Drug manufacturer Eli Lilly yesterday responded to the federal government’s June 25 motion to a federal judge in Indianapolis to dismiss the company’s case challenging the legality and constitutionality of the government’s 340B contract pharmacy requirements and 340B administrative dispute resolution (ADR) process.
U.S. District Judge Sarah Evans Barker is scheduled to hear arguments in the case on July 30. In March, Barker enjoined the U.S. Health Resources and Services Administration (HRSA) from enforcing its ADR regulations against Lilly, saying the company was likely to ultimately win its argument that HHS violated procedural requirements when it finalized the ADR rule.
“The court should grant judgment for Lilly on all of its claims,” the manufacturer says in its brief filed yesterday.
The brief cites last month’s court ruling in AstraZeneca’s contract pharmacy lawsuit invalidating the government’s Dec. 30 advisory opinion on 340B contract pharmacy. The now-withdrawn opinion concluded that manufacturers cannot refuse to offer 340B pricing covered entities where entities use contract pharmacies.
Lilly said the focus of its case is now on HRSA’s May 17 letter determining that the company’s contract pharmacy policy has resulted in overcharges and violates the 340B statute.
“The question at the heart of the May 17 determination is thus the central question currently before this court: Does Lilly’s policy comply with the statute?” Lilly said. “The answer to that question is straightforward: Yes. Lilly’s policy, which is consistent with the agency’s own prior guidance, fully complies with the 340B statute, which does not require manufacturers to deliver 340B drugs to contract pharmacies.”
Lilly also said HRSA’s May 17 letter is arbitrary and capricious and violates the Administrative Procedure Act. The company also restated its prior arguments about the illegality and unconstitutionality of HRSA’s ADR process.
“The court should confirm that Lilly’s policy does not violate the statute; set aside the May 17 determination; set aside the ADR Rule; and enter judgment for Lilly,” the company said.