SMCI Supports the 21st Century Cures Act

(Congressional House Resolution 6)

cures-act

SMCI is proud to join 60 other organizations in supporting the 21st Century Cures Act 

This pending legislation has significant importance for ME/CFS. We wholeheartedly support this bill and invite you join us in support (see actions you can take at the bottom of this article). For two years, Representatives Fred Upton and Diana DeGette have been leading a bipartisan charge to modernize, expedite, and streamline American biomedical research enterprise. The goal of House Resolution 6 (HR 6) is to “accelerate the discovery, development, and delivery of life saving and life improving therapies.”

There are a few key provisions in HR 6 that could significantly change the research landscape for ME/CFS:

  • Funding for research

A key provision of the 21st Century Cures Act is the substantial increase in funding for the National Institutes of Health (NIH). Over the years, NIH funding has stagnated. Other than tiny increases to keep up with inflation, the overall NIH budget has seen a 20% decline since 2003 when adjusted for real purchasing power. The funding lapse and the decline in R01 grants (which academic research labs rely on for stability) has caused alarm in the research community—particularly that the US will start lagging behind other nations in biomedical research. The 21st Century Cures Act increases the NIH budget by 3% and provides an additional $1.86 billion per year for a new “Cures Innovation Fund” charged with supporting new “high-risk, high-reward” areas of research that have the highest potential to lead to breakthroughs. The new grant program also includes a focus on promising young scientists and biomedical research.

  • Increased accountability at the NIH

In a new process that will be welcome news to many ME/CFS advocates, the 21st Century Cures Act provides increased oversight, accountability, and transparency at the NIH. The new law requires the NIH to issue and publish a strategic plan and increases accountability at the NIH overall, including the system used in the distribution of grant awards. SMCI has continually pressed the NIH for this information regarding ME/CFS with virtually no success.

  • Removing barriers to increased research collaboration

Provisions directed at data standardization, data collection and sharing, and clinical trial reporting are specifically designed to increase collaboration between researchers for better results. There are also provisions to modernize clinical trials and increase the use of patient-generated registries, both of which have been key barriers in ME/CFS research.

  • New incentives to research rare diseases

The legislation will create a public-private partnership to specifically target and accelerate research, treatments, and cures for rare and misunderstood diseases. This includes specific economic incentives for faster and more immediate therapies for “serious and life threatening conditions.” We hope to see ME/CFS in the forefront of this area. Although ME/CFS is not a “rare” disease, it qualifies as “misunderstood.”

  • Incorporating the patient perspective

One of the most controversial parts of the bill increases the ability for researchers and the FDA to consider the direct experience of patients as data to modify and improve potential treatments. This new structured framework would take patient reports into account when analyzing a drug’s benefits and risks.

After reviewing the legislation in detail, SMCI is proud to formally support HR 6. This month, the #CuresNow movement is in its final push to make the 21st Century Cures Act a reality.

Join the Solve ME/CFS Initiative in taking action!

  • Read the House 21st Century Cures Bill section-by-section summary here and the Senate Health Committee press release on the progress of the companion legislation here.
  • If you have you participated in a clinical trial or conducted translational research, share your story.
  • Tell your members of Congress (both senators and representatives) that we need #CuresNow here.
  • Sign up for the #CuresNow Thunderclap campaign on or before August 24.