Why the 21st Century Cures Act is a Good Thing

A Q&A with Mary Woolley, President and CEO of Research!America

Originally published Feb. 8, 2017

Q: You attended the December signing by President Obama of the 21st Century Cures Act and are recognized to be a strong supporter. Yet harsh criticism of it has quickly appeared in JAMA, BMJ, a variety of other venues, as well as on these pages. Please tell our readers why this is good legislation and how the public health will be protected from exploitation in this very different regulatory world.

A: The bi-partisan 21st Century Cures Act is grounded in a commitment to assuring that our nation’s research ecosystem has the capacity to accelerate the pace at which safe and effective medical advances reach patients. The Act will expand the efficiency, reach and impact of medical discovery in a manner that sustains crucial safeguards against unsafe or ineffective products. The law finances more research, helps to reduce the administrative cost surrounding basic research, and takes additional steps to overcome challenges the Food and Drug Administration (FDA) faces. Patient groups, health care professionals, academic leaders, industry leaders and the FDA and the National Institutes of Health (NIH) were frequently consulted regarding provisions of this bipartisan bill, and their insights were incorporated. We at Research!America were closely involved throughout development of the bill, and are pleased that it crossed the finish line last December.

After years of automatic spending cuts and flat-funding, researchers have been stressed as they work to find solutions to deadly and complex diseases. The 21st Century Cures provides some relief in that regard with an initial $352 million in FY17 to support the NIH Precision MedicineBRAIN, and Cancer Moonshot initiatives. Congress recognizes that these dollars are targeted and temporary; they do not supplant the need to grow NIH’s annual budget. As reflected in surveys that Research!America commissions regularly, Americans recognize the importance of federally-funded research and support streamlining the pursuit of medical research and innovation.

The FDA, which has for years been underfunded, will also receive new funding with an initial $20 million in FY17 to improve efficiencies in the R&D pipeline. This new funding, in combination with other provisions of the law, is particularly meaningful as it will give the FDA more flexibility to recruit additional experts needed to assure that our regulatory system can properly evaluate rapidly evolving science in areas such as immunology and regenerative medicine.

One important example of rapidly evolving science is the potential to diversify the evidence base used to evaluate the safety and efficacy of medical advances by leveraging “real world evidence” (RWE). The Cures Act defines real world evidence as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials.” While concerns have been raised that the RWE provisions would force the FDA to relax critical safety and efficacy standards, these provisions were developed with agency input. This section of the law is designed to empower, not require, the FDA to capitalize on real world data. Real world data will be used when — and only when — it is appropriate to do so.

Faster medical progress saves lives. The 21st Century Cures Act will fuel faster progress. It’s incumbent upon research advocates to engage elected officials to build on the Cures Act, and ensure that adequate funding is provided to make the promise of science and innovation a reality in our lifetime.

Copyright: This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Biden Announces Steps to Improve Clinical Trials Under Cancer Moonshot

Excerpt:

“Vice President Joe Biden outlined a plan to improve the efficiency and transparency of the U.S. clinical research system as part of the national cancer moonshot initiative.

“The plan includes specific steps to help patients locate trials quickly, incentivize clinical trial design to broaden participation while reducing burden and risk, and strengthen the transparency of trial results.”

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"Radiation Combined With Immune-Stimulating Drugs Could Pack a Powerful Punch Against Cancer Cells"

Excerpt:

“In his final State of the Union address, President Obama tasked Vice President Joe Biden with leading a new National Cancer Moonshot initiative. The hope is that this will put America on course to be ‘the country that cures cancer once and for all.’ Listed among the cutting-edge research areas of the initiative is a class of treatments called cancer immunotherapy and combination therapy.

“Cancer immunotherapies are treatments that stimulate the immune system to target and attack cancer. Researchers now believe that combining immunotherapy with traditional therapies could open up new possibilities for cancer treatment.

“For instance, radiation is one of the oldest and most commonly used forms of cancer treatment out there. But there are limits to how much radiation a person can receive, and it can’t kill every cancer cell. However, in combination therapy, radiation could be paired with immunotherapy to pack a one-two punch against .”

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Do you have questions about this story? Let us know in a comment below. If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our Ask Cancer Commons service.


ASCO Report Finds U.S. Cancer Care System Ill-Equipped to Deliver New Advances to Patients

“As the nation embarks on an ambitious ‘moonshot’ to accelerate progress against cancer, our system for delivering today’s cancer treatments must be better prepared to bring advances to all patients, warns a new report from ASCO.

The State of Cancer Care in America: 2016, published March 15 in the Journal of Oncology Practice and presented at a Congressional briefing in Washington, DC, is ASCO’s third annual assessment of national trends in cancer care delivery. The report highlights many promising cancer care developments, including new drugs and technologies, declining mortality rates, expanded access to healthcare generally, and a shift towards value-based care. But ASCO also highlights major challenges for patients and physicians, including uneven health insurance coverage, rapidly rising costs, and other barriers to accessing new treatments.”