Alexander: Over 320 Organizations Representing Patients, Doctors, and Researchers Urge Senate to Pass 21st Century Cures

WASHINGTON, December 5 – Ahead of today's Senate vote to move forward on the 21st Century Cures Act, Senate health committee Chairman Lamar Alexander (R-Tenn.) announced more than 320 organizations – from leading research hospitals to organizations representing patients with rare diseases – are urging Congress to pass the legislation.

On Wednesday, the House of Representatives passed the legislation by a vote of 392 to 26, readying the game-changing medical innovation package that includes new research funding, mental health reforms, and state grants to fight opioid abuse for Senate action this week. 

“Patients, doctors and scientists are supporting 21^st Century Cures and encouraging Congress to finish its work on this bipartisan legislation that will impact the health of virtually every American,” said Alexander. “This transformational bill will lead to lifesaving medical breakthroughs and advance President Obama’s Precision Medicine Initiative and Vice President Biden’s Cancer Moonshot. It passed overwhelmingly in the House and now it’s time for the Senate to deliver on the promise of 21^st Century Cures for patients.”

Groups representing patients, doctors, and scientists across the country are voicing their support for 21^st Century Cures:

Mayo Clinic: “Efforts to advance biomedical innovation and accelerate the development and delivery of cures are of great importance to Mayo Clinic and our patients. We are pleased to see the inclusion of dedicated funding streams for the Food and Drug Administration and National Institutes of Health—including funds for research efforts such as the President’s Precision Medicine initiative, the Vice President’s Cancer Moonshot, and the BRAIN initiative to speed diagnosis and treatment of conditions such as Alzheimer’s disease… Mayo Clinic is grateful for your leadership, wholeheartedly supports this comprehensive legislation and looks forward to this innovative effort being signed into law, and we pledge to be a committed partner in its implementation.”

Friends of Cancer Research: “The Cures bill deserves urgent support not only because it is about accelerating cures, but also because it reflects extensive and comprehensive work on a bipartisan basis over two years to identify effective ways to do it. The bill translates recent progress in scientific understanding of disease mechanisms, data integration and analysis, and patient engagement to streamline and speed the development of medical treatments while enabling a deeper understanding about their safety and effectiveness for particular patients… These new tools to promote health also help create jobs and boost American competitiveness globally.”

IBM: “This bipartisan legislation will support health innovation and advance precision medicine in the United States by fostering increased collaboration between patients, industry, researchers, and government. We particularly support provisions in the bill that will empower the use of real-world medical evidence and the sharing of data in delivering new scientific breakthroughs that will improve the lives of Americans.”

National Organization for Rare Disorders: “On behalf of the 30 million men, women, and children in the U.S. living with a rare disease, the National Organization for Rare Disorders (NORD) is pleased to support the 21st Century Cures Act, and we urge its swift enactment.”

Premier Healthcare Alliance: “We are in strong support of the HIT interoperability provisions that will improve the ability of healthcare providers, patients and researchers too seamlessly and securely access health information across different electronic health record (EHR) systems… Premier agrees that this could be one of the most important pieces of legislation that Congress passes this year and we urge you to work together to advance these HIT interoperability provisions across the finish line before adjourning this year.”

American Society of Clinical Oncology: “The American Society of Clinical Oncology (ASCO) strongly supports the 21st Century Cures Act and encourages a “yes” vote on this important legislation when it is considered by the House and Senate this session. We applaud the House Energy and Commerce and Senate Health, Education, Labor, and Pensions Committees in their bipartisan work on this pivotal legislation. It is more important than ever to realize the potential that big data and precision medicine have to offer in new treatments to patients, and this legislation will help in that effort.” 

Parent Project Muscular Dystrophy: “On behalf of Parent Project Muscular Dystrophy (PPMD), the leading organization fighting to end Duchenne muscular dystrophy, I am writing to enthusiastically endorse The 21st Century Cures Act. For nearly two years, you and your colleagues have undertaken an impressive process to develop and refine a piece of legislation that, if enacted into law, will supercharge our national commitment to biomedical research and will accelerate the process by which we deliver safe and effective therapies to patients in need, particularly those with profound unmet medical need.”

