UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
VANDA PHARMACEUTICALS, INC.,
Plaintiff,
v. Case No. 22-cv-938 (CRC)
FOOD AND DRUG ADMINISTRATION,
Defendant.
MEMORANDUM OPINION
In this Freedom of Information Act (“FOIA”) case, Plaintiff Vanda Pharmaceuticals
seeks records created by the Food and Drug Administration (“FDA”) during its review of
Vanda’s application to add a new approved use for its sleep-disorder drug, Hetlioz. Specifically,
Vanda requested two reviews created by the interdisciplinary team of FDA experts that evaluated
the application. The FDA withheld both reviews under FOIA Exemption 5 to protect its
deliberative process.
Both parties seek summary judgment as to whether the FDA properly invoked Exemption 5.
For the reasons explained below, the Court will grant summary judgment for Vanda and deny
summary judgment for the FDA.
I. Background
The Food, Drug, and Cosmetic Act requires that the FDA approve a new drug before it
can be introduced on the market. 21 U.S.C. § 355(a). To receive approval, a pharmaceutical
company submits a New Drug Application (“NDA”)—including scientific data to support that
the drug is safe and effective—to the FDA’s Center for Drug Evaluation and Research
(“CDER”). 21 U.S.C. § 355(a)–(b); Def.’s Mot. Summ. J., Ex. 3 ¶ 5 (“Farchione Decl.”).
Similarly, a pharmaceutical company seeking to market an already-approved drug for another
use must file a supplemental New Drug Application (“sNDA”) to obtain CDER’s pre-approval.
21 C.F.R. § 314.70(b); see Farchione Decl. ¶ 6. Upon receipt of an NDA or sNDA, CDER
assembles an interdisciplinary review team of clinicians and scientists to review the submission
and compile its opinions and recommendations, including reviews of the drug’s clinical
effectiveness and the statistical soundness of the manufacturer’s studies. Farchione Decl. ¶¶ 5–8,
15–16. After consulting the reviews, CDER either approves the drug for its proposed use or
sends the manufacturer a Complete Response Letter (“CRL”) detailing the application’s
deficiencies. See id. ¶¶ 8-9. If a CRL is sent, the sponsor is faced with several options: it can
withdraw its application, submit additional information to address the deficiencies, or appeal the
decision through the FDA’s formal dispute resolution process. Pl.’s Cross Mot. Summ. J., Ex. 2
¶ 14 (“Jarow Decl.”).
Vanda manufactures the prescription drug Hetlioz, a melatonin receptor agonist approved
by the FDA to treat non-24-hour sleep-wake disorder, a circadian-rhythm disorder that disrupts
normal sleep cycles. Pl.’s Mot. at 5. In 2018, Vanda filed an sNDA for approval to market
Hetlioz as a treatment for jet lag. Id. at 6. Following the multi-disciplinary assessment, CDER
issued a CRL and the application is still pending. Farchione Decl. ¶¶ 11–14.
A few months after receiving the CRL, Vanda submitted a FOIA request to the FDA for
the “[Clinical] Review 1 and Statistical Review” generated during the multi-disciplinary
assessment of the Hetlioz sNDA. Compl., Ex. A. The clinical review “covers the strength of the
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While Vanda’s FOIA request asked for the “Medical Review,” the parties refer to this
document as a “clinical review” in their briefs. See Def.’s Mot. at 3 n.2; Pl.’s Mot. at 4 n.1. The
Court will follow suit.
