A New Dawn for Challenges to FDA Actions? Kisor and the Tenuous Vitality of Administrative Deference
In Kisor v. Wilkie1—a closely watched case decided in a closely divided opinion towards the end of the Supreme Court’s last term—the Court upheld the doctrine of Auer deference, much to the surprise of many given the Court’s new conservative majority. Although technically a win for the government, the decision 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.
This article examines the Kisor opinion and its potential impact on firms regulated by the U.S. Food and Drug Administration (“FDA”) and other agencies that rely heavily on scientific and technical expertise. While Kisor does not represent a fatal blow to administrative agencies seeking to invoke deference, the opinion provides heavily regulated entities with more ammunition to push back on arguments for deference, particularly when bringing certain kinds of Administrative Procedure Act (“APA”) claims. The case also provides additional cover for judges conceptually uncomfortable with Auer to examine agency actions more closely. Future cases citing Kisor may continue to undermine the jurisprudence FDA and other agencies have long relied upon to insulate their actions from substantive judicial scrutiny. That said, Kisor and related cases also highlight the types of circumstances in which courts are likely to continue to rely on Auer, notwithstanding the directional shift.
How We Got Here
Auer deference, taking its name from the 1997 Supreme Court decision in Auer v. Robbins,2 calls for judges “to defer to agencies when they interpret their own ambiguous rules.”3 Auer deference is premised on a number of principles, including that (1) the agency that “wrote the regulation” is best positioned to interpret it;4 (2) agencies possess particular expertise in administering a “complex and highly technical regulatory program” in which policy decisions must be made;5 and (3) a uniform agency interpretation imparts “predictability to the administrative process.”6 Under Auer, courts generally defer to agency interpretations of their regulations unless those interpretations are “plainly erroneous or inconsistent with the regulation.”7
In recent years, critics have increasingly called the Auer decision into question as unwise and potentially unconstitutional. For example, Justice Scalia asserted that Auer deference has the pernicious effect of giving agencies “the incentive  to speak vaguely and broadly, so as to retain a ‘flexibility’ that will enable ‘clarification’ with retroactive effect.” He also questioned the doctrine’s constitutional validity, arguing that Auer deference “contravenes one of the great rules of separation of powers: He who writes a law must not adjudge its violation.”8 As a practical matter, Auer has stood as a significant obstacle to attempts to challenge administrative agency action through litigation.
James Kisor, a Vietnam War veteran, challenged a determination of the Board of Veterans Appeals within the Department of Veterans Affairs (collectively, the “VA”), that he was not entitled to benefits for post-traumatic stress disorder pursuant to the VA’s interpretation of the relevant regulation. The Court of Appeals for the Federal Circuit ultimately affirmed the VA’s finding, based on its view that the relevant regulation was “ambiguous” and that Auer deference to the VA’s interpretation was thus warranted.9
Kisor then sought review in the Supreme Court, teeing up a frontal challenge to Auer that incorporated many of the critiques of Auer deference made by Justice Scalia and others. The petition for certiorari argued that “Auer incentivizes agencies to promulgate vague and broad regulations,” that “Auer deference provides agencies an end-run around the notice-and-comment procedures required by the” APA, and further, that Auer raises separation of powers concerns because it limits the authority of the courts.10
The decision by the Supreme Court on December 10, 2018 to grant Kisor’s petition was viewed by many as likely to portend a major shift in administrative law. Anti-Auer commenters predicted that the grant meant Auer was indeed “on its last gasp,”11 and pro-Auer commenters fretted that the “Roberts Court, with its newly cemented conservative majority, [could seek to dismantle] the administrative state.”12
In a surprise to many, and much to the consternation of Auer’s critics, the opinion—authored by Justice Kagan for the Court as to Parts I, II-B, III-B, and IV—affirmed Auer, at least as a technical matter. In so doing, however, the Court described important limits on the application of Auer, thereby raising questions about its future application. According to the Kisor majority, in order for Auer deference to apply, the following conditions must be met:
