Abbott Laboratories v. Gardner

Abbott Laboratories and other drug manufacturers (plaintiffs) challenged a federal regulation requiring prescription drugs to be labeled with their generic names, contending it exceeded statutory authority. They sought pre-enforcement review, and the question was whether such a challenge could be heard before the regulation was actually enforced against them.

Whether a pre-enforcement challenge to the validity of a federal regulation is ripe for adjudication, and whether judicial review of the agency action is available.