BOARD OF SUPERVISORS BUSINESS MEETING ACTION ITEM Date of Meeting: January 19, 2017 # 7 SUBJECT: ELECTION DISTRICT: Lyme Disease Commission Recommendation on Composition of the 21 st Century Cures Act s Proposed Tick-Borne Diseases Working Group Countywide CRITICAL ACTION DATE: January 19, 2017 STAFF CONTACT: Dr. David Goodfriend, Health Department ADVISORY BOARD CONTACT: Dr. Samuel Shor, Lyme Disease Commission PURPOSE: The purpose of this item is for the Board of Supervisors (Board) to consider the request from the Loudoun Lyme Disease Commission to endorse their recommendation that the Tick-Borne Diseases Working Group in the proposed Federal legislation known as the 21st Century Cures Act include specific clinician representatives from both the IDSA (Infectious Diseases Society of America) and ILADS (International Lyme and Associated Diseases Society). RECOMMENDATIONS: Loudoun Lyme Disease Commission: At its meeting on December 9, 2016, the Loudoun Lyme Disease Commission unanimously passed the following motion: The Loudoun County Lyme Commission would support the inclusion of clinician representatives of both the IDSA (Infectious Diseases Society of America) and ILADS (International Lyme and Associated Diseases Society) in the Tick-Borne Diseases Working Group as established by the 21st Century Cures Act. Staff: Staff supports the Loudoun Lyme Disease Commission s recommendation. BACKGROUND: On May 19, 2015, United States House of Representatives (House) Resolution 6, titled 21 st Century Cure Act, was introduced in the House. It passed the House on July 10, 2015; a revised version of this Act passed Congress on December 7, 2016 and was signed into law on December 13, 2016. The stated purpose of this act is to accelerate the discovery, development, and delivery of 21st century cures. (available online at 21st Century Cures Act - SEC.2062. Tick-Borne Diseases)
Item 7, Board Endorsement of Lyme Disease Commission Recommendation Board of Supervisors Business Meeting January 19, 2017 Page 2 Section 2062 of this Act (Attachment 1) would require the United States Department of Health and Human Services (HHS) to establish a Tick-Borne Diseases Working Group comprised of seven Federal Government members representing at least the following agencies: (1) the Office of the Assistant Secretary for Health, (2) the Food and Drug Administration, (3) the Centers for Disease Control and Prevention, and (4) the National Institutes of Health. Seven non-federal public members, representing a diversity of scientific disciplines and views, would also serve on the Working Group and be selected from the following categories: (1) Physicians and other medical providers with experience in diagnosing and treating tick-borne diseases, (2) scientists or researchers with expertise, (3) patients and their family members, (4) nonprofit organizations that advocate for patients with respect to tick-borne diseases, and (5) other individuals whose expertise is determined by the HHS Secretary to be beneficial to the functioning of the Working Group. ISSUES: 1. The Infectious Diseases Society of America (IDSA) states that it represents physicians, scientists and other health care professionals who specialize in infectious diseases. IDSA s purpose is to improve the health of individuals, communities, and society by promoting excellence in patient care, education, research, public health, and prevention relating to infectious diseases. The IDSA has established guidelines on the diagnosis and treatment of Lyme disease, available online at https://www.idsociety.org/lyme/. The International Lyme and Associated Diseases Society (ILADS) states that it is a nonprofit, international, multidisciplinary medical society dedicated to the appropriate diagnosis and treatment of Lyme and associated diseases. ILADS promotes understanding of Lyme and associated diseases through research, education and policy, and strongly support physicians, scientists, researchers and other healthcare professionals dedicated to advancing the standard of care for Lyme and associated diseases. ILADS has also established treatment guidelines for Lyme disease, available online at http://www.ilads.org/lyme/treatment-guideline.php. There are differences between the IDSA and ILADS treatment guidelines for Lyme disease, particularly with respect to the efficacy of using long term antibiotic therapy. While the 21 st Century Cures Act addresses the need to have clinicians with experience in diagnosing and treating tick-borne diseases, such as Lyme, and a diversity of scientific disciplines and views on the Working Group, it does not specify from where those non- Federal members must be selected. 2. It should be noted that the Chair of the Loudoun Lyme Disease Commission also currently serves as President of ILADS, which he disclosed to the Lyme Disease Commission prior to their vote on this motion. FISCAL IMPACT: There is no fiscal impact associated with this action.
