General Publications November 16, 2018

Alston & Bird Healthcare Week in Review, November 16, 2018

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   

  • November 27, 2018: The FDA announced a public meeting entitled, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions. The purpose of the hearing is to give stakeholders the opportunity to provide input on the underlying systemic causes of drug shortages and make recommendations for actions to prevent or mitigate drug shortages.
  • December 5, 2018: The FDA announced a public hearing to discuss its efforts to eliminate youth electronic cigarette use as well as other tobacco use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies.
  • December 5-6, 2018: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Board of Scientific Counselors, Office of Infectious Diseases (BSC OID).  The BSC OID will hear updates from the infectious disease national centers and discuss recent outbreaks and affected populations.
  • December 11, 2018: The FDA announced a public meeting entitled, Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI. The meeting is intended to fulfill commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) and the 21st Century Cures Act (Cures Act) by soliciting comments on Drug Development Tool Qualification at FDA related to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act); discussing taxonomy for biomarkers and related concepts used in drug development; and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use.

II. Congressional Legislation & Committee Action

U.S. Senate

  • There were no health-related hearings this week.

House of Representatives

  • There were no health-related hearings this week.

III. Reports, Studies, & Analyses

IV. Other Health Policy News

  • On November 13, 2018, the Centers for Medicare & Medicaid Services (CMS) sent a letter to State Medicaid Directors regarding opportunities to design service delivery systems for adults with a serious mental illness or children with a serious emotional disturbance. The letter outlines existing and new opportunities for states to utilize institutions for mental diseases (IMDs) for these patients using section 1115 waiver authority. The letter is available here.
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