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