Senate Panel Passes Breakthrough Device, Other Measures; FDA Funding Debated
This article was originally published in The Gray Sheet
The Senate HELP Committee voted March 9 in favor of a breakthrough device provision, watered down from a version approved in the House last year. Other bills voted out of committee include a combination products reform measure, the digital-health focused MEDTECH Act, and four others. Senators are still debating whether NIH and FDA should get additional funds to cover the cost of the bills, which will be wrapped up into a broader package before Senate floor debate.
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A combined House/Senate "21st Century Cures" package will get a vote in the House on Nov. 30, and soon in the Senate. The medical innovation package includes a breakthrough device pathway that, in its current form, would allow 510(k), as well as PMA and de novo, devices to participate. The bill also provides a modest $500m to help support a range of additional FDA device and drug pathway streamlining reforms. Meanwhile, it would authorize $4.8bn for the Precision Medicine Initiative, a BRAIN Initiative, and for cancer "Moonshot" research funds at NIH.
Republican senators argue that new Government Accountability Office reports critical of FDA's efforts to track its strategic plan and regulatory science progress show that that agency needs significant reform.
A system using nerve stimulation to treat diaphragm atrophy in mechanical ventilation patients is the latest product to be granted EAP designation. FDA officials recently confirmed that 17 devices have been accepted to the expedited development pathway about a year after the program launched.