UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
_________________________________________ ) VANDA PHARMACEUTICALS INC., ) ) Plaintiff, ) ) v. ) Case No. 24-cv-2514 (APM) ) FOOD AND DRUG ADMINISTRATION, et al., ) ) ) Defendants. ) _________________________________________ )
MEMORANDUM OPINION
I.
In September 2023, Plaintiff Vanda Pharmaceuticals, Inc. (“Vanda”) submitted a new drug
application (NDA) to Defendant Food and Drug Administration (FDA) seeking approval of its
drug tradipitant to treat gastroparesis symptoms in adults. Compl., ECF No. 1, ¶¶ 25–26. Nearly
a year later, in August 2024, Vanda learned that FDA had named Dr. Kathaleen Donohue as the
“signatory authority” for its NDA. Id. ¶ 28. That designation meant that Dr. Donohue would be
the FDA employee who would decide whether to approve Vanda’s NDA or issue a complete
response letter (CRL), which would afford Vanda the opportunity to provide additional information
before the agency made a final decision. Id. ¶¶ 20, 28. Vanda believed, however, that Dr. Donohue
lacked the authority to make that determination. Id. ¶ 38. According to Vanda, Dr. Donohue was
not qualified to make a binding agency decision primarily because she had not been properly
appointed as an inferior officer consistent with the Appointments Clause. Id. ¶¶ 37–42.
Vanda filed this suit and sought preliminary injunctive relief to halt Dr. Donohue’s review
of the NDA. Vanda Pharms. Inc. v. Food & Drug Admin., No. 24-cv-2514 (APM), 2024 WL 4263868, at *1 (D.D.C. Sept. 18, 2024). In response, FDA identified Dr. Donohue’s superior,
Dr. Nikolay Nikolov, as an alternative or additional signatory authority. Id. at *3. The agency
claimed that Dr. Nikolov was an inferior officer properly appointed by the Secretary of Health and
Human Services (HHS), thereby obviating any Appointments Clause issue. Id. The court denied
Vanda’s request for preliminary injunctive relief, finding that it had not established irreparable
harm. See id. at *2–3. The court also held that Vanda had not shown a likelihood of success on
the merits. Contrary to Vanda’s position, the court concluded that Congress had vested the
Secretary of HHS with the power to appoint inferior officers at FDA, including Dr. Nikolov,
consistent with the Appointments Clause. Id. at *3–5. On September 18, 2024, FDA issued a
CRL, signed by both Dr. Donohue and Dr. Nikolov, declining to approve Vanda’s NDA. Suppl.
Compl., ECF No. 26, ¶ 27.
Subsequent events changed the trajectory of this case. On January 16, 2025, FDA issued
Vanda a Notice of Opportunity for a Hearing, indicating that FDA intended to issue an order
refusing Vanda’s NDA. Proposal to Refuse to Approve a New Drug Application for
TRADIPITANT; Opportunity for a Hearing, 90 Fed. Reg. 4748 (Jan. 16, 2025). The Notice was
signed by the Director of the Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni.
Id. at 4750. Vanda then provided notice that it would participate in the process, and in March
2025, it provided “documentation and analysis in support of a request for summary judgment, or,
alternatively, a hearing.” See Defs.’ Suggestion of Mootness, ECF No. 45; Proceeding on the
Proposal to Refuse to Approve a New Drug Application for Tradipitant, Agency Decision,
ECF No. 45-1 [hereinafter Final Order], at 8.
A year later, on March 13, 2026, FDA issued a final order, signed by Principal Deputy
Commissioner, Dr. Sara Brenner, refusing a hearing because Vanda “ha[d] failed to raise a genuine
2 and substantial issue of fact with respect to the approvability of [its NDA].” Id. at 33–34. As part
of its final order, FDA rejected Vanda’s twin contentions that “NDA approval decisions must be
evaluated and signed by the Commissioner” and that the agency personnel who issued the CRL
lacked the authority to do so under the Appointments Clause. Id. at 30–32. It concluded the same
as to Dr. Brenner’s signing of the final order. Id.
