Vanda Pharmaceuticals, Inc. v. Food and Drug Administration
Brigid DeCoursey Bondoc & Keunbong Do*
I. Why It Made the List
The Freedom of Information Act (FOIA) has allowed public to access government-held information upon request, while providing exemptions to protect certain information from disclosure. Over time, however, concerns that some agencies are overusing these FOIA exemptions have grown. To address the concerns, Congress enacted the FOIA Improvement Act of 2016, creating additional requirements for the agencies to withhold information and thereby increasing the burden on the agencies to sustain a FOIA denial. This case is one of the first challenges of a FOIA denial by the U.S. Food and Drug Administration (FDA) since the FOIA Improvement Act went into effect, where the denial is based on the deliberative process privilege that the agency has frequently invoked. Against FDA’s general policy of not disclosing review records associated with unapproved or pending drug applications, the district court in this case found that the agency should disclose certain review documents associated with a pending drug application that received a complete response letter from the agency.
A. Legal Background
In 1966, FOIA amended Section 3 of the Administrative Procedure Act (codified as 5 U.S.C. § 552), requiring federal agencies to disclose certain information in response to a proper request under FOIA. FOIA provides that this disclosure requirement does not apply to information protected by one or more of the nine exemptions enumerated in 5 U.S.C. §§ 552(b)(1) to (9). Among these nine exemptions, agencies have frequently invoked the exemption under 5 U.S.C. § 552(b)(5) to deny FOIA requests. This exemption category is often referred to as “Exemption 5,” which 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.”
The Supreme Court has observed that Exemption 5 includes the attorney–client privilege, attorney work-product privilege, and deliberative process privilege. The Supreme Court has required the information be both “predecisional” and “deliberative” to be protected under the deliberative process privilege.
Since 1967, Congress has revised 5 U.S.C. § 552 multiple times, most recently in the FOIA Improvement Act of 2016. With this most recent legislation, Congress tried to address concerns that some agencies are overusing FOIA exemptions, particularly Exemption 5. To address such concerns, the FOIA Improvement Act added 5 U.S.C. § 552(a)(8)(A)(i), requiring agencies to withhold information only if “the agency reasonably foresees that disclosure would harm an interest protected by an exemption” or “disclosure is protected by law.”
Section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA) requires FDA’s approval of a new drug application (NDA) under subsection 505(b) or an abbreviated new drug application (ANDA) under subsection 505(j) before introducing a new drug into interstate commerce. According to 21 C.F.R. § 314.70(b)(2)(v)(A), certain changes in labeling, e.g., to amend the indications and usage in the prescribing information of an approved drug, require a supplemental submission and approval prior to distribution of the drug with those changes. FDA refers to such supplemental submission as a supplemental new drug application (sNDA). After review of an NDA or an sNDA, FDA may issue a complete response letter if the agency determines not to approve the application. The sponsor may respond to a complete response letter with a resubmission that addresses the deficiencies set forth in the complete response letter. However, FDA generally has not disclosed the underlying review documents until it approves the application.
B. Factual Background
FDA approved Vanda’s NDA for the drug Hetlioz® (tasimelteon) in January 2014 for the treatment of “Non-24-Hour Sleep-Wake Disorder.” In October 2018, Vanda filed an sNDA to add “Jet Lag Disorder” to the label. In August 2019, FDA issued a complete response letter declining to approve this sNDA. In December 2019, Vanda submitted a FOIA request to FDA requesting disclosure of FDA’s clinical and statistical review documents that supported FDA’s complete response letter. In a letter dated January 15, 2020, FDA denied Vanda’s FOIA request, invoking Exemption 5. Vanda appealed that same month, and in May 2021, the Department of Health and Human Services (HHS) upheld FDA’s FOIA denial. In the decision letter, HHS acknowledged that the requested review documents do not contain information exempt under the attorney–client privilege or attorney work-product privilege. Nevertheless, HHS concluded that FDA properly withheld the requested documents based on the deliberative process privilege under Exemption 5.
C. Court Decision
Vanda filed a complaint against FDA in the U.S. District Court for the District of Columbia in April 2022, alleging that Exemption 5 does not apply to FDA’s review documents it requested and demanded an injunctive relief directing FDA to produce the requested documents. Vanda pointed out that HHS acknowledged that the attorney–client and work-product privileges do not apply to the requested documents and argued that the deliberative process privilege does not apply to the requested documents because they are neither predecisional nor deliberative. From a policy standpoint, Vanda argued that disclosure of such information would foster drug development by enabling the sponsors to make informed product development decisions and to meaningfully respond to FDA’s adverse actions.
