Teva Pharmaceuticals USA, Inc. v. Robert F. Kennedy, Jr.

Summary

The court held that the IRA's review bar precludes review of CMS's drug-specific determinations but does not preclude review of generally applicable legal standards governing those determinations. It upheld CMS's grouping of Austedo and Austedo XR as one qualifying single source drug and rejected Teva's due process claim, but held that Teva's challenge to CMS's bona fide marketing requirement was ripe and remanded that claim for initial consideration by the district court.