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'Cures' Bill Passes, As More Budget, Safety Debates Wait In The Wings

This article was originally published in The Gray Sheet

Executive Summary

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.

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House Set To Vote On Cures Nov. 30; Latest Version Includes 510(k)s In Breakthrough Pathway

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.

US House Members Urge Hearings On Device Safety

A bipartisan coalition of seven members of the US House asked Energy and Commerce Committee leaders to hold hearings on medical device safety, trying to bring more attention to provisions that might strengthen safety oversight amid all the talk of accelerating medical innovation.

Quest For Political Capital, Legacy Could Push 'Cures' Over The Finish Line

When Congress returns to work after the summer recess, the House and Senate medical innovation packages may gain momentum as legislators seek a “feather in the cap” for reelection campaigns, and House Energy and Commerce Committee Chair Fred Upton and Vice President Joe Biden look to cement legacies, say legislative analysts. Also, a Zika virus funding rider is expected be attached to a continuing resolution.

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