House 21st Century Cures Initiative Draft Legislation Released

On Tuesday, January 21st the House Energy and Commerce Committee release it’s highly anticipated 21st Century Cures discussion draft legislation as part of its push to better realize medical breakthroughs. As outlined in a summary by the committee, the legislation focuses on five particular areas: Putting patients first by incorporating their ...

On Tuesday, January 21st the House Energy and Commerce Committee release it’s highly anticipated 21st Century Cures discussion draft legislation as part of its push to better realize medical breakthroughs.

As outlined in a summary by the committee, the legislation focuses on five particular areas:

  1. Putting patients first by incorporating their perspectives into the regulatory process and addressing unmet medical needs
  2. Building the foundation for 21st century medicine, including helping young scientists
  3. Modernizing clinical trials
  4. Accelerating the discovery, development, and delivery cycle and continuing 21st century innovation at NIH, FDA, CDC, and CMS
  5. Modernizing medical product regulation

In a press release, the committee stressed that the draft legislation is still a work in progress:

The committee is seeking feedback on the proposals outlined in this document, with continued urgency on behalf of patients who are struggling with diseases today.  The committee will continue on an aggressive schedule to introduce 21st Century Cures legislation and ultimately send a bill to President Obama’s desk for signature by the end of the year.  The document is a starting point in the legislative process to spur discussion.  The inclusion of a policy in this draft should not be seen as an endorsement.

Full Committee Chairman Fred Upton (R-MI) issued the following statement regarding the bill:

Throughout this initiative, we have done things differently.  We have been bipartisan from the get-go, we spent a year listening and asking questions, and we have been fully transparent at every step.  Transparency and collaboration have been and will continue to be the hallmarks that drive our success.  These ideas represent an important milestone – a critical first step in a legislative process.  Our solutions to boost cures and jobs are starting to take shape as we move from broad principles to legislative language. However, this document is far from the final product. Some things may be dropped, some items may be added, but everything is on the table as we hope to trigger a thoughtful discussion toward a more polished product.  #Cures2015 is now underway.  Together, we will get this done.

In a statement, Full Committee Ranking Member Frank Pallone (D-NJ) cast doubt about the bill’s bipartisan support and future success: 

I am disappointed that the discussion document released today by Chairman Upton does not reflect true bipartisan collaboration.  In its current form, I am concerned that the nearly 400 page draft could create more problems for our health care system than it solves.  Further, the draft does not include any real dollars to fund additional basic research at the National Institutes of Health. Increased funding was a common theme during last year’s public engagement, from both sides of the aisle, and is fundamental to truly advancing 21st century cures.  Moving forward, I stand ready to work with Chairman Upton, and all Members of the Energy and Commerce Committee, to find bipartisan consensus legislation that would pass the House and the Senate and ultimately be signed by the President.

The draft legislation is a result of work that began last year by full committee Chairman Congressman Fred Upton (R-MI) and Congresswoman Dianne DeGette (D-CO) who held numerous meetings, discussions, and hearings on the topic.  Additionally, they sought feedback from a wide variety of stakeholders.  HIMSS provided the following recommendations in July of 2014 

Source: www.himss.org