Abbott Laboratories, Inc. v. Gardner – Case Brief Summary (U.S. Supreme Court)

In Abbott Laboratories, Inc. v. Gardner, 387 U.S. 136 (1967), the Court found ripe for judicial review a pre-enforcement challenge to an FDA regulation requiring that labels and advertisements for prescription drugs include the corresponding generic name of a drug every time the proprietary (trade) name was used.

The Court found the issues presented were appropriate for judicial resolution, as the regulations were a "final agency action," the issue of statutory construction presented was a purely legal one, and no further administrative proceedings were contemplated. Id. at 149.

The Court also found the impact of the regulations was "sufficiently direct and immediate" to render the issue appropriate for judicial review. Id. at 152.