Exempting User Fees From Sequester Could Take Flight
This article was originally published in The Tan Sheet
A bipartisan group of House Appropriations Committee members criticize the current policy of FDA user fee revenue being captured by the mandatory budget cuts. FDA Commissioner Margaret Hamburg says losing user fee revenue is “troubling” to the agency and the private sector.
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The FDA commissioner says a budget sequester would slow implementation of FDA Safety and Innovation Act provisions and reduce some overseas inspections. More emphasis could be placed on using systems that target the riskiest facilities to reduce the number of onsite inspections, Hamburg says.
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.