- First, because “a court should not afford Auer deference unless the regulation is genuinely ambiguous,” before determining that a regulation is genuinely ambiguous, “a court must exhaust all the ‘traditional tools’ of construction.” The Court emphasized that where a regulation is unambiguous, “a court has no business deferring to any other reading, no matter how much the agency insists it would make more sense.”14
- Second, the agency’s reading “must still be ‘reasonable,’”15 meaning that the agency interpretation must “fall ‘within the bounds of reasonable interpretation.’”16 The Court clarified that this “is a requirement an agency can fail.”17
- Third, before applying Auer 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.18 Factors that should be considered include whether the agency interpretation is “the agency’s authoritative or official position,” whether the “agency’s interpretation  in some way implicate[s] its substantive [e.g., technical- or policy-based] expertise,” whether the “agency’s reading of a rule . . . reflect[s] fair and considered judgment,” and whether the agency’s interpretation creates a “lack of fair warning” to regulated parties.19
Justice Gorsuch, joined by Justice Thomas and in part by Justices Alito and Kavanaugh, published a concurring opinion that might fairly be characterized as a de facto dissent.20 In it, he asserted that “[i]t should have been easy for the Court to say goodbye to Auer v. Robbins,” a doctrine that in Justice Gorsuch’s view created “a ‘systematic judicial bias in favor of the federal government, the most powerful of parties, and against everyone else.’”21
Perhaps most tellingly, both Chief Justice Roberts and Justice Kavanaugh—the former having joined most of Justice Kagan’s opinion and the latter having joined most of Justice Gorsuch’s opinion—wrote separately to emphasize that the decision may have the practical effect of limiting Auer’s application, despite its headline holding that Auer was not overruled. Chief Justice Roberts noted that “the distance between the majority and Justice Gorsuch is not as great as it may initially appear,” as “the cases in which Auer deference is warranted largely overlap with the cases in which it would be unreasonable for a court not to be persuaded by an agency’s interpretation of its own regulation.”22 Justice Kavanaugh agreed, asserting that courts will thus often “have no need to adopt or defer to an agency’s  interpretation.”23
In a twist that will undoubtedly encourage more petitions for certiorari, both Chief Justice Roberts and Justice Kavanaugh implicitly questioned the continued wisdom of Chevron deference. The Chief Justice wrote that “[i]ssues surrounding judicial deference to agency interpretations of their own regulations are distinct from those raised in connection with judicial deference to agency interpretations of statutes enacted by Congress” and thus Kisor does not “touch upon the latter question,” a point with which Justice Kavanaugh explicitly agreed.24 These concurring opinions thereby foreshadow that Chevron may meet a different fate if reconsidered.
Key Takeaways for FDA-Regulated Entities
Few administrative agencies oversee as technically complex and broad-reaching a body of regulations as FDA. FDA has primary responsibility for regulating the development, manufacture and distribution of human and animal drugs, biologics, and medical devices; most processed and unprocessed foods; tobacco products; and cosmetics. Its oversight requires significant scientific and medical expertise to establish, among other responsibilities, the requirements and standards for developing new products and evaluating their safety and efficacy; to assess and respond appropriately to health risks posed by products once they are on the market; and to evaluate whether manufacturers’ claims about various regulated products are supported by scientific evidence.
Similarly, few agencies have been the subject of as much litigation as FDA in recent years, ranging from First Amendment challenges to the constitutionality of restrictions on pharmaceutical promotion to APA and other statutory challenges to FDA rules and adverse administrative actions (including clinical trial holds, complete response letters, and marketing application denials), to basic jurisdictional challenges to the agency’s ability to regulate certain products. As FDA-regulated entities consider the feasibility of challenges to adverse FDA actions, Kisor will likely impact the analysis in several ways.
There Are Now Multiple Avenues to Attack the Applicability of Auer
The Supreme Court’s decision in Kisor means that FDA can continue to invoke Auer deference as one of its defenses during litigation. However, even the opinion upholding Auer in principle sets forth a number of (relatively stringent) requirements that must be met in order for Auer to apply. In seeking to reassure skeptics that Auer is not boundless—and, perhaps, to secure needed support from Chief Justice Roberts—the opinion delivered by Justice Kagan for the Court gives those challenging FDA action multiple avenues to assert that Auer deference is not appropriate in a given situation.