Alliance of Specialty Medicine: “Specialty physicians encourage support for medical innovation that integrates the patient’s perspective into the regulatory process; facilitates responsible communication of scientific and medical developments; modernizes clinical trials; fosters the future of science, including encouraging young scientists; invests in advancing research; incentivizes the development of new drugs and devices for unmet medical needs; promotes interoperability; and supports 21st Century digital medicine by facilitating data sharing and the use of new technologies.”

Advanced Medical Technology Association (AdvaMed): “Policy improvements are essential if America is to retain its global leadership in medical technology and innovation. The 21st Century Cures Act includes a number of proposals designed to strengthen the innovation ecosystem and support the development of life-saving, life-enhancing medical technology. This includes key improvements to FDA’s premarket program for medical devices – most significantly the establishment of an expedited pathway for breakthrough, innovative technologies – which will increase the efficiency, predictability and transparency of the agency’s review process and improve patient access to the best in medical progress. The bill also provides increased NIH funding which will help strengthen our R&D infrastructure, and funding for the FDA to implement the reforms advanced by the legislation. Collectively, these provisions are important and significant steps to strengthen our innovation ecosystem.”

Association of Public & Land-Grant Universities/Association of American Universities: “On behalf of our associations’ more than 200 research universities, we respectfully urge Congress to pass and send to the president this year a 21st Century Cures/medical innovation bill which provides a surge of multi-year, guaranteed funding as well as robust authorization levels for the National Institutes of Health (NIH). The House and Senate’s bipartisan efforts on such legislation in the 114th Congress have been truly extraordinary and should not go unfulfilled. As NIH Director Francis Collins has indicated many times, the state of biomedical research is at a point of exceptional scientific opportunity, with promise for advances in medicine greater than ever before. The research and people supported by the NIH will achieve these advances, improving the lives of patients and their families as well as boosting the U.S. economy and strengthening our global competitiveness.”

United for Medical Research: “This bill is about finding cures and improving our nation’s health. It’s about funding the research, discovery and innovation necessary to prevent, treat, and cure our most vexing diseases. The 21st Century Cures Act includes essential funding for the National Institutes of Health (NIH) that helps the United States remain the world’s engine for medical innovation, and passage this year would provide a needed boost to critical research and breakthrough treatments, as well as hope for patients. Amazing medical advances are happening every day because of NIH research funding, and the 21st Century Cures Act would provide an infusion of funds for this valued agency at a critical time for biomedical advancement.”

Biotechnology Industry Organization: “21St Century Cures takes important steps towards placing patients at the center of the drug development process by establishing a framework for incorporating patient views into the development and regulatory review process in a more structured and transparent way, both with respect to patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making. BIO believes this legislation will help spur the development of treatments focused on rare conditions and other unmet medical needs by extending the Rare Pediatric Disease (RPD) Priority Review Program (PRV). The RPD PRV program is a vital tool in helping foster the development of new treatments for children with rare diseases, providing hope to many patients, families and caregivers.”

American Hospital Association: “On behalf of the American Hospital Association’s (AHA) nearly 5,000 member hospitals, health systems and other health care organizations, and our 43,000 individual members, I am writing to commend the Congress for its work on the revised 21st Century Cures bill, and express our support for the legislation…The bill includes important provisions related to hospital outpatient services, rural health care, a much needed socioeconomic adjustment to the readmissions program, relief for long-term care hospitals (LTCHs), and important provisions related to behavioral health and opioids.”

Infectious Diseases Society of America: “On behalf of the Infectious Diseases Society of America (IDSA), thank you for continued efforts to spur biomedical innovation through approval of the new 21st Century Cures Act. IDSA particularly appreciates measures within the bill that help address the public health crisis of antimicrobial resistance (AR), support the next generation of scientists, and deal with the opioid epidemic that is contributing to a surge in new HIV and hepatitis C infections. We urge Congress and the president to approve the legislation as soon as possible.”

