Akin Gump Lawyers Pen Analysis for Law360 re: Court Affirmation of FDA Policy Toward Drug Compounding
Law360 has published “Athenex Ruling Helps Clarify FDA Drug Compounding Policy,” an article by Akin Gump health care and life sciences partners Nathan Brown and Howard Sklamberg, counsel Eli Tomar and associate Sudhana Bajracharya.
The piece analyzes the impact of the U.S. District Court for the District of Columbia’s affirmation of a U.S. Food and Drug Administration (FDA) decision to exclude vasopressin from its List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act.
The authors note that the court’s decision endorses the FDA’s approach to reviewing bulk drug substances for use by outsourcing facilities based on clinical need. They write, “Thus the decision gives the agency a green light to move forward in reviewing — and excluding — more substances from compounding under Section 503B of the federal Food, Drug, and Cosmetic Act.”
They also note that, in the wake of this decision in Athenex Pharma Solutions LLC v. Azar II, health care providers and others using compounded drugs “should ensure they are only prepared from bulk drug substances in accordance with FDA policies, and prepare for FDA to move more expeditiously in evaluating individual substances based on the ‘clinical need’ analysis previously announced by the agency.”
The article presents the background to the case, beginning with Athenex Pharma Solutions LLC and Athenex Pharmaceutical Division LLC’s suit against the Department of Health and Human Services, and goes on to discuss the decision itself as well as what it means for health care providers, outsourcing facilities and drug manufacturers.