Court Opinion

ID: 9927351
Source: CourtListenerOpinion
Date Created: 2024-01-26 21:01:17.56806+00
Date Added: 2024-06-11T09:25:37.903428
License: Public Domain

UNITED STATES DISTRICT COURT
                                FOR THE DISTRICT OF COLUMBIA

VANDA PHARMACEUTICALS, INC.,

                 Plaintiff,

         v.                                                   Civil Action No. 1:22-cv-2775 (CJN)

UNITED STATES FOOD AND DRUG
ADMINISTRATION, et al.,

                 Defendants.

                                      MEMORANDUM OPINION

         The Federal Food, Drug, and Cosmetic Act requires the FDA to grant or hold a hearing on

new drug applications within a specified period of time. The FDA concedes that it has done neither

in this case and that the deadline has passed. The agency nevertheless contends that the Court

should not require it to act. The Court disagrees, and accordingly grants Vanda’s motion for

summary judgment in part, denies the FDA’s motion for summary judgment in part, and orders

the FDA to either finally resolve Vanda’s application or commence a hearing by March 5, 2024.

                                             I.    Background

         This case concerns the process by which the FDA approves or denies new drug

applications.

         1. Start with the statute. It requires that “within one hundred and eighty days after the

filing    of    [a   new      drug]   application . . . the    Secretary   shall   either . . . approve   the

application . . . or . . . give the applicant notice of an opportunity for a hearing before the

Secretary . . . on the question [of] whether such application is approvable.” 21 U.S.C. § 355(c)(1).

Thus, once an application has been filed, the FDA must within 180 days either approve it or let the

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applicant know it can request a hearing. The same provision goes on to say that “[i]f the applicant

elects to accept the opportunity for hearing by written request within thirty days after such notice,

such hearing shall commence not more than ninety days after the expiration of such thirty days

unless the Secretary and the applicant otherwise agree.” Id. § 355(c)(1)(B). The applicant thus

has 30 days after it gets notice of an opportunity for a hearing in which to accept; if it does so, the

agency has 90 days after that 30-day period has elapsed to begin the hearing. Adding these steps

together (and assuming the applicant accepts the opportunity for a hearing), the entire process from

application to commencement of hearing should take no longer than 300 days.

       2. The FDA has adopted regulations governing this process, which institute a different

timeline. Under the regulations, when the FDA receives an application, it is not deemed “filed”

until 60 days thereafter. See 21 C.F.R. § 314.101. Then, if the FDA “determines that [it] will not

approve the application . . . in its present form,” the agency will (by a date not spelled out in the

regulations) “send the applicant a complete response letter.” Id. § 314.110(a).

       After receiving a “complete response letter, the applicant must” either resubmit the

application after addressing any deficiencies, withdraw the application, or request an opportunity

for a hearing. Id. § 314.110(b). But requesting an opportunity for a hearing does not trigger a

hearing. Rather, such a request obligates FDA to provide notice of an opportunity for the applicant

to submit a second request for a hearing: “Within 60 days of the date of the request for an

opportunity for a hearing, or within a different time period to which FDA and the applicant agree,

the agency will either approve the application . . . or refuse to approve the application [and] give

the applicant written notice of an opportunity for a hearing.” Id. § 314.110(b)(3). The regulations

appear to permit the agency to satisfy this obligation by giving private notice to the applicant under

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§ 314.200(b): “FDA will provide the notice of opportunity for a hearing to applicants . . . by

delivering the notice in person or by sending it by . . . mail.”

       The regulations also require the FDA to provide public notice. The relevant provision

states that “FDA will publish the notice in the Federal Register and will state that the

applicant . . . has 30 days after the date of publication of the notice to file a written notice of

participation and request for hearing.” Id. § 314.200(a)(2).       The regulations do not appear to

include a deadline by which FDA must issue public notice. See Ex. D, Hughes Decl., ECF No.