Within a week, Vanda filed a petition in the D.C. Circuit seeking review of the refusal of
its NDA. See Vanda Pharms. Inc. v. FDA, No. 26-1064 (D.C. Cir.) [hereinafter Vanda Pharms.
Docket]. In its opening brief, Vanda raised a challenge under the Appointments Clause. Pet’r’s
Opening Br., Vanda Pharms. Docket, ECF. No. 2181999, at 21. Though directed primarily at
Dr. Brenner’s authority to reject the NDA, the underlying argument mirrors the one made in this
case. Id. at 57–62. Namely, Vanda argued that no statute or reorganization plan authorizes the
Secretary of HHS to appoint an inferior officer at FDA. Id.
II.
The parties’ dispositive cross-motions, which became ripe in March 2025, are now before
the court. Vanda’s Mot. for Summ. J., ECF No. 28; Defs.’ Cross-Mot. to Dismiss, ECF No. 30;
Defs.’ Cross-Mot. for Summ. J., ECF No. 31. Though this court arguably had jurisdiction to
resolve the parties’ dispute at first, it no longer does.
Under the Food, Drug, and Cosmetic Act, an FDA order “refusing or withdrawing approval
of” a drug application is directly reviewable by courts of appeals. 21 U.S.C. § 355(h). “Upon the
filing of such petition such court shall have exclusive jurisdiction to affirm or set aside such order
. . .” Id. Put differently, district courts are explicitly stripped of their jurisdiction to review an
FDA order refusing or withdrawing an application upon the filing of a petition challenging the
order. Cf. Bohon v. FERC, 92 F.4th 1121, 1122 (D.C. Cir. 2024) (making the same observation
3 about an exclusive jurisdiction statute for review of FERC orders). Thus, Vanda’s filing of a
petition in the D.C. Circuit foreclosed any review in this court of FDA’s refusal of Vanda’s NDA.
The petition’s filing also divests this court of jurisdiction to hear Vanda’s pending
Appointments Clause challenge. That is because, as a matter of “general administrative-law
principles,” “an agency’s subsidiary decisions merge into the final agency action, which is then
subject to review.” Mullin v. Doe, Nos. 25-1083 & 25-1084, 2026 WL 1825840, at *10 (U.S. June
25, 2026). “If the final agency action is unreviewable, then so too are subsidiary determinations.”
Id. Applied here, that means FDA’s “subsidiary determination[]” to issue a CRL “merge[d]” into
its final decision refusing the NDA. Because the latter decision is not reviewable in this court,
neither is the “subsidiary” decision to issue a CRL. This court therefore lacks jurisdiction to hear
Vanda’s Appointments Clause challenge.
At the oral hearing on the motions, Vanda argued that merger principles were inapplicable
here because its challenge is to the process that led to the NDA’s refusal and favorable relief would
ensure that properly appointed officials would review any future drug applications Vanda might
submit. But that is a distinction without a difference, at least in this case. Vanda has raised the
same Appointments Clause arguments made here in the D.C. Circuit. A favorable ruling on that
question would have precedential effect, rendering this court’s relief inconsequential. See Suppl.
Compl. at 19 (seeking as relief a declaration that “FDA’s grant of authority to Dr. Donohue,
Dr. Nikolov, or any other non-officer as signatory authority over Vanda’s NDA is unconstitutional
under the Appointments Clause”).
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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
_________________________________________ ) VANDA PHARMACEUTICALS INC., ) ) Plaintiff, ) ) v. ) Case No. 24-cv-2514 (APM) ) FOOD AND DRUG ADMINISTRATION, et al., ) ) ) Defendants. ) _________________________________________ )
MEMORANDUM OPINION
I.
