Biotechnology company persuades FDA to lift clinical hold on experimental gene therapy

Client(s) Biotechnology company

Jones Day represented a biotechnology company in a lawsuit against the Food and Drug Administration (FDA) for placing a clinical hold on the company's experimental gene therapy. The complaint and preliminary injunction, filed in the United States District Court for the District of Columbia, asserted that the clinical hold was arbitrary and capricious under the Administrative Procedure Act; that it violated the Food, Drug, and Cosmetic Act as well as FDA's own regulations; and that the statute authorizing the FDA to issue clinical hold orders was unconstitutional under the nondelegation doctrine. Less than two months after the company filed its complaint, and following a preliminary injunction hearing at which the court declined the FDA's request to dismiss the complaint, the FDA agreed to remove the clinical hold and allow the experimental gene therapy to continue.