Chevron’s Hard-Hitting Footnote Nine Revived
by Kisor v. Wilkie and Recent Decisions on Deference

By Chad Landmon, Alexander Alfano & Michelle Divelbiss

I. Introduction

Although we have all become accustomed to courts deferring to decisions made by the Food and Drug Administration (FDA) or other federal agencies under the Supreme Court’s Chevron test, such deference has come under increasing scrutiny by certain scholars and has been questioned during recent confirmation hearings for Supreme Court justices. Just last year in its Kisor v. Wilkie[1] decision, the Supreme Court had to wrestle with the Chevron framework, and many commentators before the decision was issued questioned if the Court was going to strike a blow against agency deference.

But, has Chevron changed since Kisor? At the heart of Kisor was the principle that deference to agency decisions only applied to genuinely ambiguous terms, and that most terms—after employing all standard tools of interpretation—have only one logical meaning. While the justices concurring in the judgment generally agreed that the decision had no effect on Chevron and simply clarified Auer deference,[2] two subsequent district court decisions addressing deference to FDA’s statutory interpretations tell a different story.[3] Despite some justices’ assertions to the contrary, it appears that the teachings of Kisor may lead district courts to more stringently consider statutory language under the Chevron analysis after all.

Chevron deference is a divisive topic. On one hand, Chevron provides seemingly straightforward guidance to determine first, whether the statute is clear, and second, whether the agency’s interpretation is reasonable. On the other hand, those two steps are ripe for disagreement and interpretation. Perhaps Chevron’s divisiveness arises at least in part from its uneven application, leading to unpredictability. While some judges may easily find language ambiguous, others might scour the record and refuse to consider unlikely constructions, leading only to one unambiguous interpretation. Since Kisor, however, it seems that courts have taken to heart Justice Kagan’s direction to leave no stone unturned in the search for meaning. This should be encouraging to practitioners and the regulated industries. Parties may now have an expanded ability to make creative arguments based on a deep dive into the statutory and regulatory language and history. Although challenging an agency decision in court is often an uphill battle,[4] it appears that courts will not simply defer to agency decisions when there are strong arguments against such decisions based on the statutory and regulatory language. Of course, only time will tell as we see further administrative challenges play out in court.

II. APA gives Courts power to review agency action

The Administrative Procedure Act (APA) grants federal courts jurisdiction to review actions taken by executive branch agencies like FDA. The APA states that “the reviewing court shall decide all relevant questions of law, interpret constitutional and statutory provisions, and determine the meaning or applicability of the terms of an agency action.”[5] The APA directs the reviewing court to “compel agency action unlawfully withheld or unreasonably delayed” and to “hold unlawful and set aside agency action, findings, and conclusions” that are, among other considerations, “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”[6] The APA thus establishes that judges are the decision makers of all questions of law properly before them and contemplates some level of deference if the agency’s interpretation of the statute is reasonable, i.e., not arbitrary, capricious, or an abuse of discretion.^[7]

Courts have created doctrinal tests to determine when and how much deference to give an agency’s interpretation of a statute or regulation. An agency’s interpretation of a statute is subject to the two-step Chevron test, which defers to an agency’s reasonable interpretation of ambiguous statutory language.^[8] Chevron deference requires the reviewing court to (1) determine whether Congress has directly spoken to the issue and give effect to Congress’s unambiguous intent; and then (2) defer to the agency’s interpretation if the statute is ambiguous unless that interpretation is not based on a permissible construction of the statute.^[9]

When reviewing an agency’s interpretation of a regulation, a court will apply Auer deference, which requires the court to defer to the agency’s interpretation of an ambiguous rule unless that interpretation is plainly erroneous or inconsistent with the regulation being interpreted.[10] This framework was further clarified in the 2019 Supreme Court decision Kisor v. Wilkie.[11]

III. Kisor – There must be genuine ambiguity for deference

A. Kisor Assesses the VA’s Interpretation of “Relevant”

Kisor v. Wilkie[12] involves a veteran, James L. Kisor, who applied for benefits from the Department of Veterans Affairs (VA) in 1982 for his yet-undiagnosed post-traumatic stress disorder (PTSD).[13] Although it was acknowledged that Kisor had participated in a particular military action that Kisor believed gave him PTSD, the VA psychiatrist failed to diagnose PTSD. As a result, the VA denied benefits. Decades later, in 2006, Kisor moved to reopen his claim for benefits, and this time, Kisor was diagnosed with PTSD. Accordingly, Kisor was granted benefits, but only retroactively from 2006, when he moved to reopen his claim, and not from 1982, when he had first applied.

