A federal appeals court has ordered the Food and Drug Administration to reconsider Vanda Pharmaceuticals Inc.'s application for expanding the use of its drug Hetlioz to treat jet lag disorder, ruling that the agency's initial rejection was procedurally flawed.
Court Finds FDA Action "Arbitrary and Capricious"
The US Court of Appeals for the District of Columbia Circuit ruled Friday that the FDA lacked justification to deny Vanda an evidentiary hearing before rejecting the company's supplemental new drug application. Judge Bradley N. Garcia, writing for the court panel, characterized the FDA's refusal to hold a hearing as "arbitrary and capricious."
The court's decision mandates that the case be sent back to the FDA for future proceedings, providing Vanda with a fresh opportunity to present its case for Hetlioz's expanded indication.
Background on Hetlioz Application
The legal dispute centers on Vanda's supplemental new drug application seeking to expand Hetlioz's approved uses to include treatment of jet lag disorder. The FDA had previously rejected this application without granting the company an evidentiary hearing to present supporting data and arguments.
Implications for Regulatory Process
This ruling highlights the importance of procedural fairness in FDA drug approval processes. The court's finding that the agency acted arbitrarily suggests that pharmaceutical companies have certain rights to present evidence when seeking expanded indications for already-approved medications.
The decision could set a precedent for how the FDA handles similar supplemental applications in the future, potentially requiring more thorough consideration of requests for evidentiary hearings before rejecting applications for new indications.
