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BRISTOL-MYERS SQUIBB CO. v. SHALALA

No. 95-5399.

91 F.3d 1493 (1996)

BRISTOL-MYERS SQUIBB COMPANY, Appellant, v. Donna E. SHALALA, Secretary of Health and Human Services, and David A. Kessler, M.D., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided August 16, 1996.

Attorney(s) appearing for the Case

Michael B. Waitzkin, Washington, DC, argued the cause for appellant. Terry S. Coleman, John D. Kiser and Matthew D. Peterson were on the briefs.

Howard S. Scher, United States Department of Justice, Washington, DC, argued the cause for appellee, with whom Douglas N. Letter, Litigation Counsel, and Eric H. Holder, Jr., United States Attorney, were on the brief.

Before: GINSBURG, RANDOLPH and TATEL, Circuit Judges.

Opinion for the Court filed by Circuit Judge GINSBURG.

GINSBURG, Circuit Judge:

Bristol-Meyers Squibb brought an action in the district court to challenge the regulations of the Food and Drug Administration that govern approval of a new generic drug based upon research paid for by the manufacturer of the "innovator" or "pioneer" drug with which the generic product is therapeutically interchangeable. The district court dismissed

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