DOCSLIB.ORG

The 21St Century Cures Act — Will It Take Us Back in Time? Jerry Avorn, M.D., and Aaron S

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
The 21St Century Cures Act — Will It Take Us Back in Time? Jerry Avorn, M.D., and Aaron S The NEW ENGLAND JOURNAL of MEDICINE Perspective The 21st Century Cures Act — Will It Take Us Back in Time? Jerry Avorn, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H. n May 2015, the 21st Century Cures Act was intro- tem. An underlying premise of duced in the U.S. House of Representatives, with the bill is the need to accelerate I approval for new products, but the goal of promoting the development and speeding this process is already quite effi- the approval of new drugs and devices.1 Championed cient. A third of new drugs are currently approved on the basis by the pharmaceutical, biotech- provide an additional $2 billion of a single pivotal trial; the me- nology, and device industries, the per year for 5 years to create an dian size for all pivotal trials is bill was approved unanimously “NIH Innovation Fund.” Together, just 760 patients. More than two (51 to 0) in committee and con- this support would help counter- thirds of new drugs are approved tinues to be debated. If enacted act the effects of sequestration on the basis of studies lasting into law, some of its provisions and budget cuts that have re- 6 months or less3 — a potential could have a profound effect on duced the purchasing power of problem for medications de- what is known about the safety the NIH to its lowest level in signed to be taken for a lifetime. and efficacy of medical products, years. Given the crucial role that Once the Food and Drug Admin- as well as which ones become NIH-funded research plays in istration (FDA) starts its review, it available for use. generating the findings on which approves new medications about Some aspects of the bill could so many new drugs are based,2 as quickly as any regulatory indeed enhance the development this boost would be a welcome agency in the world, evaluating of and access to new drugs. The development. Another useful pro- nearly all new drug applications legislation calls for annual in- vision could make deidentified within 6 to 10 months, an im- creases in the stagnating budget data from NIH-funded clinical tri- pressive turnaround for such for the National Institutes of als more available to researchers. complex assessments. Health (NIH) amounting to about Other proposed changes could Nonetheless, as introduced, the 3% per year for 3 years when ad- lead to less salutary outcomes for 21st Century Cures Act instructs justed for inflation. It would also patients and the health care sys- the FDA to consider nontraditional n engl j med nejm.org 1 The New England Journal of Medicine Downloaded from nejm.org at PARTNERS HEALTHCARE on June 3, 2015. For personal use only. No other uses without permission. Copyright © 2015 Massachusetts Medical Society. All rights reserved. PERSPECTIVE The 21st Century Cures Act study designs and methods of even as it increased their risk of proven antibiotics, which could data analysis to further speed myocardial infarction. In 2013, encourage their more widespread approvals. Adaptive trial designs patients began to receive a new use. The bill gives the secretary and the use of Bayesian methods drug for tuberculosis approved of health and human services the hold promise in some kinds of on the basis of a randomized authority to expand this nontradi- evaluations, particularly in oncol- trial relying on a surrogate mea- tional approval pathway to other ogy. However, more problematic sure of bacterial counts in the drug categories as well, if “the proposals include encouraging sputum — even though patients public health would benefit from the use of “shorter or smaller given the drug in that trial had a expansion.” clinical trials” for devices and death rate four times that in the The 21st Century Cures Act the request that the FDA develop comparison group, mostly from goes still further in altering the criteria for relying on “evidence tuberculosis.4 These provisions in requirements for approving med- from clinical experience,” includ- the legislation would not imme- ical devices — an area long criti- ing “observational studies, regis- diately change FDA approval stan- cized for lack of rigor as com- tries, and therapeutic use” instead dards, but they would give the pared with drug evaluations,5 of randomized, controlled trials agency greater discretion, backed though regulatory oversight has for approving new uses for exist- by congressional support, to ap- improved in recent years. As pro- ing drugs. Although such data prove drugs on the basis of less posed, the new law would re- can provide important informa- rigorous data. define the evidence on which tion about drug utilization and The proposed legislation would high-risk devices can be approved safety once a medication is in use, make immediate changes with to include case studies, registries, there is considerable evidence that respect to new antibiotics and and articles in the medical litera- these approaches are not as rigor- antifungals by enabling their ap- ture, rather than more rigorous ous or valid as randomized trials proval without conventional clin- clinical trials. Another section in assessing efficacy. ical trials, if needed to treat a would allow device makers to The bill would also encourage “serious or life-threatening infec- pay a third-party organization to the FDA to rely more on