Opportunities for Health Industry Following 21st Century Cures Initiative Launch

On April 30, 2014, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Committee Member Diana DeGette (D-CO) announced the launch of 21st Century Cures, a new bipartisan initiative that aims to accelerate the pace of cures and medical breakthroughs in the United States — from "discovery to development to delivery." Through this effort, the House Energy and Commerce Committee seeks to collaborate with the National Institutes of Health (NIH), Food and Drug Administration (FDA), industry, academia and patients to advance ideas for streamlining the drug approval process and spurring greater scientific collaboration. As described in an introductory video, this initiative would bridge the gap between "the science of cures and the way that we actually regulate these therapies."

Chairman Upton outlined the following key objectives of the 21st Century Cures initiative in his March 5, 2014, U.S. News and World Report opinion piece:

• Encouraging personalized medicine through greater understanding of the human genome and biology at the molecular level
• Harnessing the power of social networks by supplying people with individualized health information
• Using modern social networks along with genetic databases to contact and monitor individuals more efficiently and lower the cost of clinical trials
• Modifying the U.S. Food and Drug Administration's (FDA) risk culture by using molecular understanding of diseases along with social networks to help improve safety
• Fostering improved partnerships between the government and drug companies and encourage greater collaboration among scientists, clinicians, patients and big data analysts

Opportunities

The Energy and Commerce Committee is in the early stages of defining the 21st Century Cures initiative beyond its initial core objectives. According to the Committee Chairman, "Over the next several months, the House Energy and Commerce Committee, which I chair, will begin a series of listening sessions and roundtables to gather advice and advance ideas about how to streamline the approval process, spur more scientific collaboration and ensure the United States remains the world leader in this field." As a first step, the Committee is convening a Roundtable in Washington, D.C. on May 6 to explore "the state of biomedical innovation in the United States and what else can be done to accelerate the process of bringing new treatments and cures to patients."

While many details have yet to be determined, both sides of the aisle have expressed interest in starting a conversation on how to best address 21st century science across relevant regulatory agencies. An early high-level White Paper was also released by the Committee in an effort to ignite conversations about the 21st Century Cures initiative. The bipartisan commitment exhibited to date signals that this initiative has the potential to move in the coming months. The 21st Century Cures initiative provides an open door for stakeholders — industry, patient advocates and academia — to join the dialog through examinations of best practices, relevant case studies and innovative public policy options.