Cases & Deals

Drug manufacturer challenges HHS guidance on Section 340B drug pricing

Clients Drug manufacturer

Jones Day represents a drug manufacturer in litigation challenging the U.S. Department of Health and Human Service’s (HHS) advisory opinion under Section 340B of the Public Health Service Act. Section 340B requires pharmaceutical manufacturers participating in Medicare and Medicaid to offer outpatient drugs at discounted prices to certain “covered entities” that provide care for many uninsured or low-income patients. HHS’s advisory opinion interprets Section 340B to require drug manufacturers to provide 340B discounts to contract pharmacies and to prohibit manufacturers from imposing conditions on such sales. The manufacturer’s complaint argues that the Advisory Opinion violates the Administrative Procedure Act.