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clinical evidence” in the application and the statistical review “covers the statistical validity of
the findings of the clinical studies performed” by the drug’s sponsor. Pl.’s Mot. at 4. The FDA
withheld the reviews based on FOIA Exemption 5, asserting that they were protected from
disclosure under the deliberative process privilege. Pl.’s Mot., Ex. 10. Vanda appealed the
decision within the agency, and the FDA upheld the withholdings. 2 Pl.’s Mot., Ex. 13. Vanda
then filed suit and both parties moved for summary judgment on whether Exemption 5 and the
deliberative process privilege were properly applied to the reviews. 3
II. Legal Standards
Summary judgment is the typical mechanism to determine whether an agency has met its
FOIA obligations. See, e.g., Jud. Watch, Inc. v. CFPB, 60 F. Supp. 3d 1, 6 (D.D.C. 2014). In
FOIA cases, an “agency is entitled to summary judgment if no material facts are genuinely in
dispute and the agency demonstrates ‘that its search for responsive records was adequate, that
any exemptions claimed actually apply, and that any reasonably segregable non-exempt parts of
records have been disclosed after redaction of exempt information.’” Prop. of the People, Inc. v.
Office of Mgmt. & Budget, 330 F. Supp. 3d 373, 380 (D.D.C. 2018) (quoting Competitive Enter.
Inst. v. EPA, 232 F. Supp. 3d 172, 181 (D.D.C. 2017)).
The agency may satisfy its burden to justify claimed exemptions through declarations that
“describe[ ] the justifications for withholding the information with specific detail” and
“demonstrate[ ] that the information withheld logically falls within the claimed exemption.”
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Initially, the FDA also invoked the attorney-client privilege and the attorney-work-
product privilege to withhold the reviews. Pl.’s Mot., Ex. 10. On appeal, the FDA conceded that
those justifications did not apply. Pl.’s Mot., Ex. 13
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After the FDA moved for summary judgment, Vanda moved for limited discovery,
which the Court denied. See Order, ECF No. 14.
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ACLU v. Dep't of Def., 628 F.3d 612, 619 (D.C. Cir. 2011). “Such declarations are entitled to a
presumption of good faith, and the court can award the agency summary judgment based solely
on the information so provided.” Jud. Watch, Inc. v. CIA, 310 F. Supp. 3d 34, 41 (D.D.C. 2018).
Agency declarations will not support summary judgment, however, if the plaintiff puts forth
contrary evidence or demonstrates the agency's bad faith. ACLU, 628 F.3d at 619.
Exemption 5 protects “inter-agency or intra-agency memorandums or letters that would
not be available by law to a party other than an agency in litigation with the agency.” 5 U.S.C.
§ 552(b)(5). The exemption thus incorporates, “albeit in a less-than-straightforward
way[,] . . . the privileges available to Government agencies in civil litigation,” including the
deliberative process privilege. U.S. Fish & Wildlife Serv. v. Sierra Club, Inc., 141 S. Ct. 777,
785 (2021). The deliberative process privilege exists “[t]o protect agencies from being forced to
operate in a fishbowl.” Id. (internal quotation marks omitted). To that end, it “shields from
disclosure documents reflecting advisory opinions, recommendations and deliberations
comprising part of a process by which governmental decisions and policies are formulated.” Id.
(internal quotation marks omitted). An agency may only invoke the deliberative process
privilege “for documents that are both predecisional and deliberative.” Reps. Comm. for
Freedom of the Press v. FBI, 3 F.4th 350, 362 (D.C. Cir. 2021). “Documents are ‘predecisional’
if they were generated before the agency's final decision on the matter, and they are
‘deliberative’ if they were prepared to help the agency formulate its position.” U.S. Fish &
Wildlife Serv., 141 S. Ct. at 786.
The government must also demonstrate at summary judgment that it has satisfied the
standards imposed by the FOIA Improvement Act of 2016, which allow an agency to withhold
information only if it “reasonably foresees that disclosure would harm an interest protected by an
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exemption” to FOIA or “disclosure is prohibited by law.” 5 U.S.C. § 552(a)(8)(A)(i). The
statute's “distinct foreseeable harm requirement . . . foreclose[s] the withholding of material
unless the agency can articulate both the nature of the harm [from release] and the link between
the specified harm and specific information contained in the material withheld.” Reps. Comm., 3
F.4th at 369 (second alteration in original) (internal quotation marks omitted). As applied to the
deliberative process privilege and Exemption 5, the requirement is only satisfied if the agency
can “concretely explain how disclosure ‘would’—not ‘could’—adversely impair internal
deliberations.” Id. at 369–70 (quoting Machado Amadis v. Department of State, 971 F.3d 364,
371 (D.C. Cir. 2020).
