1. Scrip

Merck & Co. Files First IRA Suit, Signaling Industry Is Ready To Fight

 
• By Sue Sutter and Jessica Merrill

Coming less than three months before the statutory deadline for CMS to publish the initial list of drugs, Merck’s lawsuit calls US Medicare drug price negotiations ‘extortion’ in a complaint that could be the first of more legal pushback to follow.

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MERCK’S SUIT CALLS THE IRA A ‘VORTEX OF FORCED BELOW-MARKET SALES’ WITH ‘NO EVIDENT MEANS OF ESCAPE.’ • Source: Shutterstock

Merck & Co., Inc. has taken the first legal action to fight a new Medicare drug price negotiation program that is being implemented as part of the Inflation Reduction Act (IRA). Changing certain elements of the program or delaying its implementation altogether would be victory for industry.

Key Takeaways

  • Merck’s lawsuit raises constitutional challenges to President Biden’s signature healthcare achievement.

Litigation has been considered one path industry might take in response to the passage of the landmark drug pricing law...

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BIO Notebook: MFN Pricing, Next-Gen Obesity R&D, FDA’s Rare Disease Hub & Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

Stock Watch: Generics Firms Trapped Between US Tariffs And European Austerity

 
• By Andy Smith

Successive annual reductions in European drug prices following the pandemic are affecting the global sales of generic pharmaceutical companies. Additionally, the imposition of US import tariffs may result in generic drug supply becoming unprofitable.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Europe’s Drugmakers Lament EU Pharma Package

 
• By Kevin Grogan

EFPIA says reforms make the continent less attractive for innovative firms.

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KalVista’s Delayed FDA Approval In HAE Comes Through

 
• By Joseph Haas

KalVista’s Ekterly obtains US approval as the first oral, on-demand therapy for hereditary angioedema. It will compete with established injectables.

Cogent Peaks With Bezaclastinib SUMMIT Results

 
• By Alaric DeArment

The biotech announced positive topline results from the Phase II SUMMIT study in non-advanced systemic mastocytosis, with data for advanced SM and GIST expected later this year.

France’s AB Science Plots Pivotal Masitinib Trial In Prostate Cancer

 
• By Kevin Grogan

Still holding out hope after multiple rejections for the tyrosine kinase inhibitor.