Healthcare Week in Review March 15, 2019

Alston & Bird Healthcare Week in Review, March 15, 2019

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news.

I. Regulations, Notices, & Guidance

Event Notices   

  • March 22, 2019: The FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will discuss and make recommendations on the H3N2 seasonal influenza strain. The World Health Organization recommended the strain for inclusion in the 2019-2020 seasonal influenza vaccines.
  • April 2-3, 2019: The Health Resources and Service Administration (HRSA) announced a meeting of the National Advisory Council on the National Health Service Corps (NHSC). No agenda has been posted but the Council is expected to make recommendations on the NHSC.
  • April 10, 2019: The FDA announced a public meeting entitled, Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards. The purpose of the meeting is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission systems’ past performance, future targets, emerging industry needs and technology initiatives.
  • April 29, 2019: The FDA announced a public meeting entitled, Perspectives on the Impact of Rare Diseases: Bridging the Commonalities. The meeting is intended to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to asses commonalities that may help the FDA and medical product developers further understand and advance the development of treatments for rare diseases.

II. Congressional Legislation & Committee Action

U.S. Senate

House of Representatives

  • On March 12, 2019, the House Energy and Commerce Committee held a hearing entitled, The Fiscal Year 2020 HHS Budget. HHS Secretary Alex Azar testified.
  • On March 12, 2019, The House Committee on Oversight and Reform held a hearing entitled, Examining the Public Health Risks of Carcinogens in Consumer Products.  Witnesses included: Ann McTiernan, MD, Fred Hutchinson Cancer Research Center; Scott Faber, Vice President of Government Affairs, Environmental Working Group; and Marvin Salter, Son Deceased Ovarian Cancer Patient.
  • On March 13, 2019, The House Energy and Commerce Subcommittee on Health held a hearing entitled, Lowering the Cost of Prescription Drugs: Reducing Barriers to Market Competition. The witnesses included: Lou Kennedy CEO and Owner, Nephron Pharmaceuticals; Anthony Barrueta, Senior Vice President, Government Relations, Kaiser Permanente; Michael Carrier, Professor, Rutgers Law School; Kurt Karst, Director, Hyman, Phelps & McNamara; Jeff Kushan, Partner, Sidley Austin;  Marc Boutin, CEO, National Health Council; and Chester Davis, President and CEO, Association for Accessible Medicines.
  • March 13, 2019, the House Appropriations Committee held a hearing entitled, Department of Health and Human Services Budget Request for FY 2020. HHS Secretary Alex Azar testified.

III. Reports, Studies, & Analyses

IV. Other Health Policy News

  • On March 12, 2019, HHS released the fiscal year 2020 HHS Budget. The document is available here.
  • On March 15, 2019, the Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC) issued their 2019 March reports to Congress. The MedPAC report is available here. The MACPAC report is available here.
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