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WEINBERGER v. BENTEX PHARMACEUTICALS, INC.

No. 72-555.

412 U.S. 645 (1973)

93 S.Ct. 2488

37 L.Ed.2d 235

WEINBERGER, SECRETARY OF HEALTH, EDUCATION, AND WELFARE, ET AL. v. BENTEX PHARMACEUTICALS, INC., ET AL.

Supreme Court of United States.

Decided June 18, 1973.

Attorney(s) appearing for the Case

Deputy Solicitor General Friedman argued the cause for petitioners. On the briefs were Solicitor General Griswold, Assistant Attorney General Kauper, Deputy Solicitor General Wallace, Andrew L. Frey, Howard E. Shapiro, George Edelstein, and Peter Barton Hutt.

George F. Townes argued the cause for respondents. With him on the brief were Sol E. Abrams and C. Ben Bowen.*

Briefs of amici curiae urging affirmance were filed by Lloyd N. Cutler, Daniel Marcus, and William T. Lake for Pharmaceutical Manufacturers Assn., and by Thomas D. Finney, Jr., Thomas Richard Spradlin, and Daniel F. O'Keefe, Jr., for the Proprietary Assn.

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...

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