Vanda Pharmaceuticals Sues FDA Over New Drug Approval Structure

The FDA’s process for reviewing a new drug application is unconstitutional because it appoints an “illegitimate decisionmaker” to oversee applications, Vanda Pharmaceuticals Inc. said in a lawsuit filed against the agency.

The Food and Drug Administration violated the appointments clause of the US Constitution when it gave signatory authority to an acting director in the agency to review Vanda’s new drug application (NDA) for its product tradipitant, the drugmaker wrote in a complaint filed Aug. 30 in the US District Court for the District of Columbia.

Vanda brings the lawsuit as the agency is set to decide no later than ...