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RUTHERFORD v. UNITED STATES

No. 77-2049.

582 F.2d 1234 (1978)

Glen L. RUTHERFORD, Individually and on behalf of a class composed of terminally ill cancer patients, Plaintiffs, Appellees, v. UNITED STATES of America, Joseph A. Califano, Secretary of Health, Education and Welfare, Donald Kennedy, Commissioner of the Food and Drug Administration, et al., Defendants, Appellants.

United States Court of Appeals, Tenth Circuit.

Decided July 10, 1978.

Rehearing Denied August 8, 1978.

Attorney(s) appearing for the Case

Barry Grossman, Atty., Dept. of Justice, Washington, D. C. (John H. Shenefield, Asst. Atty. Gen., Catherine G. O'Sullivan, Atty., Dept. of Justice, Peter L. De La Cruz, Atty., Dept. of Justice, Washington, D. C., of counsel, Richard M. Cooper, Chief Counsel, Eugene M. Pfeifer, Associate Chief Counsel for Enforcement, Rockville, Md., and Arnold I. Friede, Asst. Chief Counsel for Enforcement, Food and Drug Div., Dept. of Health, Education and Welfare, Washington, D. C., with him on the brief), for appellants.

Kenneth R. Coe, of Looney, Nichols, Johnson & Hayes, Oklahoma City, Okl., for appellees.

Charles F. Wheatley, Jr., William T. Miller, Grace Powers Monaco, Robert A. O'Neil, of Wheatley & Miller, Washington, D. C., on the brief for amicus American Cancer Society.

Before SETH, Chief Judge, and BARRETT and McKAY, Circuit Judges.

SETH, Chief Judge.

The Government appellants seek review of a district court holding which set aside a determination of the Commission of Food and Drugs that Laetrile, a controversial cancer drug, is a "new drug" within the meaning of the Federal Food, Drug, and Cosmetic Act ("the Act"), 21 U.S.C. § 301 et seq., and thus excludable from interstate commerce due to the absence of an approved new drug application.

The central question here is whether...

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