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The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- This week, the FDA added a new frequently asked question (FAQ), “Can the FDA help me get a COVID-19 vaccine,” to our COVID-19 FAQs, under the vaccine section. The answer is no. The FDA’s authority includes authorizing or approving COVID-19 vaccines for use in the United States. The FDA is not responsible for vaccine distribution. Go to the CDC website to find your state and local health departments who are responsible for COVID-19 vaccine distribution. If you are contacted directly by someone who says they are from the FDA about a COVID-19 vaccine appointment, it is a scam.
- The FDA has added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency.” The updated guidance includes a new question-and-answer regarding whether FDA considers receipt of medical products authorized under an emergency use authorization for use in clinical care, such as a vaccine to prevent COVID-19, or a monoclonal antibody to treat COVID-19, to be receipt of “investigational” medical products. This information may be relevant when sponsors are considering eligibility criteria that exclude patients from enrolling in clinical trials if they have received certain medical products.
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On Jan. 27, the FDA approved an abbreviated new drug application for furosemide injection, indicated for the treatment of edema (fluid retention) associated with congestive heart failure, cirrhosis of the liver, and renal disease. Common side effects of furosemide injection include hypokalemia (low potassium level), hypotension (low blood pressure), and dizziness. This drug is included in the FDA’s Drug Shortage Database. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
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The FDA updated the immediately in effect guidance: Enforcement Policy for Coagulation Systems for Measurement of Viscoelastic Properties During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The policy remains unchanged from the initial publication of this guidance; however, this update provides a minor clarification for one of the labeling recommendations. Specifically, the revised guidance recommends that the labeling for devices modified as described in the guidance include, in addition to other elements, a prominent and clear statement for users that results generated by the device are adjunctive (supporting) and should not be solely or primarily relied upon to diagnose or treat COVID-19 associated coagulopathy.
- As part of the FDA’s effort to protect consumers, the agency issued warning letters jointly with the Federal Trade Commission to Allimax Us and to AusarHerbs, for selling unapproved products with fraudulent COVID-19 claims.
- The FDA placed all alcohol-based hand sanitizers from Mexico on a country-wide import alert to help prevent entry of violative and potentially dangerous products from entering the U.S. until the agency is able to review the product’s safety. FDA analyses of alcohol-based hand sanitizers imported from Mexico found 84 percent of the samples analyzed by the agency from April through December 2020 were not in compliance with FDA’s regulations. FDA, with its Latin American office, continues to work proactively with regulatory counterparts in Mexico.
- