By Sara Radcliffe Sometimes you have to tip your hat for a job well done. That is the case with the 21st Century Cures Act, recently passed unanimously by the House Committee on Energy and Commerce. Advanced by Chairman Fred Upton, R-Mich., Rep. Diana DeGette, D-Colo., and a bipartisan group of key committee leaders, this legislation proposes meaningful, comprehensive reforms to accelerate biomedical research and development in the United States.
The 21st Century Cures Initiative seeks to address a complex problem: life-saving medicines, medical devices and diagnostics take too long, and cost too much, to develop and bring to patients in need. The average new drug or medical device requires years of investment and extraordinary amounts of money to travel from the scientist’s bench to the patient’s bedside. Life sciences research is also an extremely high-risk endeavor, with innovators encountering failure far more often than success.
To overcome these unfortunate facts, there are several barriers that must be addressed. On the basic discovery side, we must not only bolster funding but also streamline how the National Institutes of Health awards grants. We must also enhance the Food and Drug Administration’s review and approval processes to better accommodate the challenges and opportunities presented by modern science. We also must ensure that patients have equitable access to new technologies, by ensuring both fair and appropriate payment and access policies.
To address these issues, the committee began a long and thorough investigation process last spring. Members spent nearly a year holding hearings and roundtable discussions to identify the systemic problems that needlessly delay or impede biomedical innovation. During these meetings, they heard from researchers, patient advocates, doctors, investors, innovators, government agency leadership and other experts. As a result, the 21st Century Cures Act — though by no means perfect — is rightly being lauded as a visionary package of innovative reforms that will help propel biomedical research, investment and innovation, benefiting patients here and around the world for many years to come.
The 21st Century Cures Act includes a series of improvements to accelerate the pace of drug, device and diagnostics discovery and development. There are provisions to repurpose existing drugs for life-threatening rare diseases; modernize clinical trials; increase collaboration between patients, researchers and providers; advance personalized medicine; and accelerate the development of new antibiotics to address bacterial resistance. It also contains a provision that would ensure that the FDA will have full access to the private monies it receives through user fees should sequestration be triggered in fiscal 2016 and beyond.
The legislation also proposes a number of mechanisms to enhance the NIH granting process, providing scientists an improved pathway to fund their research. It also calls on the NIH to work with researchers, industry and patient groups to establish a strategic research investment plan for the agency — which currently includes 27 institutes and centers. The goal is to create a more effective NIH, in which all participants row in the same direction.
The bill also contains provisions to increase funding for federal science agencies, including NIH and FDA, a worthy goal that would go far to help us address unmet medical needs.
That is why the 21st Century Cures Initiative is so important — we must gain the upper hand against disease. At this moment, there are 10,000 known diseases, many of them rare, but we only have effective treatments for 500. Streamlining the discovery, development and delivery processes will have an enormous impact on health and save the nation billions of dollars in unnecessary hospitalizations, ineffective treatments and lost productivity.
We applaud the House Energy and Commerce Committee for their far-reaching and comprehensive legislation and the thorough stakeholder engagement and evaluation process they put towards developing it.
The legislative process can be intricate and all caveats apply. However, the 21st Century Cures Act is a tremendous accomplishment. We encourage Congress to move quickly in advancing this legislation to the House floor, through the Senate, where leaders will undoubtedly and appropriately have their own ideas and priorities, and ultimately to the president’s desk. Let’s put the promise of the 21st Century Cures Act to practice for the millions around the world who will benefit.
Sara Radcliffe is president & CEO of the California Life Sciences Association.
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