UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

VANDA PHARMACEUTICALS, INC.,

Plaintiff,

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Civil Action No. 23-280 (TSC)

Defendants,

and

TEVA PHARMACEUTICALS USA, INC.,

Intervenor-Defendant.

MEMORANDUM OPINION

Plaintiff Vanda Pharmaceuticals, Inc. has sued the Food and Drug Administration

(“FDA”); its Commissioner, Robert M. Califf; the Department of Health and Human Services; and

its Secretary, Xavier Becerra (collectively, “Defendants”). Am. Suppl. Compl. ¶¶ 9–13, ECF No.

44-1. Plaintiff alleges that Defendants violated the Administrative Procedure Act (“APA”) in

approving an application by Teva Pharmaceuticals USA, Inc. (“Teva”) to market the generic drug

tasimelteon, and in denying Plaintiff’s petition to revoke that approval. Id. ¶¶ 3–8. Teva

intervened as a defendant, see Feb. 5, 2023 Min. Order, and the parties have cross-moved for

summary judgment. For the reasons set forth below, the court will DENY Plaintiff’s Motion for

Summary Judgment, ECF No. 47; GRANT Teva’s Cross-Motion for Summary Judgment, ECF

No. 48; and GRANT Defendants’ Cross-Motion for Summary Judgment, ECF No. 50.

Page 1 of 29 I. BACKGROUND

A. Statutory and regulatory framework

The Federal Food, Drug, and Cosmetic Act (“FDCA”) requires that drug manufacturers

apply for and receive FDA approval before marketing any new drugs.

(a). When

a drug is the first of its kind, applicants must submit extensive information about its safety,

effectiveness, composition, production, and labeling.

§ 355(b)(1)(A). The FDA must carefully

evaluate that information—verifying its accuracy and considering the new drug’s risks and

benefits—before approving an application. Id. § 355(d). The process of securing approval for

such “pioneer” drugs is thus often “expensive and time-consuming.” Am. Bioscience, Inc. v.

Thompson,

(D.C. Cir. 2001).

In contrast, if a manufacturer seeks approval to market a generic version of a pioneer drug

that the FDA has already approved, it can do so through an abbreviated new drug application

(“ANDA”).

(j). The ANDA need not provide independent evidence that the

proposed generic drug is safe or effective for its intended use. Instead, it must show that the generic

drug is “the same” as its pioneer counterpart.

(j)(2)(A)(i)–(v), 355(j)(4)(B)–(G);

, 314.127. That showing allows the generic manufacturer to “piggyback[] on

the original manufacturer’s evidence of safety and efficacy,” Teva Pharms., USA, Inc. v. Leavitt,

(D.C. Cir. 2008), and thus to “develop generic drugs inexpensively, without

duplicating the clinical trials already performed on the equivalent brand-name drug,” PLIVA, Inc.

v. Mensing,

, 612 (2011). “In creating this shortcut, Congress sought to encourage

the development of generic drugs to increase competition and lower prices,” Amgen Inc. v.

Hargan,

(D.D.C. 2018) (citation and quotation marks omitted), thereby

increasing the availability of beneficial drugs without introducing any new dangers.

Page 2 of 29 By law, each ANDA must contain certain information demonstrating that the generic drug

is the same—and therefore as safe—as the pioneer one. For instance, the ANDA must show that

(1) the generic drug is “bioequivalent” to the pioneer drug; (2) its active ingredients, route of administration, strength and dosage form are “the same as” those of the pioneer drug; and (3) the inactive ingredients are not “unsafe for use under the conditions prescribed, recommended, or suggested in the labeling proposed for the drug.”

Zeneca, Inc. v. Shalala,

(4th Cir. 2000) (quoting

(j)(4)(C), (D),

(H)).

Two ANDA requirements are particularly relevant here. First, the FDCA requires each

ANDA to “show that the labeling proposed for the new drug is the same as the labeling approved

for the [pioneer] drug.”

(j)(2)(A)(v). That showing matters because the FDA’s

approval of the pioneer drug depends on whether it is “safe for use under the conditions prescribed,

recommended, or suggested in the proposed labeling thereof,” and whether its label is “false or

misleading.”

§ 355(d). The FDCA does not require that showing, however, if there are label

“changes required . . . because the new drug and the [pioneer] drug are produced or distributed by

different manufacturers.” Id. § 355(j)(2)(A)(v). FDA regulations elaborate on that exception and

provide potential examples, explaining that such label changes “may include differences in

expiration date, formulation, bioavailability, or pharmacokinetics, labeling revisions made to

comply with current FDA labeling guidelines or other guidance, or omission of an indication or

other aspect of labeling protected by patent or accorded exclusivity.”

(a)(8)(iv).

The FDA has interpreted the “different manufacturers” exception to permit generic

manufacturers to depart from the pioneer drug label where the original manufacturer had

“voluntarily adopted” certain standards “that are more onerous or rigorous than the standards FDA

Page 3 of 29 has determined are necessary.” Corrected Confidential J.A. at 357, ECF No. 59-1 (“J.A.”). 1 For

example, the FDA has approved generic labels that included “only one disposal method where the

[pioneer drug] labeling included two,” or “did not include halal and kosher certifications in their

labeling, where the [pioneer drug] did,” or “did not include a statement about peanut protein testing

included in the [pioneer drug] labeling.”

. Likewise, the FDA has approved a generic

drug label that “included an ingredient safety warning that was not in the [pioneer drug] labeling,

where the generic manufacturer chose to formulate its product with a different inactive ingredient.”

Finally, the FDA has “also considered differences in font, color, trade name, and other trade

dress to be permissible differences due to different manufacturers,” noting that “nearly all generic

drug product labeling” changes at least some of those aspects from the original brand-name drug

label.

The second relevant ANDA requirement is related to the first: Each ANDA must “show

that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the

new drug have been previously approved” for a pioneer drug.

(j)(2)(A)(i). The

FDA defines “conditions of use” to refer to “how, to whom, and for which purposes a drug product

is administered.” J.A. at 890. There are no exceptions to this requirement.

B. Factual record

This case involves medication developed to treat Non-24-Hour Sleep-Wake Disorder

(“Non-24”). Mem. in Supp. of Pl.’s Mot. Summ. J. at 4, ECF No. 47-1 (“Pl.’s MSJ”). Non-24 is

a “chronic disorder in which the body cannot synchronize its internal circadian rhythmicity—the

process that regulates the sleep-wake cycle—with the 24-hour day.”

(citing J.A. at 500, 508–

1 The court’s citations to the J.A. refer to the Bates number of the cited page in the administrative record—e.g., this citation to page 357 corresponds to the J.A. page labeled “FDA000357,” even though that is the 180th page of the docketed PDF file containing the J.A.

Page 4 of 29 21). Individuals affected by Non-24 experience patterns of sleep, body temperature, and hormone

rhythm that misalign with ordinary day-night cycles, leading to nighttime insomnia and excessive

daytime sleepiness.

at 4–5 (citing J.A. at 509–10, 512–13). People suffering from blindness

are frequently affected by Non-24 because they do not “register the light signals which are needed

to fine-tune the body clock to a 24-hour day.”

at 5 (quoting J.A. at 511). The FDA “estimate[s]

that over half of totally blind individuals suffer from Non-24 and that approximately 100,000

people in the United States have the disorder.”

(quoting J.A. at 524).

In 2014, the FDA granted Plaintiff approval to market the drug tasimelteon under the brand

name “Hetlioz.” J.A. at 880. Hetlioz treats Non-24 by “bind[ing] to and activat[ing] receptors in

the brain for melatonin, a hormone that regulates the sleep cycle.” Am. Suppl. Compl. ¶ 20.

During the new drug application process, Plaintiff voluntarily proposed including braille lettering

on the Hetlioz label to assist blind individuals in reading it. J.A. at 477. While the FDA did not

require that inclusion, it did require Plaintiff “to provide a certified translation of the braille; to

justify [the] decision not to include more information in braille; and to conduct a labeling

comprehension study to assess the risk that braille could cause medication errors.” Federal Defs.’

Opp’n to Pl.’s Mot. for Summ. J. & Mem. in Supp. of Cross-Mot. for Summ. J. at 9, ECF No. 50-

1 (“Defs.’ MSJ”) (citing J.A. at 282–88, 568, 570, 876–78); see J.A. at 904. The FDA also required

Plaintiff to include two printed statements in bold Roman script on the label: “Dispense in original

container” and “Do not cover Braille.” J.A. at 696–99. Plaintiff complied with those requirements.

“Thus, the approved container label for Hetlioz includes” those two printed statements, along with

“the Hetlioz name and [20 mg] dosage strength in both Roman script and braille.” Defs.’ MSJ at

9 (citing J.A. at 719–51); see Am. Suppl. Compl. ¶ 47 (displaying approved label).

Page 5 of 29 In 2018, Teva submitted an ANDA, seeking approval to market generic tasimelteon—and

proposing a label without braille lettering. J.A. at 9. The FDA’s review of the ANDA involved

consultation with several internal offices about the lack of braille. Id.at 19–21 (record of initial

labeling review); see also

at 24–39, 42–57, 69–89, 90–112, 120–41 (reiterating these

consultations in subsequent labeling reviews). Two officials from the Division of Psychiatry

initially expressed uncertainty, indicating that they were “not sure that folks for whom the product

is intended could use the product safely if they can’t read the label. . . . So, even if [the original

manufacturer] didn’t need to add braille, now that they have it, it seems like it might be less safe

to not have braille on the generics.”

. But the Medical Officer in the Office of New

Drugs did not perceive any significant safety concerns, stating that while the Hetlioz label’s braille

was “a nice idea (and probably helps with public relations) . . . , the Agency did not require it,”

and that he did not see a “need to require generic manufacturers to include braille.”

.

Based on these responses, the FDA ultimately determined that the braille labeling, while “nice to

have,” was “not a requirement for the generic products” because it “was not [a] condition of

approval” for Hetlioz.

. The FDA also recommended that Teva remove the printed

statements “Dispense in original container” and “Do not cover Braille” from its label, as they were

no longer necessary. Defs.’ MSJ at 9–10 (citing J.A. at 4, 10, 12, 19, 22).

The FDA granted Teva approval to market its generic version of tasimelteon in December

2022, shortly after Plaintiff’s exclusive license to a patent on tasimelteon expired. Teva’s

Combined Cross-Mot. for Summ. J. & Opp’n to Pl.’s Mot. for Summ. J. at 7, 10, ECF No. 48-1

(“Teva’s MSJ”) (citation omitted). Teva’s finalized label, like Hetlioz’s, stated the product name

and dosage strength in Roman script, along with instructions for use and storage. J.A. at 10. But

in addition to some differences in font, arrangement, and design, Teva’s label did not include

Page 6 of 29 braille lettering restating its product name and dosage, and did not include the printed statements

“Dispense in original container” or “Do not cover Braille.” Compare Am. Suppl. Compl. ¶ 47

(displaying Hetlioz label), with

(displaying Teva’s generic label). Teva began marketing

its generic tasimelteon on December 28, 2022. Teva’s MSJ at 10.

C. Procedural posture

Soon after Teva began marketing generic tasimelteon, Plaintiff challenged its ANDA

approval in proceedings before the FDA and this court. On January 25, 2023, Plaintiff filed a

“citizen petition” with the FDA—a procedure for interested parties to ask the FDA “to issue,

amend, or revoke a regulation or order.”

(a); see J.A. at 474–489. Plaintiff’s

petition “demand[ed] that the Commissioner of Food and Drugs immediately revoke the approval”

of Teva’s ANDA and “order a recall of Teva’s product.” J.A. at 474. It contended that because

Teva’s label lacked braille and the two accompanying printed statements, it violated laws requiring

generic labels to be the same as, and to include the same conditions of use as, the original pioneer

drug label.

at 474–75. And it warned that those differences “pose[d] grave danger to public

health and patient safety.”

.

Plaintiff brought this suit six days after filing the citizen petition and sought a preliminary

injunction eight days after that. See Compl., ECF No. 1; Pl.’s Mem. in Supp. of Mot. for Prelim.

Inj., ECF No. 7-1 (“Mot. for Prelim. Inj.”). The arguments Plaintiff raise here mirror those in its

citizen petition: that Teva’s approval violated “the statutory and regulatory requirements that an

ANDA holder propose the same labeling and same conditions of use as the [brand-name] drug of

which it is a generic,” and that it “risk[ed] substantial public-health harms.” Compl. ¶¶ 3–4; see

J.A. at 474. Thus, Plaintiff raises claims under the APA, asserting that the approval was both

“contrary to law” and “arbitrary and capricious.”

