Breaking: Federal Judge Grants Lilly’s Motion to Halt 340B Dispute Resolution System

In a decision that could have significant implications for 340B stakeholders, a federal district judge in Indianapolis today granted drug manufacturer Eli Lilly’s motion for a preliminary injunction stopping the U.S. Health and Human Services Department from implementing or enforcing regulations establishing the 340B drug pricing program’s new administrative dispute resolution.

Judge Sarah Evans Barker’s March 16 order is a major victory for Lilly, which last summer was the first drug maker to deny 340B pricing on its products when they are dispensed by covered entities’ contract pharmacies. Several other manufacturers have followed suit, either denying 340B pricing on drugs dispensed to contract pharmacies or conditioning such pricing on entities’ provision of 340B contract pharmacy claims data.

Barker’s decision is also a setback for the federal government, which argued that Lilly’s arguments in support on an injunction were meritless, that the company would suffer no irreparable harm if it had to respond to ADR claims brought against it, and that it was in the public interest to let the rule take effect.

This is a developing story. We will report in greater depth about the decision tomorrow.

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