Appropriators Continue Pressing US FDA To Conduct Surprise In-Person Inspections
Omnibus package also gives FDA expanded authority over nicotine products and creates President Biden’s Advanced Research Projects Agency for Health.
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Senate Appropriations Committee proposes $1.185bn to CFSAN and $2.19bn to CDER, both levels short of House appropriators passed in June. FDA requested $30.36m in user fees from monograph drugs but no amount was specified in Senate draft bill.
Some lawmakers want FDA to prioritize in-person visits, but others are complaining that more remote inspections are needed because approvals are being delayed.
Proposed Advanced Research Project Agency for Health also needs to distinguish itself from NCATS, which faced many of the same questions when it was created a decade ago. Disagreements also persist about whether ARPA-H should be housed in NIH or HHS.