Regulations provided that the VA could grant retroactive benefits back to 1982 if there were “relevant official service department records” that had not been considered at the time of the initial denial in 1982.[14] Although Kisor had presented new service records confirming his participation in the military action that had not been considered in the 1982 decision, the Board of Veterans’ Appeals found that the “records were not ‘relevant’ because they did not go to the reason for the denial—that Kisor did not have PTSD.”[15] After appealing to the Court of Appeals for Veterans Claims, which affirmed the interpretation of “relevant,” Kisor appealed to the Federal Circuit. The Federal Circuit found it ambiguous as to whether “relevant” records were those that “counter[ed] the basis of the prior denial” or “relat[ed] to the veteran’s claim more broadly.”[16] Although the Court found that there was an ambiguity as to the meaning of the term, it found that both interpretations were reasonable and subsequently invoked Auer deference. In applying deference to the agency’s interpretation, the Federal Circuit found that “[t]he agency’s construction of its own regulation would govern unless ‘plainly erroneous or inconsistent with the VA’s regulatory framework.’”[17] Kisor’s challenge was ultimately reviewed by the Supreme Court.

B. Justice Kagan Reiterates Requirements for Genuine Ambiguity

When the Supreme Court granted Kisor’s petition, opponents of administrative deference hoped that this would be the case to finally bring down the deference regime. Although those hopes were dashed, Kisor leaves open the possibility that destroying deference is still on some of the justices’ to-do lists.

One thing that Kisor did do, however, was reign in and clarify the bounds of Auer deference. Justice Kagan, writing for the majority, explained that “Auer deference retains an important role in construing agency regulations,” and in upholding Auer, the Supreme Court “reinforce[d] its limits.”[18]

Quoting footnote nine of Chevron, Justice Kagan explained that “a court must exhaust all the ‘traditional tools’ of construction” before finding ambiguity.[19] Kagan emphasized that:

the possibility of deference can arise only if a regulation is genuinely ambiguous. And when we use that term, we mean it—genuinely ambiguous, even after a court has resorted to all the standard tools of interpretation.[20]

As if trying to teach through repetition, Justice Kagan repeated twelve times throughout the majority opinion that ambiguity must be genuine. With this repetition, Kagan might be implying that courts have previously resorted to calling something ambiguous when it is not truly and genuinely ambiguous. Perhaps this emphasis was a nod to then-Judge Gorsuch’s claim that agency deference is “a judge-made doctrine for the abdication of the judicial duty.”[21] Alternatively, maybe Kagan was framing ambiguousness as Justice Scalia might have—rarely finding ambiguity because using tools of construction will not often result in a genuinely ambiguous term or regulation.[22]

Speculation aside, Justice Kagan wrote that Auer deference “gives agencies their due, while also allowing—indeed, obligating—courts to perform their reviewing and restraining functions.”[23] And, paying respect to one of the most vocal opponents of deference, Kagan cited to Justice Scalia’s dissent in Pauley v. BethEnergy Mines, Inc.:  “A regulation is not ambiguous merely because ‘discerning the only possible interpretation requires a taxing inquiry.’”[24] One of the more surprising aspects of the majority opinion was that the Supreme Court clarified that deference is not always appropriate:  “[N]ot every reasonable agency reading of a genuinely ambiguous rule should receive Auer deference.”[25] The court should determine “whether the character and context of the agency interpretation entitles it to controlling weight”[26] and assess whether “Congress intended to invest interpretive power” in that agency.[27] Such deference is not appropriate if the decision or interpretation is not “the agency’s authoritative or official position,” does not “implicate [the agency’s] substantive expertise,” or does not reflect “fair and considered judgment.”[28]

