The following is the A&B Healthcare Week In Review for the week ending November 22, 2017.
I. Regulations, Notices, & Guidance
- On November 20, 2017, the Department of Health and Human Services (HHS) issued a notice entitled, Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2018 through September 30, 2019. The notice announces the calculated Federal Medical Assistance Percentages (FMAP) rates for Fiscal Year (FY) 2019 pursuant to the Social Security Act. The notice also reminds states of available disaster-recovery FMAP adjustments for qualifying states.
- On November 21, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Tobacco Product Manufacturing Practice; Request for Comments. The FDA is requesting public input on updated recommendations for regulations on good manufacturing practice for electronic nicotine delivery systems that were submitted to the FDA by a group of 13 tobacco companies. The FDA is providing an opportunity for interested parties to comment on the tobacco companies’ recommendations.
- On November 21, 2017, the FDA issued a guidance entitled, General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products; Guidance for Industry; Availability. The guidance is intended to assist people who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic version of a solid oral opioid drug product that references an opioid drug product with abuse-deterrent properties described in its labeling. The guidance recommends studies that a potential ANDA applicant should conduct and submit to FDA to demonstrate that a generic solid oral opioid drug product is no less abuse deterrent than its reference listed drug with respect to all potential routes of abuse.
- November 28, 2017: The National institutes of Health (NIH) announced a public meeting of the National Cancer Institute Board of Scientific Advisors and the National Cancer Advisory Board (NCAB). The meeting will discuss global cancer research and epidemiology population science.
- 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.
- November 30-December 1, 2017: The FDA announced a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. On November 30, the Committee will meet in open session to discuss bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. On December 1, 2017, the Committee will meet in open session to discuss strategies to reduce the risk of transfusion-transmitted Zika virus.
- 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 receive an update 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 5-6, 2017: The NIH announced it will host a public workshop about Methods for Evaluating Experiments in Obesity. The workshop seeks to discuss, among other things, population-based data sources that have been used in studies for obesity prevention and control.
- December 7, 2017: The HHS announced a public meeting of the National Preparedness and Response Science Board (NPRSB). Pursuant to the Public Health Service Act, the NPRSB can provide advice and guidance to the HHS Secretary and/or the Assistant Secretary for Preparedness and Response (ASPR) on other matters related to public health emergencies. The meeting will deliberate and vote on the future of the NPRSB Work Group Draft Letter to the ASPR.
- December 7-8, 2017: The NIH announced the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC is a federally chartered external advisory group composed of scientists from the public and private sector. The BSC will provide input to the NTP on programmatic activities and issues. The meeting is open to the public.
- December 7-8, 2017: The NIH announced a public meeting of the Sleep Disorders Research Advisory Board. The meeting will evaluate sleep and circadian research activities and discuss plans for the proposed revision of the NIH Sleep Disorders Research Plan and potential opportunities for the inter-agency coordination activities.
- December 8, 2017: The Health resources and Services Administration (HRSA) announced a meeting for the Advisory Commission on Childhood Vaccines (ACCV). The ACCV agenda items include a review of petitions to add injuries to the vaccine injury table, and updates from the Department of Justice, CDC, and FDA.
- December 11, 2017: The Center for Disease Control and Prevention (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, 2017: The HHS announced the next meeting of the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objections for 2030. The Committee will advise the Secretary on the Healthy People 2030 mission, vision, framework, and organizational structure.
- December 11-12, 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 15, 2017: The FDA announced a public workshop entitled, Medical Gas Regulation Workshop I.” The topic to be discussed is potential areas of federal drug regulation that should be revised with respect to medical gases.
- 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.
- December 18-20, 2017: The Department of Health and Human Services (HHS) announced the next meeting of the Physician-Focused Payment Model Technical Advisory Committee which will be held in Washington, D.C. The meeting will include voting and deliberations on proposals for physician-focused payment models (PFPMs) submitted by members of the public. All meetings are open to the public.
- January 10, 2018: the FDA announced a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the agency on FDA’s regulatory issues. The meeting will be open to the public.
- January 11-12, 2018: The CDC announced a public meeting for the Board of Scientific Counselors (BSC) and the National Center for Health Statistics (BSC, NCHS). The meeting will provide an update on the National Health and Nutrition Examination Survey Reports and activities; provide an update on the Division of Health Care Statistics Reports and Activities; provide an update on vital statistics activities; and an update on the international activities of the NCHS.
- January 24, 2018: The FDA announced a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC). The general function of the TPSAC is to provide advice and recommendations to the FDA’s regulatory issues. The TPSAC will discuss modified risk tobacco product applications submitted by tobacco companies. The FDA intends to make background material available to the public no later than two business days before the meeting.
- January 24, 2018: The NIH announced a meeting to review the Draft Report on Carcinogens (RoC) Monograph on Antimony Trioxide. The RoC is a congressionally mandated report that identifies agents, substances, mixtures, or exposures in the environment that pose a cancer hazard for people in the United States.
- February 9, 2018: The FDA announced a public workshop entitled, Medical gas Regulation Workshop II.” The topic to be discussed is potential areas of federal drug regulation that should be revised with respect to medical gases.
II. Congressional Legislation & Committee ActionU.S. Senate
- There were no health care-related hearings.
- There were no health care-related hearings.
- On November 21, 2017, the Journal of the American Medical Association (JAMA) published a research letter entitled Trends in Emergency Department Visits for nonfatal Self-inflicted Injuries Among Youth Aged 10 to 24 Years in the United States, 2001-2015. The study examines trends in nonfatal self-inflicted injuries in hospital EDs among children, adolescents, and young adults aged 10 to 24 years old.
Iv. Other Health Policy News
- On November 21, 2017, Senator Lisa Murkowski (R-AK) says she supports efforts to repeal the Affordable Care Act’s individual mandate.
- On November 30, 2017, the Senate Health Subcommittee of the House Energy and Commerce Committee will hold a hearing on “Implementing the 21st Century Cures Act: An Update from FDA and NIH.”
- Breaking the Myth: eating turkey does not make you sleepy! More information can be found here.