Boehringer Ingelheim Pharma Gmbh & Co. Kg v. United States Food and Drug Administration

MEMORANDUM OPINION

COLLEEN KOLLAR-KOTELLY, United States District Judge

In this challenge to an action of the United States Pood and Drug Administration (“FDA”) under the Administrative Procedure Act, the underlying facts are complex, the related science even more so. But the legal issue before this Court is relatively narrow: the legal sufficiency of the FDA’s interpretation of the statutory reference to “the date an application was initially submitted for such [approved] drug product” and the agency’s implementation of that interpretation. 1 Before the Court are Plaintiffs’ [23] Motion for…