14-4 (FDA taking this position in correspondence with Vanda). But public notice triggers the 30-

day period by which the applicant must submit the second request for a hearing. See 21 C.F.R. §§

314.200(a)(2), (c)(1)(i). That is important because “[i]f the Commissioner grants a hearing, it will

begin within 90 days after the expiration of time for requesting the hearing.” Id. § 314.200(g)(5).

       The FDA has also adopted what it calls “summary judgment” procedures.                 Those

procedures permit the agency to deny an applicant a hearing “if it conclusively appears . . . that

there is no genuine and substantial issue of fact which precludes the refusal to approve the

application.” Id. § 314.200(g)(1).

       3. This case concerns the drug Hetlioz® (tasimelteon), which the FDA approved in 2014

to treat non-24-hour sleep-wake disorder, “a condition in which an individual’s circadian rhythms

become misaligned with the 24-hour day.” Pl.’s Mem. in Supp. of Mot. for Summ. J. at 7, ECF

No. 13-1 (“Pl.’s Br.”). After conducting “several clinical trials and studies to examine whether

tasimelteon may be an effective treatment for Jet Lag Disorder,” on October 16, 2018, Vanda filed

a supplemental new drug application with the FDA for approval of the drug to be used to treat Jet

Lag Disorder. Id. On August 16, 2019 (304 days later), FDA issued a complete response letter

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stating that it would not approve the application in its present form. Ex. A, Hughes Decl., ECF

No. 14-1. 1

       After unsuccessful informal attempts to change the agency’s view, Pl.’s Br. at 8, Vanda

eventually requested an opportunity for a hearing on July 1, 2022, Ex. B, Hughes Decl., ECF No.

14-2. On August 26, 2022 (56 days later) the FDA gave Vanda a private notice of opportunity for

a hearing, but did not publish the notice in the Federal Register. Ex. C, Hughes Decl., ECF No.

14-3. Vanda accepted the private notice and requested a hearing under it. Ex. E, Hughes Decl.,

ECF No. 14-5.

       On September 13, 2022—74 days after Vanda’s request for an opportunity for a hearing—

the FDA had still not published public notice, and Vanda filed this action. Compl., ECF No. 1.

Vanda’s complaint focused primarily on FDA’s alleged failure to timely provide public notice.

See generally id.

       On October 11, 2022 (now 102 days after Vanda’s request for an opportunity for a hearing),

FDA published public notice in the Federal Register. Ex. F, Hughes Decl., ECF No. 14-6. Thirty

days later, Vanda requested a hearing under that public notice. Ex. G, Hughes Decl., ECF No. 14-

7. Ninety-eight days later, the FDA had not scheduled a hearing (or otherwise acted on Vanda’s

application), and Vanda filed an amended complaint adding claims regarding FDA’s failure to

provide a timely hearing. See generally Am. Compl., ECF. No. 11.

       On June 12, 2023—two hundred and sixty-two days after Vanda’s most recent request for

a hearing—the FDA’s Center for Drug Evaluation and Research (CDER) submitted a proposed

1
  The parties agree that the statutes and regulations covering new drug applications also apply to
supplemental new drug applications. See Pl.’s Br. at 4–5; Def.’s Mem. in Supp. of Cross-Motion
for Summ. J. at 2–3, ECF No. 21-1 (“Def.’s Br.”).

                                                4
order to the Secretary suggesting that the Secretary grant summary judgment against Vanda and

thereby deny Vanda a hearing. Ex. 2, Pl’s Status Rep., ECF. No. 29-2.

        4. As these events were unfolding, both parties moved for summary judgment on all claims

and on various grounds. Vanda seeks several forms of relief targeting different perceived defects

in FDA’s process. See Pl.’s Mot. for Summ. J., ECF No. 13. The FDA argues that some of

Vanda’s claims are moot and, most relevant here, that the Court should not order it to commence

a hearing by a date certain.

        At the January 11, 2024 oral argument on the parties’ motions, FDA represented that it was

anticipating that the Secretary would decide within the next six months whether to adopt CDER’s

proposed order and grant summary judgment against Vanda. Following oral argument, the FDA

filed a status report stating that, as of January 25, 2024, it “currently anticipates” that it will issue

a decision on whether to grant Vanda a hearing by April 12, 2024. ECF No. 30. The agency has

not, however, stated a date by which it would commence a hearing in the event that it decides that

summary judgment is not warranted.

