Schering Corporation v. Food and Drug Administration

OPINION OF THE COURT

MANSMANN, Circuit Judge.

The issue before us, brought in the context of a pioneer drug 1 manufacturer’s challenge to the propriety of FDA approval of non-systemically effective generic drugs pursuant to an abbreviated approval process, is one of first impression in the courts of appeals. We must determine whether the bioequivalence requirements, set forth in section 355(j)(7)(B) of Title I of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Act”), Pub.L. No. 98-417, 98 Stat. 1585 (1984), otherwise known as the “Hatch-Wax-man Amendments” to the Food,…