Recent Developments in 340B Program
The week of July 27 – August 10, 2026, saw significant updates in 340B litigation across the United States. 340B cases are developing rapidly, with multiple courts ruling on motions to dismiss and summary judgments.
A South Dakota law was challenged in two cases, and the court granted the state government’s motion to dismiss. This ruling may impact the development of contract pharmacy arrangements in the state.
Three separate drug manufacturers filed complaints against the Illinois Attorney General, challenging an Illinois state law governing contract pharmacy arrangements.
In another case, a 340B covered entity filed a complaint against a drug manufacturer, challenging its policy of requiring detailed claims-level data for 340B ceiling price purchases.
Four separate cases involved 340B covered entities alleging breach of contract and violation of state laws against a group of pharmacy benefit managers and their vertically-integrated pharmacies. They filed motions to dismiss in each case.
Related: Court backs agency on drug origin rulings
A 340B covered entity brought a case against the federal government, challenging the Exclusion Rule. The court granted the covered entity’s motion for summary judgment, which may have implications for the federal government’s 340B policies.
In four appealed cases, the D.C. Circuit Court affirmed the district court’s opinion denying a drug manufacturer’s motion for summary judgment and granting the federal government’s cross motion for summary judgment. This ruling relates to the federal government’s decision not to approve a drug manufacturer’s rebate model.
A U.S. District Court for the District of Maine issued an order granting defendants’ motion to dismiss a plaintiff’s complaint in a case challenging a Maine state law governing contract pharmacy arrangements.
In another case, parties stipulated to dismiss an action with prejudice, alleging breach of contract against an insurance company.
Four cases brought by drug manufacturers challenging a Utah state law governing contract pharmacy arrangements saw the Utah state government file a memorandum in support of its motion to dismiss.
Related: Court defines good faith contract rules
Two appealed cases brought by drug manufacturers challenging a Tennessee state law governing contract pharmacy arrangements saw the plaintiff-appellants file their reply briefs.
A consolidated case in Hawaii had the plaintiffs file a reply in support of their motion to compel discovery from a nonparty third-party administrator.
It is essential to stay informed about the latest developments in 340B litigation.
Three cases brought by drug manufacturers challenging a Missouri state law governing contract pharmacy arrangements saw amici file a brief in support of appellant and rehearing en banc.
The developments in these cases will likely impact the 340B program in Missouri and potentially other states.
