Non-Binding Guidance: A Discussion Of Kisor v. Wilkie

The seventh installment of Ropes & Gray's podcast series, Non-binding Guidance, dives into the closely watched administrative law case, Kisor v. Wilkie. This Supreme Court case addresses the continued validity of the doctrine articulated in the 1997 Supreme Court case Auer v. Robbins, regarding judicial deference to federal administrative agency interpretations of their own regulations. In this episode, Ropes & Gray partner Greg Levine interviews his colleagues, Doug Hallward-Driemeier and Beth Weinman, about the factual background, opinions, and potential implications of Kisor, with particular emphasis on its significance for FDA-regulated life sciences companies seeking to challenge FDA or other federal agency regulatory interpretations. Among other things, Beth and Doug discuss the signals the Kisor case sends about the future of Chevron deference, which addresses the related question of judicial deference to agency interpretations of statutes. Tune in to this discussion to learn about key takeaways from the Supreme Court's Kisor ruling and its potential impact on FDA-regulated companies.

For a more in depth review of the Kisor v. Wilkie opinion and its potential impact on FDA-regulated life sciences companies, check out the corresponding article, " A New Dawn for Challenges to FDA Actions? Kisor and the Tenuous Vitality of Administrative Deference."

Transcript:

Greg Levine: Hi, I'm Greg Levine, a partner in the life sciences regulatory and compliance practice group at Ropes & Gray, based in our Washington, D.C. office. Welcome to Non-binding Guidance, a podcast series from Ropes & Gray focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry. I'm here today with my colleague, Doug Hallward-Driemeier, a litigation partner who leads Ropes & Gray's appellate and Supreme Court practice, and who has presented more than 85 appellate arguments, including arguing 17 times before the U.S. Supreme Court. I'm also joined by Beth Weinman, counsel in the life sciences regulatory and compliance group who joined us about a year ago from FDA's Office of Chief Counsel. In the Chief Counsel's Office, Beth worked primarily on Federal Food Drug & Cosmetic Act criminal enforcement and parallel False Claims Act investigations. She also appeared regularly in front of administrative law judges and handled defensive civil litigation on behalf of the government.

On today's episode, we will be talking about Kisor v. Wilkie, a closely watched agency deference case that has attracted significant attention in administrative law circles and among companies operating in highly regulated industries. Today, we'll focus primarily on the impact of that case for FDA regulated entities. Some expected that Kisor might spell the end of the Auer doctrine deference, but Auer appears to live on, at least in name. So I'll turn first to Doug to give us some background and set the stage for the discussion. Doug, what is Auer deference, why does it matter, and why is Kisor potentially so important?

Doug Hallward-Driemeier: Well, thank you, Greg. The Auer doctrine takes its name from a 1997 Supreme Court decision called Auer v. Robbins. And basically, it calls for judges to defer to agencies when they're interpreting their own ambiguous rules. So the reasoning behind Auer deference is basically premised on a number of principles. First, the idea that the agency that "wrote the regulation" is in the best position to interpret it. Second, that agencies often possess particular expertise in administering what are admittedly "highly complex and technical regulatory programs" in which they're charged with making policy determinations. And third, the idea was that uniform agency interpretation gives "predictability about the administrative process" for regulated entities.

So under Auer, courts generally would defer to agency interpretations of their regulations unless that interpretation was "plainly erroneous or inconsistent with the regulation" and the court was able to determine that. So in recent years, Auer really has come under considerable criticism. And one of the leading critics of that was Justice Scalia before his death. He argued, and you can sort of see this in the rule itself, that it gives actually an incentive to agencies to speak vaguely and in broad terms so that they retain flexibility about how they will "clarify" their ambiguous regulatory language, which ultimately has the consequence of a real retroactive application of what is really, in many instances, a new rule on conduct that predated that clarification of that rule. So one of the criticisms he leveled was that Auer deference "contravenes the great rule of separation of powers that he who writes a law must not adjudge its violation," precisely to avoid that kind of retroactivity.

So as a practical matter, Auer stood as a considerable obstacle to any efforts to challenge administrative agencies through the courts. Now, as the Supreme Court and many lower courts have grown more conservative, opposition to the regulatory state has grown along with that change. And many court watchers expected that the court would act to tamp down, in some way, what they saw as inappropriate, sometimes even I think they thought it was...