Source: https://supreme.justia.com/cases/federal/us/412/645/
Timestamp: 2019-04-23 02:06:31+00:00

Document:
Justia › US Law › US Case Law › US Supreme Court › Volume 412 › Weinberger v. Bentex Pharmaceuticals, Inc.
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. 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.
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.
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.
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, [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.
"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 1938-1962, 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."
finally a hearing before the Commissioner and judicial review. Id. at 9475.
This case, like the cross-petition in the Hynson case (No. 72-414) raises the question whether FDA has authority to decide in an administrative hearing whether a drug satisfies the new effectiveness requirements of the Act. As noted, the Commissioner ordered that three NDA's for the drugs in question be withdrawn. Review of the order was not sought in the Court of Appeals as provided in § 505(h), 21 U.S.C. § 355(h). Rather, the aggrieved manufacturers of "me-too" drugs filed suit in the District Court, with the results we have already detailed. The narrow question is whether the FDA may decide whether a drug is a "new drug" on referral from a district court.
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.
"not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use."
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.
"in the absence of compelling evidence that such was Congress' intention . . . , prohibit administrative action imperative for the achievement of an agency's ultimate purposes."
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 reputation of drugs among experts in the field is not a matter well left to a court without chemical or medical background."
"[I]n cases raising issues of fact not within the conventional experience of judges or cases requiring the exercise of administrative discretion, agencies created by Congress for regulating the subject matter should not be passed over. This is so even though the facts, after they have been appraised by specialized competence, serve as a premise for legal consequences to be judicially defined. Uniformity and consistency in the regulation of business entrusted to a particular agency are secured, and the limited functions of review by the judiciary are more rationally exercised, by preliminary resort for ascertaining and interpreting the circumstances underlying legal issues to agencies that are better equipped than courts by specialization, by insight gained through experience, and by more flexible procedure."
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.
"other brands, potencies, dosage forms, salts, and esters of the same drug moiety as well as of any drug moiety related in chemical structure or known pharmacological properties."
It also provides all persons with an interest in such drugs an opportunity for hearing on any proposed withdrawal of NDA approval for the basic drug. A district court order directing FDA to apply the NAS-NRC evaluation to all "me-too" drugs is reproduced in 37 Fed.Reg. 26623-26624.
35 Fed.Reg. 3073 and 7250.
See the Appendix in Hynson, ante, p. 412 U. S. 34.
Hearings on the Present Status of Competition in the Pharmaceutical Industry before the Subcommittee on Monopoly of the Senate Select Committee on Small Business, 92d Cong., 2d Sess., pt.. 22, p. 8525.
Filings are due in June, 1973. 37 Fed.Reg. 26432. 6 S.Rep. No. 92-924, p. 2.
S.Rep. No. 92-924, p. 2.

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