For example, Kisor makes clear that “a court cannot wave the ambiguity flag just because it found the regulation impenetrable on first read” and must instead, before determining a rule to be “genuinely ambiguous,” consider “the text, structure, history, and purpose of a regulation, in all the ways it would if it had no agency to fall back on.”25 Similarly, if FDA’s position appears to be merely a “‘convenient litigating position’ or ‘post hoc rationalization advanced’ to ‘defend past agency action against attack,’” no deference is due.26
Further, Auer may be harder for FDA to invoke in response to a claim that FDA’s interpretation of the regulation is inconsistent with the regulation’s plain meaning, or with a position FDA has taken in the past. In post-Kisor cases involving such challenges to other agencies’ actions, courts have cited Kisor and refused to apply Auer deference (though, to be fair, the cases citing Kisor in this context have thus far tended to involve strained readings of regulations or overt changes in agency policy that courts may have rejected even before Kisor clarified the scope of Auer deference).27 Nevertheless, guardrails set forth in Kisor will likely operate to prevent FDA from taking convenient litigating positions not supported by its specialized technical expertise, and more generally from taking actions inconsistent with FDA regulations. For this reason, Kisor may limit the extent to which an agency’s interpretation of a regulation can “evolve” in the absence of further rulemaking.
FDA Will Very Likely Continue to Receive Deference in Certain Cases
While Kisor therefore may lead to more challenges to the applicability of Auer deference, there are many situations where FDA is likely to continue to prevail in invoking this form of judicial deference. In particular, the plurality opinion in Kisor observes that most judges “probably have no idea of what a [technical FDA] rule means,” and that where “a rule is technical” or “implicate[s] policy expertise,” it remains appropriate to defer to the agency.28 In other words, where an issue is a technical one that is best judged by experts at an agency (e.g., scientific experts at FDA who understand the implications of a particular data set on a drug’s potential safety or efficacy, or who understand what kind of testing must be conducted to demonstrate the biocompatibility of materials used to manufacture an implanted device), and are not instead “interpretive issues [that] fall more naturally into a judge’s bailiwick,” Kisor suggests that Auer deference continues to be warranted.29
This distinction between legal interpretation and factual expertise is not new to Kisor. For example, in National Cable & Telecommunications Association v. Brand X Internet Services,30 a Chevron case dealing with the Federal Communication Commission’s interpretation of the Communications Act of 1934 (as amended by the Telecommunications Act of 1996), Justice Thomas, writing for the Court, noted that Chevron deference was appropriate in part because the relevant question “turn[ed] not on the language of the Act, but on the factual particulars of how Internet technology works and how it is provided, questions Chevron leaves to the Commission to resolve in the first instance.”31 In other words, the Supreme Court has signaled for some time that agencies are entitled to more deference under Chevron (and Auer) when they are dealing with factual issues uniquely within their expertise.
As a result, arguments that FDA has erred by failing to abide by the plain meaning of its regulations may be more likely to gain traction post-Kisor. However, arguments that FDA should defer to a challenger’s superior interpretation of clinical data or scientific conclusions may continue to face hurdles, as the Kisor plurality opinion suggests that such technical and scientific inquiries are often best resolved by administrative agencies.32
FDA Will Be Forced to Justify Its Actions
Regardless of whether a court ultimately finds that Auer deference is warranted, Kisor suggests that courts must conduct a more careful review to ensure that Auer applies.33 This, in turn, means that FDA will be required to more fully justify any invocation of deference.
