Healthcare Week in Review November 3, 2017

Alston & Bird Healthcare Week in Review, November 3, 2017

I. Regulations, Notices, & Guidance

Event Notices
  • October 30, 2017: The NIH announced a meeting of the Frederick National laboratory Advisory Committee to the National Cancer Institute. The agenda includes a discussion of ongoing and new activities at the Frederick National Laboratory for Cancer Research.
  • October 31, 2017: The FDA announced a public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss NDA 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence.
  • November 1, 2017: HHS announced that the Office of Disease Prevention and Health Promotion (ODPHP) is hosting a listening session entitled, Partnering to Prevent Hypoglycemia. The purpose of this listening session is to exchange information about the public health importance of hypoglycemia, and discuss federal efforts to reduce preventable hypoglycemia from diabetes medications.
  • November 2-3, 2017: the NIH announced the Center for Scientific Review Special Emphasis Panel will hold a closed meeting to review and evaluate grant applications.
  • November 3, 2017: HHS announced that the Agency for Healthcare Research and Quality (AHRQ) will hold a public meeting in accordance with section 10(a) of the Federal Advisory Committee Act. The purpose on the meeting is to advise the HHS Secretary and the Director of AHRQ to conduct its mission including providing guidance on priorities for health care research, the field of health care research including training needs and information dissemination on health care quality.
  • November 6 – 7, 2017: The FDA announced a public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). On November 6, 2017, the SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Systems Biology Subcommittee and the Subcommittee Site Visit Report and a response to this review. There will be updates from the NCTR Research Divisions and a public comment session. On November 7, 2017, the Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Tobacco Products, Center for Veterinary Medicine, and the Office of Regulatory Affairs will each briefly discuss their center-specific research strategic needs and potential areas of collaboration.
  • November 12-14: The National Institute of Environmental Health Sciences issued a notice of meeting. The meeting will cover AHRQ’s current research, programs, and initiatives and also include an update on work in learning health care systems and an update on AHRQ’s data platform.
  • November 16, 2017: The FDA announced a public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (≥18 years of age) with respiratory bacterial pathogens.
  • November 30, 2017: The FDA announced a public meeting entitled, Assessment of FDA Hiring and Retention. The purpose of the meeting is to share findings from a recently completed assessment of FDA’s hiring process. The meeting will also outline near-term actions FDA will take to improve the hiring process, an update on the Prescription Drug User Fee Act (PDUFA) and Biosimilar User Fee Act hiring and retention commitments, and to solicit input on FDA hiring processes.
  • December 4-5, 2017: The NIH announced meetings of the Eunice Kennedy Shriver National Institute of Child Health and Human Development committee of the National Advisory Board on Medical Rehabilitation Research. The meetings will cover a variety updates and reports conducted regarding rehabilitation research.
  • December 5, 2017: The NIH announced a meeting of the Muscular Dystrophy Coordinating Committee. The purpose of the meeting is to bring together the Committee members to update one another on progress relevant to the Action Plan for the Muscular Dystrophies.
  • December 5, 2017: The Federal Advisory Committee on Minority Health announced it will hold a meeting conducted via telephone conference call. The topics to be discussed during the teleconference include finalizing recommendations regarding improving access and quality of data related to the opioid usage and health disparities. The finalized recommendations will be given to the Deputy Assistant Secretary for Minority Health.
  • December 11, 2017: The CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). The agenda will include discussion on 1) update on preliminary tuberculosis funding formula; 2) update on whole genome sequencing data sharing plan; and 3) an update on the three-month Isoniazid/Rifapentine regime guidelines.
  • December 11-12, 2017: On October 30, 2017, the FDA announced a public workshop entitled, Packaging, Storage, and Disposal Options to Enhance Opioid Safety - Exploring the Path Forward; Public Workshop; Request for Comments. The workshop will host a scientific discussion with experts and seek input from interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products.
  • December 18, 2017: The FDA announced a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA may be used to inform regulatory decision making. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act.

II. Congressional Legislation & Committee Action

U.S. Senate  
  • On October 31, 2017, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, Implementation of the 21st Century Cures Act: Achieving the Promise of Health Information TechnologyThe witnesses included Jon White, Deputy National Coordinator for Health Information Technology at HHS; Kate Goodrich, Director of the Center For Clinical Standard and Quality And Chief Medical Officer at CMS; James Cannatti, Senior Counselor For Health Information Technology in the HHS OIG.
House of Representatives
  • On November 3, 2017, the House of Representatives passed H.R. 3922, the CHAMPION Act, which would extend funding for the Children’s Health Insurance Program (CHIP) for five years and Community Health Centers for two years. The bill was approved a 242-174
III. Reports, Studies, & Analyses
  • On October 27, 2017 the Congressional Budget Office (CBO) released its report on R. 849, Protecting Seniors’ Access to Medicare Act. H.R. 849 would repeal provisions of the Affordable Care Act (ACA) that established the Independent Payment Advisory Board (IPAB). The CBO estimates that enacting H.R. 849 would increase direct spending by $17.5 billion over the 2018-2027 period.
  • On October 30, 2017, the Government Accountability Office (GAO) released a report entitled, Opioid Use Disorders: HHS Needs Measures to Assess the Effectiveness of Efforts to Expand Access to Medication-Assisted Treatment (MAT). The report recommends that HHS take two actions: (1) establish performance measures with targets related to expanding access to MAT, and (2) establish timeframes for its evaluation of its efforts to expand access to MAT.
  • On November 1, 2017 the President’s Commission on Combating Drug Addiction and the Opioid Crisis released its recommendations. The report provides recommendations to: consolidate federal funding; prioritize opioid addiction prevention strategies; provide for full-spectrum opioid addiction treatment; and improve research and development for pain management and addiction research.

Iv. Other Health Policy News

  • The Medicare Payment and Advisory Commission (MedPAC) held its November meetings this week. The sessions covered a wide-range of topics including finding alternatives to the Merit-based Incentive Payment System. MedPAC’s agenda can be accessed here.
  • On November 1, 2017, the House Majority Leader Kevin McCarthy released the 2018 Congressional calendar.
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