September 9, 2016 at 5:00 am ET
The 21st Century Cures Act is an amalgam of ideas with one objective: improving the laborious process of moving medical innovation from the lab to patients’ bedsides. Two years in the making, this bipartisan effort — like any other in Washington — has been amended by compromise and political expedience.
The version overwhelmingly passed by the House in 2015 contains modest but very real improvements sought by many in the medical industry. Among other things, it will streamline clinical trials, reduce the regulatory burden for new antibiotic approvals, prioritize limited use pathways, and fund the NIH and FDA at sustainable levels.
The legislation may have lofty aims, but its fate is subject to the same stumbling block lying before so many other legislative efforts: funding. In their plan, House Republicans offset mandatory spending with other budgetary savings and spending cuts.
There are some truly promising provisions in the package. The medical device breakthrough pathway is a step in the right direction, lining up a reimbursement pathway with the approval of life-saving devices. Enhancing access to novel antibiotics in a time of few manufacturers and superbugs is a no-brainer. On the biopharma side, addressing the communication of economic and scientific information, an additional exclusivity for new orphan indications, and even exempting user fees from sequestration could aid innovation.
The Senate continues to wage its own battle. Democrats like Senate HELP Committee Ranking Member Patty Murray (D-Wash.) are looking to mandatory spending to avoid federal spending limits. Republicans like HELP Chairman Lamar Alexander (R-Tenn.) see a temporary flow of mandatory funding paid for by offsetting budget cuts as the solution. Nevertheless, the two sides continue their efforts to reach a compromise — Alexander and Murray are exploring the creation of a NIH innovation Fund that would provide a surge in one-time NIH funding for close-ended priorities like Cancer Moonshot and the Precision Medicine Initiative.
And Alexander and Murray have proven they can work together on big-ticket issues with bipartisan support. The pair rewrote No Child Left Behind just last year.
But the Senate has its own way of doing things, as evident by the 19 bills on various aspects of medical innovation approved by the HELP Committee, to the House’s single Cures package. House Energy and Commerce Committee Chairman Fred Upton (R-MI), looking to preserve his legacy-making bill, is working hard to make Cures a reality this year. Senate Majority leadership may agree to Upton’s request for a Senate vote if Upton can pass the Senate version of Cures in the House with overwhelming bipartisan support.
Upton, meanwhile, is working to appease conservatives opposed to the mandatory spending which funds 21st Century Cures. The Senate has indicated a willingness to circumvent its own fiscal hawks if Democrats come out in droves to support the bill. But Senate Democratic Leadership may oppose action on Cures before the election.
This process is about as complicated as it could possibly get.
Certainly there’s the potential for Cures, or at least the life sciences and telehealth policies it contains, to move with the next PDUFA drug and user fee reauthorization in 2017. But does a bipartisan idea that gives everyone at least some of what they want really need a must-pass bill to cut through the gridlock? Is it possible that even a modest effort like Cures will take a back seat to partisan squabbling and political posturing?
At this point, only the fall session will tell.
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