Justice Kavanaugh, joined by Justice Alito, concurred in the judgment and wrote separately to emphasize two points. First, Kavanaugh pointed out that:

the majority borrows from footnote 9 of this Court’s opinion in Chevron to say that a reviewing court must “exhaust all the traditional tools of construction” before concluding that an agency rule is ambiguous and deferring to an agency’s reasonable interpretation.[29]

Justice Kavanaugh also explained that “[i]f a reviewing court employs all of the traditional tools of construction, the court will almost always reach a conclusion about the best interpretation of the regulation at issue.”[30] Although Kavanaugh believes that “[f]ormally rejecting Auer would have been a more direct approach, [] rigorously applying footnote 9 should lead in most cases to the same general destination.”[31] The second point that Kavanaugh made was to clarify his agreement with Chief Justice Roberts—that this decision is not regarded as having addressed Chevron deference.

Turning the focus back to the majority opinion, the Supreme Court found that “the Federal Circuit jumped the gun in declaring the regulation ambiguous” when it did not “make a conscientious effort to determine, based on indicia like text, structure, history, and purpose, whether the regulation really has more than one reasonable meaning.”[32] Additionally, the majority noted that “the Federal Circuit assumed too fast that Auer deference should apply in the event of genuine ambiguity” because “[a] court must assess whether the interpretation is of the sort that Congress would want to receive deference” before actually applying that deference.[33]

IV. Administrative Interpretations in a Post-Kisor Regime

In less than a year, Kisor has made its mark on administrative deference, but it is unknown how consequential that mark is. It is unclear how closely lower courts are listening to Justice Kagan’s instructions to use “all the standard tools of interpretation”[34] to determine whether something is genuinely ambiguous. Although the Supreme Court’s majority opinion in Kisor cited Chevron and referred to Chevron deference several times, Chief Justice Roberts and Justice Kavanaugh stated unequivocally that they do not believe that Kisor addressed Chevron deference.[35]

Two notable cases against FDA have come through the U.S. District Court for the District of Columbia and shed some light on administrative deference in a post-Kisor era:  Braeburn Inc. v. FDA[36] and Athenex Inc. v. Azar.[37]

A. Braeburn Successfully Disputes FDA’s Interpretation of “Conditions of Approval”

Braeburn involves the interpretation of the statutory language “the conditions of approval” in the Federal Food, Drug, and Cosmetic Act (FDCA),[38] which was challenged by Braeburn Inc. (Braeburn) as being arbitrary and contradictory. Braeburn’s product, Brixadi, “delivers buprenorphine through an injectable depot that releases buprenorphine over either a weekly or monthly period.”[39] Both the weekly and monthly products were tested on de novo patients, patients who have not previously taken buprenorphine, and non-de novo patients, patients who have previously taken or are currently taken buprenorphine.[40]

After going through the approval process outlined in the FDCA, Brixadi received tentative approval for both Brixadi Weekly and Monthly, and final approval of Brixadi Weekly was contingent on the submission of proposed labeling to FDA. Brixadi Monthly, however, was not eligible for final approval until expiration of the three-year exclusivity for Indivior’s buprenorphine drug product, Sublocade, which is also administered monthly.[41]

In a letter from FDA explaining that Brixadi Monthly was not yet eligible for final approval, FDA explained that the phrase “the conditions of approval” was interpreted to “mean that the FDA may not approve any application under § 355(b) for a drug product that shares the exclusivity-eligible drug’s ‘innovation represented by its approved drug product that is supported by new clinical investigations essential to approval.’”[42] FDA’s interpretation “prevents the FDA from approving a drug application if the applied-for drug [e.g., Brixadi Monthly] shares a quality that the FDA deems another drug sponsor to have innovated and to have obtained approval for in the prior three years [e.g., Sublocade].”[43]

FDA explained that based on “the conditions of approval,” “Sublocade blocked [approval of] Brixadi Monthly because both are ‘a monthly depot buprenorphine product to treat moderate to severe [opioid use disorder].’”[44] Dissatisfied with FDA’s interpretation of “the conditions of approval” and wanting final approval for Brixadi Monthly, Braeburn sued FDA.

