Vanda Pharmaceuticals Inc. (Vanda) announced that it secured a landmark victory over the U.S. Food and Drug Administration (FDA) in its longstanding dispute with the agency regarding the approvability of HETLIOZ® (tasimelteon) to treat jet lag disorder (Vanda Pharmaceuticals Inc. v. FDA, case no. 24-1049)
Vanda submitted its supplemental New Drug Application (sNDA) in October 2018 to market HETLIOZ® to treat jet lag disorder. After the FDA substantially delayed resolving Vanda's request for a hearing with respect to this application, a federal district court found that the FDA "violated" the requirements of the Food, Drug, and Cosmetic Act, and the court ordered the FDA to finally resolve Vanda's sNDA or commence a hearing (Vanda Pharmaceuticals Inc. v. FDA, No. 22-cv-2775-CJN).
The FDA did not commence a hearing. It instead granted summary judgment to itself and issued an order refusing to approve the sNDA. The FDA took the position that it could essentially disregard the voluminous factual evidence Vanda had presented to it. Vanda thus filed a petition for review with the U.S. Court of Appeals for the D.C. Circuit (the Court).
In a sweeping win for Vanda, the Court set aside the FDA's action. The Court explained that Vanda provided expert views that were "specific, reasoned, and rooted in evidence" and that the FDA's "treatment of Vanda's evidence is cursory." In particular, the Court stated that Vanda "clearly offered meaningful evidence of tasimelteon's efficacy in improving sleep disturbance" and, further, that each of its trials "showed statistically significant improvement on the primary endpoint measured."
This decision significantly alters the relationship between the FDA and the parties it regulates. The Court's holding establishes that the FDA must meaningfully engage with the evidence presented by drug innovators, and the FDA may not shield its decisions via a plea for deference. The Court has remanded the case back to the FDA, where Vanda anticipates the FDA will either approve the sNDA or Vanda will receive a hearing.
This is an outstanding development for all those who suffer from jet lag. Vanda has spent more than a decade undertaking innovative clinical studies, now published in peer-reviewed journals, developing HETLIOZ® so that jet lag sufferers may finally have access to a meaningful therapeutic. Whether for an athlete, a business traveler, a government official, a tourist, or rapidly deployed troops, HETLIOZ® has the potential to fundamentally change the landscape of circadian resetting during transmeridian global travel. This is a treatment that Americans want and need.
Ultimately, this decision requires that the FDA act fairly when evaluating scientific evidence. The FDA's decisions regarding new drug applications are enormously consequential. Innovators like Vanda labor to bring novel therapeutics to Americans who suffer from unmet medical needs. Improper denials by the FDA deprive the public of access to potentially life-changing medication. The Court's decision establishes that the FDA must now actually engage with the evidence presented to it.
The Court's decision confirms Vanda's efforts to challenge unlawful actions by the FDA. For too long, drug manufacturers failed to exercise their rights to lawful treatment by the FDA. Vanda has demonstrated how courts can set aside illegal government actions that harm innovation and deprive Americans of important new therapeutics.
