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A World Without Rebates: Is FDA’s Gottlieb Offering New Vision?

 
• By Cathy Kelly

US FDA Commissioner Gottlieb suggests administrative action to prohibit drug rebates as a way to lower drug prices. His remarks may preview an upcoming proposal from President Trump and HHS Secretary Azar.

US FDA Commissioner Scott Gottlieb, who seems to be the Trump Administration’s advance man on prescription drug pricing policy these days, recently signaled there may be interest in a more fundamental approach to solving the problem of rebates – making them illegal.

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• By Cathy Kelly

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New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
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Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

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• By Eliza Slawther

The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.

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EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
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The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.