B. “Conditions of Approval” is “Genuinely Ambiguous” and Proceeds to Chevron Step Two

The court determined that “whether an already-approved drug product bars final approval of a later product [here, Brixadi Monthly,] depends . . . on the overlap between ‘the conditions of approval’ of the two products.”[45] In applying Chevron step one, the court found that there are at least four plausible readings of the phrase “the conditions of approval.” Therefore, “Congress has [not] directly spoken to the precise question at issue” because “the statute is silent or ambiguous with respect to the specific issue.”[46]

In proceeding to Chevron step two, the court (citing Kisor) analyzed whether “the agency reasonably construed the statutory language, a standard that the agency can fail.”[47] In doing so, “an agency must give a reasonable explanation for how its interpretation serves the statute.”[48] FDA “failed to say which factors in the clinical studies were important for its determination,”[49] and therefore did not provide a reasonable explanation for its interpretation. Instead, FDA interpreted “the conditions of approval” “to limit exclusivity to instances in which a follow-on drug product shares the ‘innovation’ supported by the first product’s ‘new clinical investigations essential to approval.’”[50] This interpretation has the effect of prohibiting approval of a second drug during the three years of exclusivity for the first drug “no matter the two products’ differences, if the [second] product incorporates the first’s innovative features.”[51]

The court plainly rejected FDA’s interpretation and found that “FDA’s standard simply supplants the ambiguous phrase ‘the conditions of approval’ for the ambiguous term ‘innovation,’”[52] highlighting the unreasonableness of its explanation. Not only was FDA’s explanation unreasonable in the eyes of the court, but it was also inconsistent with previous FDA decisions.

During the exclusivity approval process for Sublocade, FDA found that the drug was “not novel relative to previous buprenorphine drug products” but “was the first product demonstrated to safely and effectively treat moderate-to-severe [opioid use disorder] through a monthly buprenorphine depot.”[53] FDA found that the administration of Sublocade on a monthly basis was novel and “innovative” in light of existing buprenorphine products, and that the novelty was deserving of exclusivity.

Comparing Brixadi Monthly with Sublocade, the court questioned why FDA found that a monthly administration was “innovative” and “novel relative to previous buprenorphine drug products” and thus deserving of approval and exclusivity but that testing on different patient populations was not “innovative” and “novel.”[54] Sublocade had been tested only on “new-to-treatment [opioid use disorder] patients ‘who have initiated treatment . . . followed by a dose adjustment for a minimum of 7 days.’”[55] In contrast, Brixadi Monthly had been tested on patients “new-to-treatment and [patients] transitioning from prior buprenorphine treatment.”[56] Even though the patient populations were different, FDA did not address any differences in the drug product based on the patient population treated; FDA found that Brixadi was not “innovative” or “novel” relative to Sublocade, and was not deserving of approval over Sublocade’s exclusivity.[57]

In support of its argument that FDA was acting inconsistently, Braeburn demonstrated that FDA had previously approved exclusivity for a drug, Envarsus XR, when the only difference between it and the existing dug was in the patient population treated.[58] Specifically, Envarsus XR was approved and granted exclusivity for its use in treating “conversion patients” (non-de novo patients) because the first drug was only approved for de novo patients.[59]

The court explained that it is well-settled that an agency decision is not “reasonable and reasonably explained”[60] if “it exhibits internally inconsistent reasoning”[61] and if the agency “offer[s] insufficient reasons for treating similar situations differently.”[62] Based on the differences in the patient populations, the court found inconsistencies in both FDA’s rationale and actions; FDA’s interpretation was therefore not reasonable but instead was arbitrary and capricious, and FDA’s action must be set aside.[63]

In evaluating whether the statutory language “conditions of approval” was ambiguous, the court seems to have used all of the tools of construction at its disposal to determine the meaning of the disputed phrase. Nevertheless, the court ultimately reasoned that the language was ambiguous, particularly in light of FDA’s inconsistent actions. Although the Supreme Court made clear that Kisor dealt with Auer deference regarding regulations and not Chevron deference regarding statutes, it seems that the Braeburn court kept Kisor in mind as it searched for tools to discern the meaning of “conditions of approval.”

Less than two weeks after the Braeburn decision, the district court issued its opinion in Athenex Inc., v. Azar,[64] which also addressed administrative deference.

