Through the Looking Glass? Loper Bright Will Force FDA to Change Its Approach to Litigation and Advocacy

The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the Agency’s interpretation of ambiguous statutory provisions. Stripping FDA of the key tool of deference, Loper Bright will undoubtedly reinvent the way FDA advocates in federal courts.

The majority opinion in Loper Bright finds that this is a necessary change from the now-defunct Chevron regime, demanded by the text of both the Administrative Procedures Act and the Constitution. The majority also insists that it is not forcing judges to walk all the way through the looking glass to a mirror-image world where FDA’s input and interpretation of its own final agency actions are rendered into nonsense. Judges will now consider, but not defer to, FDA’s positions on matters of statutory interpretation if those positions are persuasive. As a result, there is now an open question as to how FDA and their litigation partners at the Department of Justice will respond to this new standard. What is clear is that FDA will consider the impact of Loper Bright in its litigation strategy going forward.

It is important to note that Loper Bright did not do away with consideration of agency expertise.  First, with respect to issues of statutory interpretations, the Court turned the clock back to the 1944 touchstone of Skidmore v. Swift. Substituting Chevron deference with Skidmore deference, courts are now to use “interpretations and opinions” of an agency that are rooted in “specialized experience” to help make decisions. As Loper Bright noted, the degree to which a court would respect and rely on agency judgment would “depend upon the thoroughness evident in its consideration, the validity of its reasoning, its consistency with earlier and later pronouncements, and all those factors which give it power to persuade, if lacking power to control.”

Second, because Chevron deference was about statutory interpretation, even in a post Loper Bright world, the Administrative Procedure Act “does mandate that judicial review of agency policymaking and factfinding be deferential. See §706(2)(A) (agency action to be set aside if ‘arbitrary, capricious, [or] an abuse of discretion’).” The upshot of this would seem to be that the stakes are now much higher as to whether a dispute with the FDA is over a question of law or policy.

In the former category of legal disputes, “courts, not agencies, will decide ‘all relevant questions of law’ arising on review of agency action, §706 (emphasis added)—even those involving ambiguous laws—and set aside any such action inconsistent with the law as they interpret it.” Additionally, there should probably be no expectation that judges will shy away from cases where hyper-technical facts mix with questions of law. In the latter category of policy questions, however, the deferential arbitrary and capricious standard applies.

The dissenting justices in Loper Bright took a dim view of the assumption that in the absence of deference, federal judges will exercise sufficient consideration of agencies’ subject matter expertise in controversial cases. Justice Kagan wrote that “[i]f the majority thinks that the same judges who argue today about where ‘ambiguity’ resides . . . are not going to argue tomorrow about what ‘respect’ requires, I fear it will be gravely disappointed.” Under this view, no matter how effectively FDA advocates for its public health mission and the congressional intent to enable it, future controversies that might be cabined as statutory interpretation and not internal policymaking will prove to be a “font of uncertainty and litigation.”

We have yet to fully understand how far FDA litigation over statutory interpretation has gone through the mirror here. As FDA is left to restructure how it will litigate its way out of the likely surge of lawsuits, the contours around Loper Bright will take years to iron out. Future posts will tackle this shifting new legal landscape as cases develop.