Weinberger v. Bentex Pharmaceuticals, Inc 8212 555

Decision Date18 June 1973
Docket NumberNo. 72,72
PartiesCaspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al., Petitioners, v. BENTEX PHARMACEUTICALS, INC., et al. —555
CourtU.S. Supreme Court
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 juris- diction, 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. P. 651 652.

(b) The reach of scientific inquiry under both § 505(d) and § 201(p) is the same, Weinberger v. Hynson, Westcott and Dunning, Inc., 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 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.

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 petitioners.

George F. Townes, Greenville, S.C., for respondents.

Mr. Justice DOUGLAS delivered the opinion of the Court.

In this case Bentex and some 20 other firms that market drugs containing pentylenetetrazol filed this suit for a declaratory judgment that their drugs containing pentylenetetrazol are generally recognized as safe and effective, and thus not 'new drugs' within the meaning of § 201(p)(1) of the Federal Food, Drug, and Cosmetic Act of 1938, as amended, 76 Stat. 781, 21 U.S.C. § 321(p) (1). They also sought exemption from the new effectiveness requirements by reason of § 107(c)(4) of the 1962 amendments to the Act, known as the 'grandfather' clause.

As part of 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 f 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.1 Accord- ingly, the notice invited the holders of the 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. See § 505(d), 21 U.S.C. § 355(d). Only one NDA holder submitted further evidence, which the Commissioner held did not satisfy the statutory standard. He thereupon gave notice of intent to issue an order withdrawing approval of the NDA's under § 505(e), 21 U.S.C. § 355(e). Again, all those who might be adversely affected by withdrawal of the NDA's were given the opportunity to participate. Only one NDA holder requested a hearing but filed no data to support it. The Commissioner issued orders withdrawing approval of the three NDA's (35 Fed.Reg. 14412); no appeal was taken. This suit in the District Court followed. It appears that all of the parties to this suit market 'me-too' drugs, none of which was expressly covered by an effective NDA.

The District Court held that although it could determine whether the drugs were 'new' or 'grandfathered' drugs, its jurisdiction was concurrent with that of FDA and that FDA should resolve the 'new drug' issue in an administrative proceeding. It entered an injunction to preserve the status quo and ruled that if FDA should decline to hold a hearing it would determine the issue. The Court of Appeals reversed and remanded with directions that the District Court determine whether the challenged drugs may lawfully be marketed without approved NDA's. 463 F.2d 363. It held that FDA has no jurisdiction, either primary or concurrent, to decide in an administrative proceeding what is a 'new drug' for which an NDA is required. In its view the 1962 Act established two forums for the regulation of drugs: an administrative one for premarketing clear- ances for 'new drugs' or withdrawal of previously approved NDA's, with the right of appeal; and, second, a judicial one for enforcement of the requirement that 'new drugs' be cleared as safe and effective before marketing by providing the Government with judicial remedies of seizure, injunction, and criminal prosecution available solely in the District Court. Id., at 371—372.

We reverse the Court of Appeals.

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,2 already discussed in Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207, defining the 'scientific principles which characterize an adequate and well-controlled clinical investigation,'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.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.5 The Senate Report stated:6

'The effective enforcement of the drug provisions of the Act requires the ready availability of a current inventory of all marketed drugs. The Secretary is just completing a thorough review of the effectiveness of drugs marketed pursuant to new drug applications during the period 19381962, as required by the Drug Amendments of 1962. Application of the results of this important review to related drugs would be frustrated if a list of all marketed drugs were not easily obtained.'

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, analgesic) 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...

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