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GOP Drug Shortage Strategy Pushes FDA Reform, Reimbursement Over Notification

 
• By Derrick Gingery

House hearing includes arguments that regulatory delays thwart the market’s response to shortage price signals, suggesting reforms could be included in user fee legislation along with the popular early warning requirement.

A Republican strategy for addressing drug shortages as part of user fee legislation appears to still include regulatory streamlining and reimbursement changes even as legislation to require more notification builds steam.

Rep. John Shimkus, R-Ill. suggested regulations may need to be changed to bring additional manufacturers online quicker in shortage situations. He highlighted permit, siting and regulatory delays that would slow...

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