an "imminent hazard to the public health," but in such cases the manufacturer is entitled to an expedited post-withdrawal hearing. 21 U.S.C. § 355(e). Otherwise, the Secretary has delegated authority to the FDA to withdraw approval after hearing, a circumstance often caused by receipt of new information. 21 U.S.C. § 355(e); 21 C.F.R. § 5.10(a)(1), 5.82. If FDA refuses approval from the outset, the applicant is also entitled to a prompt hearing. 21 U.S.C. § 355(j)(4)(C). Thus the statutory pattern implemented by regulations contemplates development of an administrative record resulting in an order to be reviewed directly by the Court of Appeals.
There is no regulation or statutory provision that contemplates rescission of an approval issued by mistake. ATI contends that the FDA acted contrary to "an express mandate of the statute" and "invokes the ultra vires-type of exception" recognized in Leedom v. Kyne, 358 U.S. 184, 188-89, 3 L. Ed. 2d 210, 79 S. Ct. 180 (1958), to justify its disregard of the otherwise exclusive jurisdiction of the Court of Appeals.
Whether the action of FDA is so clearly ultra vires as to justify United States District Court intervention is, however, far from apparent. Abbott Laboratories v. Gardner, 387 U.S. 136, 18 L. Ed. 2d 681, 87 S. Ct. 1507 (1967), which presented an imminent threat of criminal prosecution based on an ultra vires action, is not directly on point. Here, an agency almost immediately discovers its own error in awarding approval of a drug which the statute directed should not be awarded based on facts available at the time. Yet ATI pictures itself, quite incorrectly, as having been deprived of a vested right. It had no right to put on the market a drug when facts were available indicating that the public health might be injured. Even assuming arguendo that a right had vested, ATI was not deprived of a factual hearing to prove its qualifications to make and sell the drug, and, given the circumstances, the post-denial hearing offered easily met due process requirements. See Mathews v. Eldridge, 424 U.S. 319, 335, 47 L. Ed. 2d 18, 96 S. Ct. 893 (1976). In reality, ATI seeks only to profit from FDA's inadvertent and quickly corrected mistake, ignoring entirely FDA's responsibility to safeguard the public.
FDA is entitled to some deference when its actions are examined. This was a good faith mistake promptly discovered and corrected, nothing more. There is authority that suggests an agency must be given some leeway to remedy mistakes. See Gun South, Inc. v. Brady, 877 F.2d 858 (11th Cir. 1989), and cases cited therein; Boesche v. Udall, 373 U.S. 472, 476-78, 10 L. Ed. 2d 491, 83 S. Ct. 1373 (1963). No precedent from this circuit has been cited that indicates a contrary approach. It is not the function of a district court under these circumstances to intervene where an unresolved issue of statutory interpretation and administrative law within the exclusive jurisdiction of the Court of Appeals is presented.
Plaintiff's motion for judgment on the pleadings will be denied and the complaint dismissed. An appropriate Order is filed herewith.
ORDER - February 28, 1990, Filed
Upon consideration of the pending motions, the oppositions thereto, defendants' request for dismissal, and the record herein, and it appearing for reasons stated in the accompanying Memorandum that this Court lacks jurisdiction, it is hereby
ORDERED that plaintiff's Motion for Judgment on the Pleadings is denied and defendants' request for dismissal is granted; and it is further
ORDERED that the complaint is dismissed; and it is further
ORDERED that plaintiff's Motion to Strike Portions of the Declaration of Daniel L. Michels is denied.