21st Century Cures: A Medical ‘Innovation Game-Changer’

SENATE MAJORITY LEADER MITCH McCONNELL (R-KY): “Too many people are waiting for the promise of a cure or a medical advancement to combat a life-threatening disease. . . Cutting back on bureaucratic red tape, advancing lifesaving research and tackling the scourge of cancer would move our country forward and help millions looking for more than hope, but a chance at long, healthy lives.” (“$6.3 Billion Measure Aims to Cure Ailing Health Care Policies,” The New York Times, 11/28/2016)

SEN. LAMAR ALEXANDER (R-TN), HELP COMMITTEE CHAIRMAN: “This bipartisan legislation . . . will help us take advantage of the breathtaking advances in biomedical research and bring those innovations to doctors’ offices and patients’ medicine cabinets around the country. This legislation will advance Vice-President Biden’s moonshot to find cures for cancer, President Obama’s Precision Medicine Initiative, and Alzheimer’s research – and it will help states in the fight against opioid abuse and the one in five adults in this country suffering from a mental illness. It’s time for the Senate to deliver on the promise of 21^st Century Cures for patients.” (Sen. Alexander, Press Release, 11/30/2016)

PRESIDENT OBAMA: “There’s a bill in Congress that could help unlock cures [for] Alzheimer’s, end cancer as we know it, and help people seeking treatment for opioid addiction finally get the help they need. It’s called the 21st Century Cures Act. It’s an opportunity to save lives, and an opportunity we just can’t miss. . . This week, the House passed it overwhelmingly, and in bipartisan fashion. The Senate will vote in the next few days, and I hope they’ll do the same. I’ll sign it as soon as it reaches my desk . . . I believe we should seize every chance we have to find cures as soon as possible. When it’s your family, hope can’t come soon enough.” (President Obama, “Weekly Address: Pass the 21st Century Cures Act,” 12/03/2016)

With ‘Overwhelming Bipartisan Vote,’ House Advances 21^st Century Cures Act

The 21^st Century Cures Act passed the House by a vote of 392-26. (H.R. 34, Roll Call Vote #592: Motion agreed to 392-26 : R 218-20; D 174-6, 11/30/2016)

REPS. FRED UPTON (R-MI) & DIANA DeGETTE (D-CO): “With today’s overwhelming bipartisan vote, we took a giant leap forward on the #Path2Cures. . . 21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need. The White House has expressed its enthusiastic endorsement of this critical legislation. So it’s now on to the Senate, where we are just one final vote away from delivering #CuresNow.” (U.S. House of Representatives Energy & Commerce Committee, Press Release, 11/30/2016)

“Democrats . . . are keen to secure various elements of the bill, which includes funding for Vice President Joe Biden’s Cancer Moonshot Initiative and its goal of accelerating advances in cancer diagnosis, treatment, and prevention. It also includes $1 billion over two years to combat the national opioid crisis, which has hit Massachusetts and the rest of New England hard. In the House, six Massachusetts Democrats were cosponsors of the original bill that passed in July 2015. Massachusetts’ junior senator, Ed Markey, has pushed hard for the opioid funding included in the bill . . .” (“Warren Splits With Party, Mass. Interests Over Drug Bill,” The Boston Globe, 11/30/2016)

‘Sweeping … Bipartisan’ Legislation Funds Disease Research, Gives Regulatory Relief, And ‘Address[es] Problems In The Nation’s Mental Health Systems’

“In one of the most sweeping . . . bipartisan acts of this Congress, lawmakers will move this week on a $6.3 billion bill to increase funding for research into cancer and other diseases, address problems in the nation’s mental health systems and enact potentially far-reaching regulatory changes for drugs and medical devices. The bill, known as the 21st Century Cures Act, is the product of years of debates over health care policy issues . . .” (“$6.3 Billion Measure Aims to Cure Ailing Health Care Policies,” The New York Times, 11/28/2016)

• “[T]he bill’s extensive scale — from cancer to Alzheimer’s to mental illness and drug addiction — addresses problems that touch nearly every American life.” (“$6.3 Billion Measure Aims to Cure Ailing Health Care Policies,” The New York Times, 11/28/2016)