III. Analysis
The FDA asserts that the clinical and statistical reviews at issue are both predecisional
and deliberative, and therefore are protected by the deliberative process privilege in the first
instance, and that their release would cause foreseeable harm by (1) chilling agency discourse
regarding drug applications and (2) harming public health by causing consumer confusion or
contributing to false advertising. Vanda disputes each of those claims
While the parties offer cogent arguments on multiple fronts, the Court will begin and end
with Vanda’s “principal argument” that disclosure will not harm the agency’s deliberative
process. Pl.’s Reply at 3. Finding that the agency has not satisfied its obligation to show a
foreseeable harm from publication regardless of whether the reviews are predecisional or
deliberative, the Court will grant summary judgment in Vanda’s favor.
A. Chilling Effect
The FDA asserts that “[d]isclosing clinical and statistical reviews prepared for the
evaluation of a drug application would have a chilling effect on staff communications.”
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Farchione Decl. ¶ 18. In its view, the agency scientists who review sNDAs do “not anticipate
that their comments [will] be used for anything but internal deliberations” and publication of the
reviews would thus deter the scientists from giving their honest assessments. Def.’s Mot. at 13.
The FDA fears that such a chilling effect would harm agency decision-making because “a
comprehensive record” of staff opinions is critical “given the complexity of interdisciplinary
discussions.” Farchione Decl. ¶ 18. The FDA considers the risk of chilling “particularly
concerning here” because the agency may need to further deliberate on Vanda’s sNDA. Id.
The Court is not convinced that disclosure of reviews related to pending sNDAs would
lead to the chilling effect the agency fears. As Vanda points out, the FDA currently discloses
clinical and scientific reviews to the public in a variety of circumstances. For starters, the agency
is required by statute to publish underlying reviews whenever an NDA is approved. See 21
U.S.C. § 355(l)(2)(A), (C)(i), (C)(iv) (requiring, upon approval of an NDA, the release of
“[d]ocuments generated by the [FDA] related to the review of the application” and “a summary
review that documents conclusions from all reviewing disciplines about the drug, noting any
critical issues and disagreements with the applicant and within the review team and how they
were resolved[.]”). Although the record does not contain definitive statistics on the approval rate
of NDAs, at least one study cited by Vanda puts it at over 90%. See Biotechnology Innovation
Organization et al., Clinical Development Success Rates and Contributing Factors 2011-2020 at
9 (Feb. 2021) (“[The] unlimited allowance of submission attempts pushes the overall success [of
NDA submissions] above 90.6% across all diseases[.]”). And in at least one instance, the agency
has also disclosed clinical reviews to defend its decision not to grant an evidentiary hearing for
an NDA it declined to approve. Pl.’s Mot. at 15; Pl.’s Mot., Ex. 14; Pl.’s Mot., Ex. 15. In
addition, while the FDA avers that it does not release reviews associated with approved sNDAs
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as a matter of course, the agency acknowledges that it will release reviews from approved
sNDAs in response to a FOIA request or “a request by one of FDA’s Review divisions if deemed
important for public health reasons.” Def.’s Mot., Ex. 2 ¶¶ 13–14 (“Philips Decl.”).
The FDA may be correct that it does not have a practice of releasing statistical and
clinical reviews underlying pending sNDAs like Vanda’s. As explained above, however, a
pending sNDA may become an approved sNDA should the sponsor choose to adopt the
recommendations offered by the review team in the CRL explaining the basis for the conditional
denial of the application. As a result, reviews associated with pending sNDAs would be subject
to release at least under the circumstances noted above, should the application ultimately be
approved.
As the FDA acknowledges, the clinical reviewers do not know whether or not an
application will be approved when the reviews are compiled. Def.’s Mot. at 11; see Jarow Decl.
