[author: Allison F. Kassir]

A bipartisan group of Members, led by Energy & Commerce Committee Chairman Fred Upton (R-MI) and Oversight & Investigations Subcommittee Ranking Member Diana DeGette (D-CO), launched the 21st Century Cures Initiative, an effort to accelerate the pace of cures and medical breakthroughs in the United States. Over the next several months or more, Chairman Upton and Congresswoman DeGette have committed to lead a comprehensive review of the entire spectrum of discovery, development, and delivery to determine what steps need to be taken to ensure that the United States maintains its edge in leading worldwide innovation as well as translates this innovation to patient care and improved health outcomes. This effort also has the support of the highest levels of leadership in both parties – from House Majority Leader Eric Cantor (R-VA) and from House Minority Whip Steny Hoyer (D-MD). Majority Leader Cantor noted, "we ought to be a country that promotes a culture of cures" and observed that we need to think "outside the box" on how to improve processes and make choices in setting priorities to accomplish that mission.

The 21st Century Cures Initiative held its first meeting on May 6, a roundtable discussion featuring eleven experts, including National Institutes of Health (NIH) Director Francis Collins, top current and former Food and Drug Administration (FDA) officials, university research officials, patient advocates, think tank representatives, and a venture capitalist. The group held a wide ranging discussion covering a number of topics including: the need for steady research funding, the need to rethink our current clinical trials system, removing regulatory burdens that do not serve to advance biomedical research, shifting surveillance from pre- to post-market, learning as much as we can from trial failures as successes, providing career opportunities for young researchers, potentially restructuring agencies to encourage cross-government collaborations, and ensuring the patients are at the center of these efforts.

Chairman Upton and Congresswoman DeGette released a white paper outlining the mission of the 21st Century Cures Initiative and are soliciting comments, ideas (big and small), and input from the public. We are working with several clients to provide this input and participate in this remarkable process, and we would welcome additional interest and involvement.