Ciba Corp. v. Weinberger, 412 U.S. 640 (1973)

CERTIORARI TO THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

Petitioner manufactures a drug called Ritonic Capsules, for which it filed a new drug application (NDA) that became effective in 1959, on the basis of the drug’s safety. After the enactment of the 1962 amendments to the Federal Food. Drug, and Cosmetic Act, the Food and Drug Administration (FDA) withdrew approval of the NDA on the ground that there was no substantial evidence that the drug was effective as claimed, under § 505 of the Act. Petitioner sought review of the withdrawal order in the Court of Appeals for the Second Circuit, as provided in § 505(h), and that court affirmed the order. Prior to the issuance of the withdrawal order, petitioner sought declaratory and injunctive relief in the District Court in New Jersey, which granted the Government’s motion to dismiss the complaint for lack of jurisdiction. The Court of Appeals for the Third Circuit affirmed, holding that FDA was authorized to decide the jurisdictional question as an incident of its power to approve or withdraw approval for NDA’s, that its decision was reviewable on direct appeal by a court of appeals, and, since the Court of Appeals for the Second Circuit had ruled against petitioner on that appeal, the jurisdictional issue could not be relitigated in a separate suit for a declaratory judgment.

Held:

1. FDA has jurisdiction in an administrative proceeding to determine whether a drug product is a "new drug" within the meaning of § 201(p) of the Act. Weinberger v. Bentex Pharmaceuticals, Inc. post, p. 645. Pp. 643-644.

2. While the Act provides FDA with sanctions, such as civil injunction proceedings, criminal penalties, and in rem seizure and condemnation, to enforce the prohibition against sale in commerce of any article in violation of § 505, the Act does not create a dual system, one administrative and the other judicial. P. 644.

3. Where petitioner had nn opportunity to litigate the "new drug" issue before FDA and to raise the issue on appeal to a court of appeals, it may not relitigate the issue in another proceeding. P. 644.

463 F.2d 225, affirmed.

DOUGLAS, J., delivered the opinion of the Court, in which all Members joined, except BRENNAN, J., who took no part in the consideration or decision of the case, and STEWART, J., who took no part in the decision of the case.