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Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

21st Century Cures Initiative Holds Final Roundtable

September 12, 2014—The House Energy and Commerce Committee’s 21st Century Cures Initiative Sept. 10 held a final roundtable featuring a panel of health leaders who discussed the feedback the committee has received to date. 

Energy and Commerce Chair Fred Upton (R-Mich.) opened the meeting saying, “I want to thank these folks who have offered their input on the 21st Century Cures initiatives…. We intend to release a Cures legislative discussion draft in early January 2015 and will look to swiftly move the legislation early in the next Congress.” He noted that although this is the initiative’s last formal meeting in Washington, a number of events have been scheduled around the country.

Rep. Diana DeGette (D-Colo.), who is the co-convener of the initiative, said “Some of the common topics that we’ve seen are modernizing clinical trials, facilitating data collection and data sharing, incentivizing drug and device research for unmet needs, incorporating the patient perspective into the research and regulatory process, and developing young emerging scientists as well as making sure we have adequate and stable funding for biomedical research in this country.”

National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D., suggested ideas fall into three categories: enhance participant protection and increase transparency; facilitate scientific collaborations and innovation; and reduce administrative burden and increase efficiency.

With regard to the need for additional funding, Dr. Collins said the NIH began working on a vaccine for Ebola in 2001. “We have steadily pursued that effort over these last 13 years, hoping that by the time a big outbreak occurred we would be ready for it,” he said, adding, “But I have to tell you, if we had not gone through this 10-year decline in the support of biomedical research, we would be a year or two ahead of where we are now. And think about the difference that would make, had we in 2014 been in the position to distribute rapidly tens of thousands of doses, in collaboration with our colleagues at GSK, of this vaccine, how much different would this be and how many lives would have been saved.”

Dan Theodorescu, M.D., director, University of Colorado Cancer Center, recommended aligning the reimbursement process with the regulatory process for biomarkers, saying “We need to establish the guidelines for biomarker development because the biomarker sphere is really an area that is a lot less reimbursed than drug development and yet is really fundamental to precision medicine.”

Dr. Theodorescu also said, “Patients are basically the heart and soul of translational medicine. We rely on them, we’re eternally grateful for their participation, but we need to encourage them to participate which means removing barriers.”  He cautioned, “If the barriers to approving patients to clinical trials are so high, then we're going to get progressively fewer young investigators wanting to embark on those careers.”

Rep. Joe Pitts (R-Pa.), chair of the Energy and Commerce Subcommittee on Health, said, “while I understand the importance of insuring that funding for NIH remains stable and predictable, Congress is at a crossroads where federal dollars are already committed particularly as they relate to federal entitlement and safety net programs.”

He went on to say, “And if we’re going to find resources to stabilize and/or potentially increase NIH funding, Congress is going to have look hard at prioritizing resources that are focused on advancing science and research to help spur the next generation of cures…. Are there existing sources of research funding such as PCORI that Congress should examine as it attempts to find federal dollars to help advance the next generation of cures?”

Rep. Bill Cassidy, M.D. (R-La.) asked about the correlation between research funding and disease burden, challenging Dr. Collins, “I got to say when I look at your funding for Alzheimer’s it seems miniscule relative to the disease burden and the future expense, the near future expense to Medicare [and] Medicaid.”

Noting NIH’s efforts to increase its investment in Alzheimer’s research, Dr. Collins also said, “I think targeted research is critical when we can see a pathway towards finding a solution for a disease. But serendipity and supporting basic science that is not too tightly connected to a disease is one of the reasons that America has been so successful for the last 50 years.”

The panel also featured Secretary of Health and Human Services Sylvia Burwell; Margaret Hamburg, M.D., commissioner, Food and Drug Administration;  Michael Milken, chair, The Milken Institute; Dean Kamen, founder, DEKA Research and Development; and William Parfet, chairman and CEO, MPI Research.

Contact:

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559
Email: dbmoore@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org