On September 23, 2019, New York-based outsourcing facility Athenex, Inc. (Athenex) withdrew its appeal of the U.S. District Court for the District of Columbia’s ruling related to the United States Food & Drug Administration’s (FDA) placement of Vasopressin on the Agency’s “clinical need” list.
As may be recalled from our previous alert, Athenex sued FDA in March 2019, based on allegations that the Agency’s interpretation of key provisions of Section 503B of the Federal Food, Drug, & Cosmetic Act (FDCA) ran afoul of Congress’ desire that FDA not interfere with the practice of medicine. Specifically, Athenex challenged FDA’s decision to remove bulk drug substance Vasopressin from FDA’s “clinical need” list – that is, a list of bulk drug substances that FDA has approved for compounding by outsourcing facilities. Without placement on this list, outsourcing facilities cannot compound with the bulk drug substance unless it appears on FDA’s drug shortage list.
In August 2019, the U.S. District Court for the District of Columbia ruled in FDA’s favor and against Athenex, finding that: (1) the Agency’s method of determining whether there is a “clinical need” for a bulk drug substance gives effect to the intent of Congress; and (2) the exclusion of Vasopressin from the 503B Bulks List was not arbitrary and capricious. Although Athenex previously indicated its plans to appeal the ruling, Athenex recently withdrew its appeal and has ceased compounding with Vasopressin.
The District Court’s decision came out approximately one month before FDA published notice of its intent to exclude nine more bulk drug substances from its “clinical need” list in the Federal Register. Stakeholders interested in submitting comments to FDA’s notice have until November 4, 2019, to comment. Should you have any questions regarding the notice or any of the issues raised in this alert, please do not hesitate to reach out to Rachael Pontikes, Emily Hussey, or Kelly Kearney for further discussion.