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21st Century Cures could arrive this century
May 2015
by Jeffrey Bouley  |  Email the author
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I couldn’t even get past the headline without some snark; sorry, it’s just that I don’t expect much from the U.S. Congress these days—or years. It’s that combination of middle age and natural journalistic curmudgeonly jadedness. But, it happens that a congressional subcommittee is actually examining and discussing a 200-page draft discussion of a bill based off an initiative called 21st Century Cures that was conceived by Reps. Fred Upton (R-Mich.) and Diane DeGette (D-Colo.) a little over a year ago.
 
Here’s what Congress has to say about it (well, the House Energy & Commerce Committee, anyway):
 
“If we want to save more lives and keep this country the leader in medical innovation, we have to make sure there’s not a major gap between the science of cures and the way we regulate these therapies. That is why, for the first time ever, we in Congress are going to take a comprehensive look at what steps we can take to accelerate the pace of cures in America. We are looking at the full arc of this process—from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase.”
 
I’m normally skeptical about these kinds of things, but there’s actually some optimism bubbling up from the depths of my soul.
 
Maybe that’s in part because so many organizations in the pharma and biotech realms are looking with one degree of optimism or another.
 
Healthcare advisory and business intelligence firm Avalere notes that two highlights for it are that the bill would update current law to enable greater communication of scientific and economic evidence to medical providers and health plans. Avalere also noted that the bill proposes an expansion of the FDA’s Patient-Focused Drug Development initiative, which could include greater use of patient reported outcomes as part of the FDA review process.
 
But what I really like—and I’m sure plenty of you would as well—is the proposal to increase mandatory funding to the National Institutes of Health by $10 billion over a five-year period, beginning in fiscal year 2016. That would come about with $31.81 billion in funding in fiscal 2016, $33.33 billion in fiscal 2017 and $34.85 billion in fiscal 2018.
 
"One provision we are particularly pleased with calls for $10 billion in mandatory funding for a National Institutes of Health (NIH) Innovation Fund over the next five years,” wrote the leaders of the American Society of Clinical Oncology. “Research funding is the bedrock of advancing medical care, and we are pleased that the committee leadership has made this a priority.”
 
The Pharmaceutical Research and Manufacturers of America (PhRMA) also seem hopeful for this bipartisan effort, with PhRMA CEO John J. Castellani saying, “We continue to support more effective collaborative efforts within the institutes and centers of the National Institutes of Health (NIH) to ensure the groundbreaking basic research done by NIH is shared and translated into practical applications for the ongoing medical research, discovery and development done in the private sector. We share the committee’s interest in modernizing the FDA’s regulation of healthcare communication to ensure healthcare providers have access to scientifically accurate and up-to-date information in order to achieve the best possible outcomes for patients. We remain committed to patients having access to the medicines they need, and look to ensure delivery reforms enhance quality of care without limiting access to the newest and most innovative treatments.”
 
And finally, as Peter L. Saltonstall, president and CEO of the National Organization for Rare Disorders (NORD) noted, he is encouraged by many of the ideas included in this second discussion draft now under review, especially given that since the initiative was launched in April 2014, NORD has advocated for several provisions included in this draft, including incorporating the patient perspective through the patient-focused drug development initiative, developing registries of natural history data of rare disease patients, increasing transparency in the expanded access process and increased funding for NIH.
 
“Nothing is more important to the rare disease community than providing an environment conducive to the development of new therapies and access to them. We will conduct a thorough evaluation and will continue to work closely with the committee and members of the House and Senate as legislation moves forward,” wrote Saltonstall.
 
May the policymakers in D.C. show themselves worthy of our hopes.

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