Post-Kisor, FDA may face difficulty invoking Auer deference where it cannot demonstrate that its actions are evidence-based and that they comported with prescribed administrative processes. For example, Kisor clarifies that no deference is warranted when an interpretation advanced by an agency does not “emanate from those actors, using those vehicles, understood to make authoritative policy in the relevant context.”34 Kisor also approvingly cites a case from the United States Court of Appeals for the Seventh Circuit declining to defer to a statement in an agency regulatory guide that the agency itself had disclaimed as authoritative.35 Accordingly, should a litigant challenge the application of a non-binding guidance document, FDA may be hard-pressed—given the disclaimers it typically attaches to such guidance documents as well as the characterization of guidance documents in FDA’s own Good Guidance Practice regulations36—to assert that Auer deference is warranted based on the guidance alone.
It is possible that Kisor could lead FDA to reconsider the method by which it issues rules, regulations, warning letters, and other documents. And, for prospective litigants that feel they have been given the run-around by the agency—or are seeking explanations FDA is reluctant to provide—Kisor may make it easier to obtain those answers in court.
The Assigned Judge Is More Key than Ever
Justice Gorsuch’s de facto dissent in Kisor asserts that the “decision to adorn Auer with so many new and ambiguous limitations” guarantees further litigation over Auer’s scope, and expresses the “hope that . . . judicial colleagues on other courts will take courage from today’s ruling and realize that [Kisor] has transformed Auer into a paper tiger.”37 At the very least, the fragmented Kisor opinion gives lower court judges room to take varying tacks. A judge sympathetic to the rationales supporting Auer deference must now contend with the limitations set forth in Kisor, but remains free to apply Auer deference if the judge, following a thorough and reasoned consideration of those enumerated factors, believes that deference is warranted. By contrast, a judge with a perspective similar to that of Justice Gorsuch may now indeed “take courage” from Kisor, and accept the invitation set forth in several of the Kisor opinions to apply a rigorous textual review to regulations and defer only where the agency’s interpretation has “the power of persuasion.”38
One recent case may foreshadow the transformed but still very present fault lines in administrative litigation following Kisor. In Alon Refining Krotz Springs, Inc. v. EPA,39 the D.C. Circuit considered the Environmental Protection Agency’s (“EPA”) obligation under the Clean Air Act to publish renewable fuel standards each year and disputed language in EPA’s implementing regulations regarding how often it must actually re-evaluate such standards. The majority cited Justice Kavanaugh’s concurring opinion in Kisor for the proposition that State Farm, rather than Chevron or Auer, supports the principle that agencies can use broad language in regulations and then exercise their discretion to select from multiple reasonable interpretations supported by the text. The majority ultimately found reasonable EPA’s interpretation.40 The concurring judge, on the other hand, cited Kisor in his criticism of what he viewed as the majority’s “reflexive” deference to EPA, arguing that the majority had failed to apply any of the “‘traditional tools’ of statutory construction” before waving “’the ambiguity flag.’”41 The majority, inclined to defer to EPA, shied away from embracing Auer; the concurrence, inclined not to defer, found support in Kisor. While Kisor thus does not resolve the divergence in opinions with respect to administrative deference, it may ultimately shift the center of the conversation away from deference.
In short, Kisor will almost certainly provoke more litigation, and the outcome of post-Kisor challenges will likely vary. If a litigant challenges an FDA action and is assigned a judge sympathetic to Auer, there may now be a more reasoned opinion that arrives at the same outcome of deference. If a litigant challenges an FDA action and is assigned a judge unsympathetic to Auer, by contrast, there is a greater probability than in the past that the judge will decline to grant FDA deference (and, in turn, rule against FDA on the merits if FDA’s arguments are not persuasive). Administrative litigation may therefore become, at least for a time, both more ideological and more unpredictable. As a result, challenging FDA in court could become an even more attractive proposition.
