ICYMI: Cures Act is delivering on promises to advance research
Cures Act is delivering on promises to advance research
By U.S. Rep. Fred Upton
September 22, 2018
The 21st Century Cures initiative began with the spark of an idea: What could we in Congress do to ensure that life-saving drugs and devices move to market in the fastest and safest way possible? That spark was the start of a multiyear journey that took us from Michigan to Colorado, the halls of Congress to the Oval Office.
And after listening, gathering stakeholder feedback and drafting and re-drafting legislation, the final product was what some called the most meaningful legislation we passed in the 114th Congress. While it was enacted into law in late 2016, we've only begun to see what it can do to advance cutting-edge healthcare and promote the nation's overall health.
When a bipartisan group of lawmakers including myself and my partner in this effort, U.S. Rep. Diana DeGette (D-Colo.), gathered in the White House to sign the 21st Century Cures Act—also referred to as Cures—into law, it marked a momentous occasion. We not only had made needed reforms to the Food and Drug Administration and National Institutes of Health in order to encourage more efficient and safer approvals, we also had boosted research at the NIH, funded new mental-health programs, and appropriated money to states to fight the ongoing opioid epidemic.
More specifically, Cures is boosting four major innovative initiatives at the NIH: the Beau Biden Cancer Moonshot, which works to accelerate progress in cancer prevention and screening; the Precision Medicine Initiative, which is a long-term research endeavor aimed at understanding how a person's genetics, environment and lifestyle can help determine the best approach to prevent or treat disease; the Brain Research through Advancing Innovative Neurotechnologies Initiative, which supports a more dynamic understanding of brain functions; and the Regenerative Medicine Innovation Project, which aims to accelerate the field of stem cell science.
Cures provided the FDA with new authorities and also established an FDA Innovation Account so officials can concentrate on a broad range of goals including patient-focused drug development to incorporate the patients' perspective, advancing new therapies to transform the way drugs are developed, modernizing drug-testing trial design, and development of methodology to use real-world evidence in the process, and more.
Cures also focuses on reforming our nation's mental health system, which is why we worked so hard to include the Helping Families in Mental Health Crisis Reform Act in the bill.
And, amid our country's opioid crisis, Cures provides $1 billion for states to fight the epidemic at the local level through the end of 2018. We're now focused on ensuring that this funding continues, and more.
Currently, we are looking at how the Cures implementation is progressing. We're curious to find out how, exactly, it is changing the medical innovation ecosystem and what tweaks can be made to ensure we're always putting patients first. When FDA Commissioner Dr. Scott Gottlieb and NIH Director Dr. Francis Collins testified in late July before the Energy and Commerce Committee's Health Subcommittee on the continuing rollout of this law, they reminded us just how Cures is already having a monumental impact on health and healthcare delivery.
More than a year after it was signed into law, Cures is proving its worth. We look forward to continued engagement with patients, stakeholders and other lawmakers.