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Weinberger v. Bentex Pharmaceuticals, Inc.
United States Supreme Court
412 U.S. 645 (1973)
- Written by Alex Ruskell, JD
Facts
Bentex Pharmaceuticals, Inc. (plaintiff) filed suit for a declaratory judgment that its pre-1962 drug containing pentylenetetrazol was generally recognized as safe and effective and was thus not a new drug subject to regulation. The court of appeals held that the Food and Drug Administration (FDA) had no jurisdiction to determine in an administrative proceeding what was a new drug requiring a new-drug application. The government appealed to the United States Supreme Court.
Rule of Law
Issue
Holding and Reasoning (Douglas, J.)
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