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.
Footnotes
1. Vanda Pharmaceuticals Inc., v. U.S. Food & Drug Administration, No. 24-1049 (D.C. Cir. Aug. 15, 2025).
2. 21 C.F.R. § 314.101.
3. Op. at 4.
4. Op. at 4-5.
5. Vanda also met with FDA after receiving the CRL and submitted two formal dispute-resolution requests arguing that tasimelteon should be approved as submitted or, that CDER approve tasimelteon for the treatment of insomnia symptoms associated with jet lag. FDA denied both of these requests.
6. Op. at 5-6.
7. Op. at 6.
8. Op. at 13-14.
9. Op. at 13-15.
10. Op. at 16.
11. Op. at 16.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
