General Publications September 28, 2018

Alston & Bird Healthcare Week in Review, September 28, 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

  • On September 25, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities. This guidance sets forth FDA’s policy regarding compounding and repackaging of radiopharmaceuticals for human use by entities that are registered with FDA as outsourcing facilities. This guidance describes how FDA generally intends to apply section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions under which FDA generally does not intend to take action for violations of certain provisions of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals.
  • On September 27, 2018, the FDA issued guidance entitled, The Special 510(k) Program.  The FDA established the Special 510(k) Program to facilitate the submission, review, and clearance of changes to a manufacturer’s own legally marketed predicate device. This draft guidance, when finalized, will provide the framework that FDA will use when considering whether a premarket notification (510(k)) is appropriate for review as a Special 510(k). This draft guidance is not final nor is it in effect at this time.
  • On September 28, 2018, the FDA issued guidance entitled, Adaptive Designs for Clinical Trials of Drugs and Biologics. This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance describes the basic principles for designing, conducting, and reporting the results from an adaptive clinical trial. The draft guidance will replace the 2010 draft guidance for industry entitled “Adaptive Design Clinical Trials for Drugs and Biologics.”
  • On September 28, 2018, the FDA issued guidance entitled, Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications. The draft guidance provides recommendations to industry and FDA staff regarding the content and submission procedures for use-related risk analyses, human factors validation study protocols and reports, threshold analyses, and comparative use human factors study protocols and reports.
  • On September 28, 2018, the Centers for Medicare & Medicaid Services (CMS) issued proposed rules, Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures. This proposed rule would revise the regulations setting forth the appeals process that Medicare beneficiaries, providers, and suppliers must follow in order to appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B or determinations for prescription drug coverage under Part D. These changes would help streamline the appeals process and reduce administrative burden on providers, suppliers, beneficiaries, and appeal adjudicators. These revisions, which include technical corrections, would also help to ensure the regulations are clearly arranged and written to give stakeholders a better understanding of the appeals process.

Event Notices   

  • October 27, 2018: The FDA announced a public meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general functions of the committees is to provide advice and recommendations to the FDA on regulatory issues.
  • November 5, 2018: The FDA announced a public hearing and an opportunity for public comment on the future format of the National Drug Code (NDC). FDA is seeking input from a variety of stakeholders through comments and responses to FDA questions included in the above notice and associated web content that will be published before the hearing.
  • November 7, 2018: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The CLIAC will hear updates from other agencies on a range of laboratory-related issues, including laboratory interoperability.
  • November 8, 2018: The FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will hear an overview of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review.
  • 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.

II. Congressional Legislation & Committee Action

U.S. Senate

  • On September 25, 2018, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, Health Care in Rural America: Examining Experiences and Costs. Witnesses present included: Tom Glause, Commissioner, Wyoming Department of Insurance; Morgan Reed, President, App Association; Alan Levine, Executive Chairman, Ballad Health; and Deborah Richter, M.D., Family Physician and Addiction Medicine Specialist, Vermont Healthcare for All.

House of Representatives

  • On September 27, 2018, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Better Data and Better Outcomes: Reducing Maternal Mortality in the U.S. Witnesses present included: Representative Jaime Herrera Beutler (R-WA); Lynne Coslett-Charlton M.D., Pennsylvania District Legislative Chair, The American College of Obstetricians and Gynecologists; Joia Crear Perry, M.D., Founder and President, National Birth Equity Collaborative; Charles Johnson, Founder, 4Kira4Moms; Stacey Stewart, President, March of Dimes.

III. Reports, Studies, & Analyses

IV. Other Health Policy News

  • On September 25-26, 2018, the Department of Health and Human Services Pain Management Best Practices Inter-Agency Task Force (Task Force) held its second public meeting. The Task Force presented draft recommendations on pain management, including acute and chronic pain. The draft recommendations were approved by the Task Force and will be available for public comment in the coming weeks.
Media Contact
Alex Wolfe
Communications Director

This website uses cookies to improve functionality and performance. For more information, see our Privacy Statement. Additional details for California consumers can be found here.