United States v. Baxter Healthcare Corp.
United States Court of Appeals for the Seventh Circuit
901 F.2d 1401 (1990)
- Written by Mary Phelan D'Isa, JD
Facts
Two drug companies, Baxter Healthcare Corp. and Glaxo Specialties, Inc., engaged in a large-scale program to reconstitute, repackage, freeze, and distribute lyophilized (freeze-dried) drug powders and liquid concentrates into dosage packages suitable for immediate use by health-care providers without first seeking Food and Drug Administration (FDA) approval. The FDA contended that Baxter and Glaxo must apply for separate, new-drug approval for this program even though the drugs—in their pre-reconstituted formulas—were already approved. Baxter and Glaxo argued that the FDA was unreasonable in seeking more than one approval for the same drug products given that an already-approved labeling system allows individual doctors and hospital pharmacies to reconstitute the same drugs on a smaller scale. The FDA argued that the reconstituted drugs differed in important ways from the component drugs and therefore required separate approval.
Rule of Law
Issue
Holding and Reasoning (Cummings. J.)
Dissent (Pell, J)
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