¶¶ 126–38 (citing

(2)). The

Complaint asks the court to declare Teva’s ANDA unlawful, vacating or suspending its approval, Page 7 of 29 then to compel FDA to recall all of Teva’s generic tasimelteon, destroying or properly relabeling

it. Compl. at 29. Plaintiff sought essentially the same relief in a preliminary injunction. Mot. for

Prelim. Inj. at 42 (seeking “a preliminary injunction suspending FDA’s approval of Teva’s

unlawfully approved ANDA” and forcing a “recall [of] all product produced pursuant to this

ANDA”). The court granted Teva’s motion to join the case as an intervenor-defendant. Feb. 5,

2023 Min. Order.

Both of Plaintiff’s initial challenges were rebuffed. This court denied the preliminary

injunction in March 2023, explaining that Plaintiff “failed to meet its burdens with respect to clear

showings on irreparable harm, the balance of equities, and the public interest.” Tr. of Hr’g on

Mot. for Prelim. Inj. at 44:25–45:5, ECF No. 36; see Order, ECF No. 30. Several months later,

the FDA denied Plaintiff’s citizen petition, reasoning that “the omission of braille on the generic

tasimelteon products’ container labeling is a permissible difference due to difference in

manufacturer,” that “omitting the special instructions, ‘Dispense in original container” and “Do

not cover Braille’ on the container labeling for the generic tasimelteon products [does not] violate[]

the ‘conditions of use’ requirements,” and that “the differences in labeling . . . do not raise any

safety concerns.” J.A. at 895; see

at 879–95. Following a consent motion from the parties, the

court granted Plaintiff leave to file the Amended and Supplemental Complaint, which added

allegations and legal challenges related to the citizen petition’s denial. Mar. 4, 2024 Min. Order;

see generally Am. Suppl. Compl.

Before the court are cross-motions for summary judgment from Plaintiff, Defendants, and

Teva. Plaintiff argues that the approval of Teva’s ANDA and the denial of Plaintiff’s petition are

unlawful because they violate the sameness requirements for generic labels and conditions of use,

and because the FDA’s decision-making was arbitrary and capricious. See Pl.’s MSJ at 1–4.

Page 8 of 29 Defendants and Teva contest each of those arguments and seek judgment rejecting Plaintiff’s

claims and validating the FDA’s actions. Defs.’ MSJ at 1–4; Teva’s MSJ at 1–4. The parties’

motions all rely on the Joint Appendix, which compiles the relevant portions of the administrative

record.

II. LEGAL STANDARD

Federal Rule of Civil Procedure 56(a) provides that the court “shall grant summary

judgment if the movant shows that there is no genuine dispute as to any material fact and the

movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). In an APA challenge,

however, a district court may only set aside agency action that is “arbitrary, capricious, an abuse

of discretion, or otherwise not in accordance with law.”

(2)(A). And because that

standard turns on the evidence and law before the agency, “the focal point for judicial review

should be the administrative record already in existence, not some new record made initially in the

reviewing court.” Camp v. Pitts,

(1973). “The entire case on review is a

question of law.” Am. Bioscience,

(citation and quotation marks omitted). The

challenging party bears the burden of establishing that the agency action violated the APA. Pierce

v. SEC,

(D.C. Cir. 2015).

Plaintiff claims that the FDA’s actions were both (1) arbitrary and capricious and (2) not

in accordance with law, and those two claims implicate distinct legal standards. An agency “acts

arbitrarily or capriciously if it ‘has relied on factors which Congress has not intended it to consider,

entirely failed to consider an important aspect of the problem, offered an explanation for its

decision that runs counter to the evidence before the agency, or is so implausible that it could not

be ascribed to a difference in view or the product of agency expertise.’” Am. Wildlands v.

Kempthorne,

, 997–98 (D.C. Cir. 2008) (quoting Motor Vehicle Mfrs. Ass’n v. State

Farm Mut. Auto. Ins. Co.,

(1983)). A court “is not to substitute its judgment for Page 9 of 29 that of the agency.” State Farm,

. And where the agency action relied on a

“scientific determination” within “its area of special expertise,” a court “must generally be at its

most deferential.” Balt. Gas & Elec. Co. v. Nat. Res. Def. Council, Inc.,

(1983).

Evaluating a claim that agency action is contrary to law necessarily involves interpreting

the relevant statutes and regulations. The Supreme Court recently held that “courts must exercise

independent judgment in determining the meaning of statutory provisions.” Loper Bright Enters.

v. Raimondo,

, 2262 (2024). In doing so, however, courts may “seek aid from the

interpretations of those responsible for implementing particular statutes. Such interpretations

‘constitute a body of experience and informed judgment to which courts and litigants may properly

resort for guidance’ consistent with the APA.”

(quoting Skidmore v. Swift & Co.,

(1944)). But before reaching any conclusion, the “court must exhaust all the traditional

tools of construction”—considering the law’s “text, structure, history, and purpose.” Kisor v.

Wilkie,

(2019) (citation and quotations marks omitted).

III. ANALYSIS

Plaintiff challenges the approval of Teva’s ANDA—and the FDA’s denial of its citizen

petition to revoke that approval—on three grounds. First, that Teva’s changes to the generic

tasimelteon label violated the statutory same-label requirement and were not permitted by the

exception for different manufacturers. Second, that the changes unlawfully altered the drug’s

conditions of use. And third, that the FDA’s decision-making process was arbitrary and capricious

in several respects. All three challenges fail.

A. Same-labeling requirement

The FDA did not unlawfully approve Teva’s ANDA, which proposed a generic label

without braille lettering voluntarily included on the Hetlioz label, but provided the same

Page 10 of 29 information in printed Roman text, and which the FDA concluded would not affect the drug’s

safety or efficacy.

1. Statutory construction Plaintiff’s first claim is that Teva’s ANDA did not comply with the FDCA requirement to

contain “information to show that the labeling proposed for the new drug is the same as the labeling

approved for the [pioneer] drug.”

(j)(2)(A)(v); see

(a)(8)(iv).

As noted above, there is an important exception to that same-label requirement, allowing for label

“changes required . . . because the new drug and the [pioneer] drug are produced or distributed by

different manufacturers.”

(j)(2)(A)(v); see

(a)(8)(iv). The

primary inquiry here is the scope of that different-manufacturer exception—specifically, whether

it permitted the FDA to approve Teva’s ANDA despite lacking the braille lettering and

accompanying printed statements that appeared on the Hetlioz label. After considering all the

“traditional tools of construction”—the law’s “the text, structure, history, and purpose,” Kisor,

(citation and quotations marks omitted)—the court concludes that the approval was

lawful.

