John D. Copanos and Sons, Inc. v. Food and Drug Administration

John D. Copanos & Sons, Inc., and Kanasco, Ltd., affiliated enterprises owned by John D. Copanos (collectively, Kanasco) (defendant) produced sterile injectable drugs pursuant to a number of New Drug Applications (NDAs) and New Animal Drug Applications (NADAs) approved by the Food and Drug Administration (FDA). Under the Federal Food Drug and Cosmetic Act (FDCA), the FDA can withdraw prior approval of a drug on a number of statutory grounds. One such ground is a finding that the manufacturer’s methods, facilities, and controls were not adequate to assure and preserve the identity, strength, quality, and purity of the drugs as set forth in the agency’s Current Good Manufacturing Practice (CGMP) regulations. Over a three-year period, the FDA inspected Kanasco’s facilities on multiple occasions. The agency found numerous violations of the CGMP regulations during each of these inspections. The FDA issued a FDA-483 form after each inspection, detailing the nature of the Kanasco’s violations. Despite promises to come into compliance with FDA regulations, Kanasco failed to remedy its violations. It also violated agreements not to distribute its products until it was in compliance and kept false records to cover up various violations. The FDA eventually published a Notice of Opportunity for a Hearing (NOOH) in the Federal Register, in which the agency proposed to withdraw Kanasco’s NDAs and NADAs for sterile injectable products. The NOOH stated that if Kanasco wanted a hearing, it must present specific facts showing a genuine and substantial issue of fact that requires a hearing, and that if such information is not provided, the FDA could enter summary judgment against the manufacturer. In response to the NOOH, Kanasco requested a hearing and moved for summary judgment. Its hearing request included declarations and other exhibits designed to show that the company was in compliance with CGMP. The FDA denied Kanasco’s requests, and summarily withdrew its approval of the company’s applications. Kanasco petitioned for review of the FDA’s decision.