A federal court has delivered a decisive blow to Johnson & Johnson's attempt to restructure drug pricing under the 340B Drug Pricing Program, ruling that the US government acted lawfully when it rejected the pharmaceutical giant's proposal to shift from upfront discounts to a rebate-based model.
Judge Rudolph Contreras of the US District Court for the District of Columbia ruled Friday that the US Health Resources and Services Administration (HRSA) "provided multiple reasons why J&J's rebate model is different from replenishment models" and acted within its statutory authority in rejecting the proposal.
Court Upholds Government Authority
The 340B Drug Pricing Program requires pharmaceutical manufacturers participating in Medicaid and Medicare Part B to sell outpatient drugs at reduced prices to qualifying hospitals, clinics, and healthcare providers that serve a disproportionate number of low-income and uninsured patients. Under current regulations, covered entities purchase drugs at steep discounts upfront.
Johnson & Johnson's rejected proposal would have fundamentally altered this structure by allowing covered entities to pay full commercial prices initially and then submit data to receive rebates later. The company argued that HRSA's rejection was arbitrary and capricious under the Administrative Procedure Act.
However, Judge Contreras found that "HRSA reasonably explained key differences that justify different treatment of the models," concluding that "J&J's argument that the differential treatment was arbitrary and capricious is without merit."
Statutory Interpretation Favors Government
The court's analysis focused heavily on statutory construction, examining the text, structure, purpose, and history of the 340B statute. Contreras determined that the parenthetical phrase "taking into account any rebate or discount, as provided by the Secretary" grants the Secretary discretion to provide for a rebate model or not.
"These tools of statutory construction all support Defendants' interpretation," the judge wrote, adding that the government had the "best interpretation" based on the plain and unambiguous language of the 340B statute.
The ruling emphasized that "HRSA was not required to address every concern J&J had raised to determine it had not approved rebates broadly," ultimately granting the government's motion for summary judgment.
Industry Implications and Company Response
Johnson & Johnson was the first pharmaceutical company to propose a 340B rebate model and the first to legally challenge HRSA's rejection of such a proposal. The company expressed strong disagreement with the court's decision.
"The court's ruling contradicts the statute and allows for the continuing abuse and potential fraud that undermines the 340B Program's original intent to provide medicines at discounted prices to vulnerable patients," a J&J spokesperson stated. The company announced its intention to appeal the order and emphasized it "is working to bring more transparency to help the 340B Program achieve its original intent to support prescription drug access for vulnerable patients."
Broader Legal Landscape
The decision represents another victory for HRSA in its ongoing legal battles with pharmaceutical companies over 340B pricing modifications. The agency has previously scored victories in similar lawsuits filed by Bristol Myers Squibb Co., Novartis AG, Eli Lilly & Co., Sanofi SA, and health tech company Kalderos Inc.
The ruling is particularly significant for hospitals and healthcare groups that rely on upfront 340B pricing to manage drug costs, especially when serving vulnerable patient populations in low-income and rural areas. These entities had faced fierce resistance to any changes that would delay access to discounted medications or create additional administrative burdens.
