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NAT. ASS'N OF PHARMACEUTICAL MFRS. v. F. D. A.

79 Civ. 4450 (LFM).

487 F.Supp. 412 (1980)

NATIONAL ASSOCIATION OF PHARMACEUTICAL MANUFACTURERS and National Pharmaceutical Alliance, Plaintiffs, v. FOOD AND DRUG ADMINISTRATION, Defendant.

United States District Court, S. D. New York.

March 18, 1980.

Attorney(s) appearing for the Case

Bass, Ullman & Lustigman by Milton A. Bass, Jacob Laufer and Joan Licht Mantel, New York City, for plaintiffs.

Robert M. Fiske, Jr., U. S. Atty., S.D.N.Y. by Harvey J. Wolkoff, Asst. U. S. Atty., New York City, Kathleen A. Blackburn, Asst. Chief Counsel for Enforcement by Eugene M. Pfeifer, Food & Drug Administration, Dept. of Health, Education & Welfare, Rockville, Md., for defendant.

MEMORANDUM

MacMAHON, Chief Judge.

Defendant Food and Drug Administration ("FDA") moves to dismiss the complaint pursuant to Fed.R.Civ.P. 12(b)(6) for failure to state a claim upon which relief can be granted.

In September 1978, following notice-and-comment procedures, the FDA promulgated "current good manufacturing practice" ("CGMP") regulations1 applicable to certain "adulterated" drugs under the Food, Drug and Cosmetic...

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