John D. Copanos and Sons, Inc. v. Food and Drug Administration
854 F.2d 510, 272 U.S.App.D.C. 101 (1988)
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Rule of Law:
The Food and Drug Administration (FDA) may summarily withdraw a drug's approval without an evidentiary hearing when a manufacturer has a documented history of persistent, uncorrected violations of Current Good Manufacturing Practice (CGMP) regulations. To obtain a hearing, the manufacturer must raise a genuine and material issue of fact regarding its compliance and its failure to correct deficiencies within a reasonable time.
Facts:
- Starting in 1984, the Food and Drug Administration (FDA) conducted a series of inspections of the drug manufacturing facilities of John D. Copanos & Sons, Inc. (Kanasco).
- These inspections repeatedly revealed numerous, significant deficiencies and violations of the FDA's Current Good Manufacturing Practice (CGMP) regulations.
- Identified violations included inaccurate and falsified manufacturing records, unsanitary conditions, inadequately trained personnel, failure to calibrate laboratory equipment, and improper handling of sterile products.
- The FDA notified Kanasco of these deficiencies after each inspection by issuing a Form FDA-483.
- Despite repeatedly promising to take corrective action, Kanasco failed to remedy many of the violations, and subsequent FDA inspections found the same or similar problems persisting over several years.
- In 1985, Kanasco secretly manufactured and shipped over one million vials of injectable veterinary drugs in direct violation of a prior agreement with the FDA that prohibited such activity without authorization.
- A final series of FDA visits in late 1986 and early 1987, just prior to the withdrawal action, continued to find both new and recurring CGMP deficiencies, such as failure to provide employee training data and failure to protect sterile equipment during facility renovations.
Procedural Posture:
- The FDA published a Notice of Opportunity for a Hearing (NOOH) in the Federal Register, proposing to withdraw Kanasco's drug approvals for sterile injectable products due to CGMP violations.
- Kanasco responded to the NOOH by requesting a hearing and also moving for summary judgment in its own favor.
- The FDA denied Kanasco's request for a hearing, denied its motion for summary judgment, and issued a final order summarily withdrawing its approval of Kanasco's drug applications.
- Kanasco then filed a Petition for Reconsideration and a 'Citizen's Petition for Revocation' with the FDA, both of which the agency denied.
- Kanasco petitioned the U.S. Court of Appeals for the D.C. Circuit for review of the FDA's final withdrawal order.
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Issue:
Does the FDA's summary withdrawal of a drug manufacturer's New Drug Applications for persistent violations of manufacturing standards violate the manufacturer's statutory right to 'due notice and opportunity for a hearing' when the manufacturer fails to raise a genuine and material issue of fact to dispute the violations?
Opinions:
Majority - Circuit Judge D.H. Ginsburg
No, the FDA's summary withdrawal of the drug approvals does not violate the manufacturer's statutory rights. The court held that the FDA may proceed by summary judgment when it is clear from the record that there is no genuine and substantial issue of material fact requiring a hearing. Kanasco received adequate notice of the basis for the FDA's action through a long and detailed regulatory history of inspections, violation notices, and correspondence. Kanasco's response failed to create a genuine and material dispute because the record documented numerous uncontested or manifest violations of CGMP regulations that persisted long after Kanasco received notice. Allowing a manufacturer to obtain a full hearing by disputing a few minor allegations while a clear pattern of significant, uncorrected violations remains would undermine the FDA's enforcement authority and statutory mandate.
Analysis:
This decision significantly strengthens the FDA's authority to enforce manufacturing standards by affirming its power to use summary administrative action against chronic violators. It establishes that a manufacturer cannot evade withdrawal of its drug approvals by making temporary fixes or raising factual disputes on minor points when the overall record demonstrates a pattern of serious, uncorrected non-compliance. The case serves as a key precedent limiting the right to a full evidentiary hearing in withdrawal proceedings, thereby enabling the FDA to act more decisively to remove drugs produced under substandard conditions from the market.
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