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

 
• By Brenda Sandburg

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 inhibitor Kapidex (now marketed as Dexilant) for an unapproved use. A district court dismissed the suit, brought by a Takeda sales representative, and the U.S. Court of Appeals for the Fourth Circuit affirmed the decision. The sales rep filed a

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

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

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

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