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?
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Senate Approves FDA User Fee Reauthorization Bill On 94-1 Vote
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.
Health-Care Bill Failure Triggers Renewed Search For Device Tax Repeal Option
The early morning failure of a "skinny repeal" health care bill on July 28 caused by the defection of Republican Sens. John McCain, Lisa Murkowski and Susan Collins was also a setback for device lobbyists, as the bill contained an extended delay of the device tax until Dec. 31, 2020. But with the Obamacare repeal effort over for now, there may be quicker action on another top industry priority –passage of FDA user-fee reauthorization.
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.