Ciba Corporation v. Weinberger 8212 528

• Decision Date: 18 June 1973
• Docket Number: No. 72,72
• Citation: 37 L.Ed.2d 230,93 S.Ct. 2495,412 U.S. 640
• Parties: CIBA CORPORATION, Petitioner, v. Caspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al. —528
• Court: U.S. Supreme Court

412 U.S. 640

93 S.Ct. 2495

37 L.Ed.2d 230

CIBA CORPORATION, Petitioner,

v Caspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al.

No. 72—528.

Argued April 17, 1973.

Decided June 18, 1973.

Syllabus

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 NDAs, 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 produce is a 'new drug' within the meaning of § 201(p) of the Act. Weinberger v. Bentex Pharmaceuticals Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235. Pp. 644—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 an 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.

Opening statement by Daniel M. Friedman, Washington, D.C., for Caspar W. Weinberger, Secretary, HEW, in all five cases.

Daniel M. Friedman, Washington, D.C., for respondents.

Clyde A. Szuch, Newark, N.J., for petitioner.

Mr. Justice DOUGLAS delivered the opinion of the Court.

Petitioner manufactures a drug called Ritonic Capsules^* for which it filed a new drug application (NDA) that became effective in 1959. Under the Act then in force, an NDA for a 'new drug' required the manufacturer to submit to the Food and Drug Administration (FDA) adequate proof of the drug's safety. This particular NDA became effective on the basis of the drug's safety. As we have noted in the companion cases, the 1962 amendments to the Federal Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1040, as amended, 76 Stat. 780, directed FDA to withdraw approval for NDA's which became effective prior to that time if, after notice and opportunity for hearing, it found a lack of 'substantial evidence' that the drug involved was effective as claimed in its labeling. And, as we have noted, 'substantial evidence' as used in the Act, §§ 505(d) and 505(e)(3), 21 U.S.C. §§ 355(d) and 355(e)(3), means 'adequate and well-controlled investigations' from which experts may conclude that the drug will have the claimed effect.

A panel of the National Academy of Sciences-National Research Council (NAS—NRC) reviewed the claims made for Ritonic Capsules and found it 'ineffective' for each of the claims. FDA concluded there was a lack of substantial evidence of its efficacy and gave notice of its intent to withdraw the NDA, offering petitioner an opportunity to submit the required kind of data bearing on the efficacy of the drug and stating that withdrawal of approval of the NDA would cause the Ritonic Capsules to be a 'new drug' for which no NDA was in effect, thereby making future sales unlawful.

Petitioner responded, submitting data on the issue of efficacy and maintained that Ritonic Capsules was not a 'new drug' for purposes of the Act as amended. FDA concluded that petitioner's evidence was insufficient to establish effectiveness and gave notice of a hearing on the withdrawal of the NDA. Petitioner responded, contested FDA's authority to proceed further, and claimed that the product was not a 'new drug' under the 1962 Act. It reserved the right to establish its position in the administrative proceedings, in judicial proceedings, or in both. Petitioner filed no more data to support its position; and accordingly FDA withdrew approval of the NDA on the ground that there was no substantial evidence that the drug was effective as claimed. Petitioner sought review of the withdrawal order in the Court of Appeals for the Second Circuit, as provided in § 505(h), 21 U.S.C. § 355(h). The Court of Appeals affirmed the withdrawal order. CIBA-Geigy Corp. v. Richardson, 2 Cir., 446 F.2d 466.

Meanwhile, and prior to the issuance of the withdrawal order, petitioner brought suit in the District Court for the District of New Jersey seeking declaratory and injunctive relief. After hearing, the District Court granted the Government's motion to dismiss the complaint for lack of jurisdiction. On appeal, the Court of Appeals for the Third Circuit affirmed, 463 F.2d 225, 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 on that issue was reviewable on direct appeal by a court of appeals, and since the Court of...