THE 21st CENTURY CURES ACT

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Albert Horton
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THE 21st CENTURY CURES ACT 2017 Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD February 2017 MRC2.CORP.D.00224 advice or professional diagnosis.

1 THE 21st CENTURY CURES ACT 2017 Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD February 2017 MRC2.CORP.D advice or professional diagnosis. Users seeking medical advice should consult with their physician or other healthcare professional.

2 THE 21st CENTURY CURES ACT Signed into law by President Obama on December 13, 2016 (Public Law No: ) 1 Goals of the legislation 2 Discover, develop, and deliver new treatments and cures Maintain America s global status as the leader in biomedical innovation 21 st Century Cures Act includes provisions from two other (unpassed) bills 3 Helping Families in Mental Health Crisis Act of 2016 (H.R.2646) Mental Health Reform Act of 2016 (S. 2680) 1. U.S. House of Representatives Energy and Commerce Committee. (2016). 21st Century Cures Key documents. Retrieved March 2017 from U.S. House of Representatives Committee on Emergy and Commerce: 2. U.S. House of Representatives Committee on Energy and Commerce. (2016). The 21st Century Cures Act (Fact Sheet). Retrieved from National Alliance on Mental Illness (NAMI). (2016). We Did It! Mental Health Reform Is Headed to the President's Desk. Retrieved March 2017 from We Did It! Mental Health Reform Is Headed to the President's Desk - See morhttp:// P#sthash.6sS8x60y.dpuf 2

3 Discover New Treatments & Cures 1 The legislation includes $4.8 billion in new funding for the National Institutes for Health (NIH) Precision Medicine Initiative: For research into the genetic, lifestyle & environmental variations of disease Cancer Moonshot : To hasten research on cancer BRAIN Initiative: Brain Research through Advancing Innovative Neurotechnologies; aims to improve understanding of diseases like Alzheimer's 3

4 Develop New Therapies For Patients 1 Modernize clinical trials, and the accumulation and analysis of safety and efficacy data Putting patients at the heart of the regulatory process More focus on biomarkers earlier in process to assess how a therapy is working for particular types of patients Streamline & provide clarity in regulations for developers of medical technologies, vaccines, & regenerative medicine therapies Provide incentives to develop drugs for pediatric diseases & medical counter-measures; give FDA flexibility in reviewing breakthrough technologies $500 million for FDA to modernize regulations, recruit & retain an exemplary workforce FDA=U.S. Food and Drug Administration 4

5 Deliver New Treatments & Cures 1 Deliver drugs & devices to the right patient at the right time Ensure interoperability of electronic health record systems for seamless patient care Embrace the benefits of a learning health care system, improving education for health care providers Facilitate seniors access to the latest medical technology 5

6 Major Provisions Of The 21st Century Cures Act Affecting Behavioral Health Care 1 Provides $1 billion* over two years to fund addiction treatment for opioid use disorder Grants the U.S. Food & Drug Administration (FDA) greater discretion in evaluating new devices and medicines for approval (to hasten the approval process and ensure consumer feedback is considered) Provides $4.8 billion* to National Institutes of Health (NIH) $1.8 billion for cancer research; & nearly $3 billion to build on the BRAIN & Precision Medicine Initiatives biomedical research efforts to create research models to find cures & treatments for mental illness & Alzheimer s disease Supports greater use of health information technology and electronic health records (EHR) to collect data needed for research and treatment (the Act does not include specific funds to help provider organizations adopt EHRs) * Subject to appropriations 6

7 Other Provisions Affecting Behavioral Health Care 1 Helps implement & enforce the federal Mental Health Parity & Addiction Equity Act (MHPAEA), per the recommendation of a federal task force. Reauthorizes current language and appropriations for programs that support youth suicide prevention, teacher training, jail diversion, and behavioral health integration Addresses workforce shortages by establishing, maintaining, or improving programs that train professionals to recognize, diagnose and treat mental and substance use disorders Allows existing funds to be used by police and other first responders for crisis intervention and specialized training in addressing mental health needs 7

Response To 21 st Century Cures Act 1 This bi-partisan legislation has generally received praise in the media and is supported by industry, provider, and consumer groups.

8 Response To 21 st Century Cures Act 1 This bi-partisan legislation has generally received praise in the media and is supported by industry, provider, and consumer groups. Supporters of the legislation include: 1 American Psychiatric Association American Psychological Association American Society for Clinical Oncology American Society of Human Genetics American Heart Association The main detractors of the legislation, including the Public Citizen Health Research Group and Senator Elizabeth Warren, have stated that the legislation rolls back FDA regulations that could potentially benefit pharmaceutical and medical device companies. 2 FDA=U.S. Food and Drug Administration 1. Thompson, Dennis. (2016, December 13). Obama signs 21st Century Cures Act into law. Health Daily News. Retrieved from 2. Public Citizen. (2016, December). Preventing Patient Harm in 21 st Century Cures. Retrieved from 8

NIH FY 2017 Budget Roll-Out Francis S. Collins, M.D., Ph.D. Director, National Institutes of Health February 9, 2016

NIH FY 2017 Budget Roll-Out Francis S. Collins, M.D., Ph.D. Director, National Institutes of Health February 9, 2016 NIH s FY 2017 Budget Request Year FY 2015 FY 2016 FY 2017 Request Program Level ($B)