Abbott Laboratories v. Gardner

Abbott Laboratories v. Gardner
Argued January 16, 1967
Decided May 22, 1967
Full case nameAbbott Laboratories, et al. v. Gardner, Secretary of Health, Education, and Welfare, et al.
Citations387 U.S. 136 (more)
87 S. Ct. 1507; 18 L. Ed. 2d 681; 1967 U.S. LEXIS 2974
Holding
Drug companies were not prohibited by the ripeness doctrine from challenging an FDA regulation requiring a prescription drug's generic name to appear on all related printed materials.
Court membership
Chief Justice
Earl Warren
Associate Justices
Hugo Black · William O. Douglas
Tom C. Clark · John M. Harlan II
William J. Brennan Jr. · Potter Stewart
Byron White · Abe Fortas
Case opinions
MajorityHarlan, joined by Black, Douglas, Stewart, White
DissentFortas, joined by Warren, Clark
DissentClark
Brennan took no part in the consideration or decision of the case.
Laws applied
Administrative Procedure Act

Abbott Laboratories v. Gardner, 387 U.S. 136 (1967), was a case heard before the United States Supreme Court. The Court 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. 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.