Eli Lilly, AstraZeneca, and Sanofi filed suits against HHS over the Office of General Counsel’s advisory opinion that contract pharmacies should be treated as agents of covered entities and should be supplied 340B discounted drugs. The suits, filed in Delaware, Indiana, and New Jersey, allege HHS did not follow the Administrative Procedures Act when drafting the opinion and that manufacturers would be open to liability for any limitations on contract pharmacies, which could expose them to fines or revocation of their ability to participate in other federal programs like Medicare and Medicaid. The advisory opinion does not have the force of law. This is just the latest salvo in the ongoing battle between drug manufacturers and covered entities over the 340B program. NCPA will continue to convene the 340B Task Force to discuss the impacts on pharmacy and policy solutions to ensure community pharmacy participation in 340B.
NCPA
