Alston & Bird Healthcare Week in Review

Alston & Bird

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   

  • 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.
  • May 9 – 10, 2019: The FDA announced a meeting of the Pain Management Best Practices Inter-Agency Task Force. The Task Force will review clinical guidelines and identify gaps and/or inconsistencies for best practices for pain management.
  • May 13, 2019: The FDA announced a public meeting entitled, The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products. The hearing is set to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.

II. Congressional Legislation & Committee Action

U.S. Senate  

  • On April 2, 2019, the Senate Committee on Aging held a hearing entitled, Alzheimer’s: New Directions in Biomedical Research and Caregiving. Witnesses present included: Mary Hartt, Family Caregiver; Clay Jacobs, Executive Director, Greater Pennsylvania Area Chapter of the Alzheimer’s Association; Sharon Fekrat, Professor of Ophthalmology and Associate Professor of Surgery, Duke School of Medicine; and Richard Hodes, Director, National Institute on Aging, NIH.

House of Representatives

III. Reports, Studies, & Analyses

  • On April 1, 2019, the Government Accountability Office (GAO) issued a report entitled, Behavioral Health: Research on Health Care Costs of Untreated Conditions is Limited. GAO was asked to describe what is known about adults with untreated behavioral health conditions and examined reasons why some adults with behavioral health conditions do not receive treatment for their condition, and what is known about health care costs associated with untreated conditions. The GAO found, among other things, that not treating behavioral health conditions can lead to other health care costs, such as the costs of emergency care for an overdose. However, research on such costs is limited and there is no generally accepted estimate of all the health care costs associated with untreated behavioral health conditions.

IV. Other Health Policy News

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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