On May 4, 2021, 340B safety-net providers and their trade associations filed a brief in the case brought by AstraZeneca Pharmaceuticals LP (AstraZeneca) against the U.S. Department of Health and Human Services (HHS) seeking to invalidate the former HHS General Counsel’s 2020 Advisory Opinion on contract pharmacy arrangements. The brief was filed jointly with the National Association of Community Health Centers (NACHC) and certain plaintiffs in RWC-340B v. Becerra that agreed to also act as Amici (RWC-340B, Little Rivers and FamilyCare). The brief was accepted by the Court on May 5, 2021.
AstraZeneca’s lawsuit is important to many communities, providers, and legislators because it directly relates to the critical safety-net funding and pharmaceutical access that contract pharmacy arrangements provide to our Nation’s most underserved communities and at zero cost to taxpayers. The Advisory Opinion clarified that 340B contract pharmacies are legal and have been widely recognized for over twenty years. It was issued in December 2020 following the unilateral acts by certain drug manufacturers, including AstraZeneca, to halt offering 340B pricing on drugs shipped to contract pharmacies, in total disregard for damage that these actions caused for the Nation’s healthcare safety-net. Many safety-net providers believe that the drug companies’ actions are intended to upend the 340B program as a method of increasing their annual profits. AstraZeneca filed a lawsuit against HHS on January 12 and, on April 13, filed a motion to invalidate the Advisory Opinion. The safety-net providers and organizations filed the brief in opposition to AstraZeneca’s motion for two principal reasons: (1) to clarify critical issues relating to the history and operation of contract pharmacy arrangements and (2) to provide the Court with crucial evidence elucidating the harms that have befallen, and will continue to befall, small federal grantees, their vulnerable patients, and underserved communities because of the inability to access 340B pricing at contract pharmacies. The brief alerts the Court to the fact that an order to invalidate the Advisory Opinion will not only embolden AstraZeneca to continue its harmful and violative acts, but it will also encourage other drug companies to discontinue 340B pricing on drugs shipped to contract pharmacies, further compromising critical safety-net services throughout our Nation. The brief argues that, among other things, this result would cause grave harms to the lives and healthcare of countless underserved patients and communities. The brief also recounts the history of the United States War on Poverty and the expanding role that safety-net healthcare providers and others play to fight against rising national economic inequality.