In April 2014, the 21st Century Cures initiative was launched by Energy and Commerce Committee Chairman Fred Upton (R-MI) and Representative Diana DeGette (D-CO) to accelerate the rate of innovation and research in medicine. American scientists and researchers lead the world, but thousands of diseases and disorders lack effective treatments. The bipartisan leaders have worked closely with committee colleagues, patients, innovators, researchers, and stakeholders to outline policies that will improve the lives of countless Americans, including people affected by autism.
In the mission statement for the initiative, the bipartisan leaders stated, “We are looking at the full arc of this process – from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase. We know we don’t have all the answers. That’s why we’re asking questions first. We are listening. We want to know how to close the gaps between advances in scientific knowledge about cures and the regulatory policies created to save more lives.”
At a time when 1 in 68 children have autism, the 21st Century Cures initiative holds great promise for our community. The initiative aims to speed the discovery, development, and delivery of new treatments, with a focus on the promise of personalized medicine. This is great news for a community like ours where so many individuals diagnosed with autism often require individualized treatments.
On May 21st the House Energy and Commerce Committee unanimously approved the 21st Century Cures Act by a vote of 51-0. The legislation, which was introduced by Chairman Upton, Oversight and Investigations Subcommittee Ranking Member DeGette, full committee Ranking Member Frank Pallone, Jr. (D-NJ), Health, Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX), will be scheduled for consideration by the full House.
The 21st Century Cures Act would make many important changes, including the following:
· Increasing funding for the National Institutes of Health (NIH);
· Establishing a $10 billion innovation fund at NIH to support biomedical research;
· Allowing the NIH Director to require those whose research is fully funded by NIH to share their data;
· Facilitating collaborative research through a clinical trial data system and other provisions;
· Requiring the Food and Drug Administration (FDA) to incorporate patient experience into regulatory decision making; and
· Requiring FDA to advance the development of personalized medicine.