Legislative Outlook: Animal Drug User Fee Could Carry Human Drug Proposals
ADUFA reauthorization may become the vehicle to move track and trace and compounding legislation. Reimbursement changes to mitigate shortages appear less likely.
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In legislation passed by both chambers of Congress Jan. 1, the cost of a one-year reprieve from sharp cuts to Medicare physician payments, scheduled to begin in 2013, would be offset by a reduction in Medicare’s bundled payment for end-stage renal disease. The reduced payment would take into account a drop in the use of erythropoiesis-stimulating agents observed over the last several years.
The agency has the option to issue regulations requiring biologics manufacturers to notify FDA of emerging production problems, but so far it’s only “something that we’re thinking about.”
Advocates for the agency worry that while each of the performance assessments seems reasonable individually, together the reports could burden staff to the point of pulling some from application reviews or other tasks to help complete them.