bio- tion” in patients with an “unmet determine whether the manufac- markers and other surrogate mea- medical need.” In place of proof turer can be relied on to assess sures rather than actual clinical that the antimicrobial actually the safety and effectiveness of end points in assessing the effi- decreases morbidity or mortality, changes it makes to its devices, cacy of both drugs and devices. the FDA would be empowered in place of submitting an appli- The FDA already uses surrogate to accept nontraditional efficacy cation to the FDA. Thus certified end points in about half of new measures drawn from small stud- by the external company, a de- drug approvals.3 Some biomark- ies as well as “preclinical, phar- vice maker would be authorized ers are accurate predictors of macologic, or pathophysiologic to continue to assess its own disease risk and can be useful evidence; nonclinical suscepti- products on an ongoing basis. measures of the efficacy of a bility and pharmacokinetic data, Informed consent by patients new drug (such as low-density data from phase 2 clinical trials; in drug trials has traditionally lipoprotein cholesterol for statins). and such other confirmatory evi- been sacrosanct, with exceptions But though a drug’s effect on a dence as the secretary [of health made only when consent is im- biomarker can make approval and human services] determines possible to obtain or contrary to quicker and less costly, especially appropriate to approve the drug.” a patient’s best interests. But an- if the comparator is placebo, it Antimicrobials approved in this other clause in the proposed law may not always predict the drug’s manner would carry disclaimers adds a new kind of exception: capacity to improve patient out- on their labeling, but there is no studies in which “the proposed comes. Bevacizumab (Avastin) de- evidence that such a precaution clinical testing poses no more layed tumor progression in ad- would restrict prescribing to only than minimal risk” — a major vanced breast cancer but was the most appropriate patients. If departure from current human shown not to benefit patients. passed in its current form, the subject protections. It is not clear Similarly, rosiglitazone (Avandia) bill would also provide hospitals who gets to determine whether a lowered glycated hemoglobin with a financial bonus for ad- given trial of a new drug poses levels in patients with diabetes ministering costly new but un- “minimal risk.” 2 n engl j med nejm.org The New England Journal of Medicine Downloaded from nejm.org at PARTNERS HEALTHCARE on June 3, 2015. For personal use only. No other uses without permission. Copyright © 2015 Massachusetts Medical Society. All rights reserved. PERSPECTIVE The 21st Century Cures Act Embedded in the language of apeutic efficacy and risk. Patients 1. 21st Century Cures Act. May 19, 2015. (http://docs.house.gov/meetings/IF/IF00/ the 21st Century Cures Act are and physicians would not benefit 20150519/103516/BILLS-1146ih.pdf). some good ideas that could from legislation that instead of 2. Kesselheim AS, Tan YT, Avorn J. The roles streamline the development and catapulting us into the future, of academia, rare diseases, and repurposing in the development of the most transforma- evaluation of new drugs and de- could actually bring back some of tive drugs. Health Aff (Millwood) 2015;34: vices; its call for increased NIH the problems we thought we had 286-93. funding may prove to be its most left behind in the 20th century. 3. Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evi- Disclosure forms provided by the authors useful component. But political dence supporting FDA approval of novel are available with the full text of this article forces have also introduced other therapeutic agents, 2005-2012. JAMA 2014; at NEJM.org. provisions that could lead to the 311:368-77. 4. Avorn J. Approval of a tuberculosis drug From the Program on Regulation, Thera- approval of drugs and devices based on a paradoxical surrogate measure. peutics, and Law (PORTAL), Division of that are less safe or effective than JAMA 2013;309:1349-50. Pharmacoepidemiology and Pharmacoeco- 5. Dhruva SS, Bero LA, Redberg RF. Strength existing criteria would permit. nomics, Department of Medicine, Brigham of study evidence examined by the FDA in and Women’s Hospital and Harvard Medi- Over the past 80 years, this premarket approval of cardiovascular devic- cal School, Boston.
Load more

Recommended publications
  • 21St Century Cures Sign on Letter
    November 16, 2016 The Honorable Mitch McConnell The Honorable Harry Reid Majority Leader Minority Leader United States Senate United States Senate Washington, DC 20510 Washington, DC 20510 The Honorable Paul Ryan The Honorable Nancy Pelosi Speaker Minority Leader US House of Representatives US House of Representatives Washington, DC 20515 Washington, DC 20515 Dear Leader McConnell, Leader Reid, Speaker Ryan, and Leader Pelosi: 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 21st Century Cures Act and urge you to support and move this legislation forward by the end of 2016. This legislation, which passed the House in July 2015 with broad bipartisan support, will help deliver treatments and cures to people who desperately need them. It is based on thoughtful recommendations of the entire health community, and we thank the Energy and Commerce and Health, Education, Labor, and Pensions Committees for their tireless work to incorporate our feedback into the legislation. 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.
