Federal judges in Delaware and Indiana will hear arguments today in drug manufacturers’ AstraZeneca and Eli Lilly’s separate lawsuits challenging the 340B contract pharmacy requirements.
A judge in Wilmington, Del., earlier this week denied AstraZeneca’s motion for an emergency stay in its suit against the U.S. Health and Human Services Department. The request was prompted by the U.S. Health Resources and Services Administration’s May 17 letters to Astra and five other manufacturers informing them that their denial of and conditions on 340B pricing on drugs dispensed by contract pharmacies are illegal and must end immediately. HRSA asked the companies by June 1 to share their plans to resume contract pharmacy-related sales. It said it will decide whether civil monetary penalties against the companies are warranted based on each company’s “willingness to comply with its obligations” under the 340B statute.
U.S. Judge Leonard Stark today will consider AstraZeneca’s fallback motion that he expedite a final decision in the case. Arguments begin at 1:00 p.m. Eastern.
Two hours later in Indianapolis, U.S. District Judge Sarah Evans Barker will hear arguments over
Lilly’s motion for a temporary order restraining HHS and HRSA from taking any action against the company based on HHS’s Dec. 30 legal advisory opinion that, under the 340B statute, manufacturers must offer 340B prices on covered outpatient drugs when covered entities use contract pharmacies to dispense medicines. Barker has scheduled a June 16 hearing on Lilly’s related request for a preliminary injunction against HHS and HRSA. In March, Barker granted Lilly’s motion for a preliminary injunction stopping HHS from implementing or enforcing its 340B administrative dispute resolution regulations against Lilly.