“In addressing a question of statutory interpretation, we begin with the text.” Eagle

Pharms., Inc. v. Azar,

(D.C. Cir. 2020) (quoting City of Clarksville v. FERC,

(D.C. Cir. 2018)). Unless the law specifies otherwise, courts apply its plain

meaning. FCC v. AT&T Inc.,

(2011). But a provision’s meaning is not always

plain from its words, especially if they are read in isolation. See, e.g., Yates v. United States,

, 537 (2015) (“Ordinarily, a word’s usage accords with its dictionary definition. In law

as in life, however, the same words, placed in different contexts, sometimes mean different

things.”).

Page 11 of 29 Here, the parties diverge in defining key words in the different-manufacturer exception.

Take the term “required,” for instance, which often means “need[ed]” or “necessary.” Require,

Webster’s Third New Int’l Dictionary 1929 (1986). Plaintiff focuses heavily on that definition,

asserting that the exception authorizes only labeling changes “demand[ed] by virtue of a law,

regulation, etc.,” such that it “does not apply” where “it was clearly possible” for a generic

manufacturer to perfectly imitate the brand-name drug label. Pl.’s Combined Reply. in Supp. of

Pl.’s Mot. for Summ. J. & Opp’n to Defs.’ Cross-Mots. for Summ. J. at 5, ECF No. 52 (“Pl.’s

Reply) (quoting Require, Webster’s New World Dictionary 1208 (2d coll. ed. 1986));

;

see Pl.’s MSJ at 27. But “required” can also mean “suitable or appropriate in a particular case.”

Require, Webster’s Third New Int’l Dictionary 1929 (1986). Defendants appear to favor this

definition instead, contending that the exception “permits labeling differences that flow from a

generic manufacturer’s permissible choices about its proposed product,” with permissibility

“determined on a case-by-case basis, considering the statutory and regulatory requirements and

the effect of the difference on safety and efficacy.” Defs.’ MSJ at 2; see also Teva’s Reply in

Supp. of Cross-Mot. for Summ. J. at 4–5, ECF No. 54 (“Teva’s Reply”).

That’s not the only definitional dispute. The parties also offer competing interpretations

of the word “because” in the exception. Teva observes that “because” is typically understood in

statutes “to indicate only ‘but-for’ causation—i.e., ‘the [effect] would not have occurred in the

absence of—that is, but for— [the cause].’” Teva’s MSJ at 17 (quoting Univ. of Tex. Sw. Med.

Ctr. v. Nassar,

, 347–348, 350 (2013)). Thus, it contends, the exception allows label

changes “for which the existence of a new manufacturer is a but-for, but not sole, cause.”

Plaintiff argues instead that “because” must be read alongside the preceding word “required” to

allow changes caused only by “the presence of a different manufacturer.” Pl.’s Reply at 4, 12–14.

Page 12 of 29 The briefing thus illustrates the range of possible interpretations for the different-

manufacturer exception’s bare text. On the one hand, if “required” is interpreted broadly and

“because” refers to but-for causation, the exception might be read to permit label changes so long

as they are merely convenient for and chosen by the generic manufacturer. On the other hand, if

“required” and “because” are understood in their strictest senses, all label changes are prohibited

unless “it would be impossible for a generic manufacturer to use the same labeling as the brand

manufacturer.” Defs.’ MSJ at 29; Pl.’s Reply at 26. Thus, depending on the definitions selected,

the very same words in the different-manufacturer exception could be read to permit almost all

generic label changes, or almost none at all.

The court need not consider the full spectrum of the exception’s possible meanings,

however, because the parties rightly agree on several critical limiting principles. To begin,

everyone agrees that the exception does not wholesale authorize “any change that FDA elects to

approve”—a reading that would defeat the same-label requirement. Pl.’s Reply at 9; see Federal

Defs.’ Reply in Supp. of Cross-Mot. for Summ. J. at 9, ECF No. 55 (“Defs.’ Reply”); Teva’s Reply

at 5–6. Rather, the FDA must—at the very least—ensure that a generic manufacturer’s proposed

changes fully comply with applicable statutory and regulatory provisions, including the safety and

efficacy requirements that the same-label requirement serves. Defs.’ Reply at 9–11; Teva’s Reply

at 5–6; see supra Section I.A. (explaining the relationship between

(j)(2)(A)(v)

and § 355(d)). At the other end of the spectrum, there is consensus that the exception permits at

least some changes to the label that reflect optional choices by the generic manufacturer, such as

“omitt[ing] halal or kosher certifications”, or “tinker[ing] with label colors or font.” Pl.’s Reply

at 21–22; see Defs.’ Reply at 6; Teva’s MSJ at 19. Plaintiff also acknowledges that label changes

reflecting “allowable product differences” are permitted. Pl.’s Reply at 26. Indeed, it seems likely

Page 13 of 29 that the parties’ respective interpretations of the exception would lead to the same conclusion about

whether most label changes are allowed.

The parties’ agreement substantially narrows the interpretive question before the court, and

two facts specific to this case narrow it even further. First, Plaintiff’s decision to include braille

lettering on the Hetlioz label was itself voluntary, not required by the FDA for safety or efficacy

reasons. See Defs.’ MSJ at 8–9 (citing J.A. 887, 904). Second, the information conveyed by that

braille lettering—the Hetlioz name and 20 mg dosage strength—was also printed in Roman script

on the label. Id. (citing J.A. 719–51). Consequently, the different-manufacturer exception presents

only the following, limited question: If a pioneer drug label includes a voluntary element that is

not necessary for safety, can the FDA approve a generic version of that label that chooses not to

adopt the voluntary element but still conveys the same information?

Reading the different-manufacturer exception’s text in accordance with its statutory

context, purpose, history, and precedent, the court concludes that the FDA did not unlawfully

approve Teva’s ANDA. As explained in Section I.A., the exception is nested within a broader set

of requirements that each ANDA contain information showing that the generic drug is the same as

is pioneer counterpart. See

(j)(2)(A). Those sameness requirements mirror the

showings of safety and efficacy that the pioneer drug manufacturer must make in its new drug

application.

§ 355(d). Here, the same-label requirement at issue corresponds to the required

showing for the pioneer drug that it is “safe for use under the conditions prescribed, recommended,

or suggested in the proposed labeling thereof,” and that its label is not “false or misleading.” Id.