American Society for Radiation Oncology: “Not only does 21st Century Cures provide additional support for existing medical research programs, it paves the way for advancements and additional innovations in research and treatment for cancer and across medicine. ASTRO has long supported strong, sustainable funding for the National Institutes of Health and National Cancer Institute to ensure that medical breakthroughs are not threatened. As our understanding of cancer has evolved, so must the technologies used to treat it. This bill goes a long way to support clearer pathways to achieve that goal.”

Health IT Now: “We believe that provisions of the 21st Century Cures Act, as considered on the House floor today, recognizes health IT as a medium for positive reform in our healthcare system. The legislation correctly seeks to provide needed clarity to FDA oversight of software products, and puts forward important reforms to solve issues of electronic health record interoperability that has stymied the flow of health information in the United States.”

American Association for Cancer Research: “We are writing today to convey our strong support for the 21st Century Cures Act, and we urge you and your colleagues to pass this legislation before the end of the lame duck session. We are especially grateful for the bill’s establishment of an NIH Innovation Account, through which $1.8 billion in supplemental funding over seven years is designated for cancer research, and specifically for the National Cancer Moonshot Initiative. Extraordinary scientific opportunities exist today for making major advances against the more than 200 diseases we call cancer. As described in the AACR Cancer Progress Report 2016, definitive advances continue to be made to effectively prevent, detect, diagnose, and treat many forms of cancer. However, continued rapid progress against cancer depends on robust, sustained, and predictable funding increases, and the 21st Century Cures Act would provide significant supplemental support for many of the initiatives and programs that have been recommended to advance the National Cancer Moonshot Initiative.”

Permobil: “On behalf of Permobil, Inc., I am writing to express our company’s strong support for the 21st Century Cures Act and our deep appreciation for your stalwart leadership in guiding this legislation through the U.S. Congress.”

The University of Chicago Medicine & Biological Sciences: “The Act also includes important funding for addressing the opioid crisis and support for biomedical research, including the cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative. In addition, the Act includes funding to improve mental health care, including suicide prevention on college campuses and screening pregnant women for depression.”

Mental Health Liaison Group: “We are pleased that the underlying healthcare package incorporates S. 2680, the Mental Health Reform Act of 2016, which unanimously passed out of the Senate Health, Education, Labor, and Pensions Committee earlier this year. These important bipartisan provisions strengthen federal coordination of mental health resources, increase reporting on mental health parity, advance integrated service delivery, support the mental health workforce, increase early access to mental health services, promote suicide prevention…“The need for reform is urgent, and you have the opportunity to act now to improve the lives of tens of millions of Americans, their families, and our communities. The House overwhelmingly passed H.R. 34 Wednesday evening. We urge you to follow suit so that meaningful mental health reform can be enacted this year.”

Undersigned medical diagnostic companies: “The undersigned organizations are writing to express their support for the FDA Device Accountability Act, S. 1622, and to urge the Committee to advance its passage into law using all means at your disposal. If enacted, S.1622 will help foster advances in medical technologies that have the potential to provide patients with better and more affordable health care that patients deserve.”

Coalition for CLIA Waiver Reform

Advanced Medical Technology Association

National Coalition of STD Directors

Abbott

Alere

Becton Dickinson & Company

BioFire Diagnostics

ChemBio Diagnostic Systems

Roche Diagnostics

Sekisui Diagnostics

Spartan Bioscience

TearLab Corporation

Coalition of 217 rare disease foundations: “This is a patient-focused bill that will advance the discovery and development of treatments, strengthen the patient voice in the research and regulatory environment, increase funding for the National Institutes of Health and Food and Drug Administration, and greatly improve our innovation ecosystem. Millions of Americans are desperately waiting for effective treatments and cures for their chronic disease or disability. The organizations that represent these people with chronic conditions urge Congress to pass the 21st Century Cures Act in 2016 in order to speed the development of treatments and cures. Patients simply can't afford to wait -- time is running out.”

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