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Off-Label Discussion, But No Additions, For House User Fee Bill

 
• By Derrick Gingery

Several Republicans remain interested in expanding off-label communications, suggesting the issue could come up outside the user fee context, potentially as part of future drug pricing discussions.

Capitol House

Updates to the US FDA's off-label communications policy remain a priority for some in the House of Representatives, even though they may not become part of the user fee reauthorization bill.

Members of the House Energy and Commerce Subcommittee on Health promoted two bills that would expand sponsor off-label conversations with payers during the May 18 mark-up of the FDA

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FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

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HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
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Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
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Most Favored Nation Policy ‘Lazy, Misguided,’ But US Price Reforms Politically ‘Inevitable’

 
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More from North America

New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations

 
• By Sarah Karlin-Smith

New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and BMS expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.