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US Medicare Price Negotiation: Gaming FDA Approval Dates Could Delay Drug Selection

 
• By Cathy Kelly

The early February date for publishing the list of products eligible for price negotiations could dictate approval strategies for drugs with potential for big sales in Medicare going forward.

Early February may become an extremely busy period for FDA approvals. • Source: Shutterstock

The US Food and Drug Administration may find that the flow and approval of new drug and biologic applications going forward are influenced by the Inflation Reduction Act’s timeline for when drugs become eligible for Medicare price negotiation, regulatory attorneys suggested during a 25 January Food and Drug Law Institute webinar.

Sponsors could time application submissions and push to get approvals in early February in order to maximize their products’ time on the market without price controls, they said. Under the...

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