        This opinion and associated order address Vanda’s claims that the Court should compel

the FDA to commence a hearing.

                                           II.   Discussion

        The FDA “concedes that it has not commenced the hearing here within the time required

by the statute”—i.e., that it “has violated the statute.” Jan. 11, 2024 Hearing. It would be untenable

to contend otherwise. After all, the statute requires that a hearing shall commence within 300 days

after an application is filed. Vanda’s application has been pending for almost 2,000 days and it

has been over 500 days since Vanda made its most recent request for hearing. FDA nevertheless

contends that the Court should not require it to comply with the statutory (or even regulatory)

deadlines.

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       1. The Administrative Procedure Act directs that courts “shall . . . compel agency action

unlawfully withheld or unreasonably delayed.” 5 U.S.C. § 706. Relying on that provision, Vanda

asks the Court to compel the FDA to commence a hearing. Both parties agree that such relief is

appropriate only if warranted by the principles laid out in Telecomm. Research and Action Ctr.

[TRAC] v. F.C.C., 750 F.2d 70 (D.C.Cir.1984). See Pl.’s Br. at 31–32; Def.’s Mem. in Supp. of

Cross-Motion for Summ. J. at 20, ECF No. 21-1 (“Def.’s Br.”).

       TRAC explained: (1) “the time agencies take to make decisions must be governed by a rule

of reason”; (2) “where Congress has provided a timetable or other indication of the speed with

which it expects the agency to proceed in the enabling statute, that statutory scheme may supply

content for this rule of reason”; (3) “delays that might be reasonable in the sphere of economic

regulation are less tolerable when human health and welfare are at stake”; (4) “the court should

consider the effect of expediting delayed action on agency activities of a higher or competing

priority”; (5) “the court should also take into account the nature and extent of the interests

prejudiced by delay”; and (6) “the court need not find any impropriety lurking behind agency

lassitude in order to hold that agency action is unreasonably delayed.” 750 F.2d at 80 (citations

omitted).

       2. The Court concludes that under those principles, the FDA’s delay in this case warrants

judicial intervention. Start with the first two factors. Congress has indeed provided a timetable

here that the agency acknowledges it has exceeded. The FDA’s arguments for why its “actions

are nonetheless reasonable,” Def.’s Br. at 21, are unavailing.

       The agency argues that the hearing is not that delayed relative to the timeline contemplated

in its regulations, which “provide that, if the Commissioner grants a hearing, it will begin within

120 days after the notice is published in the Federal Register.” Def.’s Br. at 21. There are two

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flaws with this argument. First, even if the FDA achieves the timetable it currently “anticipates,”

it will make a decision about whether to hold a hearing approximately 430 days after it was

required to do so by the regulations. (According to FDA’s current representations, that decision

will be made about 550 days after public notice was published, when the regulations required

action within 120 days).

       Second, the FDA’s regulations conflict with the tighter statutory requirements, “and a

regulation contrary to a statute is void,” Orion Reserves Ltd. P’ship v. Salazar, 553 F.3d 697, 703

(D.C. Cir. 2009). In particular, treating the date of public notice as the relevant date for analysis

ignores two statutory commands. For one, FDA’s focus on public notice is flawed because the

clock started when the FDA gave Vanda private notice. The statute states that FDA shall either

approve an application or “give the applicant notice of an opportunity for a hearing,” and “[i]f the

applicant elects to accept the opportunity for hearing by written request within thirty days after

such notice, such hearing shall commence not more than ninety days after the expiration of such

thirty days.” 21 U.S.C. § 355(c)(1). Thus, once the agency “give[s] the applicant notice of an

opportunity for a hearing,” the clock starts (assuming the applicant accepts). And here, when FDA

gave Vanda private notice, it “g[a]ve the applicant notice of an opportunity for a hearing” and

therefore started the clock. FDA cannot avoid that result by issuing regulations that tie the timeline

for a hearing to only a second form of notice (that itself has no deadline). The 120-day clock for

a hearing thus began on August 26, 2022 and the agency is on track to miss its deadline by about

480 days (not just 430 days).

