Global pharmaceutical maker Ipsen Biopharmaceuticals Inc. can sue the HHS over its informal rejection of Ipsen’s method for calculating Medicaid rebates for a specialty drug, a federal appeals court in the District of Columbia said.
Two letters Ipsen received from the Health and Human Services Department said Ipsen couldn’t treat a newly approved prescription version of an existing drug as a new drug for purposes of the Medicaid drug rebate program. Those letters constituted final agency action that Ipsen could challenge in court, the U.S. Court of Appeals for the District of Columbia Circuit said.
Letters from an agency to ...