US FDA User-Fee Bill Swiftly Passes US House, Now Moves To Senate
The FDA Reauthorization Act, which would reauthorize the MDUFA IV user-fee agreement and enact additional device regulatory reforms, passed the US House July 12 on a unanimous vote. Lawmakers applauded the bill's inclusion of device facility inspection reforms and an over-the-counter hearing aid provisions. The legislation now moves to the Senate, where a crowded legislative schedule could mean delayed consideration.
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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.
Senate Majority Leader Mitch McConnell, R-Kent., filed cloture on H.R. 2430, the FDA Reauthorization Act on device and drug user fees this week, and indicated debate and a vote on the bill will likely take place on Aug. 3.
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?