FDA Funding Debate Reframed By GAO Reports On Strategic Planning
This article was originally published in The Gray Sheet
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.
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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.
The 21st Century Cures bill passed on a 344-77 vote, attracting significant bipartisan support in the House. It includes multiple provisions supported by the device industry, including a priority review pathway for breakthrough devices. Attention now moves to the Senate, which is working on its own bill that could face budget barriers and calls for more safety protections.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.