¶ 17. They are, therefore, unaware during the review process whether their work will be made
public under any of the circumstances described above. Given that uncertainly, the agency has
not established that reviewers currently expect written descriptions of their views and
deliberations to be shielded from public view. That is certainly the case for teams conducting
reviews for NDAs, upwards of 90% of which, based on the evidence before the Court, are made
public following approval of the application. And the agency offers no explanation for why it is
not also the case for teams assigned to sNDAs. It does not suggest, for example, that sNDA
applications are reviewed by different experts within the agency, or that sNDA reviews entail
different types of analyses or deliberations. Absent any current expectation of confidentiality, in
the context of NDAs and sNDAs alike, the Court struggles to see how requiring FOIA disclosure
of statistical and clinical reviews associated with pending sNDAs would in any way chill the
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reviewers’ frank and honest deliberations. Disclosure cannot chill deliberations if those
deliberating do not reasonably expect their deliberations to remain private.
To be clear, the Court does not hold that the FDA somehow waived its ability to invoke
Exemption 5 by voluntarily releasing isolated NDA and sNDA reviews to the public. It finds,
rather, that the agency has not established that the reviewers presently expect their deliberations
to be kept private given the meaningful potential for release of both types of reviews. And if the
reviewers don’t expect confidentiality now, this ruling should not affect the tenor of their
deliberations in the future.
The FDA’s public disclosure of NDA and sNDA reviews distinguishes this case from
Machado Amadis and others on which the FDA relies. 971 F.3d at 370-71. In Machado, for
example, the D.C. Circuit found that releasing the recommendations of agency line attorneys
would undermine candid debate within the agency. Id. at 371. But there was no indication that
the attorney recommendations there were publicly disclosed by the agency in other
circumstances. Id. Here, the experts reviewing NDAs and sNDAs know that their reviews could
very well be published. Accordingly, the FDA has not met its burden to “concretely explain”
how release would chill internal agency deliberations. See Reps. Comm., 3 F.4th at 369–70
B. Public Health
The FDA also asserts that “disclosure of clinical and statistical reviews in the context of
an unapproved sNDA raises public health and safety concerns.” Farchione Decl. ¶ 19. In
particular, the FDA expresses concern that drug sponsors may misrepresent the opinions
expressed in the reviews to mislead consumers and medical practitioners about the efficacy and
safety of the drug under review. Def.’s Mot. 13–14. But this concern is insufficient to justify
withholding the reviews. To start, the FDA speculates about harm that “could” happen if the
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reviews were released but has not “concretely explain[ed]” what harm “would” occur. See Reps.
Comm., 3 F.4th at 369–70. Such conjecture does not satisfy the agency’s foreseeability
requirement. Id. Moreover, as Vanda points out, there are a number of factors that lessen the
FDA’s stated concern. First, drug manufacturers are prohibited from promoting the unapproved
use of an already-approved drug. See 21 U.S.C. §§ 331(a), 352(a); Jarow Decl. ¶¶ 22–23.
Second, even if a consumer was confused by misinformation about Herzoil, the consumer could
not act on that misinformation alone because Herzoil is only available by prescription. Jarow
Decl. ¶ 27. Prescribing doctors serve as learned intermediaries who educate consumers about the
uses and misuses of the drug. See id. Last, the agency’s public-safety concerns are weaker here,
where the FDA has already determined that Herzoil is safe for consumption and has no known
serious adverse effects. Pl.’s Mot., Ex. 1, ¶¶ 12–15 (“Comb Decl.”). The FDA does not contest
any of these points.
Accordingly, the FDA has failed to show any foreseeable harm that would arise if the
requested reviews were released.
IV. Conclusion
For these reasons, the Court will grant Plaintiff’s Cross Motion for Summary Judgment
and deny the FDA’s Motion for Summary Judgment.
A separate Order shall accompany this opinion.
CHRISTOPHER R. COOPER
United States District Judge
Date: March 27, 2023
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