In September 2023, Plaintiff Vanda Pharmaceuticals, Inc. (“Vanda”) submitted a new drug
application (NDA) to Defendant Food and Drug Administration (FDA) seeking approval of its
drug tradipitant to treat gastroparesis symptoms in adults. Compl., ECF No. 1, ¶¶ 25–26. Nearly
a year later, in August 2024, Vanda learned that FDA had named Dr. Kathaleen Donohue as the
“signatory authority” for its NDA. Id. ¶ 28. That designation meant that Dr. Donohue would be
the FDA employee who would decide whether to approve Vanda’s NDA or issue a complete
response letter (CRL), which would afford Vanda the opportunity to provide additional information
before the agency made a final decision. Id. ¶¶ 20, 28. Vanda believed, however, that Dr. Donohue
lacked the authority to make that determination. Id. ¶ 38. According to Vanda, Dr. Donohue was
not qualified to make a binding agency decision primarily because she had not been properly
appointed as an inferior officer consistent with the Appointments Clause. Id. ¶¶ 37–42.
Vanda filed this suit and sought preliminary injunctive relief to halt Dr. Donohue’s review
of the NDA. Vanda Pharms. Inc. v. Food & Drug Admin., No. 24-cv-2514 (APM), 2024 WL 4263868, at *1 (D.D.C. Sept. 18, 2024). In response, FDA identified Dr. Donohue’s superior,
Dr. Nikolay Nikolov, as an alternative or additional signatory authority. Id. at *3. The agency
claimed that Dr. Nikolov was an inferior officer properly appointed by the Secretary of Health and
Human Services (HHS), thereby obviating any Appointments Clause issue. Id. The court denied
Vanda’s request for preliminary injunctive relief, finding that it had not established irreparable
harm. See id. at *2–3. The court also held that Vanda had not shown a likelihood of success on
the merits. Contrary to Vanda’s position, the court concluded that Congress had vested the
Secretary of HHS with the power to appoint inferior officers at FDA, including Dr. Nikolov,
consistent with the Appointments Clause. Id. at *3–5. On September 18, 2024, FDA issued a
CRL, signed by both Dr. Donohue and Dr. Nikolov, declining to approve Vanda’s NDA. Suppl.
Compl., ECF No. 26, ¶ 27.
Subsequent events changed the trajectory of this case. On January 16, 2025, FDA issued
Vanda a Notice of Opportunity for a Hearing, indicating that FDA intended to issue an order
refusing Vanda’s NDA. Proposal to Refuse to Approve a New Drug Application for
TRADIPITANT; Opportunity for a Hearing, 90 Fed. Reg. 4748 (Jan. 16, 2025). The Notice was
signed by the Director of the Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni.
Id. at 4750. Vanda then provided notice that it would participate in the process, and in March
2025, it provided “documentation and analysis in support of a request for summary judgment, or,
alternatively, a hearing.” See Defs.’ Suggestion of Mootness, ECF No. 45; Proceeding on the
Proposal to Refuse to Approve a New Drug Application for Tradipitant, Agency Decision,
ECF No. 45-1 [hereinafter Final Order], at 8.
A year later, on March 13, 2026, FDA issued a final order, signed by Principal Deputy
Commissioner, Dr. Sara Brenner, refusing a hearing because Vanda “ha[d] failed to raise a genuine
2 and substantial issue of fact with respect to the approvability of [its NDA].” Id. at 33–34. As part
of its final order, FDA rejected Vanda’s twin contentions that “NDA approval decisions must be
evaluated and signed by the Commissioner” and that the agency personnel who issued the CRL
lacked the authority to do so under the Appointments Clause. Id. at 30–32. It concluded the same
as to Dr. Brenner’s signing of the final order. Id.
Within a week, Vanda filed a petition in the D.C. Circuit seeking review of the refusal of
its NDA. See Vanda Pharms. Inc. v. FDA, No. 26-1064 (D.C. Cir.) [hereinafter Vanda Pharms.
