340B Dispute Resolution Rule Likely Violated Proper Regulatory Procedures – Court

In a preliminary victory for biopharma, a US District Court in Indianapolis has determined the Health and Human Services Department’s final rule establishing an administrative dispute resolution process to arbitrate conflicts between manufacturers and 340B providers did not appear to follow proper administrative procedures and should be suspended.

The court granted a preliminary injunction to stop implementation of the rule in a suit brought by Eli Lilly and Company against HHS on 12 January. The suit...