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21 U.S.C.S. § 355(e), which governs the withdrawal of New Drug Applications approvals, requires the Food and Drug Administration to provide due notice and opportunity for hearing to the applicant. This provision does not guarantee the applicant a hearing in all circumstances; the agency may by regulation provide for summary withdrawal of approvals when there is no genuine and substantial issue of fact that requires a hearing.
Respondent United States Food and Drug Administration (FDA) withdrew the petitioner drug company’s New Drug Applications and New Animal Drug Applications on the grounds that the methods, facilities, and controls used to produce the sterile injectable products were inadequate to assure their identity, strength, quality, and purity. The drug company sought a petition for review, claiming that it was denied an opportunity for hearing and due notice because the FDA failed to give it notice of the type of information that was required to have been submitted to justify a hearing.
Did the FDA give the petitioners sufficient notice to serve as the basis for administrative summary judgment?
On appeal, the court denied the petition for review. The court held that it was rejecting the drug company's claim that it had a right to any more specific notice than it received because the drug company had failed to identify any evidence, or type of evidence, that it might have presented but for lack of notice as to its relevance. The court further held that the FDA was entitled to withdraw the drug company's applications without holding a hearing because the record demonstrated that in several respects the methods, facilities, and controls were inadequate and were not made adequate within a reasonable time after receipt of written notice.