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Discussion Draft Released For 21st Century Cures initiative

Posted By Administration, Wednesday, February 25, 2015
Updated: Wednesday, February 25, 2015
Members and friends of Virginia Bio,

Recently the U.S. House of Representatives Energy and Commerce Committee released a discussion draft related to its 21st Century Cures initiative.

The 21st Century Cures initiative is a bi-partisan effort to take a coherent look at the whole system, from drug and device discovery, to development to delivery, and the impact of the Food and Drug Administration, National Institutes of Health and other federal agencies. The driving idea is that as a nation we created and for the last 75 years have enjoyed the world’s greatest system for turning biomedical innovation into practice. To remain the global leader, to retain and grow research, companies and jobs, and to bring health and therapies to more people more quickly and efficiently, we must improve.

This discussion draft document reflects the work and industry input from 27 public hearings and roundtables and 5 white papers over 10 months dating back to April of 2014.

One of those public roundtables occurred in Blacksburg last October. Virginia Bio was pleased to be able to help organize the event with Rep. Morgan Griffith (VA-7), a member of the Committee’s Subcommittee on Health. The Roanoke Times published their coverage of the roundtable here and later published an Op-Ed with our comments found here.

The Committee has characterized this draft as "far from perfect" but as you will see, this legislative draft includes provisions authored by both Republicans and Democrats that would: (1) incorporate patient perspectives into the regulatory process and help address their unmet medical needs; (2) build the foundation for 21st Century Medicine; (3) streamline clinical trials; (4) accelerate the discovery, development, and delivery cycle and support continued innovation at our Federal public health agencies; and (5) modernize medical product regulation.

Here, you can find an initial analysis of sections of the 393 page legislative draft that would have an impact on the life sciences in Virginia. I tip my hat here to our friends at Pennsylvania Bio who compiled much of this summary.

The full legislative draft document for the 21st Century Cures initiative can be found here.

I encourage you to read through the legislative draft and reach out to us with comments or additional areas of concern. If you prefer to send your comments straight to the House Energy and Commerce Committee, you can do so via email at Or to Rep. Griffith, via his staff member on this initiative, Adam Harbison at

You have a chance to meet with Congressman Griffith, to hear his comments on the 21st Century Cures Initiative and to discuss the Discussion Draft at our statewide conference April 23 at the Westfields Marriot Dulles Conference Center, THRIVE: Creating the future of bioscience in Virginia. Congressional staff members and other federal policy experts will be present on a panel with Rep. Griffith to provide additional resources and viewpoints for the discussion. I invite you to attend, learn and provide your comments. Register to attend THRIVE here.

Thank you for your ongoing support.

Best Regards,

Jeff Gallagher

Tags:  21st century cure  government  virginia bioscience 

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