    [Show full text]
  • Public Health and Other Related Provisions in P.L 115-271, the SUPPORT for Patients and Communities Act
    Public Health and Other Related Provisions in P.L 115-271, the SUPPORT for Patients and Communities Act December 3, 2018 Congressional Research Service https://crsreports.congress.gov R45423 SUMMARY R45423 Public Health and Other Related Provisions in December 3, 2018 P.L 115-271, the SUPPORT for Patients and Elayne J. Heisler, Communities Act Coordinator Specialist in Health On October 24, 2018, President Donald J. Trump signed into law H.R. 6, the Substance Services Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (P.L. 115-271; the SUPPORT for Patients and Communities Act, or Johnathan H. Duff, the SUPPORT Act). Coordinator Analyst in Health Policy The SUPPORT Act is a sweeping measure designed to address widespread overprescribing and abuse of opioids in the United States. The act includes provisions For a copy of the full report, involving law enforcement, public health, and health care financing and coverage. please call 7-5700 or visit Broadly, the legislation imposes tighter oversight of opioid production and distribution; www.crs.gov. imposes additional reporting and safeguards to address fraud; and limits coverage of prescription opioids, while expanding coverage of and access to opioid addiction treatment services. The law also authorizes a number of programs that seek to expand consumer education on opioid use and train additional providers to treat individuals with opioid use disorders. The SUPPORT Act builds on recent efforts by the federal government to address the opioid epidemic, including the Comprehensive Addiction and Recovery Act of 2016 (CARA; P.L. 114-198) and the 21st Century Cures Act (Cures Act; P.L.
    [Show full text]
  • 21St Century Cures Act Understanding Sex- and Gender-Based Differences in Disease and Participation of Women in Clinical Research
    Exploring the Impact of the 21st Century Cures Act Understanding Sex- and Gender-Based Differences in Disease and Participation of Women in Clinical Research BRENDA HUNEYCUTT, EMILY ORTMAN, ANNA DEGARMO, SARAH WELLS KOCSIS, TANISHA CARINO, AND AMY MILLER MILKEN INSTITUTE EXPLORING THE IMPACT OF THE 21ST CENTURY CURES ACT 1 EXPLORING THE IMPACT OF THE 21ST CENTURY CURES ACT Understanding Sex- and Gender- Based Differences in Disease and Participation of Women in Clinical Research The Milken Institute recognizes the integral role of equality, diversity, and inclusion in driving shared prosperity. Our research and programmatic work reflect the value in all human talent and the right to build a meaningful life regardless of biological sex, gender, race, sexual orientation, or socioeconomic status. The Institute is committed to elevating these principles across industries, from finance and business to government and health care. Women are essential stakeholders in health care, serving as workers, caregivers, and consumers—yet they have not been afforded an equal voice in its leadership or research. This inequality is why the nonprofit Society for Women’s Health Research (SWHR) was founded in 1990 to ensure the appropriate inclusion of women in medical research at a time when they were intentionally excluded. Thanks in part to SWHR’s advocacy efforts, women are now routinely included in most clinical trials, and offices dedicated to women’s health exist across the federal government. SWHR has a long and successful history of encouraging investment in women’s health and urging researchers to consider sex as a biological variable to uncover differences between women and men in the prevention, diagnosis, and treatment of disease.
    [Show full text]
  • Twenty-Three States Reported Allowing Unenrolled Providers to Serve Medicaid Beneficiaries
    Other general comment U.S. Department of Health and Human Services Office of Inspector General Twenty-Three States Reported Allowing Unenrolled Providers To Serve Medicaid Beneficiaries OEI-05-19-00060 Christi A. Grimm March 2020 Principal Deputy Inspector General oig.hhs.gov Report in Brief U.S. Department of Health and Human Services March 2020 OEI-05-19-00060 Office of Inspector General Twenty-Three States Reported Allowing Why OIG Did This Review An effective provider enrollment Unenrolled Providers To Serve Medicaid process plays a vital role in Beneficiaries safeguarding Medicaid from Key Takeaway fraudulent and abusive providers. To What OIG Found The Medicaid program strengthen Medicaid provider We found that—contrary to Federal and its beneficiaries are enrollment, the Cures Act stipulated requirements—23 States had not enrolled all exposed to providers that that States must require all Medicaid providers serving Medicaid beneficiaries in have not been screened providers—both those in Medicaid their respective Medicaid programs, exposing by the States. FFS and Medicaid managed care—to them to potentially harmful providers that had enroll with their respective State not been screened for fraud, waste, and abuse. Medicaid agencies. The Cures Act These 23 States reported that they had not enrolled all providers in Medicaid mandated that OIG submit a report managed care or that they had not enrolled all ordering, referring, or to Congress—by March 31, 2020— prescribing (ORP) providers in Medicaid fee-for-service (FFS). that assesses the extent to which ➢ Twenty-one of the 23 States had not enrolled all providers in Medicaid States had enrolled all providers that managed care.
