21st Century Cures Act

21st Century Cures Act
U.S. Government · Public domain · source
Short title	21st Century Cures Act
Long title	An Act to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes
Enacted by	United States Congress
Enacted under	Barack Obama
Effective date	December 13, 2016

Contents

21st Century Cures Act is a landmark legislation signed into law by Barack Obama on December 13, 2016, aiming to accelerate the discovery, development, and delivery of National Institutes of Health-supported medical innovations, in collaboration with the Food and Drug Administration and the Centers for Disease Control and Prevention. The Act is the result of a bipartisan effort, led by Fred Upton, Dianna DeGette, Frank Pallone, and Gene Green, to address the complex and often slow process of bringing new medical treatments to market, with input from American Medical Association, American Cancer Society, and National Academy of Medicine. The legislation builds upon previous efforts, such as the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act, to improve the regulatory framework for Food and Drug Administration-approved products, including those developed by Pfizer, Merck & Co., and Johnson & Johnson. The Act also draws on the expertise of renowned research institutions, including the National Cancer Institute, National Institute of Mental Health, and National Institute of Neurological Disorders and Stroke.

Introduction

The 21st Century Cures Act is designed to foster a more collaborative and streamlined approach to medical innovation, involving key stakeholders such as National Institutes of Health, Food and Drug Administration, Centers for Disease Control and Prevention, and the Biotechnology Innovation Organization. By promoting the use of precision medicine and genomic medicine, the Act aims to improve patient outcomes and reduce healthcare costs, as envisioned by Francis Collins, Margaret Hamburg, and Tom Frieden. The legislation also recognizes the importance of clinical trials and regulatory science in the development of new treatments, with support from organizations such as the Clinical Trials Transformation Initiative and the Regulatory Affairs Professionals Society. Furthermore, the Act acknowledges the need for increased funding for medical research, as advocated by American Association for Cancer Research, American Heart Association, and American Diabetes Association, and provides a framework for National Institutes of Health to allocate resources effectively, in consultation with National Academy of Sciences, Institute of Medicine, and National Research Council.

The 21st Century Cures Act was introduced in the United States House of Representatives on May 19, 2015, by Fred Upton and Dianna DeGette, with input from Frank Pallone and Gene Green. The bill underwent significant revisions and markups, with contributions from Energy and Commerce Committee, Ways and Means Committee, and House Committee on Appropriations. The legislation was influenced by various stakeholders, including Pharmaceutical Research and Manufacturers of America, Biotechnology Innovation Organization, and American Medical Association, as well as patient advocacy groups such as American Cancer Society, American Heart Association, and National Organization for Rare Disorders. The bill passed the House on July 10, 2015, and was later taken up by the United States Senate, where it was amended and passed on December 7, 2016, with support from Lamar Alexander, Patty Murray, and Richard Burr. The final version of the bill was signed into law by Barack Obama on December 13, 2016, following a thorough review by Office of Management and Budget and Congressional Budget Office.

The 21st Century Cures Act includes several key provisions aimed at accelerating medical innovation, such as the creation of a National Institutes of Health Precision Medicine Initiative, led by Francis Collins and Elizabeth Nabel, and the establishment of a Food and Drug Administration Breakthrough Devices program, modeled after the Breakthrough Therapy designation. The Act also provides funding for National Institutes of Health-supported research initiatives, including the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, the Cancer Moonshot, and the Regulatory Science program, with input from National Academy of Sciences, Institute of Medicine, and National Research Council. Additionally, the legislation includes provisions related to electronic health records, health information technology, and medical device regulation, with guidance from Office of the National Coordinator for Health Information Technology and Federal Communications Commission. The Act also promotes the development of gene therapy and regenerative medicine, with support from National Institute of General Medical Sciences and National Center for Advancing Translational Sciences.

The 21st Century Cures Act has been praised for its potential to accelerate medical innovation and improve patient outcomes, with endorsements from American Medical Association, American Cancer Society, and National Organization for Rare Disorders. However, the legislation has also faced criticism from some stakeholders, including Public Citizen and Knowledge Ecology International, who argue that the Act may compromise Food and Drug Administration's regulatory standards and increase healthcare costs, as noted by Medicare Payment Advisory Commission and Congressional Budget Office. Others, such as American Academy of Family Physicians and American College of Physicians, have expressed concerns about the Act's provisions related to electronic health records and health information technology, citing the need for greater emphasis on interoperability and patient privacy, as highlighted by Office of the National Coordinator for Health Information Technology and Federal Trade Commission. Despite these concerns, the Act has been widely recognized as a significant step forward in promoting medical innovation, with support from National Institutes of Health, Food and Drug Administration, and Centers for Disease Control and Prevention.

The implementation of the 21st Century Cures Act is ongoing, with key agencies such as National Institutes of Health, Food and Drug Administration, and Centers for Disease Control and Prevention working to establish new programs and initiatives, in consultation with Office of Management and Budget and Congressional Budget Office. The Act provides funding for various research initiatives and programs, including the Precision Medicine Initiative and the Cancer Moonshot, with allocations from National Institutes of Health and National Cancer Institute. The legislation also includes provisions related to funding and budgeting, with guidance from Congressional Budget Office and Medicare Payment Advisory Commission. As the Act is implemented, stakeholders such as Pharmaceutical Research and Manufacturers of America, Biotechnology Innovation Organization, and American Medical Association will play a critical role in shaping the future of medical innovation, in collaboration with National Academy of Sciences, Institute of Medicine, and National Research Council. The success of the Act will depend on the ability of these stakeholders to work together to address the complex challenges facing the medical research community, including those related to intellectual property, patent law, and trade secrets, as noted by United States Patent and Trademark Office and World Intellectual Property Organization. Category:United States federal healthcare legislation