BURROUGHS WELLCOME CO., a North Carolina corporation, Appellant,
Pharmaceutical Manufacturers Assoc., The Upjohn Co., Amici Curiae,
v.
Richard S. SCHWEIKER, etc., et al., Appellees,
Generic Pharmaceutical Industry Assoc., Inc., et al., Amici Curiae.
BURROUGHS WELLCOME CO., a North Carolina corporation, Appellee,
v.
Richard S. SCHWEIKER, etc., et al., Appellees, and
Generic Pharmaceutical Industry Assoc., Inc., Appellant.
United States Court of Appeals, Fourth Circuit.https://leagle.com/images/logo.png
Argued May 4, 1981.
Decided May 11, 1981.
Rehearing Denied June 15, 1981.
Attorney(s) appearing for the Case
Alan H. Kaplan, Washington, D. C. (Thomas O. Henteleff, Richard S. Morey, Peter O. Safir, Glenn E. Davis, Peter R. Mathers, Kleinfeld, Kaplan & Becker, Washington, D. C., William M. Sullivan, Kathryn V. Crean, Research Triangle Park, N. C., Ann E. Salitsky, James K. Dorsett, Jr., Michael E. Weddington, Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, Raleigh, N. C., on brief), for appellant Burroughs Wellcome Co.
Richard Cashman, New York City (Richard A. Givens, Botein, Hays, Sklar & Herzberg, New York City, on brief), for appellant Generic Pharmaceutical Industry Assoc., Inc.
James H. Laskey, Dept. of Justice, Washington, D. C. (Robert B. Nicholson, Dept. of Justice, Washington, D. C., William F. Baxter, Asst. Atty. Gen., Dept. of Justice, Washington, D. C., Jeffrey B. Spinger, Acting Chief Counsel, Forrest T. Patterson, Associate Chief Counsel for Enforcement, Food and Drug Administration, Rockville, Md., on brief), for appellees Schweiker, et al.
Jacob Laufer, New York City, Milton A. Bass, Steven R. Trost, Bass, Ullman & Lustigman, New York City, on brief for National Association of Pharmaceutical Manufacturers.
Joseph E. Meuth, Wills, Green & Meuth, Los Angeles, Cal., on brief, for IMS, Limited.
Stanley L. Temko, Herbert Dym, Terry Coleman, Washington, D. C., on brief, for The Upjohn Company.
Joel E. Hoffman, Robert M. Lichtman, Thomas W. Brunner, Anthony L. Young, Mark S. Fisher, Wald, Harkrader & Ross, Washington, D. C., on brief, for Pharmaceutical Manufacturers Association.
James M. Johnstone, Tom Kirby, III, Philip H. Hecht, Washington, D. C., Kirkland & Ellis, Washington, D. C., Robert G. Pugh, Sr., Robert G. Pugh, Jr., Pugh & Pugh, Shreveport, La., on brief for Boots Pharmaceuticals, Inc.
Before BUTZNER, SPROUSE, and ERVIN, Circuit Judges.
United States Court of Appeals, Fourth Circuit.
BUTZNER, Circuit Judge:
Burroughs Wellcome Company, a pharmaceutical manufacturer, appeals from a judgment of the district court that held that the Food and Drug Administration need not engage in notice and comment rule making before implementing a memorandum concerning approval of new drug applications (NDAs) for generic versions of drugs first marketed after 1962 that are based on reports in the scientific literature to establish the drug's safety and effectiveness...
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