C. Athenex Cannot Overcome FDA’s Interpretation of “Clinical Need”

Athenex Inc. (Athenex) operated an outsourcing facility to use a bulk drug substance, vasopressin, to compound a drug product. An outsourcing facility may sell compounded drugs if certain statutory requirements are met. At issue here is the statutory requirement that there must be a “clinical need” for the bulk drug substance.[65]

In March 2018, FDA issued a draft guidance regarding how it will determine whether there is a “clinical need” and, in March 2019, issued a final guidance on the subject.[66] FDA’s guidance explained that for the “clinical need” analysis, FDA will consider whether there is “an attribute of the FDA-approved drug product [that] makes it medically unsuitable to treat certain patients” and whether “the drug product proposed to be compounded is intended to address that attribute.”[67] If the answer to either is no, then a “clinical need” will not be found. If the answer to both determinations is yes, then there must also be “a basis to conclude that the drug product proposed to be compounded must be produced from a bulk drug substance rather than from an FDA-approved drug product.”[68]

FDA had determined that vasopressin is not a “bulk drug substance for which there is a clinical need” because there is already an approved drug on the market that fulfills the “clinical need.”[69] Based on this guidance, Athenex would not be able to continue using vasopressin to compound their drug product unless FDA determined there was a “clinical need” and put vasopressin on the “clinical need” list.[70]

In challenging FDA’s decision, Athenex argued that “clinical need” is determined by “asking whether there is a therapeutic use for the bulk drug substance.”[71] Athenex argued that, even though there was an approved drug, Vasostrict, it “was medically unsuitable to treat certain patients because:  (1) Vasostrict contains chlorobutanol, an allergen for some patients, and (2) it is not available in ready-to-use form but must be diluted before use.”[72] Therefore, Athenex’s product, which is free from the allergen and is in ready-to-use form, fills a “clinical need.”

FDA disagreed because it interpreted “clinical need” as a currently unfulfilled clinical need. In support of its position, FDA argued that an allergen-free formulation of Vasostrict already exists and that an absence of the ready-to-use form does not make a product inadequate for a “clinical need.”[73] Athenex and FDA’s interpretations hinged on opposite sides of whether “clinical need,” as used in the FDCA, means any clinical or therapeutic use or an unmet clinical or therapeutic use.

D.  “Clinical Need” Is Not Genuinely Ambiguous

In applying Chevron step one, the court first looked at whether “clinical need” was defined by Congress and determined that it does not appear in the FDCA or in the U.S. Code.[74] Next, in finding that “need” means “circumstances in which something is necessary,” the court found the term to be relative and ambiguous and “must be measured against some point of reference.”[75]

In an attempt to resolve the ambiguity, the court looked to ascertain Congress’ intent:  “Congress plainly thought that there are some bulk drug substances for which there is a ‘clinical need’ and others for which there is not.”[76] Based on this, the court found that if “clinical need” meant any clinical or therapeutic use, as Athenex argued, then any bulk substance would meet a clinical need and there would be no need for FDA to evaluate whether or not there is a “clinical need” at all, making the inquiry meaningless.[77]

By determining that congressional intent resolves the meaning and any purported ambiguity of “clinical need,” the court found that FDA prevailed at Chevron step one. Nevertheless, even if the ambiguity had not been resolved, the court explained that FDA would have prevailed at Chevron step two because its interpretation was reasonable and “based on a permissible construction of the statute.”[78]

Here, as in Braeburn, the meaning of a statute is at issue, which invokes a Chevron analysis. Despite some justices in Kisor explicitly stating that they do not believe that Kisor addressed the issue of Chevron deference,[79] the Athenex court seems to have applied Kisor’s teachings to its Chevron analysis. In its analysis, the court exhausted at least some tools of construction when it ascertained Congressional intent. Even absent Congressional intent, any other construction would have rendered FDA’s determination of a “clinical need” superfluous. The court seemed to take Kisor to heart when it resorted to various tools of construction as a first line of inquiry and not brushing past it and declaring deference. Based on Braeburn and Athenex, the court seems to have taken Kisor’s lessons seriously in rigorously exercising tools of construction before finding ambiguity, even in the face of statutory construction that would normally invoke Chevron.

