Abbott Laboratories v. Gardner
Abbott Laboratories v. Gardner, 387 U.S. 136 (1967), was a case heard before the United States Supreme Court. Abbott Laboratories held that drug companies were not prohibited by the ripeness doctrine from challenging a U.S. Food and Drug Administration (FDA) regulation requiring a prescription drug's generic name to appear on all related printed materials. The government argued that the case was not ripe because the regulation had yet to be enforced; however, that argument failed as the Court found the issues to be fit for judicial resolution, and that the drug companies would experience substantial hardship if denied a pre-enforcement challenge to the statute. Prosecution for non-compliance was likely, civil and criminal penalties could be imposed, and the drug companies would suffer reputational damage if required to violate the regulation before challenging it in court.
Q2334719
case
Concept
Q11201
United States Supreme Court
Concept
Q306764
Abbott Laboratories
ORG
Q7335586
ripeness
Concept
Q204711
U.S. Food and Drug Administration
Concept
Q1643563
prescription drug
Concept
Q4664365
Abbott Laboratories v. Gardner
EVE
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1967
NUMBER
instance of
court
participant