June 18, 2014

House Leadership Transitions — 21st Century Cures and the Medical Research Agenda

As shock about the primary election defeat of House Majority Leader Eric Cantor abates and eyes turn to upcoming leadership races, questions remain as to the impact the loss will have on multiple issues, including medical innovation and biomedical research.

Particularly in recent years, Cantor had positioned himself as a leading Republican voice in support of medical innovation and research. He regularly highlighted research as a priority in his speeches, and he made support for research a component of his An America that Works agenda for the Republican caucus. Earlier this year, Cantor helped push through Congress legislation that transferred taxpayer funds earmarked for national political party conventions to a fund that would support pediatric research at the National Institutes of Health (NIH). He also played a key role in enacting into law in late 2013 legislation that authorized the establishment of a network of pediatric research consortia, and his office was widely seen as the essential voice of the Republican caucus on medical research and related issues.

With Cantor's loss, none of the current or anticipated future members of the House Republican leadership have the same level of express interest in medical research. Congressman Fred Upton of Michigan, Chairman of the Energy & Commerce Committee and architect of the committee's 21st Century Cures Initiative, may become even more visible as the leading Republican voice in Congress on medical innovation and related issues. Other Republican members are strong supporters of research, but many are tied more closely to specific diseases and conditions or industries as their driving force.

Since its launch in early May, the "Cures Initiative" has received high levels of attention, particularly among patient advocacy organizations and other voices that have been challenged by reductions in research funding and limited congressional engagement on such issues in recent years. A decade ago, Congress completed its five-year push to double the budget of the NIH, but aside from the two-year infusion of federal stimulus dollars, the NIH budget has remained largely flat. And since enacting NIH Reform in early 2007, Congress has largely ceased to pass legislation that focuses on research for specific diseases or disorders.

This week, a key House subcommittee will take up a number of bills focused on conditions, including Lyme Disease and other vector borne disease, the muscular dystrophies and sudden infant death syndrome, and would follow recent activity to update an existing autism research and public health law. But much of what is moving is fairly modest and typically amends or updates existing laws, rather than establish new programs.

So far, the Cures Initiative has yielded white papers and hearings or other sessions focused on reforms to reduce the time, cost and risk of drug development and on incentives that may be warranted to attract and retain industry interest to drug development on the impact of technology — such as electronic health records and big data — on human health. The latest roundtable, on technology issues, will be held on June 24, and stakeholders can submit comments on the issue through mid-July. The most recent white paper, released in mid-May, was targeted toward patient advocates and asked for perspective on a number of issues, such as what actions organizations are already taking to support research and discovery and what actions Congress can take to be supportive.

Additional white papers, including one focused on digital health, are said to be on the horizon, as are future hearings and events, including in-district field hearings over the summer. Led by Upton and Democrat Diana DeGette of Colorado, there is hope that 21st Century Cures will remain a truly bipartisan undertaking. That desire may be tested as the committee examines more from areas of high-level agreement to those that are more prone to partisan division, such as the balance between financial incentives to pharmaceutical manufacturers and affordable medicines. Whether this effort will become a landmark in the nation's fight against diseases — or another victim of the policymaking gridlock that dominates the capital — hangs in the balance.

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