CIBA Corp. v. Weinberger
412 U.S. 640 (1973)

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U.S. Supreme Court

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

CIBA Corp. v. Weinberger

No. 72-528

Argued April 17, 1973

Decided June 18, 1973

412 U.S. 640

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. 412 U. S. 645. Pp. 412 U. S. 643-644.

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