       More fundamentally, substantial delays preceded either form of notice. Congress expressly

required that “within one hundred and eighty days after the filing of an application . . . the

Secretary shall either . . . approve the application . . . or . . . give the applicant notice of an

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opportunity for a hearing before the Secretary . . . on the question [of] whether such application is

approvable.” 21 U.S.C. § 355(c)(1). But here the FDA issued no notice until 1,400 days after

Vanda submitted its application. Taking that initial period of time into account, the FDA’s

contention that it has engaged in only a modest delay seems all the more tenuous. 2

       The agency also contends that injunctive relief is not warranted here because, under its

regulations, Vanda delayed by not requesting a hearing after the FDA issued its complete response

letter. Def.’s Br. at 22. But the statute requires the agency to either approve the application or

provide notice of an opportunity for a hearing within 180 days. Here, in contrast, it took the FDA

304 days after Vanda’s submission (or 242 days after the application was “filed” under the

regulations, which institute a 60-day delay before a submission is deemed filed) to issue a complete

response letter.

       The FDA also argues that it was impracticable to commence a hearing on the statutorily

mandated schedule because Vanda’s submission in support of its hearing request was voluminous,

totaling “nearly 14,000 pages.” Def.’s Br. at 21–22. But it appears that Vanda submitted a merely

77-page substantive brief and included the full text of referenced articles and declarations in its

submission—one of FDA’s own declarations itself describes Vanda’s filing as a “77-page

submission.” Stein Decl. ¶ 14, ECF No. 21-2. Moreover, much of the delay in this case seems to

2
  Of course, the statutory hearing deadline is not directly predicated on the date of filing. Rather,
the hearing deadline is based on the date notice was issued and the date by which notice must be
issued is tied to the date of filing. For the purposes of TRAC analysis, the Court’s discussion treats
the agency’s delays holistically. For one, doing so makes sense when assessing the reasonableness
of the delay and whether judicial intervention is warranted. For another, the agency itself points
to Vanda’s conduct before notice to justify the FDA’s delay. See Def.’s Br. at 22. In any event,
even if the Court were to ignore everything that came before notice and consider only the delay
between notice and the commencement of a hearing, FDA’s delay is substantial, and the Court’s
analysis would remain the same.

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stem from the FDA’s own staffing, resource, and procedural choices, not the complexity of

Vanda’s filings alone. See infra p. 10.

       3. FDA’s arguments on the third, fourth, and fifth TRAC factors focus heavily on In re

Barr Labs, Inc., 930 F.2d 72 (D.C. Cir. 1991). See Def.’s Br. at 23–26. In that case, the Court of

Appeals concluded that despite the FDA’s failure to comply with a 180-day deadline for

processing generic drug applications, no action was warranted because an order putting the

plaintiff “at the head of the queue [would] simply move[] all others back one space and produce[]

no net gain.” 930 F.2d at 75.

       Here, in contrast, there is no evidence that Vanda is attempting to jump a long queue.

Including the application at issue here, the FDA issued only four notices of an opportunity for a

hearing in the five years preceding summary judgment briefing in this case. See Stein Decl. ¶ 9.

And the FDA has not presented any evidence identifying any other delinquent hearing on a new

drug application currently scheduled ahead of Vanda’s that would be pushed back if the Court

ordered FDA to promptly commence a hearing on Vanda’s application. To the contrary, there is

no single decisionmaker that adjudicates all hearings. The agency appoints different presiding

officers for different hearings, making any tradeoff between Vanda’s and another hearing even

less likely. See Linowes Decl. ¶ 16, ECF No. 21-3.

