340B pricing lawsuits escalation [developing]
Key Questions
What recent Ninth Circuit decision involves 340B pricing?
The Ninth Circuit revived False Claims Act (FCA) lawsuits against AbbVie and peers, potentially worth $100M+. This escalates legal challenges over 340B pricing practices.
What lawsuit are AbbVie and Novartis filing against Washington state?
AbbVie and Novartis sued Washington over SB5981, a new 340B crackdown law. They aim to block enforcement of added conditions on the federal 340B program.
What was the 4th Circuit's ruling on 340B pricing?
The 4th Circuit affirmed a win against West Virginia's SB325, ruling states may not add conditions to the federal 340B manufacturer-covered entity relationship. This supports preemption under spending power.
How significant is the 340B outpatient market?
The 340B outpatient market exceeds $81B. Chain of Agreement (COA) filed an amicus brief in the 10th Circuit urging contract pharmacy reforms.
What broader impacts do these 340B lawsuits have on pharma margins?
Lawsuits contribute to margin drag alongside tariffs, IRA pricing, TrumpRx discounts, and PBM issues. They are blocking biosimilar uptake and adding legal risks for companies like AbbVie.
Ninth Cir revives FCA vs AbbVie/peers (~$100M+); ABBV+NVS sue WA SB5981; 4th Cir affirm vs WV SB325 win. $81B+ outpatient, COA amicus 10th Cir. Margin drag w/ tariffs/IRA/pricing/TrumpRx/PBM issues blocking biosims.