V. CONCLUSION

In upholding Auer deference, the Supreme Court urged and instructed lower courts to conduct a thorough and detailed analysis of the agency’s interpretation. Although Kisor seems to have settled Auer deference for the time being, other deference challenges still lurk. In Kisor, Justice Gorsuch stated that the Supreme Court “[thought] it past time to [reconsider Auer], [and] granted the petition [for Writ of Certiorari].”[80] From Braeburn and Athenex, it seems likely that courts might abide and use “all the textual and structural clues”[81] before finding ambiguity, a method that Justice Scalia likely would have agreed with.[82] Even though Gorsuch thought it was time to reconsider Auer, maybe adherence to this more strict framework will appease the Supreme Court’s textualist justices.

With an unambiguous instruction from the Supreme Court to “exhaust all the ‘traditional tools’ of construction” before finding ambiguity,[83] the scope of possible interpretations for disputed terms will likely narrow. Practitioners will need to be intimately familiar with the purpose and history of a statute or regulation to be adequately prepared to defend a position. Moreover, detailed judicial inquiry should be expected. Nevertheless, there will still be debate over whether terms are genuinely ambiguous. Now, instead of a two-step Chevron analysis, most disputes will stop at step one. Some who have criticized Chevron for causing unpredictability might be placated for now, but Chevron and Auer might be on the chopping block once again if opponents of administrative deference continue to face an uphill battle in the fight against the deference regime.

 

[1] 139 S. Ct. 2400 (2019).

[2] Id. at 2425 (Roberts, C.J., concurring in the judgment) (“I do not regard the Court’s decision today to touch upon [Chevron deference].”); id. at 2449 (Kavanaugh, J., concurring in the judgment) (“‘I do not regard the Court’s decision’ not to formally overrule Auer ‘to touch upon the latter question [of Chevron deference].’”).

[3] See Athenex Inc. v. Azar, 397 F. Supp. 3d 56 (D.D.C. 2019); Braeburn Inc. v. FDA, 389 F. Supp. 3d 1 (D.D.C. 2019).

[4] See Chad Landmon, Alexander Alfano & Michelle Divelbiss, Open the Floodgates: The Potential Impact on Litigation Against FDA if the Supreme Court Reverses or Curtails Chevron Deference, 74 Food & Drug L.J. 358 (2019).

[5] 5 U.S.C. § 706 (2018).

[6] Id.

[7] Ronald A. Cass, Auer Deference: Doubling Down on Delegation’s Defects, 87 FORDHAM L. REV. 531, 537 (2018).

[8] EPA v. EME Homer City Generation, L.P., 572 U.S. 489, 512 (2014).

[9] Chevron U.S.A. Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 842–43 (1984).

[10] Auer v. Robbins, 519 U.S. 452 (1997).

[11] 139 S. Ct. 2400 (2019).

[12] Id.

[13] See id. at 2409.

[14] Id.; 38 C.F.R. § 3.156(c)(1) (2013).

[15] Kisor, 139 S. Ct. at 2409.

[16] Id. (quoting Kisor v. Shulkin, 869 F.3d 1360, 1366–67 (Fed. Cir. 2017)).

[17] Id.

[18] Id. at 2408.

[19] Id. at 2415 (quoting Chevron U.S.A. Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 843 n.9 (1984)).

[20] Id. at 2414.

[21] Gutierrez-Brizuela v. Lynch, 834 F.3d 1142, 1152 (10th Cir. 2016).

[22] See, e.g., Hon. Antonin Scalia, Judicial Deference to Administrative Interpretations of Law, 3 Duke L.J. 511, 521 (1989) (“One who finds more often (as I do) that the meaning of a statute is apparent from its text and from its relationship with other laws, thereby finds less often that the triggering requirement for Chevron deference exists.”).

[23] Kisor, 139 S. Ct. at 2415.

[24] Id. (quoting Pauley v. BethEnergy Mines, Inc., 501 U.S. 680, 707 (1991) (Scalia, J., dissenting)).

[25] Id. at 2416.

[26] Id.

[27] Id. at 2417 (quoting Martin v. Occupational Safety & Health Review Comm’n, 499 U.S. 144, 153 (1991)).

[28] Id. at 2416–17 (internal quotations omitted).

[29] Id. at 2448 (Kavanaugh, J., concurring in the judgment).

[30] Id.

[31] Id.

