John D. Copanos And Sons, Inc. V FDA

Facts

John D. Copanos & Sons, Inc., and Kanasco, Ltd., (Ds) manufacture and distribute human and veterinary drugs, including, until recently, a number of sterile injectable products. The injectable drugs were produced pursuant to a number of New Drug Applications (NDAs), and New Animal Drug Applications (NADAs) approved by The FDA (P). P published a Notice proposing to withdraw D's NDAs and NADAs for sterile injectable products because the methods, facilities, and controls used to produce these drugs were inadequate to assure their identity, strength, quality, and purity. D requested a hearing but it was denied by P and P summarily withdrew its approval of the company's applications. P had conducted an inspection of D's manufacturing facility, which revealed numerous deficiencies in manufacturing and quality control procedures, including inaccurate and even falsified manufacturing records, failure to calibrate laboratory equipment, unsanitary conditions in the manufacturing area, and production of a subpotent and impure animal drug. P left with the company a Form FDA-483 listing the deficiencies noted in the inspection. P sought to enjoin D from the further manufacture and shipment of pharmaceuticals. Rather than contesting the allegations in this complaint, D agreed that it would not manufacture or ship any drugs without the prior written authorization of P, and the government dismissed the complaint without prejudice. By letter, D promised corrective measures in the future. Upon request, P returned to verify a consultant's assessment of compliance. It failed, again and again, a Form FDA-483 was left with all the problems listed. D again acknowledged the alleged deficiencies, disputing some of the agency's conclusions but promising improvements in the areas identified by the inspector. D also asked for approval to resume manufacturing (but not shipping) veterinary drugs, on the ground that it was then in compliance. P refused and D once again returned to evaluate results with respect to a media fill issue. D failed, and P once again left a Form FDA-483 listing the problems. In a follow-up letter, P stated that the 'underlying cause' of the company's problems was the number, training, and supervision of personnel. D once again responded with a letter promising improvements in the company's media fill process. P then learned that D had manufactured 23 lots--over one million vials--of injectable veterinary drugs, in violation of the 1984 Agreement. Several thousand vials had been shipped to customers without approval. In addition, the company withheld records that would have revealed the shipments. P officials visited D to monitor the company's media fills. D failed, and P left yet another Form FDA-483. P filed a second complaint for injunctive relief and returned to the company with a criminal search warrant. P concluded that D had committed further violations of the CGMP recordkeeping requirements. The district court by consent entered an interim order prohibiting D from making or distributing injectable drugs without prior judicial authorization. D agreed to a 'Consent Decree of Permanent Injunction.' A consultant recertified, but once again an inspection by P revealed violations. D disputed some of the agency's observations but again promised improvements or changes in all the noted deficiencies. P again sought a court order to cease the manufacture of all injectable drugs. D once again persuaded the agency, that the noted deficiencies had been, or would be corrected. P authorized the company to resume manufacturing and shipping injectable drugs, and so notified the court. When the FDA reinspected D's manufacturing facility in September 1986, it noted numerous potential violations. D's written response to Form FDA-483 disputed a number of the conclusions, particularly the determination that facilities and equipment were invalidated. D nonetheless promised a number of improvements. P again moved to enforce the 1985 Consent Decree. The court eventually made the injunction permanent. P visited once again and encountered both new and familiar problems. P published a notice proposing to withdraw D's NDAs and NADAs for sterile injectable products. Notice required D, if it wanted a hearing, to submit 'the data, information, and analyses relied on to justify a hearing, as specified in 21 C.F.R. 312.200,' and noted that the same regulation would govern any subsequent proceedings. D both requested a hearing and moved for summary judgment. The motion for summary judgment was based on the argument that the agency had not complied with the requirements in 21 U.S.C. Secs. 355(e) and 360b(e)(2)(B) that it provide D with proper written notice 'specifying the matter complained of' and 'a reasonable time after receipt of written notice' within which to make adequate any deficiencies. P denied both the hearing request and the motion for summary judgment and ordered that D's NDAs and NADAs be withdrawn from the market. A petition for reconsideration was also denied. D filed this petition for review.

Issues

Rule of Law

Holding and Decision

Legal Analysis

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