White House Continues To Push For Higher User Fees From Industry
The White House expressed general support for the US House-passed user fee reauthorization bill while also demanding user fees be increased, creating some confusion in industry.
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Experts say either would likely prioritize issues such as the coronavirus pandemic and the medical supply chain, but they would diverge in areas like laboratory developed test reform.
The Senate Aug. 3 swiftly approved the FDA Reauthorization Act (FDARA) on a 94-1 vote. The president is expected to sign the bill, which previously passed the House and will enact the MDUFA IV user-fee agreement and make reforms tied to device accessory review, device facility inspections, and medical imaging FDA reviews.
Capitol Hill Update: Congress Gets Reprieve On User Fee Passage, While AdvaMed Weighs Device Tax Options
Commissioner Gottlieb says the agency won't issue layoff notices "unless and until Sept. 30 passes without reauthorization" of US FDA user fee programs. Meanwhile, could the user fee bill be a vehicle for device tax repeal?