## Facts

- John D. Copanos & Sons, Inc. and Kanasco, Ltd. were affiliated drug manufacturers holding FDA-approved NDAs and NADAs for sterile injectable products.
- Over approximately three years, FDA inspections documented repeated current good manufacturing practice (CGMP) violations, including inaccurate or falsified manufacturing records, failure to calibrate laboratory equipment, unsanitary manufacturing conditions, and production of subpotent and impure product.
- After inspections, FDA issued multiple notices of inspectional observations; the companies acknowledged certain deficiencies and promised corrective actions.
- The companies entered enforcement-related agreements, including commitments not to manufacture or ship drugs without FDA authorization, but later manufactured (and in some instances shipped) product in violation of those undertakings.
- On March 10, 1987, FDA published a Notice of Opportunity for a Hearing proposing to withdraw approvals for the companies’ sterile injectable NDAs and NADAs based on inadequate “methods, facilities, and controls” to assure identity, strength, quality, and purity.
- The notice stated that a hearing would be granted only upon submission of specific facts showing a genuine and substantial issue of fact; otherwise the matter could be resolved without a hearing.
- The companies requested a hearing and submitted declarations and materials asserting that deficiencies had been corrected and that they were (or would be) in compliance.
- On August 6, 1987, FDA denied the hearing request, found no genuine and substantial factual dispute, and summarily withdrew the approvals, preventing further manufacture of the covered sterile injectables.
- FDA later denied the companies’ post-withdrawal requests to reconsider or reopen the matter.

## Issues

1. Whether the FDA provided “due notice and opportunity for hearing” before withdrawing NDA/NADA approvals when it denied an evidentiary hearing based on the sponsor’s failure to raise a genuine and substantial issue of fact.
2. Whether the FDA could lawfully use a summary judgment–type procedure to withdraw NDA/NADA approvals in the absence of a material factual dispute.
3. Whether FDA abused its discretion by denying post-withdrawal requests to reconsider or reopen the record to consider new materials.

## Decision

- The court denied the petition for review and upheld the FDA’s withdrawal order.
- The court held the notice adequately described both the factual basis for withdrawal and the showing required to obtain a hearing.
- The court held the FDCA does not require an automatic evidentiary hearing; FDA may deny a hearing when the sponsor fails to raise a genuine and substantial issue of fact under agency regulations.
- The court upheld FDA’s summary disposition because the sponsors’ submissions did not materially dispute the documented history of CGMP noncompliance and related conduct.
- The court found no abuse of discretion in FDA’s refusal to reopen the record or grant post-withdrawal relief based on materials outside the administrative record for the withdrawal decision.

## Legal Principles

- “Due notice and opportunity for hearing” under the FDCA in NDA/NADA withdrawal proceedings permits FDA to condition a hearing on the sponsor’s presentation of specific facts establishing a genuine and substantial issue of fact.
- An agency may resolve a withdrawal proceeding without an evidentiary hearing where the sponsor’s submissions fail to identify a material factual dispute, using summary judgment–like procedures authorized by regulation.
- Evidence framed as remedial assurances or claims of current/future compliance does not necessarily create a material dispute over whether the statutory withdrawal ground is met when the record shows persistent CGMP violations affecting manufacturing controls.
- Persistent, documented CGMP noncompliance, including unreliable records and disregard of prior undertakings, can support withdrawal based on inadequate manufacturing methods, facilities, and controls, without requiring proof of actual patient harm.
- Judicial review ordinarily is confined to the administrative record as it existed when the agency acted; reopening to consider new materials is discretionary and requires a showing beyond dissatisfaction with the outcome.

## Conclusion

The D.C. Circuit sustained FDA’s summary withdrawal of sterile injectable NDAs and NADAs after concluding that the manufacturers received adequate notice and failed to raise a genuine and substantial factual dispute warranting an evidentiary hearing, and it upheld FDA’s refusal to reopen the record based on post-withdrawal submissions.


John D. Copanos & Sons, Inc. v. Food & Drug Admin., 854 F.2d 510 (D.C. Cir. 1988)