Public Policy Updates

3/17/22 — Celltrion USA is recalling specific lots of the DiaTrust COVID-19 Ag Rapid Test due to a high number of false positive reports. Additionally, the tests’ labeling for the affected products includes a shelf life of 18 months. However, the FDA’s emergency use authorization specifies these tests may only be used for 12 months. Read the FDA … Continued

3/18/22 — The FDA issued a safety communication reminding people that at-home COVID-19 diagnostic tests should only be used according to manufactures’ instructions, and that tests kits should be kept out of reach of children and pets. The agency has received reports of injuries cause by incorrect use or storage of at-home COVID-19 diagnostic tests. Read … Continued

3/14/22 — In response to public comments and feedback, The Leapfrog Group Hospital Survey as announced that it will be offering an alternative path to meeting the organization’s Hand Hygiene Standard.  In its March 14 “Summary of Changes to the 2022 Leapfrog Hospital Survey & Responses to Public Comments,” Leapfrog said that the alternative path “requires … Continued

3/10/22 — The FDA and FTC issued a joint warning letter to Soda Pharm for selling unapproved products with fraudulent COVID-19 claims. 

3/7/22 — The Biden-Harris Administration is launching a new nationwide Test to Treat initiative that will give individuals an important new way to rapidly access free lifesaving treatment for COVID-19. In this program, people will be able to get tested and—if they are positive and treatments are appropriate for them—receive a prescription from a healthcare provider, … Continued

3/11/22 — The FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius. This extension applies to all refrigerated vials of the Janssen COVID-19 vaccine that have been held in accordance with the manufacturer’s storage conditions. Read … Continued

3/7/22 — The FDA and the Federal Trade Commission (FTC) issued a joint warning letter to Viraldine, LLC for selling unapproved products with fraudulent COVID-19 claims. Read the FDA/FTC warning letter.

3/14//22 — LuSys Laboratories, Inc. is recalling COVID-19 antigen (nasal/saliva) and COVID-19 IgG/IgM antibody tests because they do not have an Emergency Use Authorization (EUA), 510(k) premarket notification, or premarket approval (PMA) and therefore cannot be marketed and distributed in the U.S. The risks include potential false negative, false positive, and misinterpretation of results from these … Continued

3/10/22 — Trust for America’s Health (TFAH) released its annual evaluation of states’ performance on ten key emergency preparedness indicators in Ready or Not 2022: Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism. The report identifies gaps in states’ readiness to respond to emergencies and includes policy recommendations for strengthening the nation’s health security. This year’s … Continued