CUTLER v. HAYES

No. 82-2365.

818 F.2d 879 (1987)

Mimi CUTLER, Stephen D. Annand and National Council of Senior Citizens, Appellants, v. Dr. Arthur Hull HAYES, Jr., et al.

United States Court of Appeals, District of Columbia Circuit.

Decided May 5, 1987.


Attorney(s) appearing for the Case

William B. Schultz, with whom Katherine A. Meyer and Alan B. Morrison, Washington, D.C., were on the brief, for appellants.

Neil R. Ellis, Atty., Dept. of Justice, with whom William F. Baxter, Asst. Atty. Gen., Dept. of Justice, Robert B. Nicholson, Atty., Dept. of Justice, Washington, D.C., Thomas Scarlett, Chief Counsel, and Kenneth C. Baumgartner, Associate Chief Counsel, Food and Drug Admin., Rockville, Md., and Jeffrey N. Gibbs, Sp. Asst. U.S. Atty., Washington, D.C., were on the brief, for appellees.

Robert A. Altman, with whom J. Griffin Lesher, Bryan Jay Yolles, Daniel F. O'Keefe, Jr., and Gregory M. Fisher, Washington, D.C., were on the brief, for appellee/cross appellant The Proprietary Ass'n, Inc.

Before ROBINSON and SCALIA, Circuit Judges, and WRIGHT, Senior Circuit Judge.


Opinion for the Court filed by Circuit Judge SPOTTSWOOD W. ROBINSON, III.

SPOTTSWOOD W. ROBINSON, III, Circuit Judge:

This case presents a challenge by consumers of over-the-counter (OTC) drugs to the program undertaken by the Food and Drug Administration (FDA) comprehensively to review these drugs for their safety and effectiveness. The consumers allege (1) that the regulations implementing this program violate the Food, Drug and Cosmetic Act of 1938 (FDC...

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