Source: https://supreme.justia.com/cases/federal/us/412/645/case.html
Timestamp: 2017-09-19 20:50:53
Document Index: 495833376

Matched Legal Cases: ['§ 505', '§ 201', '§ 505', '§ 201', '§ 331', '§ 505', '§ 505', '§ 505', '§ 201']

Weinberger v. Bentex Pharmaceuticals, Inc. (full text) :: 412 U.S. 645 (1973) :: Justia US Supreme Court Center
Justia › US Law › US Case Law › US Supreme Court › Volume 412 › Weinberger v. Bentex Pharmaceuticals, Inc. › Case
412 U.S. 645 (1973)
Held: The District Court's referral of the "new drug" and "grandfather" issues to FDA was proper. Pp. 412 U. S. 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. 412 U. S. 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. 412 U. S. 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. 412 U. S. 652-653.
(c) The "new drug" and "grandfather" issues are peculiarly suited to initial determination by FDA with its specialized competence and expertise. Pp. 412 U. S. 653-654.
As part of the Food and Drug Administration's (FDA's) Drug Efficacy Study Implementation program, three separate National Academy of Sciences-National Research Council (NAS-NRC) panels reviewed the evidence concerning these drugs, and each concluded that the drug was "ineffective" for the indicated use. The Commissioner concluded there was a lack of substantial evidence that these 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). FDA had taken the 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 they were expressly covered by an effective NDA. [Footnote 1] Accordingly,
FDA, as a result of an NAS-NRC study and after due notice, faced up to the problem of proposing withdrawal of drugs found to be lacking in substantial evidence of effectiveness. One method would be to have 1,000 withdrawal hearings -- perhaps as many as 3,500, each one lasting probably for weeks. The cost in time and budget would be enormous. Accordingly, FDA issued regulations, [Footnote 2] already discussed in Weinberger v. Hynson, Westcott & Dunning, Inc., ante, p. 412 U. S. 609, defining the "scientific principles which characterize an adequate and well controlled clinical investigation," [Footnote 3] which elaborates on the statutory "substantial evidence" test. And, as we held in Hynson, no basis for a hearing under these regulations would be laid unless a party seeking a hearing proffered at least some evidence of that nature and quality.
By May, 1972, 102 final orders effecting withdrawal of approval for 452 NDA's had been issued; and they resulted in the removal from the market of an additional 1,473 "me-too" drugs. [Footnote 4] FDA was still troubled because, under the 1962 Act, no census of the marketplace was authorized. That is why Congress enacted the Drug
Listing Act of 1972, 86 Stat. 559, 21 U.S.C. §§ 331(p), 335(e), 360(e), (f), (c), (d) (1970 ed., Supp. II). That Act requires manufacturers to submit to FDA a list of all drugs they market, including data showing their composition, labeling, and advertising. [Footnote 5] The Senate Report stated: [Footnote 6]
FDA also realized that it is impossible to apply the 1962 amendments to "over the counter" (OTC) drugs on a case-by-case basis. There are between 100,000 and 500,000 of these products, few of which were previously approved by FDA. In May, 1972, FDA adopted a procedure for determining whether particular OTC products not covered by NDA's are safe products, not ineffective, and not misbranded. 37 Fed.Reg. 9464. The procedure involves the establishment of independent expert panels for different categories of OTC drugs (e.g., antacids, laxatives, analgesics) which would review all available data and prepare monographs prescribing drug composition, labeling, and manufacturing controls. OTC's conforming to the monograph will not be considered either misbranded or a "new drug" requiring an NDA. The regulation provides for a hearing before the expert panel, comments and rebuttal comments on the monograph, and
As already noted, an order denying an NDA or withdrawing one is reviewable by the Court of Appeals, § 505(h), and we see no reason why Congress could not make one method of review the exclusive one. Certainly an order that does not deny or withdraw an NDA is reviewable under the Administrative Procedure Act if it declares a "new drug" status. See Hynson, supra, at 412 U. S. 627. In bolstering that conclusion, we should note in passing that Abbott Laboratories v. Gardner, 387 U. S. 136, 387 U. S. 144, said that the provisions stated in this Act for judicial review do not manifest "a congressional purpose to eliminate judicial review of other kinds of agency action." While § 505(h) would appear to be the exclusive method of obtaining judicial review of FDA's order withdrawing an NDA covering the instant drugs, the Government apparently did not oppose the District Court's taking jurisdiction, or appeal from its action, and presents no objection to the exercise by the courts of jurisdiction in this case. It does, however, strenuously oppose the conclusions reached by the Court of Appeals.
Whether a particular drug is a "new drug" depends in part on the expert knowledge and experience of scientists based on controlled clinical experimentation and backed by substantial support in scientific literature. One function is not peculiar to judicial expertise, the other to administrative expertise. The two types of cases overlap, and strongly suggest that Congress desired that the administrative agency make both kinds of determination. Even where no such administrative determination has been made and the issue arises in a district court in enforcement proceedings, it would be commonplace for the court to await an appropriate administrative declaration before it acted. See Myers v. Bethlehem Shipbuilding Corp., 303 U. S. 41, 303 U. S. 50-51; FPC v. Louisiana Power & Light Co., 406 U. S. 621, 406 U. S. 647. It may, of course, be true that, in some cases, general recognition that a drug is efficacious might be made without the kind of scientific support necessary to
obtain approval of an NDA. But, as we indicate in Hynson, supra, at 412 U. S. 631, the reach of scientific inquiry under both § 505(d) and § 201(p) is precisely the same.
Permian Basin Area Rate Cases, 390 U. S. 747, 390 U. S. 780. And see Ricci v. Chicago Mercantile Exchange, 409 U. S. 289, 409 U. S. 304-306.
The determination whether a drug is generally recognized as safe and effective within the meaning of 201(p)(1) necessarily implicates complex chemical and pharmacological considerations. Threshold questions within the peculiar expertise of an administrative agency are appropriately routed to the agency, while the court stays its hand. As we stated in Far Eastern Conference v. United States, 342 U. S. 570, 342 U. S. 574-575:
And see Port of Boston Marine Terminal Assn. v. Rederiaktiebolaget Transatlantic, 400 U. S. 62, 400 U. S. 68; Ricci v. Chicago Mercantile Exchange, supra, at 409 U. S. 304-306.
See the Appendix in Hynson, ante, p. 412 U. S. 34.