Vanda Pharmaceuticals, Inc. v. Food and Drug Administration

• Court: District Court, District of Columbia
• Decided: March 27, 2023
• Docket: Civil Action No. 2022-0938
• Status: Published

Opinion

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

1 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.

2 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.”

2 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 3 After the FDA moved for summary judgment, Vanda moved for limited discovery, which the Court denied. See Order, ECF No. 14.

3 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

4 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.”

5 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

6 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

7 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

8 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