• “The White House used a conference call with reporters Wednesday to drum up support for the measure by emphasizing its drug-abuse treatment funds. ‘The No. 1 thing we can do right now is to make sure we’re dedicating resources to expand access to treatment all across the country,’ said Michael Botticelli, director of the White House’s Office of National Drug Control Policy.” (“House OKs Bill Bolstering Medical Research, Drug Approvals,” The Associated Press, 11/30/2016)

Medical Research Groups And Rare Disease Foundations: ‘The Cures Bill Deserves Urgent Support,’ And ‘Will Advance The Discovery And Development Of Treatments’

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 21^st Century Cures Act . . . in order to speed the development of treatments and cures.” (Letter to Sens. McConnell and Reid, Speaker Ryan, and Rep. Pelosi, 11/16/2016)

• “We, the undersigned 217 organizations, represent a widely diverse community of patients and family caregivers with distinct perspectives; yet we stand united in support of the 21^st Century Cures Act and urge you to support and move this legislation forward . . .” (Letter to Sens. McConnell and Reid, Speaker Ryan, and Rep. Pelosi, 11/16/2016)

Letter signatories include:

• Alzheimer’s Association
• American Autoimmune Related Diseases Association
• American Cancer Society Cancer Action Network
• American Foundation for Suicide Prevention
• American Heart Association
• Arthritis Foundation
• Asthma and Allergy Foundation of America
• Autism Speaks
• Caregiver Action Network
• Epilepsy Foundation
• Friends of Cancer Research
• Lupus Foundation of America
• National Alliance on Mental Illness
• National Multiple Sclerosis Society
• National Patient Advocate Foundation
• National Organization for Rare Disorders (NORD)
• Rally Foundation for Childhood Cancer Research
• The AIDS Institute
• The ALS Association
• The Michael J. Fox Foundation

Friends of Cancer Research Founder and Director of the Margolis Center for Health Policy at Duke University: “After a deeply contentious election, Congress has an opportunity to embrace common ground. The House and Senate should pass the 21^st Century Cures Act to bolster the life-saving work of the Food and Drug Administration (FDA) and National Institutes of Health (NIH). The ‘Cures bill’ unites us?—?a former FDA Commissioner and the founder of a non-profit that advances innovation in cancer research and treatment?—?because it brings the latest scientific opportunities to the urgency of saving lives.” (Ellen V. Sigal and Dr. Mark McClellan, “After a Contentious Election, A Rare Unifying Force: Pass Cures Now,” Medium, 11/25/2016)

• “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.” (Ellen V. Sigal and Dr. Mark McClellan, “After a Contentious Election, A Rare Unifying Force: Pass Cures Now,” Medium, 11/25/2016)

• “The Cures bill draws inspiration not from Washington insiders, but from scientists and medical professionals who confront disease every day.” (Ellen V. Sigal and Dr. Mark McClellan, “After a Contentious Election, A Rare Unifying Force: Pass Cures Now,” Medium, 11/25/2016)

Alliance of Specialty Medicine: “The Alliance of Specialty Medicine supports the bipartisan effort to improve the discovery, development and delivery that support continued innovation in our health care system. . . The Alliance thanks House members for their overwhelming support in passing H.R. 6, the 21^st Century Cures Act last year. . . We urge the House and Senate to work together to ensure this legislation is enacted into law this year.” (Alliance of Specialty Medicine, Release)

United for Medical Research: “On behalf of United for Medical Research (UMR), we are writing to urge the Senate to seize the unique bipartisan and bicameral momentum behind the 21^st Century Cures Act, and take it up . . . 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 21^st 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.” (David Pugach, Tim Fenton, and Lizbet Boroughs, Letter to Sens. McConnell, Reid, Cornyn, and Durbin, 10/28/2016)

• “The bipartisan leadership over the last two years in both the House and the Senate has been truly remarkable, and this legislation would be a crowning achievement for the 114^th Congress.” (David Pugach, Tim Fenton, and Lizbet Boroughs, Letter to Sens. McConnell, Reid, Cornyn, and Durbin, 10/28/2016)

• “This is a rare opportunity to make a real difference in the lives of all Americans. Our coalition strongly encourages immediate action on such a timely and widely supported measure. It is a clear national priority . . .” (David Pugach, Tim Fenton, and Lizbet Boroughs, Letter to Sens. McConnell, Reid, Cornyn, and Durbin, 10/28/2016)

