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IRA Negotiation Changes: Pharma’s Focus Remains On Near-Term Legislative, Regulatory Options

 
• By Cathy Kelly

Manufacturers still hope to advance legislation removing the “pill penalty” from the law, as well as changes they want included in the CMS guidance for the 2028 price implementation year.

Pharma lobbyists are working to implement IRA revisions. (Shutterstock)

Pharma continues to face an uphill battle to remove the so-called “pill penalty” from the Inflation Reduction Act’s Medicare price negotiation program by adding the proposal to the upcoming federal spending bill.

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More from Medicare

If CMS Takes Over 340B, Will Government Allow Rebate Model Changes?

 
• By Cathy Kelly

Manufacturers have supported the proposed shift in oversight authority, which could create a more pharma-friendly environment in the drug discount program, but uncertainty remains.

Stand-Alone PDP Market Lives to Fight Another Day, Enrollment Data Shows

 
• By Leslie Small

No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

Proposed HHS Budget Would Eliminate Medicare Negotiation Program Start-Up Funding

 
• By Cathy Kelly

The preliminary budget document supports legislation clawing back funds appropriated for the program.

Medicare Price Negotiation: Trump Order Adds Momentum To ‘Pill Penalty’ Fix

 
• By Cathy Kelly

Wide-ranging executive order to lower drug prices also hints at changes in upcoming guidance on the Medicare price negotiation program but few other potentially impactful near-term actions.

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Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

Vertex’s Alyftrek For CF Among Six Orphans On Track For Pan-EU Approval

 
• By Eliza Slawther

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Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.