That structural congruence strongly suggests that the ANDA requirements share the same function

as their counterparts for pioneer drugs: ensuring each drug’s safety and efficacy. See Leavitt,

. So long as the FDA adequately evaluates those concerns, see infra Section III.C., the

Page 14 of 29 statute’s structure does not suggest that the FDA must categorically reject generic label changes

like the omission of braille lettering. To the contrary, the FDCA should be read as “a symmetrical

and coherent regulatory scheme.” Mellouli v. Lynch,

, 809–10 (2015) (quoting FDA

v. Brown & Williamson Tobacco Corp.,

(2000)).

Relatedly, interpreting the different-manufacturer exception to allow the FDA to consider

generic proposals for safe changes to voluntary label features also aligns with how the FDCA treats

other ANDA requirements. For example, the FDCA does not demand that generic drugs be

chemically identical to pioneer drugs in every respect. Rather, it requires the same active

ingredients and a “bioequivalence” between the drugs—meaning that there is no “significant

difference” in their “rate and extent of absorption.”

(j)(2)(A)(ii), (j)(2)(A)(iv),

(j)(8)(B)(i). In this way, the FDCA provides for a degree of flexibility in the very formulation of

generic drugs, so long as they are similar enough to maintain the pioneer drug’s proven safety and

efficacy. The ANDA same-label requirement and the different-manufacturer exception should be

interpreted “consistent with th[at] statutory scheme.” Ass’n of Civilian Technicians, Inc. v. United

States,

(D.C. Cir. 2010); see

(“[W]ords are to be read in the context

in which they are used and in the broader context of the statutory scheme.”). It would be aberrant

to read the FDCA as permitting safe variation in a generic drug’s substance, but not in its label.

Given the broader statutory context and purpose, it is unsurprising that the FDA has

frequently approved ANDAs that proposed safe changes to optional features of the brand-name

drug label. Some such changes are expressly recognized by regulation, including label

“differences in expiration date, formulation, bioavailability, or pharmacokinetics.”

(a)(8)(iv). Other changes have received approval after an individualized determination,

including (1) “an ingredient safety warning that was not in the brand labeling where the generic

Page 15 of 29 manufacturer chose to formulate its product with a different inactive ingredient”; (2) “labeling that

did not include a statement about peanut protein testing included in the [brand] labeling”; (3)

“discussing only one disposal method where the [brand] labeling included two”; (4) “generic

product that did not include halal and kosher certifications in their labeling, where the [brand label]

did”; and (5) “differences in font, color, trade name, and other trade dress.” J.A. at 885. Plaintiff

does not contend that any of these approvals were unlawful.

The FDA’s repeated approvals of comparable changes in generic label ANDAs “‘constitute

a body of experience and informed judgment to which courts and litigants may properly resort for

guidance’ consistent with the APA.” Loper Bright, 144 S. Ct. at 2262 (quoting Skidmore,

). Moreover, they demonstrate that the FDA’s approval of Teva’s ANDA is

“consisten[t] with earlier and later pronouncements,” which adds further weight to the agency’s

interpretation here. Skidmore,

; see also, e.g., Alaska Dep’t of Env’t Conservation

v. EPA,

(2004) (explaining that, for these reasons, courts “normally accord

particular deference to an agency interpretation of ‘longstanding’ duration” (quoting Barnhart v.

Walton,

(2002))). While the FDA’s expertise and practice “lack[] power to

control” in this context, they supply ample “power to persuade” the court of the interpretation

underlying the approval of Teva’s ANDA. Skidmore,

.

Judicial precedent confirms that conclusion. While challenges like Plaintiff’s are rare,

courts that have reviewed analogous FDA approvals have universally upheld them. In Zeneca,

Inc. v. Shalala, a generic manufacturer elected to use a different inactive ingredient than the

pioneer drug had, and therefore proposed a label that included a changed warning specific to that

different inactive ingredient. 213 F.3d at 165–66. As in this case, the fact that the generic

manufacturer was different from the brand-name one did not compel it to change its label (or make

Page 16 of 29 the corresponding ingredient substitution). See

Nonetheless, the Fourth Circuit held that the

FDA’s approval of that change was consistent with the different-manufacturer exception, given

that it reflected “a permitted variation” and complied with FDA safety guidelines.

.

Teva’s ANDA likewise reflects an otherwise permissible (e.g., safe, effective, and accurate) choice

about its label.

The facts in Bristol-Myers Squibb Co. v. Shalala were similar.

(D.C. Cir.

1996). There, the FDA had approved a generic drug label even though it omitted one or more

“indications”— particular diseases or conditions that the drug can be used to treat—that were on

the brand-name label.

. FDA regulations expressly permit such omissions where the

brand label feature is “protected by patent” or otherwise “accorded exclusivity.”

(a)(8)(iv). In holding that the different-manufacturer exception “does accommodate”

such omissions, the D.C. Circuit relied on the FDCA’s structure, which required all conditions of

use included on the generic label to have been previously approved; but did not conversely require

all previously approved conditions of use to be included on the generic label.

(citations and quotation marks omitted). “In other words,” the Circuit explained, “the statute

expresses the legislature’s concern that the new generic be safe and effective for each indication

that will appear on its label; whether the label for the new generic lists every indication approved

for use of the pioneer is a matter of indifference.”

As explained above, the FDCA’s structure

conveys a similar message here: Congress’s concerns for safety and effectiveness obligated the

FDA to vet Plaintiff’s initial, optional inclusion of braille on the Hetlioz label, but the statute is

indifferent to the omission of that feature on Teva’s generic label—so long as removing the braille

did not implicate those concerns.

Page 17 of 29 The more recent opinions in Hill Dermaceuticals, Inc. v. FDA followed suit. No. 11-CV-

1950 (RCL),

(D.D.C. May 18, 2012), aff’d,

(D.C. Cir. 2013). That

case concerned a brand-name label statement detailing the specific peanut protein testing used for

the pioneer drug, which included refined peanut oil. Id. at *3. Years after the brand-name label

was approved, the FDA concluded that the specific peanut protein test was no longer necessary,

so long as the peanut oil met industry refining standards. Id. at *5. Accordingly, it advised against

including the statement about peanut protein testing on the drug label. Id. at *6. And when a

generic manufacturer proposed a label without the statement, the FDA allowed—though did not

require—that omission, relying on its determination that the test was “scientifically unnecessary

to protect the public health.” Id. at *6–7, *15–16. The district court found “ample evidence . . .

that the ‘different manufacturers’ exception allows the difference in labeling,” noting that the FDA

“thoroughly examined the facts and provided a reasoned explanation why” the change was

permissible. Id. at *17. The D.C. Circuit affirmed, relying in part on the regulation permitting

different-manufacturer changes “made to comply with current FDA labeling guidelines or other

guidance,”

(citing

(a)(8)(iv))—regardless of whether that

guidance is mandatory or, as in that case, optional.

