News and information useful to Cleveland-Marshall College of Law students, faculty and staff.

CDC Updates & Expands COVID-19 Increased Risk List

CDC LogoThe U.S. Centers for Disease Control and Prevention (CDC) has updated and expanded its list of People Who Are at Increased Risk for Severe Illness for getting COVID-19.  Changes are based upon continuous detailed review of available evidence.  [For example, see Morbidity & Mortality Weekly Report, volume 69, number 24, 759-765 (6/19/2020).]   Older adults and people with underlying medical conditions remain at increased risk, but age- and condition-related risks are further defined.  The specific age threshold has been removed from the older adult classification, and CDC now states risk increases steadily as one ages.  For additional information, see the CDC Coronavirus (COVID-19) page.

Wealth of Information on FDA Coronavirus Disease 2019 Site

FDA logoThe U.S. Food and Drug Administration (FDA) Coronavirus Disease 2019 website provides a wealth of information for administrators, health care professionals and the general public.  The site includes FDA Emergency Use Authorizations, Guidance Documents & Policies, and “conservation strategies” for Personal Protective Equipment, as well as News Releases, information on how individuals who have fully recovered from COVID-19 may Donate COVID-19 Plasma and numerous Educational Resources.

Public Comment on FDA COVID-19-Related Guidance Documents

FDA logoIn the 3/25/2020 issue of the Federal Register, the U.S. Food and Drug Administration (FDA) announced its process for making COVID-19-related Guidance Documents available for public comment.  FDA is issuing Guidance Documents for immediate implementation without prior public comment, but FDA will solicit post-issue comments.  FDA will periodically release consolidated “Notices of Availability” (NOA) for public comments, and comments are to be submitted to specific docket numbers (assigned to specific FDA Centers/Offices).  FDA published its first consolidated NOA, concerning 16 COVID-19-related Guidance Documents, in the 5/12/2020 issue of the Federal Register.  Based on public comments and evolving COVID-19 developments, FDA will revise Guidance Documents.  Beyond publication in the Federal Register, FDA Guidance Documents are available on the FDA website.

FTC & FDA Warn Companies Making False COVID-19 Claims

Oimage of covid-19 virusesn 3/6/2020, the U.S. Federal Trade Commission and U.S. Food and Drug Administration sent warning letters to seven companies telling the companies they were “violating federal law and putting patients at risk by falsely claiming their products … can prevent or treat the coronavirus” (ie, COVID-19).  The seven companies are:  Colloidal Vitality LLC, GuruNanda LLC, Herbal Amy Inc., The Jim Bakker Show, Quinessence Aromatherapy Ltd., Vivify Holistic Clinic, and Xephyr LLC dba N-ergetics.  All seven companies were given 48 hours to report on their specific steps to correct the violations.  Failure to correct the violations “may result in legal action, including, without limitation, seizure and injunction.”  Also, within the warning letters, the FDA states “there currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure coronavirus disease 2019 (COVID-19).”  For more information, see the FDA COVID-19 page.

Free Webinars on Public Health and the Judiciary

PolioVaccinePosterCDCWellbeeThe U.S. D.H.H.S. Centers for Disease Control and Prevention (CDC) and the Network for Public Health Law (NPHL) are sponsoring three free webinars on Public Health and the Judiciary.  The first webinar – When Public Health Goes to Court:  Judicial Structure and Functions – will be 1pm-2:30pm EST, Thursday, February 5th, 2015.  This webinar will will look at the structure and essential functions of the state and federal court systems (including administrative courts), explore the Tribal court system, and examine the role of court watch programs in addressing public health issues.  Speakers will be Judge David T. Emerson, Douglas County Superior Court, Georgia; Lorre Cuzze, JD, MPH, Law Clerk, State Court of Dekalb County, Georgia; Tina Batra Hershey, JD, MPH, Assistant Professor, University of Pittsburgh Graduate School of Public Health, Department of Health Policy and Management; and Kerri McGowan Lowrey, JD, MPH, Deputy Director, Network for Public Health Law – Eastern region.  CLEs are available for some attendees.  Register here.

The two upcoming webinars in this series will be Public Health in the Courts and The Court and Public Health Emergencies.  Details will be publicized as they become available.  In the general materials on the need for these webinars, the CDC and NPHL recognize that the US court system has a substantial impact on public health.  “The courts have been instrumental in establishing the evolving reach and boundaries of government involvement in public health since the 1800’s.  The Supreme Court’s landmark 1905 decision in Jacobson v. Massachusetts recognized the judiciary as both an enforcer of governmental public health policies, and an arbiter of the conflicts between individual liberties and public interests that arise from governmental public health action.  Because of the critical role that the U.S. judicial system plays in advancing public health goals, it is essential that public health practitioners, legal counsel, and other partners understand how the court system works and how courts are involved in public health matters.”

Above image is a 1963 CDC poster, featuring “Wellbee,” a CDC symbol of public health.