Takeda False Claim Act Case May Allow Supreme Court To Set Evidence Threshold

High court seeks Solicitor General’s views on whether a whistleblower must identify a specific false claim submitted to the government or just have evidence to infer the submission; Solicitor General has previously supported latter position.

Does a whistleblower have to identify a specific false claim that was actually submitted to the government for payment in order to bring a complaint under the False Claims Act?

The Supreme Court may tackle this question in a case alleging Takeda Pharmaceuticals North America Inc. promoted its proton pump...

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Recent And Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
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The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.