Weinberger v. Hynson, Westcott & Dunning, Inc.
United States Supreme Court
412 U.S. 609 (1973)
- Written by Alex Ruskell, JD
Facts
In 1938, the Food and Drug Administration (FDA) prohibited the introduction of new drugs into commerce unless that drug filed a new-drug application showing that it was generally recognized by qualified experts as being safe for its intended use. In 1962, the FDA amended this requirement to a drug needing to be recognized as effective for its intended use and required drugs to provide substantial evidence of their effectiveness before approval. Before 1962, Hynson, Westcott & Dunning, Inc. filed a new-drug application for Lutrexin. When the 1962 change occurred, Hynson provided a testimonial letter, a list of references, and an unpublished study to show Lutrexin’s effectiveness in the treatment of premature labor. The FDA found that Hynson had not submitted adequate evidence and withdrew Lutrexin’s prior approval without a hearing. Hynson ultimately appealed to the Supreme Court to challenge the new FDA requirements.
Rule of Law
Issue
Holding and Reasoning (Douglas, J.)
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