    [Show full text]
  • Bipartisanship in the 21St Century Cures Act in a Partisan Environment
    Bipartisanship in the 21st Century Cures Act In a partisan environment, what characteristics of political compromise lead to the passage of legislation? Courtney Scoufis Undergraduate Honors Thesis Sanford School of Public Policy Duke University Durham, NC December 2017 BIPARTISANSHIP IN THE 21ST CENTURY CURES ACT SCOUFIS 2 Acknowledgements This project would not be have been possible without the help of many people. Thank you to Julie Barnes-Weise for sparking my interest in pharmaceutical research and development my sophomore year through the Global Health Innovation Alliance Accelerator. I would also like to thank her for agreeing to be my thesis adviser and for her continuous support. I would like to thank Ken Rogerson for making what at first seemed like a daunting task doable and always helping me brainstorm my next steps. I would also like to thank Adam Hollowell for his encouragement and advice. Additionally, I would like to thank Jane Bahn for her help pulling committee reports. Thank you to my family, friends, and thesis companions for their support over the past year. Finally, thank you to the Sanford School of Public Policy for providing funding for this research. BIPARTISANSHIP IN THE 21ST CENTURY CURES ACT SCOUFIS 3 Table of Contents List of Tables …………………...………………………………………………....……...…...... 4 Abstract …………………...…………………………………………………....……………...... 5 Introduction ……..……………………………………………………………………………… 6 Literature Review …….……………………………………………………………………..…. 8 I. Bipartisanship ……………………………………………………………………… 8 II. Partisan Opinions
    [Show full text]
  • Encouraging Vaccine Innovation: Promoting the Development of Vaccines That Minimize the Burden of Infectious Diseases in the 21St Century Report to Congress
    Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century Report to Congress December 2017 U.S. Department of Health and Human Services Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century Table of Contents I. INTRODUCTION .................................................................................................................... 3 Summary .................................................................................................................................. 3 II. DEVELOPMENT OF THE REPORT ...................................................................................... 3 III. BACKGROUND .................................................................................................................... 4 IV. SCOPE OF THE REPORT ................................................................................................... 5 V. CURRENT STATUS OF VACCINE DEVELOPMENT ........................................................... 6 Small and Large Companies ................................................................................................... 7 Role of Federal Agencies ........................................................................................................ 8 National Institutes of Health (NIH) .............................................................................................. 8 Food and Drug Administration (FDA) ........................................................................................10
    [Show full text]
  • Sharing Data Under the 21St Century Cures Act
    © American College of Medical Genetics and Genomics REVIEW Sharing data under the 21st Century Cures Act Mary A. Majumder, JD, PhD1, Christi J. Guerrini, JD, MPH1, Juli M. Bollinger, MS1, Robert Cook-Deegan, MD2 and Amy L. McGuire, JD, PhD1 On 13 December 2016, President Obama signed the 21st Century “identifiable, sensitive” information and strengthens the associated Cures Act (“the Act”) into law. Many of its provisions support protections. At the same time, the Act exacerbates or neglects the creation of an “Information Commons,” an ecosystem of several challenges, for example, increasing complexity by adding a separate but interconnected initiatives that facilitate open and new definition of “identifiable” and failing to address the financial responsible sharing of genomic and other data for research and sustainability of data sharing and the scope of commercialization. clinical purposes. For example, the Act supports the National In sum, the Act is a positive step, yet there is still much work to be Institutes of Health in mandating data sharing, provides funding done before the goals of broad data sharing and utilization can be and guidance for the large national cohort program now known achieved. as All of Us, expresses congressional support for a global pediatric study network, and strengthens patient access to health Genet Med advance online publication 25 May 2017 information. The Act also addresses potential barriers to data sharing. For example, it makes the issuance of certificates of Key Words: 21st Century Cures Act; certificates of confidentiality automatic for federally funded research involving confidentiality; data sharing; HIPAA; privacy INTRODUCTION (see Table 1).