Chevron Could Be in the Crosshairs
Auer was saved by the vote of Chief Justice Roberts, who elected to side with Justice Kagan in determining that “overruling those precedents is not warranted.”42 Chief Justice Roberts cites the invocation of agency expertise as a potential rationale for retaining Auer deference in certain cases, because it is the agency that writes the regulations. He then notes that “[i]ssues surrounding judicial deference to agency interpretations of their own regulations are distinct from those raised in connection with judicial deference to agency interpretations of statutes enacted by Congress,” and he stresses that the decision in Kisor to preserve Auer does not address the latter question (governed by Chevron).43
One interpretation of this aside is that the Chief Justice simply wished to signal that Auer and Chevron are not doctrinally identical. Another interpretation is that the note communicates the view of the Court’s conservative majority that certain policy arguments for upholding Auer do not apply to statutory interpretation. Indeed, the Court conceded that legal interpretations (as opposed to issues dependent on scientific or technical expertise) are within the bailiwick of judges. Thus, Kisor could signal that Chevron—which sets forth a rule of deferring to agencies on precisely these seemingly more “legal” questions—would be vulnerable to the kind of head-on challenge that Auer ultimately (albeit narrowly) survived.44
Were Chevron to fall, FDA would no longer be entitled to deference on its interpretation of the Federal Food, Drug and Cosmetic Act. That would be a dramatic development that could invite an open season on challenges to administrative agency action. We are not at that point yet, but Kisor suggests that the future of deference to agency interpretations of statutes is not bright. FDA-regulated parties—and FDA itself—should take note, and hone their powers to persuade.
While not a blockbuster win for either side, Kisor created a series of new ambiguities that will take some time to iron out. In the four months since the decision has issued, the case has been cited frequently, and with mixed results. However, Kisor has not yet been cited by a court assessing a direct challenge to an FDA interpretation of its own regulation. Further cases, particularly those with more challenging facts and a direct focus on FDA, will provide greater clarity regarding the ongoing vitality of Auer, and the magnitude of Kisor’s impact on FDA-regulated entities.
What does seem clear already, however, is that FDA faces a more uncertain future than it did pre-Kisor. Although FDA will often continue to receive deference in cases involving application of its specialized scientific knowledge to specific factual circumstances, 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.
- 139 S. Ct. 2400 (2019).
- 519 U.S. 452 (1997).
- Kisor, 139 S. Ct. at 2414. Auer deference is analogous in certain respects to Chevron deference, the doctrine calling for judicial deference to agency interpretations of statutes enacted by Congress, which is derived from a 1984 Supreme Court case called Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).
- Mullins Coal Co. of Va. v. Dir., Office of Workers Comp. Programs, 484 U.S. 135, 159 (1987).
- Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512 (1994) (internal quotation marks omitted).
- Christopher v. SmithKline Beecham Corp., 567 U.S. 142, 158 n. 17 (2012) (internal quotation marks omitted).
- Auer, 519 U.S. at 461 (internal quotation marks omitted).
- Decker v. Nw. Envtl. Def. Ctr., 568 U.S. 597, 620-21 (2013) (Scalia, J., concurring in part and dissenting in part).
- Kisor v. Shulkin, 869 F.3d 1360, 1367-68 (Fed. Cir. 2017).
- Petition for Writ of Certiorari, Kisor, 139 S. Ct. 2400 (No. 18-15), at 14-16.
- Kimberly Hermann, Symposium: The Supreme Court and the forgotten “Three Ring Government”, SCOTUSBLOG (Jan. 29, 2019, 2:19 PM), https://www.scotusblog.com/2019/01/symposium-the-supreme-court-and-the-forgotten-three-ring-government/.
- Gillian Metzger, Symposium: The puzzling and troubling grant in Kisor, SCOTUSBLOG (Jan. 30, 2019, 10:22 AM), https://www.scotusblog.com/2019/01/symposium-the-puzzling-and-troubling-grant-in-kisor/.
- Kisor, 139 S. Ct. at 2415 (quoting Chevron, 467 U.S. at 843 n. 9).
- Id. (quoting Thomas Jefferson, 512 U.S. at 515).
- Id. at 2416 (quoting Arlington v. FCC, 569 U.S. 290, 296 (2013)).
- Id. at 2416-18 (internal citations and quotation marks omitted).
- Justice Thomas joined Justice Gorsuch’s full opinion concurring in the judgment. Justice Kavanaugh joined Parts I-V of Justice Gorsuch’s opinion, and Justice Alito joined Parts I-III.
