As part of the Food and Drug Law Institute’s Annual Conference last week, Axinn Partner and FDA Practice Group Chair Chad Landmon participated in a panel titled, “FDA (Still) Under Fire: Pending SCOTUS Decisions on Agency Deference.” There, the panelists discussed the potential impact of the Supreme Court’s upcoming decision that may limit or eliminate judicial deference to agency decisions.

Landmon discussed the two cases recently argued before the Supreme Court, Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce. Both cases involve application of the longstanding Chevron doctrine to fisheries rules providing for on-board monitoring, which were upheld by lower courts.

Fellow panelist Vanessa Burrows discussed FDA v. Alliance for Hippocratic Medicine, where the Fifth Circuit affirmed the district court’s stay of certain FDA actions in approving and expanding access to mifepristone. Burrows referenced the Fifth Circuit as one court that is less apt to defer to FDA, even where decisions implicate the Agency’s substantive scientific expertise. She posited that narrowing or overturning Chevron could exacerbate current issues with forum shopping.

The panelists agreed that narrowing or overturning Chevron deference would result in heightened uncertainty for regulated industry. Although industry players are wary of the greater uncertainty associated with abandoning a decades-old status quo, it is likely that an agency’s decisions based on its scientific expertise will continue to be more resistant to judicial scrutiny than decisions made primarily on legal interpretations.

Practically speaking, however, courts have quietly been moving away from Chevron for a number of years. Landmon pointed out that the Supreme Court leads by example in this respect, where Chevron has rarely been employed in recent years. By contrast, district courts use a Chevron analysis in approximately 80% of decisions involving FDA. But across the board, courts now pay greater attention to the statutory text under the first step of the Chevron analysis.

The panel expected that the Supreme Court may soon limit Chevron deference or even eliminate it entirely. With the upcoming decision in Loper Bright and Relentless, FDA may soon find itself faced with rapid-fire challenges.

“FDA’s decisions are constantly under fire, but if Chevron is overturned the Agency may come under rapid-fire.