CareToLive v. Von Eschenbach
United States District Court for the Southern District of Ohio
525 F. Supp. 2d 938 (2007)
Facts
Dendreon Corporation submitted a Biologic License Application (BLA) to the Food and Drug Administration (FDA) for Provenge, a biologic product intended to treat a specific type of metastatic prostate cancer. Because Provenge was an immunotherapy vaccine, regulatory authority for reviewing and approving the BLA was with the Office of Cellular, Tissue, and Gene Therapies in the FDA Center for Biologics Research and Evaluation (CBER). CBER issued a complete response letter to Dendreon in which it declined to approve the BLA in its current form because of various deficiencies. The FDA requested that Dendreon submit additional information on several matters. CareToLive, (plaintiffs), an association of cancer patients and their families, doctors, investors, and advocates, filed a citizen petition to the FDA urging it to reverse its decision to deny immediate approval of Provenge. The FDA acknowledged receipt of the citizen petition but otherwise did not respond. CareToLive sued the FDA commissioner and Department of Health and Human Services secretary (FDA) (defendants) in federal district court challenging the FDA’s denial of Dendreon’s BLA. CareToLive claimed that the FDA violated its rights under the Administrative Procedure Act (APA). The FDA moved to dismiss, arguing that the court lacks subject-matter jurisdiction over the action.
Rule of Law
Issue
Holding and Reasoning (Frost, J.)
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