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Stealth Defense: Medicare, IRS Implementation May Weaken Pharma’s Arguments Against IRA

 
• By Sarah Karlin-Smith

Flexibility included in guidance issued after many IRA lawsuits were filed put some of the arguments industry has made on shakier footing, legal experts explain.

sanding wood
Executive actions have "sand[ed] some of the hardest edges off," the IRA, making challenges to Medicare Rx negotiations harder, Nicholas Bagley says. • Source: Shutterstock

Key Biden administration decisions on how to implement the US Medicare program’s new drug price negotiation authorities could help the government in its attempts to quash the pharmaceutical industry’s and other challenges to the Inflation Reduction Act program in court, legal experts say.

These decisions came in recent Medicare and Internal Revenue Service guidance that were issued after many of the industry’s challenges...

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• By Dean Rudge

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Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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Respiratory Treatments Hit Hardest By HTA Terminations In England

 
• By Leela Barham

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New Era Begins In Korea: Policy Predictions For Biopharma

 
• By Jung Won Shin

As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.