In a summary judgment motion, FDA contended that the requested documents are subject to the deliberative process privilege because they are predecisional and deliberative. Further, attempting to meet the “foreseeable harm” requirement under 5 U.S.C. § 552(a)(8)(A)(i)(I), FDA contended that it reasonably foresees that disclosure of the requested documents would harm an interest protected by Exemption 5. In support of this contention, FDA argued that disclosing review documents such as those Vanda is requesting would have a chilling effect on FDA’s internal deliberations (“chilling effect” argument). FDA further argued that disclosing the review documents for an unapproved application may confuse consumers and medical practitioners, raising public health and safety concerns (“public health” argument).
In a cross motion for summary judgment, Vanda maintained that the requested documents do not enjoy the deliberative process privilege because they are neither predecisional nor deliberative. Vanda further argued that FDA failed to meet the “foreseeable harm” requirement, and therefore that FDA should disclose the requested documents regardless of whether the deliberative process privilege applies.
In a decision issued on March 27, 2023, the court denied FDA’s motion for summary judgment and granted Vanda’s cross motion for summary judgment. The court agreed with Vanda that FDA did not meet the “foreseeable harm” requirement, mooting the issue of whether the requested documents are predecisional or deliberative. Regarding FDA’s “chilling effect” argument, the court found that FDA’s reviewers do not reasonably expect their deliberations to be kept private and reasoned that a disclosure cannot have a chilling effect in such case. As to FDA’s “public health” argument, the court found it to be based on speculated harm, i.e., that “could” happen rather than harm that “would” happen as required by 5 U.S.C. § 552(a)(8)(A)(i)(I). The court therefore concluded that FDA failed to meet the “foreseeable harm” requirement.
III. Impact of the Decision
This case is one of the first cases challenging FDA’s FOIA denial based on the deliberation process privilege since the FOIA Improvement Act went into effect on June 30, 2016. The district court decision collides with FDA’s general policy of not disclosing review documents associated with unapproved or pending applications. While FDA has been publishing review documents associated with approved NDAs pursuant to FDCA § 505(l)(2), it has taken the position that disclosure of unapproved or pending applications raises public health and safety concerns due to potential public confusion. However, under this decision, FDA may need to disclose certain review documents associated with unapproved or pending applications in response to a FOIA request.
As Vanda argued in its complaint, access to review documents associated with FDA’s adverse actions may allow sponsors to make more informed decisions on future drug development. Further, with such access, sponsors may have the opportunity to scrutinize FDA’s decision-making process that led to an adverse action, thereby engaging with FDA in a more meaningful way. Also, the possibility of the disclosure would further promote accountability and transparency.
This case, however, does not suggest that FDA would need to disclose internal review documents before issuing a complete response letter for an application. Although Vanda’s sNDA at issue was pending when Vanda submitted the FOIA request, the request was made after FDA issued a complete response letter, indicating that its deliberative process had ended. It would be less likely for a court to mandate disclosure of review documents, for example, when FDA issues a discipline review letter (DRL). FDA may issue a DRL before issuing a complete response letter or an approval letter to communicate potential deficiencies in the application. A DRL may allow the sponsor to address an issue without receiving a complete response letter or to start early in the preparation of a resubmission in case a complete response letter follows. There, it would be less likely for a court to mandate disclosure of review documents because FDA has not taken any action with respect to an application that decisively end the deliberative process.
This case showed that the FOIA Improvement Act has indeed increased the burden on the agency to sustain a FOIA denial that is based on the deliberative process privilege and may signal the beginning of a line of Exemption 5 FOIA lawsuits against FDA or more careful handling of such requests by the agency.
* Brigid DeCoursey Bondoc is a partner at Morrison & Foerster LLP, where she counsels life sciences companies on a wide range of U.S. Food and Drug Administration pre- and post-market regulatory issues. Keunbong (KB) Do is an associate at Morrison & Foerster LLP, where he leverages his industry experience and PhD in biophysical chemistry to provide exceptional science-based advocacy to clients in both patent and regulatory matters. Brigid and KB work together frequently to advise innovative product developers on threshold FDA jurisdictional questions, developing strategies for approval and marketing, while identifying and mitigating regulatory risks.
 Vanda Pharms., Inc. v. FDA, Case No. 22-cv-938 (D.D.C. Mar. 27, 2023).
 Freedom of Information Act, Pub. L. No. 89-487, 80 Stat. 250 (July 4, 1966).
 5 U.S.C. § 552(b)(5).
 See, e.g., United States Fish & Wildlife Serv. v. Sierra Club, Inc., 141 S. Ct. 777, 785 (2021).
 Id. at 785–86.
 FOIA Improvement Act of 2016, Pub. L. No. 114-185, 130 Stat. 538 (2016).
 See S. Rep. No. 4, 114th Cong., 1st Sess. 2 (2015); H.R. Rep. No. 391, 114th Cong., 2d Sess. 10 (2016).
 5 U.S.C. § 552(a)(8)(A)(i).
 NDA 205677.