Opinion ID: 305485
Heading Depth: 1
Heading Rank: 3

Heading: Primary Jurisdiction and Exhaustion of Administrative

Text: Remedies 27 On remand, and subject to plaintiffs reactivating their last-filed application for FDA approval of Cothyrobal for interstate sale, the District Court will be confronted with two issues: (1) whether plaintiffs' drug Cothyrobal is safe and effective for interstate sale, and (2) whether plaintiffs' allegations as to the existence of a conspiracy on the part of defendants to prevent full and fair FDA consideration of plaintiffs' application for approval of Cothyrobal and thereby to favor defendants' drug Choloxin are true. These two questions appear to be inextricably linked insofar as portions of the evidence which may be offered; however, the decision on the first issue is most properly for the FDA, while decision on the second (antitrust) issue is reserved for the District Court. 28 The reason for affording the FDA the first opportunity to decide whether Cothyrobal is safe and effective for interstate sale is essentially practical: In view of the comprehensive scheme enacted by Congress for the testing of new drugs with respect to their safety and efficacy before they may be approved for interstate sale, and of the expertise required to conduct such tests, the question of the efficacy and safety of Cothyrobal is clearly inappropriate for original consideration by the courts. Plaintiffs themselves recognize this and do not dispute the primary jurisdiction of the FDA over such questions. 30 The Supreme Court has clarified the nature of primary jurisdiction: 29 The doctrine of primary jurisdiction, like the rule requiring exhaustion of administrative remedies, is concerned with promoting proper relationships between the courts and administrative agencies charged with particular regulatory duties. Exhaustion applies where a claim is cognizable in the first instance by an administrative agency alone; judicial interference is withheld until the administrative process has run its course. Primary jurisdiction, on the other hand, applies where a claim is originally cognizable in the courts, and comes into play whenever enforcement of the claim requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body; in such a case the judicial process is suspended pending referral of such issues to the administrative body for its views. . . . 31 30 Although plaintiffs' antitrust claims in the instant case are originally cognizable in the courts, enforcement of these claims involves a determination of the safety and efficacy of Cothyrobal, that is, its fitness for interstate sale as defined by the requirements of the Food, Drug and Cosmetic Act, a function clearly within the specific competence of the FDA. As put by Professor Oppenheim, The doctrine of primary jurisdiction . . . is in its strict sense a concept under which a plaintiff will be barred from proceeding in a lawsuit until all or some of the issues have been considered by the appropriate regulatory agency. 32 Only by adhering to such a procedure are the goals sought by the Supreme Court in Far East Conference v. United States attainable 31 . . . even though the facts after they have been appraised by specialized competence serve as a premise for legal consequences to be judicially defined. Uniformity and consistency in the regulation of business entrusted to a particular agency are secured, and the limited functions of review by the judiciary are more rationally exercised, by preliminary resort for ascertaining and interpreting the circumstances underlying legal issues to agencies that are better equipped than courts by specialization, by insight gained through experience, and by more flexible procedure. 33 32 It is clear, then, that the doctrine of primary jurisdiction applies to particular issues in a judicial proceeding as well as to cases in which the entire cause of action is one within the primary jurisdiction of an administrative agency. As such, it is incumbent upon plaintiffs to resubmit to the FDA, inter alia, their last drug application for approval for interstate sale of their drug Cothyrobal. The record demonstrates, however, that they have never permitted full FDA consideration of the safety and efficacy of Cothyrobal; instead, while on several occasions initiating the procedure for FDA consideration of Cothyrobal, the plaintiffs then either withdrew or abandoned their applications before the FDA was able to make a final determination, a course of action for which there can now be no justification. 33 Furthermore, for plaintiffs in the case at bar to obtain the full relief they seek-injunctive relief restraining defendants from interfering with plaintiffs' efforts to market Cothyrobal and damages for injuries caused by an alleged conspiracy on the part of defendants in violation of the antitrust laws-they must in turn obtain the following: (1) FDA evaluation, in view of its primary jurisdiction, of the safety and efficacy of Cothyrobal for interstate sale; and (2) a District Court determination that the alleged conspiracy on the part of defendants actually existed. If, however, the District Court is not directed to retain jurisdiction over plaintiffs' antitrust law violations pending the FDA evaluation of Cothyrobal, plaintiffs may not be able to obtain the full relief they seek, since clearly the FDA is not vested with any expertise to determine the accuracy of plaintiffs' antitrust allegations, nor is it empowered to award damages in the event such allegations are shown to be correct. 34 In this respect, the case at bar is similar to Jewel Companies, Inc. v. FTC, 34 a suit to enjoin an investigation by the FTC, where the Seventh Circuit held that the District Court could retain jurisdiction to entertain a complaint challenging the FTC's jurisdiction, since if the Commission proceeded to a final order this question could not be raised on appeal from an agency determination.