User-Fee Bill Advances With Broad Support, Additional Device Reforms
The US Senate Health, Education, Labor, and Pensions Committee approved the FDA Reauthorization Act, reauthorizing drug and device user fees and multiple additions device regulation reforms, on a 21-2 vote. The mark-up session also gave HELP members from both parties a chance to vent about provisions they'd want to see in a Senate version of an Affordable Care Act repeal bill.
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Differences between Senate and House Committee versions of the FDA Reauthorization Act passed in May and June to approve five-year device user-fee agreements have been smoothed over by committee staff and joined together in the latest version of the act. The bill has been placed on the House's calendar in anticipation of July 12 action to debate and approve the bill. Next steps in the Senate, meanwhile, remain to be seen.
Senate leaders had shoved a floor vote on the five-year device and drug user fee reauthorization bill to the back burner to make room for a pre-July 4 vote on the Senate's Obamacare repeal bill, the Better Care Reconciliation Act. But Senate Majority Leader Mitch McConnell is now delaying a vote to get more votes, a step that could further throw off the timing of FDARA passage.
House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.