Judicial Deference to FDA More Uncertain: Analysis

A Ropes&Gray legal analysis says that a recent Supreme Court decision on deference to agencies such as FDA that are interpreting their own regulations has changed the landscape and empowered plaintiffs. “Although FDA will often continue to receive deference in cases involving application of its specialized scientific knowledge to specific factual circumstances,” the analysis says, “plaintiffs will be empowered to demand that FDA justify its actions, conform to administrative formalities, and apply consistent reasoning throughout the administrative process. Where FDA fails to do so, its actions have never been more vulnerable to legal challenge.”

In Kisor v. Wilkie, a VA case, the court “recast Auer deference in a manner likely to have the practical effect of eroding the ability of administrative agencies to rely upon the doctrine as a complete defense to legal challenges,” the post says.

The court majority opinion said that for Auer deference to apply, these conditions must be met: 

•          deference should be applied only when a regulation is genuinely ambiguous;
•          an agency’s reading of its regulation must still fall within the bounds of reasonable interpretation; and
•          before applying deference, a court must make an independent inquiry into whether the character and context of the agency interpretation entitles it to controlling weight, assessing whether the policy and other justifications animating Auer are applicable in a particular circumstance.