Healthcare Week in Review June 24, 2017

Alston & Bird Healthcare Week in Review, June 24, 2017

I. Regulations, Notices, & Guidance

Event Notices
  • July 18, 2017: The National Institutes of Health (NIH) announced a meeting of the Office of AIDS Research Advisory Council. The Council will discuss OAR Director’s Report; Update on NIH Activities; OAR Task Force on Cost Sharing; OAR Task Force on Implementation and Behavioral and Social Science Research.
  • July 18, 2017: The FDA announced a public meeting entitled, The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access. The public meeting is intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.
  • July 19, 2017: The FDA announced a public workshop regarding scientific and clinical trial design considerations for the development of new tuberculosis (TB) treatment regimens. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders regarding scientific and clinical trial design considerations related to the development of new TB regimens.
  • September 11, 2017: The FDA announced public meeting on “Patient-Focused Drug Development for Alopecia Areata.” The FDA will post the agenda approximately 5 days before the meeting here.

II. Congressional Legislation & Committee Action

U.S. Senate  
  • On June 20, 2017, the Senate Appropriations Agriculture, Rural Development, FDA, and Related Agencies Subcommittee held a hearing on the FY 2018 FDA proposed budget. The sole witness is Dr. Scott Gottlieb, FDA Commissioner.
  • On June 21, 2017, the Senate Appropriations Military Construction, Veterans Affairs and Related Agencies Subcommittee held a hearing on the FY 2018 and FY 2019 VA budget. The sole witnesses was VA Secretary, Dr. David Shulkin.
  • On June 22, 2017, the Senate Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee held a hearing on the FY 2017 National Institutes of Health (NIH) proposed budget. The witnesses included Dr. Francis Collins, Director, NIH; Dr. Anthony Fauci, Director of NIH’s National Institute of Allergy and Infectious Diseases; Dr. Gary Gibbons, Director of NIH’s National Heart, Lung and Blood Institute; Dr. Joshua Gordon, Director of NIH’s National Institute of Mental Health; Dr. Doug Lowy, Acting Director of NIH’s National Cancer Institute (NCI); and Dr. Nora Volkow, Director of NIH’s National Institute of Drug Abuse.
House of Representatives
  • On June 21, 2017, the House Natural Resources Indian, Insular and Alaska Native Affairs Subcommittee held a hearing on H.R. 2662, the “Restoring Accountability in the Indian Health Service Act of 2017." The witnesses included  Rear Admiral Chris Buchanan, Assistant Surgeon General, SUPHS, Deputy Director, Indian Health Service; The Honorable William Bear Shield, Chairman, Rosebud Sioux Tribal Health Board; The Honorable Andy Joseph, Business Council Member, Confederated Tribes of the Colville Reservation; Mr. Robert TwoBears, District 5 Representative, Ho-Chunk Nation Legislature; and Ms. Victoria Kitcheyan, Great Plains Area Representative, National Indian Health Board.
  • On June 22, 2017, the House Veterans’ Affairs Health Subcommittee held a hearing on the FY 2018 Department of Veterans Affairs Budget Request for the Veterans Health Administration. The witnesses included Joy Ilem, National Legislative Director, Disabled American Veterans (DAV); Carl Blake, Associate Executive Director of Government Relations, Paralyzed Veterans of America (PVA); Carlos Fuentes, Director, National Legislative Service, Veterans of Foreign Wars (VFW); Matthew Shuman, Director, Legislative Division, The American Legion (American Legion); and Dr. Poonam Alaigh, Acting Under Secretary for Health, VHA, VA.
  • On June 23, 2017, the House Energy & Commerce Health Subcommittee held a hearing entitled, Examining the Extension of Safety Net Health Programs. The witnesses included Mr. Michael Holmes, Chief Executive Officer, Cook Area Health Services; Cindy Mann, Partner Manatt Health; and Ms. Jami Snyder, Associate Commissioner for Medicaid/SCHIP Services, State of Texas, Health and Human Services Commission.
III. Reports, Studies, & Analyses

IV. Other Health Policy News

  • The Congressional Budget Office (CBO) expects to have a cost estimate on the Senate’s version of the American Health Care Act (AHCA) early next week. The press release can be found here.

V. ACA Repeal News

  • On June 22, 2017, the Senate released a discussion draft of its version of the AHCA, the Better Care Reconciliation Act of 2017 (BCRA). It is expected this draft may change somewhat over the next few days as the Senate GOP works to gain the required votes. A copy of the discussion draft can be found here.
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