       Moreover, any potential burdens on the FDA that swiftly commencing a hearing might

trigger have only dissipated over time. One of the FDA’s declarations (submitted in March of

2023) repeatedly emphasized that it is “the lack of a proposed order” by the agency sub-component

and lack of “response by Vanda” that would make commencing a hearing promptly “particularly

difficult.” Linowes Decl. ¶¶ 14, 15, 16. The proposed order and Vanda’s response have now been

on the books for months.

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       Overall, there appears to be real play in the joints. At oral argument, the FDA told the

Court that the “agency’s determination” that it needed six more months based on “the agency’s

weighing of . . . priorities” “should be dispositive.” Jan. 11, 2024 Hearing. Yet after oral

argument, the agency found the ability to cut about three months from that previously required

timeframe. See Def.’s Jan. 24, 2024 Status Rep.

       That is not surprising because at least some of the FDA’s delay stems from the agency’s

extra-statutory choices. For instance, the FDA has chosen to engage in a lengthy summary

judgment process (not present in Barr) before determining whether to move to a hearing. In fact,

FDA has spent more than fourteen months evaluating whether to grant summary judgment against

Vanda. The agency could shorten 3 or forego that step and provide hearings more promptly.

       The Court has no desire to superintend FDA’s process. But where Congress has codified

deadlines that the agency claims it cannot meet because of steps it has added to the process, it is

fair to question whether the agency’s hands really are tied.

       Another difference between this case and Barr is that Barr was decided in the context of

an FDA “personnel crisis that began in the summer of 1988.” Barr, 930 F.2d. at 74. Congress has

since “ameliorated” “the funding drought” to which Barr pointed. Sandoz, Inc. v. Leavitt, 427 F.

Supp. 2d. 29, 40 (D.D.C. 2006). Indeed, potentially “responding to the D.C. Circuit’s suggestion”

in Barr “that ‘perhaps Congress should earmark more funds’” to allow the FDA to act more

3
  Even if the agency were to maintain such a summary judgment procedure (assuming doing so is
statutorily permissible), it is not required to utilize layers of review that bog down the process.
Here for example, FDA did not simply review Vanda’s filings and issue a summary judgment
decision in one shot. Instead, CDER spent the better part of a year issuing a proposed order
suggesting that the Commissioner issue summary judgment against Vanda. The agency then told
the Court that it needs another year from the issuance of that proposed order before it can decide
whether to accept or reject that proposed order. Cutting down on these layers of review (which,
again, were not present in Barr) could speed the process up.

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quickly, Congress “create[ed] the [(Prescription Drug User Fee Act)] as a mechanism for making

additional funds available for . . . the review of human drug applications.” Id. (cleaned up).

Through that Act, Congress authorized the FDA to charge a fee to those who submit a new drug

application, which the agency can dedicate to deciding applications like Vanda’s. For example, in

Fiscal Year 2024, an applicant must pay the FDA more than $4,000,000 to review its application.

Prescription Drug User Fee Rates for FY 2024, 88 Fed. Reg. 48,881, 48,887 (2023). The FDA set

that fee in part based on its assessment of its needs for “strategic hiring and retention” and “the

resource capacity needs for the process for the review of human drug applications.” Id. at 48,882.

At the very least, the FDA does not appear to be suffering under the same types of staffing and

budgetary problems that the Court of Appeals highlighted in Barr.

                                                 *****

       In sum, the Court decides that the TRAC factors favor ordering the FDA to promptly

commence a hearing in this case. 4

                                           III. Conclusion

       For these reasons, Vanda’s Motion for Summary Judgment is GRANTED in part and the

FDA’s Cross Motion for Summary Judgment is DENIED in part.                   An order will issue

contemporaneously with this opinion compelling the agency to either finally resolve Vanda’s

application or commence a hearing on or before March 5, 2024.

DATE: January 26, 2024
                                                             CARL J. NICHOLS
                                                             United States District Judge

4
  Because the Court will issue relief under the APA, it need not address Vanda’s request for similar
relief under the Mandamus Act. See Ashtari v. Pompeo, 496 F. Supp. 3d 462, 471 (D.D.C. 2020).

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