    [Show full text]
  • SAMHSA/HHS FY 2020 Justification of Estimates for Appropriations
    DEPARTMENT of HEALTH and HUMAN SERVICES Fiscal Year 2020 Substance Abuse and Mental Health Services Administration Justification of Estimates for Appropriations Committees Page intentionally left blank ii 5600 Fishers Lane • Rockville, MD 20857 www.samhsa.gov • 1-877-SAMHSA-7 (1-877-726-4727) Letter from the Assistant Secretary I am pleased to present the Substance Abuse and Mental Health Services Administration (SAMHSA) fiscal year (FY) 2020 Budget Request. SAMHSA is requesting a total of $5.6 billion. As the primary federal agency responsible for addressing the mental and substance use disorders that affect millions of Americans, SAMHSA takes seriously its responsibility to ensure that the best, most evidence-based care is reaching all communities in our nation. Now, more than ever, we must ensure individuals living with these conditions gain access to high quality prevention, treatment, and recovery services. Consistent with the goals of the 21st Century Cures Act, SAMHSA's budget demonstrates a commitment to addressing pressing public health challenges, including the opioids crisis and serious mental illness (SMI). This budget aligns with the Administration’s priorities to address mental and substance use issues for children, adults, families, and communities. Through a sustained focus on implementing evidence-based practices, SAMHSA's budget aims to improve the lives of people across the country. SAMHSA’s FY 2020 budget request includes investments to: • Expand access to care for opioid use disorders (OUD) through continued investment
    [Show full text]
  • East Meets West
    News February 2, 2016 HEALTH CARE POLICY OUTLOOK FOR 2016 In 2016, the Affordable Care Act will continue to be a contentious issue involving opposing legislative efforts and presidential debates. Clients and industries affected by health care regulations can, however, expect the emphasis of this debate to shift this year. Brownstein Hyatt Farber Schreck’s Health Care Outlook for 2016 provides insight on what to expect. Topics: Presidential Campaigns The Cost of Prescription Drugs The ACA: Repeal or Embrace? CMS and Reimbursement-Related Activities FDA-Related Issues Other Health-Related Topics Presidential Campaigns; Candidates’ Positions on Health Care System Since the presidential election of 2012, many of the major provisions of the Affordable Care Act (ACA) have taken effect. Of the people who were not covered by health insurance when President Obama was elected to his second term, an estimated 20 million now have coverage through the ACA, either through Medicaid or through state exchanges. The positions of the two parties on the ACA are well known. The administration will likely spend 2016 defending “Obamacare” and marketing its accomplishments so that continuing and expanding the ACA will be part of the message of the Democratic candidates for president. Conversely, Republican candidates will likely endorse the repeal efforts and some of the replacement proposals introduced by the Republican-led Congress. Currently, the leading candidates in both parties have started to outline their health care positions as they prepare for debates in the 2016 election. Both former Secretary of State Hillary Clinton and Sen. Bernie Sanders have made health care a central component of their campaigns early.
