FDA's Drug Shortages Strategy Focuses On Prevention, Not "Empire Building"
FDA would like additional funding for a number of its programs, but it does not appear that the agency will be pushing to expand its drug shortage team.
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Like the Senate proposal, it could include reimbursement rate adjustments in addition to requiring early notification of shortages by manufacturers, but questions remain about ensuring there are no unintended consequences.
Shortages of sterile injectables stem in part from changes to Part B reimbursement made in the Medicare Modernization Act in 2003, witnesses at a House hearing argue.
Executive order gives FDA no new authority, but will allow doubling of shortage staff and likely bolster issue awareness.