After months of litigation in a federal district court, a key decision recently came out in the legal fight over 340B drug rebates. 340B Health Vice President of Legal and Policy Amanda Nagrotsky updates us on the development.

Court deals a blow to drugmakers

D.C. district court judge Dabney Friedrich ruled on May 15 that manufacturers cannot unilaterally implement rebate models for 340B, agreeing with the Health Resources & Services Administration (HRSA) that the agency effectively has preapproval authority over rebates. In her decision, the judge cited early results from a 340B Health survey finding that shifting 340B to a rebate model would divert significant hospital resources from patient care. Drugmakers have already appealed the ruling.

Some bright spots for drugmakers in this decision

Although the decision largely went against pharmaceutical companies, the judge ruled that the 340B statute does not categorically prohibit rebates, leaving the door open for government approvals of rebates. The judge also agreed with drugmakers’ assertions that HRSA should consider how rebate models could improve 340B compliance and how requiring the sharing of data through rebates could aid in drug company audits of covered entities.

Will HRSA stop all rebates from proceeding?

Despite this decision, the legal fight over rebates isn’t over yet. The judge found that, for three of the manufacturers in these cases, HRSA has yet to issue final decisions with respect to their proposed rebate models. In the case of Sanofi, the judge found that HRSA failed to adequately explain the legal basis for rejecting the drugmaker’s rebate model, and she directed the agency to reconsider its decision and explain whether and how it would violate the 340B statute. HRSA sent rebate guidance to the White House for approval earlier this month, though as of recording this episode it was not known what that guidance would say.

Resources

1. Read Our Analysis of the First Federal Court Decision on Rebates
2. 340B Health Continues Court Fight Against Rebates