Item 7, Board Endorsement of Lyme Disease Commission Recommendation Board of Supervisors Business Meeting January 19, 2017 Page 3 ALTERNATIVES: 1. The Board may choose to endorse the Loudoun Lyme Disease Commission s motion to have the Working Group include clinician representatives of both the IDSA (Infectious Diseases Society of America) and ILADS (International Lyme and Associated Diseases Society). 2. The Board may choose not to endorse the Loudoun Lyme Disease Commission s motion to have the Working Group include clinician representatives of both the IDSA and ILADS. DRAFT MOTIONS: 1. I move that the Board of Supervisors endorse the Loudoun Lyme Disease Commission motion to support the inclusion of clinician representatives of both the IDSA (Infectious Diseases Society of America) and ILADS (International Lyme and Associated Diseases Society) in the Tick-Borne Diseases Working Group as established by the 21st Century Cures Act. OR 2. I move that the Board of Supervisors NOT endorse the Loudoun Lyme Disease Commission motion to support the inclusion of clinician representatives of both the IDSA (Infectious Diseases Society of America) and ILADS (International Lyme and Associated Diseases Society) in the Tick-Borne Diseases Working Group as established by the 21st Century Cures Act. OR 3. I move an alternate motion. ATTACHMENT: 1. Section 2062 of the 21 st Century Cures Act
SEC. 2062. Tick-borne diseases. Section 2062 of the 21 st Century Cures Act (a) In general. The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall continue to conduct or support epidemiological, basic, translational, and clinical research related to vector-borne diseases, including tick-borne diseases. (b) Reports. The Secretary shall ensure that each triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032) includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to tick-borne diseases. (c) Tick-borne diseases working group. (1) ESTABLISHMENT. The Secretary shall establish a working group, to be known as the Tick-Borne Disease Working Group (referred to in this section as the Working Group ), comprised of representatives of appropriate Federal agencies and other non-federal entities, to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities. (2) RESPONSIBILITIES. The working group shall (A) not later than 2 years after the date of enactment of this Act, develop or update a summary of (i) ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases; (ii) advances made pursuant to such research; (iii) Federal activities related to tick-borne diseases, including (I) epidemiological activities related to tick-borne diseases; and (II) basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases; (iv) gaps in tick-borne disease research described in clause (iii)(ii); (v) the Working Group s meetings required under paragraph (4); and (vi) the comments received by the Working Group; Attachment 1
(B) make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and (C) solicit input from States, localities, and nongovernmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms. (3) MEMBERSHIP. The members of the working group shall represent a diversity of scientific disciplines and views and shall be composed of the following members: (A) FEDERAL MEMBERS. Seven Federal members, consisting of one or more representatives of each of the following: (i) The Office of the Assistant Secretary for Health. (ii) The Food and Drug Administration. (iii) The Centers for Disease Control and Prevention. (iv) The National Institutes of Health. (v) Such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate. (B) NON FEDERAL PUBLIC MEMBERS. Seven non Federal public members, consisting of representatives of the following categories: (i) Physicians and other medical providers with experience in diagnosing and treating tick-borne diseases. (ii) Scientists or researchers with expertise. (iii) Patients and their family members. (iv) Nonprofit organizations that advocate for patients with respect to tick-borne diseases. (v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group. (4) MEETINGS. The Working Group shall meet not less than twice each year. (5) REPORTING. Not later than 2 years after the date of enactment of this Act, and every 2 years thereafter until termination of the Working Group pursuant to paragraph (7), the Working Group shall
(A) submit a report on its activities under paragraph (2)(A) and any recommendations under paragraph (2)(B) to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate; and (B) make such report publicly available on the Internet website of the Department of Health and Human Services. (6) APPLICABILITY OF FACA. The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act (5 U.S.C. App.). (7) SUNSET. The Working Group under this section shall terminate 6 years after the date of enactment of this Act.