- Id. at 2425 (Gorsuch, J., concurring in the judgment (quoting Paul Larking, Jr. & Elizabeth Slattery, The World After Seminole Rock and Auer, 42 HARV. J. L. PUB. POL’Y 625, 641 (2019) (internal quotation marks omitted)).
- Kisor, 139 S. Ct. at 2424-25 (Roberts, J., concurring in part).
- Id. at 2448 (Kavanaugh, J., concurring in the judgment).
- Id. at 2425 (Roberts, J., concurring in part); id. at 2449 (Kavanaugh, J., concurring in the judgment).
- Id. at 2415.
- Id. at 2417 (quoting Christopher, 567 U.S. at 155).
- See, e.g., Romero v. Barr, No. 18-1850, 937 F.3d 282, 292, 295-96 (4th Cir. 2019) (holding that the regulation at issue unambiguously conferred the Board of Immigration Appeals (“BIA”) with the authority to administratively close cases and that BIA’s new interpretation to the contrary would create “unfair surprise” and disrupt the expectations of the parties.); Sec'y of Labor v. Seward Ship's Drydock, Inc., 937 F.3d 1301, 1308-10 (9th Cir. 2019) (refusing to defer to an Occupational Safety and Health Review Commission (“OSHRC”) interpretation of an OSHA regulation that conflicted with its own previous interpretations of the regulation, as well as the interpretation of the Secretary of Labor, in connection with the obligation of employers to evaluate respiratory hazards in the work-place to determine whether respirators must be provided, because the regulation was unambiguous and the purpose of the regulation was clear from the regulatory history).
- Kisor 139 S. Ct. at 2413, 2417 (plurality opinion).
- Id. at 2417.
- 545 U.S. 967 (2005).
- Id. at 991.
- This distinction has been borne out in at least some, post-Kisor decisions. Compare United States v. Brace, No. 1:17-cv-00006 (BR), 2019 WL 3378394, at *20-21 (W.D. Pa. Aug. 12, 2019) (deferring to the Army Corps of Engineers’ definition of what constitutes “wetlands” because of the ambiguity of the relevant regulation, because “the determination of whether wetlands exist on a given site is a highly technical matter of science” and because the Corps’ interpretation was reasonable) with Braeburn Inc. v. FDA, 389 F. Supp. 3d 1 (D.D.C. 2019) (finding that FDA’s interpretation of the new drug exclusivity provisions under 21 U.S.C. § 355(c)(3)(E)(iii) was unreasonable and inconsistent with historical precedent, and, accordingly, should not be afforded deference despite the fact that such interpretation concerned an issue of scientific judgment).
- This review may in a given case include, inter alia, assessment of the regulatory language and history, prior agency interpretations of the same language, and the substantive arguments supporting an agency’s interpretation.
- Kisor, 139 S. Ct. at 2416. By contrast, where an agency is speaking authoritatively, it may continue to receive deference. See, e.g., Am. Tunaboat Ass'n v. Ross, 391 F. Supp. 3d 98, 114-15 (D.D.C. 2019) (affording deference because “the Service’s interpretation here is the ‘official position’ of the agency” and concluding that, “[g]iven that deference, it follows that the Service’s decision was not arbitrary or capricious”).
- Kisor, 139 S. Ct. at 2417 (quoting Exelon Generation Co. v. Local 15, Int’l Bhd. of Elec. Workers, 676 F.3d 566, 576-78 (7th Cir. 2012)).
- 21 C.F.R. § 10.115.
- Kisor, 139 S. Ct. at 2426 (Gorsuch, J., concurring in the judgment).
- Id. at 2424-26.
- 936 F.3d 628 (Aug. 10, 2019).
- Id. at 648-59, 668.
- Id. at 675 (quoting Kisor, 139 S. Ct. at 2415).
- Kisor, 139 S. Ct. at 2424.
- Id. at 2425.
- Notably, Chief Justice Roberts did not join Section II-A of Justice Kagan’s opinion, describing fact-intensive circumstances where deference is warranted, but did join Section II-B, where the Court observes that deference is less warranted for purely legal matters. back to top