The U.S. Health Resources and Services Administration (HRSA) said this morning it “respectfully disagrees with” and “continues to evaluate its options” about a federal district judge’s Nov. 5 finding that drug manufacturers Novartis and United Therapeutic’s 340B contract pharmacy policies “had not violated” the 340B statute.
HRSA also said it is pleased with two different federal judges’ opinions agreeing with HRSA’s findings that manufacturers Lilly, Novo Nordisk, and Sanofi’s 340B contract pharmacy policies “have unlawfully restricted access to 340B discounted drugs by covered entities that dispense medications through contract pharmacy arrangements—the core finding of HRSA’s May 17, 2021, Violation Letters.”
Besides routine updates to the courts on the status of the recent court decisions, HRSA’s statement today on the Office of Pharmacy Affairs (OPA) home page is the federal government’s first about the five court rulings on 340B contract pharmacy. The first court decision came on Oct. 29 in Lilly’s lawsuit against HRSA and the U.S. Health and Human Services Department (HHS). Two more came on Nov. 5, the first in Novo Nordisk and Sanofi’s lawsuits, the second in Novartis and United Therapeutics’ lawsuits.
Lilly, Sanofi, and Novo Nordisk have appealed the decisions in their cases.
In all five cases, the judges struck down and vacated, for different reasons, HRSA’s May 17 letters informing the companies that their policies were illegal. As of this early morning, the government had not filed notices of appeal in any of the case.
A fourth federal district judge has heard arguments in AstraZeneca’s contract pharmacy lawsuit. Both sides have asked the judge to expedite his ruling.