While each of these cases involved different applications of the different-manufacturer

exception, their through-line is clear: Courts have consistently interpreted the exception to permit

approval of generic labels with changes resulting from the generic manufacturer’s otherwise

permissible design choices and shown to maintain the drug’s safety and effectiveness. That

interpretation is in keeping with the FDA’s longstanding position and practice, and it comports

with the core purposes of the FDCA’s requirements for ANDA approval. It is also particularly

appropriate here, where the braille lettering was not required for Hetlioz’s approval, and where

Page 18 of 29 Teva’s label conveys the same information in a different form. Accordingly, the FDA’s approval

of Teva’s ANDA did not violate the FDCA.

2. Plaintiff’s counterarguments Plaintiff advances a competing interpretation of the different-manufacturer exception and

raises several objections to any reading broader than its own. But Plaintiff’s preferred

interpretation is unworkable, and its objections are not persuasive enough to discard the settled

understanding of the FDCA.

Plaintiff initially reads the exception to say that if a generic manufacturer can match the

brand-name label, it must do so. See, e.g., Pl.’s MSJ at 27 (“Because it was clearly possible for

Teva to include Braille lettering, the different-manufacturer exception does not apply.”);

(“FDA has given away the game by admitting that generic manufacturers can include Braille

lettering on their label.”). But Plaintiff’s own concessions show that the interpretation cannot be

so straightforward. Plaintiff acknowledges, for instance, that the label difference in Zeneca

resulted from “the generic manufacturer’s choice to use a different preservative”—i.e., that the

generic label could have been the same, but was not. Pl.’s Reply at 24 (discussing Zeneca,

). Nonetheless, Plaintiff endorses the generic label’s approval in that case, as it does

for the FDA’s approval of other optional label changes, like omitting kosher and halal

certifications.

at 21–22.

Recognizing that tension, Plaintiff’s reply proposes a refined reading of the exception that

would prohibit only generic label changes that are “detached from the manufacturing process.”

at 6 n.3; id. at 15 (“Generic manufacturers may make certain choices in crafting their generic

products, and these decisions may trigger the different manufacturer exception to the same-

labeling requirement.”); see also id. at 21–22, 26. But that reading has its own problems. First, it

remains incompatible with Plaintiff’s continued insistence that the exception “authorizes only

Page 19 of 29 those labeling changes when the presence of a different manufacturer in fact requires the change.”

Id. at 4 (emphasis altered). The mere presence of a different generic manufacturer in Zeneca did

not compel it to change its preservative and label, for instance. See

. Second,

there is no basis in the different-manufacturer exception’s text for the carve-out Plaintiff proposes.

At best, then, Plaintiff’s proffered exception-to-the-exception could be understood as broadening

the possible scope of “required” changes based on inferences from the FDCA’s structure. But as

explained in the previous section, that structural analysis supports rather than undermines the

approval of Teva’s ANDA.

Moreover, Plaintiff’s allowance for what it artfully terms “manufacturer difference,” Pl.’s

MSJ at 28, does not account for another set of label changes that it concedes are permissible:

modifications that (like braille) alter the presentation—but not content—of information on the

label, such as “color or font.” Pl.’s Reply at 20. To be sure, some variations in trade dress could

be in a sense “required” to avoid intellectual property violations and thus “demand[ed] by virtue

of a law, regulation, etc.” as Plaintiff suggests. Id. at 5 (quotation omitted); see id. at 16 n.7, 19–

20; see also

(a)(8)(iv) (contemplating generic changes to “other aspect[s] of

labeling protected by patent or accorded exclusivity”). But that possible subset weighs little in the

analysis because the FDA is not in a position to parse legally necessary font and color changes

from merely voluntary ones. See Am. Bioscience,

(noting that the FDA, “based

on its acknowledged lack of expertise and resources, has refused to become involved” in

intellectual property disputes).

Page 20 of 29 As for all other changes to color and font, Plaintiff dismisses them as “de minimis” label

features and therefore permissible under the exception. Pl.’s Reply at 20.2 By contrast, Plaintiff

contends, braille lettering is critical for patient safety and access to tasimelteon—even though it

likewise alters only how information on the label is presented, not its content—and so considering

braille “a mere trifle is wrong, if not offensive.”

at 20–21. Notably, the FDA disagrees with

both assessments: It considers font important enough to require certain statements to be printed in

bold-face font and with a minimum size,

(d); and it determined that Teva’s label

need not include braille “for the safe and effective use of the product,” J.A. at 887. In any event,

however, arguments on this score belong in an arbitrary and capricious challenge. See infra

Section III.C. Plaintiff’s views on the relative benefits of printed Roman fonts versus braille

lettering are irrelevant to statutory interpretation, and cannot reconcile its inconsistent concession

that the different-manufacturer exception permits changing the one but not the other.

Plaintiff’s objections to broader readings of the exception are not persuasive. The main

one is that any interpretation permitting the approval of Teva’s ANDA would have no limiting

principles and therefore swallow the statutory same-label requirement. See, e.g., Pl.’s MSJ at 24,

Pl.’s Reply at 10–11, 13, 17. That is not true, for several reasons. To begin, there is no dispute

that the FDA could not approve generic label changes that made the generic drug unsafe, false, or

misleading. See

(d);

(a)(2); Pl.’s Reply at 9; Defs.’ Reply at 9;

Teva’s Reply at 5–6. And if an FDA approval erred in one of those respects, it could be challenged

on arbitrary and capricious grounds in the ordinary course of judicial review, as Plaintiff has done

here. See infra Section III.C. In addition, this case concerns only a change to a label’s form, not

2 This appears to be a change in Plaintiff’s position. In seeking a preliminary injunction, it expressly equated braille lettering with “bold-type or all-caps” printed Roman text that “gives patients important information in a helpful way.” Mot. for Prelim. Inj. at 23.

Page 21 of 29 its content—and the form was itself voluntary. Teva’s approved label displays in printed Roman

text the same information (drug name and dosage) that Plaintiff argues must also be presented in

braille. No party has argued that the different-manufacturer exception would permit substantive

changes to that information, or the omission of label elements required for the pioneer drug’s

approval. Given these limits, Teva cannot “merely choos[e] to jettison any safety warnings it

desires,” and FDA cannot “arrogate to itself sole discretion to decide whether to approve any

changes,” as Plaintiff protests. Pl.’s Reply at 9–10, 17. More broadly, the same-label requirement

will continue to serve its core function of ensuring that generic drugs are as safe and effective as

their pioneer counterparts.