Docket]. In its opening brief, Vanda raised a challenge under the Appointments Clause. Pet’r’s
Opening Br., Vanda Pharms. Docket, ECF. No. 2181999, at 21. Though directed primarily at
Dr. Brenner’s authority to reject the NDA, the underlying argument mirrors the one made in this
case. Id. at 57–62. Namely, Vanda argued that no statute or reorganization plan authorizes the
Secretary of HHS to appoint an inferior officer at FDA. Id.
II.
The parties’ dispositive cross-motions, which became ripe in March 2025, are now before
the court. Vanda’s Mot. for Summ. J., ECF No. 28; Defs.’ Cross-Mot. to Dismiss, ECF No. 30;
Defs.’ Cross-Mot. for Summ. J., ECF No. 31. Though this court arguably had jurisdiction to
resolve the parties’ dispute at first, it no longer does.
Under the Food, Drug, and Cosmetic Act, an FDA order “refusing or withdrawing approval
of” a drug application is directly reviewable by courts of appeals. 21 U.S.C. § 355(h). “Upon the
filing of such petition such court shall have exclusive jurisdiction to affirm or set aside such order
. . .” Id. Put differently, district courts are explicitly stripped of their jurisdiction to review an
FDA order refusing or withdrawing an application upon the filing of a petition challenging the
order. Cf. Bohon v. FERC, 92 F.4th 1121, 1122 (D.C. Cir. 2024) (making the same observation
3 about an exclusive jurisdiction statute for review of FERC orders). Thus, Vanda’s filing of a
petition in the D.C. Circuit foreclosed any review in this court of FDA’s refusal of Vanda’s NDA.
The petition’s filing also divests this court of jurisdiction to hear Vanda’s pending
Appointments Clause challenge. That is because, as a matter of “general administrative-law
principles,” “an agency’s subsidiary decisions merge into the final agency action, which is then
subject to review.” Mullin v. Doe, Nos. 25-1083 & 25-1084, 2026 WL 1825840, at *10 (U.S. June
25, 2026). “If the final agency action is unreviewable, then so too are subsidiary determinations.”
Id. Applied here, that means FDA’s “subsidiary determination[]” to issue a CRL “merge[d]” into
its final decision refusing the NDA. Because the latter decision is not reviewable in this court,
neither is the “subsidiary” decision to issue a CRL. This court therefore lacks jurisdiction to hear
Vanda’s Appointments Clause challenge.
At the oral hearing on the motions, Vanda argued that merger principles were inapplicable
here because its challenge is to the process that led to the NDA’s refusal and favorable relief would
ensure that properly appointed officials would review any future drug applications Vanda might
submit. But that is a distinction without a difference, at least in this case. Vanda has raised the
same Appointments Clause arguments made here in the D.C. Circuit. A favorable ruling on that
question would have precedential effect, rendering this court’s relief inconsequential. See Suppl.
Compl. at 19 (seeking as relief a declaration that “FDA’s grant of authority to Dr. Donohue,
Dr. Nikolov, or any other non-officer as signatory authority over Vanda’s NDA is unconstitutional
under the Appointments Clause”). In such circumstances, applying merger principles to divest this
court of jurisdiction is appropriate. 1
1 Because the court finds it lacks statutory jurisdiction, it need not address FDA’s mootness argument. See State of New York v. Trump, No. 23-5103, 2026 WL 2023744, at *2 n.2 (D.C. Cir. July 14, 2026).
4 III.
For the foregoing reasons, the court grants Defendants’ Cross-Motion to Dismiss, ECF No.
30, denies its Cross-Motion for Summary Judgment, ECF No. 31, as moot, and denies Vanda’s
Motion for Summary Judgment, ECF No. 28.
A final, appealable order accompanies this Memorandum Opinion.
Dated: July 17, 2026 Amit P. Mehta United States District Judge