The U.S. Food and Drug Administration (FDA) remains very busy, as the world’s leading food and drug regulatory agency, contributing to the war against COVID-19. Busy on a number of fronts, the agency recently alerted clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may possibly lead to false negative results with molecular tests for COVID-19 via a “Letter to Clinical Laboratory Staff and Health Care Providers.” This past week, the FDA released a new webpage “Moderna COVID-19 Vaccine Frequently Asked Questions” offering more transparency to the public about the review of the Moderna COVID-19 vaccine now authorized for emergency use. The agency issued a warning letter to actors in the economy commercially marketing products as “preventions” or “treatments” for COVID-19. This was in parallel with a U.S. District Court in Georgia granting a consent decree of permanent injunction against Fusion Health and Vitality LLC, Fusion Ionz LLC and Matthew Ryncarz for illegally commercially promoting products containing vitamin D and hordenine HCl, as COVID treatments. The FDA reports that to date 311 tests and sample collection devices are authorized by the FDA under emergency use authorization, including 235 molecular tests and sample collection devices, 64 antibody tests and 12 antigen tests.
COVID-19 Products: FDA Warns Market Actors
The FDA shared recently in a press release that they are on heightened alert, scanning the market for those promoting “fraudulent products that claim to cure, mitigate, treat or prevent serious diseases like COVID-19” that may lead to the problem that consumers could “delay or stop appropriate medical treatment” thereby increasing the possibility of “serious and life-threatening harm.” The FDA went on the record to remind all to seek medical help from their health care providers and discuss various treatment options with them.
TrialSite notes that an enormous number of people in the United States, in the tens of millions, do not have health care access due to lack of insurance. Moreover, millions with insurance may not actually have a medical home. This raises a number of questions concerning the health care system and individual patient health and safety.