Earlier this summer, when the Supreme Court eliminated a longstanding legal doctrine that deferred to federal agencies on interpreting federal law, many legal observers said the move could spell the end of some contentious FDA-led decisions, pushing the agency toward issuing guidance instead of rulemaking.
In a Monday filing with the Supreme Court on a case related to FDA’s authority over flavored e-cigarettes, the FDA’s lawyers spelled out how they’re reading into the landmark decision, and other matters related to interpreting the law, regulations and issuing guidance.
“The [Supreme] Court held long ago that courts must defer to an agency’s reasonable reading of an ambiguous regulation,” FDA’s lawyers write in their brief, which cites the Chevron decision, known as Loper Bright, from June three times.
The agency also says that it should not be bound by private parties’ “good-faith” misinterpretations of its guidance, and that such a ruling could have a chilling effect on issuing guidance. While that doesn’t carry the force of law or regulation, it can help steer companies to understand the rules.
“Any guidance document will contain ambiguities,” the FDA lawyers wrote, citing Loper Bright. “By automatically resolving all such ambiguities against the agency, the Fifth Circuit’s approach discourages agencies from providing guidance in the first place — an outcome that, in the long run, harms rather than helps regulated parties.”
David Simon, associate professor of law at Northeastern University, told Endpoints via email, “FDA’s motive is plain: without deference, such broad delegations will always be subject to judicial review in some form, creating a system where courts second guess agency determinations on any number of issues. The net effect will be to reduce the efficiency of agency-decision making and potentially gum up the machinery the administrative state.”
The agency also acknowledges the reality of the situation and tries to carve out space for its work on guidance. “But FDA faces a problem,” Simon adds. “It can only urge, but not demand, that courts defer to it.”
The agency notes, “As this Court recently held, the APA requires reviewing courts to ‘determine the best reading’ of the law ‘by applying their own judgment. That holding forecloses any contention that courts should accord controlling effect to a private party’s purportedly reasonable but incorrect reading of a guidance document.”
In the Monday filing, the agency also said it doesn’t have any legal obligation to issue guidance, but such guidance can help companies understand how it interprets the law and how it plans to exercise its discretion.