[32] Id. at 2423-24 (majority opinion).

[33] Id. at 2424.

[34] Id. at 2414.

[35] Id. at 2425 (Roberts, C.J., concurring in the judgment) (“I do not regard the Court’s decision today to touch upon [Chevron deference].”); id. at 2449 (Kavanaugh, J., concurring in the judgment) (same).

[36] Braeburn Inc. v. FDA, 389 F. Supp. 3d 1 (D.D.C. 2019).

[37] Athenex Inc. v. Azar, 397 F. Supp. 3d 56 (D.D.C. 2019).

[38] See 21 U.S.C. § 355(c)(3)(E)(iii) (2012) (barring final approval under certain conditions).

[39] Braeburn Inc., 389 F. Supp. 3d at 5.

[40] See id. at 12.

[41] See id.; 21 U.S.C. § 355(c)(3)(E)(iii).

[42] Braeburn Inc., 389 F. Supp. 3d at 13.

[43] Id.

[44] Id.

[45] Id. at 20.

[46] Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 842–43 (1984).

[47] Braeburn Inc., 389 F. Supp. 3d at 21 (citing Kisor v. Wilkie, 139 S.Ct. 2400, 2416 (2019)).

[48] Id. at 23 (citing Mako Commc’ns, LLC v. FCC, 835 F.3d 146, 150 (D.C. Cir. 2016)).

[49] Chad Landmon, Alex Alfano & Ashton Copeland, Insight: Recent FDA Court Decision Shows Potential Impact of SCOTUS Deference Decision, Bloomberg Law (Aug. 20, 2019), https://news.bloomberglaw.com/us-law-week/insight-recent-fda-court-decision-shows-potential-impact-of-scotus-deference-decision.

[50] Braeburn Inc., 389 F. Supp. 3d at 23.

[51] Id.

[52] Id. at 24.

[53] Id. (emphasis added).

[54] Id.

[55] Id. at 28.

[56] Id. at 12.

[57] See id. at 28–30.

[58] See id. at 30–31.

[59] See id.

[60] Id. at 28 (quoting ANR Storage Co. v. FERC, 904 F.3d 1020, 1024 (D.C. Cir. 2018)) (internal quotations omitted).

[61] Id.

[62] Id. (quoting Cal. Cmtys. Against Toxics v. EPA, 928 F.3d 1041, 1057 (D.C. Cir. 2019)) (internal quotations omitted).

[63] See id. at 30.

[64] 397 F. Supp. 3d 56 (D.D.C. 2019).

[65] See id. at 58.

[66] Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act, Guidance for Industry, U.S. FDA (Mar. 2019), https://www.fda.gov/media/121315/download.

[67] Id. at 11.

[68] Id.

[69] Athenex Inc., 397 F. Supp. 3d at 58.

[70] Additionally, a substance may be put on the “drug shortage” list to gain approval for drug compounding with bulk drug substance, but that list is not at issue here.

[71] Athenex Inc., 397 F. Supp. 3d at 58 (emphasis added).

[72] Id. 62.

[73] See id.

[74] See id. at 64.

[75] Id.

[76] Id.

[77] See id. at 69 (where Athenex’s interpretation “would violate a basic rule of statutory construction”).

[78] Id. at 73 (quoting Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 843 (1984)).

[79] See Kisor v. Wilkie, 139 S.Ct. 2400, 2425 (2019) (Roberts, C.J., concurring in the judgment) (“I do not regard the Court’s decision today to touch upon [Chevron deference].”); id. at 2449 (Kavanaugh, J., concurring in the judgment) (same).

[80] Id. at 2431(Gorsuch, J., concurring in the judgment).

[81] Wisconsin Central Ltd. v. United States, 138 S. Ct. 2067, 2074 (2018).

[82] See, e.g., Pauley v. BethEnergy Mines, Inc., 501 U.S. 680, 707 (1991) (Scalia, J., dissenting) (“Chevron is a recognition that the ambiguities in statutes are to be resolved by the agencies charged with implementing them, not a declaration that, when statutory construction becomes difficult, we will throw up our hands and let regulatory agencies do it for us.”).

[83] Kisor, 139 S. Ct. at 2415 (quoting Chevron U.S.A. Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 843 n.9 (1984)).