Plaintiff also contends that any broader interpretation would ignore or erase statutory

language. First, it emphasizes the sameness requirement’s tethering to the “labeling approved for

the [pioneer] drug.” Pl.’s MSJ at 24–25 (quoting

(j)(2)(A)(v), (j)(4)(G)). But that

emphasis leaves open the key question in this case of whether the different-manufacturer exception

allows for deviation from that approved label. Second, Plaintiff insists that the word “required” in

that exception is superfluous unless its interpretation is adopted. Pl.’s Reply at 14. Not so. As

explained above, the word “required” has a range of possible meanings, and in context is best

understood in a way that permits the approval of Teva’s ANDA here but still substantially

constrains the kinds of generic label changes that the FDA may lawfully approve.

Finally, Plaintiff contends that its reading of the different-manufacturer exception is the

only one that leaves space for the other exception in § 355(j)(2)(A)(v), which allows a generic

manufacturer to file a “suitability petition” seeking authorization to change the “active ingredient,”

“route of administration, dosage form, or strength” of the drug. Pl.’s Reply at 11 (quoting

(j)(4)(G), (j)(2)(C)). That is incorrect. Teva, for example, could not have changed

Page 22 of 29 the active ingredient listed in its proposed label without also making that change in its drug—lest

the label be “false or misleading.”

(d). And it could not change the active

ingredient in its drug without filing a suitability petition.

§ 355(j)(2)(C). Consequently, that

label change could not be made under the different-manufacturer exception to the sameness

requirement, but instead would need to rely on the suitability-petition exception. No part of the

FDCA is rendered superfluous.

* * *

Interpreting the FDCA requires examining its text, structure, history, and purpose, along

with relevant agency and judicial precedent. Here, a holistic reading of the different-manufacturer

exception rebuffs Plaintiff’s challenge. The exception does not apply “merely because a generic

manufacturer would prefer” to change some aspect of the brand-name label. Pl.’s Reply at 23.

The FDA must review each proposed generic label and ensure that it is fully compliant with FDCA

requirements, including that the generic drug remains safe and effective as labeled, and that its

label is not inaccurate or misleading. But neither does the exception absolutely prohibit changes

to voluntarily adopted forms of presenting information on the brand-name label where the generic

one conveys the same information and the FDA has determined that the change will not diminish

the drug’s safety or efficacy. Because this case involves such a change, the FDA did not violate

the same-label requirement or its different-manufacturer exception in approving Teva’s ANDA.

B. Same conditions of use requirement

Plaintiff’s second basis for claiming that the FDA’s actions were contrary to law is the

FDCA provision requiring each ANDA to show that “the conditions of use prescribed,

recommended, or suggested in the labeling proposed for the new drug have been previously

approved for [the pioneer] drug.”

(j)(2)(A)(i). Plaintiff contends that the printed

statement “Dispense in original container” that accompanied the braille lettering on the Hetlioz Page 23 of 29 label is a condition of use, and that Teva’s label unlawfully omitted that statement. Pl.’s MSJ at

30–32.

To understand the term “conditions of use,” the court again begins with the plain meaning

of the text. In this context, “conditions” most naturally refers to “circumstance[s] that [are]

essential to the appearance or occurrence of something else.” Webster’s Third New Int’l

Dictionary 473 (1986). “Use” means “to put into action or service” or “to expend or consume by

putting to use,” or to “consume or take (as liquor or drugs) regularly.”

at 2523–2524. As a

whole, then, the term “conditions of use” denotes the circumstances that are essential to the

consumption or taking of the drug. Regulations reflect that meaning, noting in one instance that

“conditions of use” encompasses the “method or duration of administration or application” of a

drug.

(h)(5). And the FDA has explained it in even simpler terms: “how, to

whom, and for what purpose the drug is administered.” J.A. at 890 (citing ViroPharma, Inc. v.

Hamburg,

(D.D.C. 2013)).

The printed label statement “Dispense in original container” is not a condition of use. The

statement gives instructions to pharmacies for delivering the drug. It does not provide any

direction for the drug’s actual “use.” It does not explain how Hetlioz should be used, who should

use it, or the purposes it serves. Consequently, omitting the statement does not alter any of those

features. Unsurprisingly, the statement (and its counterpart “Do not cover Braille”) are grouped

separately on the Hetlioz label from the language that clearly qualifies as conditions of use, such

as “20 mg per day taken before bedtime, at the same time every night,” and “Hetlioz should be

taken without food.” Pl.’s MSJ at 8 (displaying Hetlioz label). Because “Dispense in original

container” does not pertain to the drug’s use, Teva’s omission of that statement did not change any

of the conditions of use originally included on the Hetlioz label.

Page 24 of 29 Even if the statement were considered a condition of use, it is not clear that its omission

would be unlawful. Section 355(j)(2)(A)(i) requires that all conditions of use included on the

generic label be previously approved, but does not necessarily require the converse: that all

previously approved conditions of use be included on the generic label. That is the structural

reasoning adopted by the D.C. Circuit in Bristol-Myers.

. Because Teva

undisputedly did not add anything to the label, therefore, it is difficult to see how it could have

failed to show that any additions were previously approved.

In any event, Plaintiff’s attempts to characterize the statement “Dispense in original

container” as a condition of use are unpersuasive. Plaintiff first seizes on the FDA’s description

of the statutory term as including “how . . . the drug product is administered,” Pl.’s MSJ at 15–16

(emphasis added), observing that one definition of “administer” is “dispense,” id. at 31, and thus

concluding that dispensing instructions are conditions of use. But Plaintiff’s stacking synonym on

synonym departs too far from the language of the statute, which is limited to the drug’s “use.”

(j)(2)(A)(i). The act of a pharmacy dispensing a drug, or of a patient receiving it,

does not amount to “use” of that drug in any reasonable sense of the word.

On a different tack, Plaintiff also asserts that “[i]f something on the label helps patients use

their drug safely, that is a ‘condition of use’ for the drug.” Pl.’s Reply at 29. Therefore, because

the Hetlioz bottle “can be identified by touch,” the instruction to “Dispense in original container”

assists patients in how they use the drug.

