Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

'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.

You may also be interested in...



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.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT034030

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel