, any FDA-regulated company that believes it has been aggrieved or disadvantaged by a questionable agency policy or administrative decision should carefully consider that the demise of Chevron may very well open new avenues for successful judicial review of FDA's actions.