Shortage Notification May Have Legislative Momentum Again After BIO Questions Reimbursement Fix
Preventing shortages through increased communications with manufacturers could gain the upper hand in part because creating economic incentives may prove too difficult and controversial.
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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.
Mylan’s Heather Bresch still has questions and House members ask whether it could coexist with mandatory FDA reporting legislation.
Draft bill being developed by Rep. John Carney, D-Del., also would create system to notify the public and other manufacturers of pending shortages.