Cases & Deals

Sanofi successfully challenges HHS enforcement of Section 340B drug pricing statute

Client(s) Sanofi

Jones Day successfully represented Sanofi in litigation challenging the U.S. Department of Health and Human Services' (HHS) enforcement action 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 interpreted Section 340B to require drug manufacturers to deliver drugs at discounted 340B prices to an unlimited number of contract pharmacies and to prohibit manufacturers from imposing conditions on such sales. The U.S. Court of Appeals for the Third Circuit issued an opinion rejecting HHS's interpretation of Section 340B and holding that Sanofi's conditions comply with the statute because "restrictions on delivery to contract pharmacies do not violate Section 340B." The Third Circuit provided an injunction and a declaratory judgment against the government to provide "complete relief" to Sanofi.