Again, however, instructions for dispensing a drug

are not the same as directions for actually using it, even if the former might have some incidental

benefit to the latter. Reading “conditions of use” to mean anything that might affect or relate to

conditions of use stretches the statutory text beyond plausibility. The approval of Teva’s ANDA

did not violate this requirement.

Page 25 of 29 C. FDA decision-making

Finally, Plaintiff argues that the FDA decisions approving Teva’s ANDA and denying

Plaintiff’s citizen petition were arbitrary and capricious for three reasons. First, the FDA “failed

to show that it was aware that its interpretation of the same-labeling requirement departed from its

former view.” Pl.’s MSJ at 32. Second, “it ignored record evidence detracting from its ultimate

conclusion.”

And third, it “entirely failed to consider an important aspect of the problem—its

approval of another tasimelteon ANDA that included Braille labeling—resulting in FDA treating

similarly situated ANDA applicants differently.”

Each of these reasons is fatally flawed.

Plaintiff’s contention that the FDA has unlawfully changed its position rests on the FDA’s

amicus brief in Mensing. See Br. for the U.S. as Amicus Curiae Supp. Resp’ts, PLIVA, Inc. v.

Mensing,

(2011) (Nos. 09-993, 09-1039, 09-1501),

(“FDA Br.”).

In particular, Plaintiff points to the FDA’s position “that an ANDA holder may not unilaterally

change its approved labeling.” Pl.’s MSJ at 33 (quoting FDA Br. at *16). But the FDA does not

endorse any such unilateral change here; instead, it acknowledges the statutory limits on

permissible changes to generic labels. See supra Section III.A. Regardless, there is a broader

reason why the FDA Brief does not support Plaintiff’s claim. Courts find unexplained changes in

agency position arbitrary and capricious only when comparing “factually and legally similar

contexts.” Fogo De Chao (Holdings) Inc. v. U.S. Dep’t of Homeland Sec.,

(D.C. Cir. 2014). The Mensing case involved only the FDCA’s same-label requirement for

ANDAs, not the different-manufacturer exception. See generally 564 U.S. at 612–13. Indeed, the

FDA expressly stated in that case that the exception was “not relevant.” FDA Br. at *17. Because

Mensing did not involve the different-manufacturer exception, it is not a basis for concluding that

the FDA’s position here treats “similar situations differently.” Fogo De Chao,

(quoting ANR Pipeline Co. v. FERC,

(D.C. Cir. 1995)). Page 26 of 29 Plaintiff likewise fails to identify evidence that the FDA “entirely failed to consider an

important aspect of the problem, offered an explanation for its decision that runs counter to the

evidence before the agency, or is so implausible that it could not be ascribed to a difference in

view or the product of agency expertise.’” Kempthorne, 530 F.3d at 997–98 (quoting State Farm,

).

To begin, Plaintiff claims that the FDA ignored evidence calling into question the safety

of omitting braille on Teva’s label, such as an internal comment expressing uncertainty whether

“it might be less safe to not have braille on the generic.” Pl.’s MSJ at 36 (quoting J.A. at 1, 20).

But the administrative record shows that even at the initial stage of approving Teva’s ANDA, the

FDA expressly considered that comment, as well as alternative internal analysis suggesting that

there were no safety concerns, before making its decision. J.A. at 1, 19–20; see id. at 915 (“The

various views of the individuals were considered by the [FDA] decisionmaker in reaching a

decision.”); id. at 882 n.31 (FDA “consider[ed] the totality of views” expressed in internal

comments). By the time the FDA reviewed Plaintiff’s citizen petition, moreover, the internal

comment expressing concern had been withdrawn, leaving FDA officials unanimous in their

opinion that omitting braille would not make Teva’s label unsafe. J.A. at 914–15, 919, 927.

Additionally, an FDA search of internal records found no reports of medication error or other

adverse consequences resulting from the omission of braille from the Teva label more than six

months after the drug entered the market. J.A. at 889–90, 907–08. The FDA also relied on findings

that “only 10% of the blind population reads braille” and that “other methods to convey labeling

information to the larger visually-impaired community” were adequate. J.A. at 888, 927.

Plaintiff insists that these opinions and findings should not outweigh the evidence it

submitted when it initially sought approval to include braille on the Hetlioz label and in its citizen

Page 27 of 29 petition. Pl.’s MSJ at 37. But it is not the court’s place to “substitute its own policy judgment”

where the agency has “reasonably considered the relevant issues and reasonably explained the

decision.” FCC v. Prometheus Radio Project,

, 1158 (2021) (citations omitted).

The FDA explained why it rejected the sole study cited in the citizen petition, for instance, detailing

why its methodology was problematic and its relevance to braille for tasimelteon dubious. J.A.

889, 929–30. The court’s review is “at its most deferential” for the FDA’s “scientific

determination,” “within its area of special expertise,” that Teva’s label would be safe and effective.

Balt. Gas & Elec., 462 U.S.at 103.

Lastly, Plaintiff relies on evidence that was not before the FDA either when it approved

Teva’s ANDA or when it rejected Plaintiff’s citizen petition. Citing five studies “available

online,” Plaintiff asserts that this evidence “would have turned up had FDA truly conducted an

independent search” for evidence on braille labeling. Pl.’s Reply at 37. Similarly, Plaintiff cites

a single customer complaint about the omission of braille that it received after the citizen petition

was denied.

at 35–36. “But of course, it is black-letter administrative law that in an APA case,

a reviewing court ‘should have before it neither more nor less information than did the agency

when it made its decision.’” Hill Dermaceuticals,

(quoting Walter O. Boswell

Mem’l Hosp. v. Heckler,

, 792 (D.C. Cir. 1984)). “Exceptions to that rule are quite

narrow and rarely invoked.” CTS Corp. v. EPA,

(D.C. Cir. 2014). Plaintiff has

not invoked any such exception here by contending, for instance, that “the procedural validity of

the agency’s action remains in serious question,” or that “the agency affirmatively excluded

relevant evidence.”

(citations omitted). Plaintiff’s extra-record evidence is therefore not

properly before the court.

Page 28 of 29 IV. CONCLUSION

For these reasons, the court will DENY Plaintiff’s Motion for Summary Judgment, ECF

No. 47; GRANT Teva’s Cross-Motion for Summary Judgment, ECF No. 48; and GRANT

Defendants’ Cross-Motion for Summary Judgment, ECF No. 50. A corresponding Order will

accompany this Memorandum Opinion.

Date: February 13, 2025

Tanya S. Chutkan TANYA S. CHUTKAN United States District Judge

Page 29 of 29