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.

The underlying conflict in this case arose from the decision by the Commissioner of Food and Drug to promulgate the "established name" rule pursuant to a statute granted by Congress.

[8] Based on the decisions in both of these cases, the Supreme Court set a new standard pattern for parties to receive this type of pre-enforcement relief.

[9] Today, the test developed in Abbott Laboratories helps courts in deciding whether Congress has precluded judicial review over agency action.