Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645 (1973)

Weinberger v. Bentex Pharmaceuticals, Inc.

No. 72-555

Argued April 17, 1973
Decided June 18, 1973
412 U.S. 645

CERTIORARI TO THE UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

Syllabus

Respondent drug marketers filed suit for a declaratory judgment that their drugs containing pentylenetetrazol are generally recognized as safe and effective and thus are not "new drugs" within the meaning of § 201(p) of the Federal Food, Drug, and Cosmetic Act of 1938, as amended. They also sought exemption under § 107(c)(4), the grandfather clause, of the 1962 amendments to the Act. The Food and Drug Administration (FDA) Commissioner, based on NAS-NRC panel reports, concluded that there was a lack of substantial evidence that the drugs were effective for their intended uses and gave notice of his intention to initiate proceedings to withdraw approval of the new drug applications (NDA’s). In light of FDA’s position that withdrawal of approval of an NDA would operate to remove marketing approval for all drugs of similar composition, known as "me-too" drugs, whether or not expressly covered by an effective NDA, the Commissioner invited holders of NDA’s for drugs containing pentylenetetrazol "and any interested person who might be adversely affected by their removal from the market" to submit "adequate and well controlled studies" to establish the effectiveness of the drugs. Only one NDA holder submitted further evidence, which the Commissioner held did not satisfy the statutory standard. He gave notice of intent to issue an order withdrawing approval of the NDA’s, and only one NDA holder requested a hearing, but filed no supporting data. The Commissioner issued orders withdrawing approval of the NDA’s, and no appeal was taken. Respondents here all market "me-too" drugs, none of which was expressly covered by an effective NDA. The District Court held that FDA should resolve the "new drug" and "grandfather" issues in an administrative proceeding. The Court of Appeals reversed and remanded with directions to the District Court to determine whether the challenged drugs may lawfully be marketed without approved NDA’s, holding that FDA has no jurisdiction, primary or concurrent, to decide what is a "new drug" for which an NDA is required.

Held: The District Court’s referral of the "new drug" and "grandfather" issues to FDA was proper. Pp. 649-654.

(a) While an FDA order denying an NDA and withdrawing one is reviewable by the Court of Appeals under § 505(h), an order declaring a "new drug" status under § 201(p) is reviewable under the Administrative Procedure Act by the District Court. Pp. 651-652.

(b) The reach of scientific inquiry under both § 505(d) and § 201(p) is the same, Weinberger v. Hynson, Westcott & Dunning, Inc., ante, p. 609, and it is implicit in the regulatory scheme that FDA has jurisdiction to decide with administrative finality, subject to judicial review, the "new drug" status of individual drugs or classes of drugs. Pp. 652-653.

(c) The "new drug" and "grandfather" issues are peculiarly suited to initial determination by FDA with its specialized competence and expertise. Pp. 653-654.

463 F.2d 363, reversed.

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.