The Demise of FDA’s Administrative Summary Judgment Standard: Lessons From Vanda v. FDA

On August 15, 2025, the D.C. Circuit held that the U.S. Food and Drug Administration (FDA) had improperly denied Vanda Pharmaceuticals a hearing regarding Vanda’s application to add a jet lag treatment indication to its sleep disorder drug, Hetlioz (tasimelteon).¹ Where a genuine dispute exists regarding a “material fact,” the court ruled that FDA may not use its administrative summary judgment authority to deny a sponsor’s request for a hearing. Because of FDA’s historical reliance on its summary judgment authority to deny hearing requests, the court’s decision has the potential to trigger an avalanche of challenges to FDA’s routine denial of hearings.

Background

After reviewing Vanda’s submission to add a new indication for jet lag to its sleep disorder drug, FDA’s Center for Drug Evaluation and Research (CDER) refused to approve the company’s application and issued a complete response letter (CRL) instead.² FDA found, among other things, that Vanda’s application did not contain data sufficient to meet the “substantial evidence of efficacy” standard required for approval under the Food, Drug, and Cosmetic Act (FDCA).³ Vanda subsequently requested a hearing, and, in support of its request, submitted expert declarations defending the validity of the data it had included in its application.^{4 5} In response, FDA invoked its administrative summary judgment procedure to deny the request, determining that, despite the expert declarations, no genuine issue of material fact existed. Specifically, FDA determined that the studies that had been submitted did not demonstrate that Vanda’s drug improved the symptoms of jetlag.⁶ No hearing was therefore required, and Vanda’s application would be denied.⁷

D.C. Circuit Opinion

Vanda sued, challenging FDA’s denial of its hearing request and its application. While a unanimous panel of the D.C. Circuit rejected many of the arguments Vanda raised, it agreed with Vanda that FDA was wrong to categorically deny Vanda’s hearing request. In a detailed opinion by Judge Garcia, the court held that Vanda’s expert submissions raised a genuine issue of material fact that necessitated a hearing under FDA’s regulations. Though FDA could forgo a hearing and enter summary judgment if there is no “genuine and substantial issue of fact for resolution,” the court explained that FDA’s decision to do so here was arbitrary and capricious in light of the record evidence.⁸

The court began by rejecting Vanda’s argument that FDA must hold a hearing whenever an applicant requests one and that the agency’s use of the administrative summary judgment procedure violates the FDCA. The court found nothing in the FDCA’s text that precluded the agency from invoking summary judgment and denying a hearing where the application patently could not succeed.

That was not the case, here, however. Looking to whether FDA had “shown that Vanda’s experts’ studies and testimony [were] conclusively deficient,” the court pointed to Vanda’s expert submissions stating that certain subjective evaluative tools used in clinical trials could measure symptoms relevant to jet lag and were fit for purpose, two points which FDA ruled were not in dispute.⁹ FDA had questioned the reliability of the underlying studies, but for the court, this only proved that Vanda had raised a genuine dispute of material fact.¹⁰ FDA had not pointed to a “conclusive flaw” in the experts’ rationale or in the studies supporting their conclusions — at least nothing that would render their input “facially irrelevant.”¹¹ Having failed to identify such a flaw here, FDA was required to grant Vanda a hearing.

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Though the D.C. Circuit acknowledged that the FDCA’s text and legislative history point against the widespread use of hearings in drug applications, its opinion in Vanda appears to open the door (or perhaps, the flood gates) to hearings and the use of experts to manufacture issues of material fact. While the court attempted to mitigate this possibility by instructing FDA to identify “conclusive flaw[s]” in an applicant’s submission that could obviate the need for a hearing, the opinion may nonetheless result in a significant change in the agency’s longstanding practice of wielding its administrative summary judgment authority to deny hearings and concurrently deny applications. We will be watching closely to see how FDA reacts, including whether it chooses to appeal the decision.

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© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.