    [Show full text]
  • Ohio's Response to 21St Century Cures Act in Addressing the Opioid Crisis: a Targeted Response Initiative, November 2017 – April 2019, Follow-Up Assessment
    OSAM Ohio Substance Abuse Monitoring Network Ohio’s Response to 21st Century Cures Act in Addressing the Opioid Crisis: A Targeted Response Initiative, November 2017 – April 2019 Follow-up Assessment May 2020 Mike DeWine, Governor Lori Criss, Director Prepared by: Ohio Department of Mental Health and Addiction Services Office of Quality, Planning and Research Ohio Substance Abuse Monitoring (OSAM) Network OSAM Research Administrators: R. Thomas Sherba, PhD, MPH, LPCC — OSAM Principal Investigator Sarah Balser, MPH, MSW, LSW, CHES — OSAM Coordinator Jessica Linley, PhD, MSW, LSW — OSAM Quantitative Data Analyst OSAM Regional Epidemiologists: Gretchen Clark-Hammond, PhD, MSW, LSW, LCDCIII, TTS Louis Guardiola, Jr., MSW, LSW, LICDC-CS Jennifer Olejownik, PhD Alycia Taylor, MPA Jennifer Tulli, MSW, LISW-S, LCDC III Acknowledgments: We would like to acknowledge the OSAM Regional Epidemiologists listed above for their efforts to this study in data collection and data organization. We would also like to acknowledge Donna Baker, BA, Kathleen Gallant, BA, Mandy McGlone, MS, LCDC III, OCPS II, TTS and Alina Sharafutdinova, BS for their assistance in data collection. Recommended citation for this report: Ohio Department of Mental Health and Addiction Services [OhioMHAS]. (2020). Ohio Substance Abuse Monitoring (OSAM) Network. Ohio's Response to 21st Century Cures Act in Addressing the Opioid Crisis: A Targeted Response Initiative, November 2017 – April 2019, Follow-up Assessment. Columbus, OH. Ohio Substance Abuse Monitoring Network TARGETED RESPONSE
    [Show full text]
  • 21St Century Cures Act
    L:\XML\CPRT-114-HPRT-RU00-HR6.XML JULY 2, 2015 RULES COMMITTEE PRINT 114-22 TEXT OF H.R. 6, 21ST CENTURY CURES ACT [Showing text based on H.R. 6 as ordered reported by the Committee on Energy and Commerce.] 1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 2 (a) SHORT TITLE.—This Act may be cited as the 3 ‘‘21st Century Cures Act’’. 4 (b) TABLE OF CONTENTS.—The table of contents for 5 this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. NIH and Cures Innovation Fund. TITLE I—DISCOVERY Subtitle A—National Institutes of Health Funding Sec. 1001. National Institutes of Health reauthorization. Subtitle B—National Institutes of Health Planning and Administration Sec. 1021. NIH research strategic plan. Sec. 1022. Increasing accountability at the National Institutes of Health. Sec. 1023. Reducing administrative burdens of researchers. Sec. 1024. Exemption for the National Institutes of Health from the Paper- work Reduction Act requirements. Sec. 1025. NIH travel. Sec. 1026. Other transactions authority. Sec. 1027. NCATS phase IIB restriction. Sec. 1028. High-risk, high-reward research. Sec. 1029. Sense of Congress on increased inclusion of underrepresented com- munities in clinical trials. Subtitle C—Supporting Young Emerging Scientists Sec. 1041. Improvement of loan repayment programs of the National Institutes of Health. Sec. 1042. Report. Subtitle D—Capstone Grant Program Sec. 1061. Capstone award. L:\vr\070215\R070215.001.xml July 2, 2015 (11:47 a.m.) VerDate Nov 24 2008 11:47 Jul 02, 2015 Jkt 000000 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 C:\USERS\MCHINN\APPDATA\ROAMING\SOFTQUAD\XMETAL\7.0\GEN\C\CPRT-114-HPR L:\XML\CPRT-114-HPRT-RU00-HR6.XML 2 Subtitle E—Promoting Pediatric Research Through the National Institutes of Health Sec.
    [Show full text]
  • The 21St Century Cures Act
    H.R. 6: The 21st Century Cures Act Judith A. Johnson, Coordinator Specialist in Biomedical Policy Susan Thaul, Coordinator Specialist in Drug Safety and Effectiveness Erin Bagalman, Coordinator Analyst in Health Policy August 10, 2015 Congressional Research Service 7-5700 www.crs.gov R44071 H.R. 6: The 21st Century Cures Act Summary On July 10, 2015, the House passed H.R. 6, the 21st Century Cures Act, on a vote of 344 to 77. Eight amendments were offered; five were approved by voice vote, two failed by recorded vote, and one was withdrawn. The House Energy and Commerce Committee, on May 21, 2015, unanimously ordered to be reported H.R. 6 and the House Committee on Rules published a committee print of the bill on July 2, 2015. On July 7, 2015, H.R. 6 was reported by the Committee on Energy and Commerce (H.Rept. 114-190), and the House Committee on Ways and Means was discharged from further consideration of the bill. The bill would reauthorize the National Institutes of Health (NIH) through FY2018 and provide other funding to the agency through FY2020. In addition, the bill would promote and encourage more strategic planning for research conducted by NIH; change loan support for young, emerging scientists; promote pediatric research; and encourage more collaborative research activities. The bill also focuses on changes to the Food and Drug Administration’s (FDA’s) regulatory procedures for drugs and devices by requiring the issuance of more guidance and increasing regulatory flexibility in areas such as precision (or personalized) medicine, types of data that could serve as evidence of safety and effectiveness, antibiotic drug development, orphan drugs, and medical devices.
    [Show full text]