BOB COUGHLIN, MassBio President and CEO: “This legislation will be very good for the economy in the commonwealth of Massachusetts, and more importantly, very good for patients around the world. . . The 21st Cures Act was 100 percent written in a way to promote innovation to create cures.” (“With Backing Of Mass. Trade Groups, House Passes 21st Century Cures Bill,” Boston Business Journal, 11/30/2016)

American Research Universities And Medical Colleges: Bill Provides ‘A Surge Of Multi-Year, Guaranteed Funding … For The [NIH]’ And ‘Regulatory Relief’

Association of American Medical Colleges (AAMC): “The AAMC congratulates congressional leaders and authors of the 21st Century Cures Act . . . The legislation establishes a 10-year NIH Innovation Account that will allow appropriators dedicated resources to invest in specific long-term research projects, such as precision medicine and cancer research. . . We are grateful that the package includes several other AAMC-supported provisions that will improve the ability of the nation’s medical schools and teaching hospitals to deliver the highest quality care to all patients.” (Association of American Medical Colleges, Press Release, 11/26/2016)

Association of American Universities and Association of Public & Land-Grant 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 21^st 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). . . Additionally, provisions in the House and Senate bills to provide regulatory relief and encourage the next generation of the biomedical research workforce are also significant.” (Association of American Universities and Association of Public & Land-Grant Universities, Letter to Sens. McConnell and Reid, Speaker Ryan, and Rep. Pelosi, 11/10/2016)

ELI CAPILOUTO, University of Kentucky President: “On behalf of faculty, staff, and students at the University of Kentucky who are dedicated to research that improves the lives of our citizens, we respectfully urge Congress to pass, and send to the President this year, a 21st Century Cures/Medical Innovation bill. This bill provides a surge of multi-year funding as well as robust authorization levels for the National Institutes of Health (NIH).” (University of Kentucky, Office of the President, Letter to Sen. McConnell, 12/01/2016)

• “As [an] academic, research, and healthcare enterprise, discovery is at the core of the University of Kentucky’s mission – calling upon us to answer questions at the heart of the 21st Century Cures/Medical Innovation bill. . . We are positioning ourselves as a landgrant institution to harness synergies across the vast array of disciplines at the University, and the 21st Century Cures/Medical Innovation bill will enable this talent to improve the lives of those in the Commonwealth.” (University of Kentucky, Office of the President, Letter to Sen. McConnell, 12/01/2016)

Hospitals: Provisions In The Bill ‘Will Help’ Provide ‘Wellness, Healing And Hope To All’

MIKE RUST, Kentucky Hospital Association President: “On behalf of the Kentucky Hospital Association and our 127 member hospitals, I would like to commend and thank you and the U.S. Congress for your work and for … H.R. 34, the 21^st Century Cures Act, and express our support for the bill.” (Kentucky Hospital Association, “Mike Rust Statement In Support Of The 21^st Century Cures Bill”)

• “The legislation overhauls drug development, accelerates new cures and treatments and includes a number of provisions important to Kentucky hospitals and their work to improve patient care. 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 opioid abuse and treatment.” (Kentucky Hospital Association, “Mike Rust Statement In Support Of The 21^st Century Cures Bill”)

KentuckyOne Health: “Thank you for making the 21st Century Cures Act a priority. This legislation includes many provisions that are important to KentuckyOne Health, our patients and the communities we serve across the Commonwealth. . . These provisions in the 21st Century Cures Act will help KentuckyOne Health fulfill its mission of providing wellness, healing and hope to all.” (Sharri Craig, KentuckyOne Health Division Vice President, Public Policy, Letter to Sen. McConnell, 11/29/2016)

• “Passage of this legislation will accomplish the following: . . . Take initial steps toward reform of the mental health care system . . . Authorize $1 billion in funding from 2017-2018 to help states address the opioid abuse crisis. . . Extend the Rural Community Hospital Demonstration Program for five years.” (Sharri Craig, KentuckyOne Health Division Vice President, Public Policy, Letter to Sen. McConnell, 11/29/2016)