On March 6, Mike Ruttinger argued on behalf of Accord Healthcare, Inc. in an appeal involving questions of federal preemption related to drugs approved under the Food, Drug, and Cosmetic Act’s § 505(b)(2) approval pathway. The Fifth Circuit agreed to hear the case on an interlocutory appeal from the U.S. District Court for the Eastern District of Louisiana, which oversees the In re: Taxotere (Docetaxel) Products Liability Litigation.

The Fifth Circuit is the first federal appellate court to consider the post-approval obligations owed by a drugmaker whose drug has been approved under § 505(b)(2), including the duty to address “newly acquired information” about a drug as defined in 21 C.F.R. § 314.3(b).

As Law360 quoted Mike, “[w]hen the district court certified this case for an interlocutory appeal, the court expressed the need for guidance as to how the newly acquired information regulation applies in the context of a 505(b)(2)” drug.

Listen to the oral argument recording on the website of the United States Court of Appeals for the Fifth Circuit here. Read more about the case in Law360 here.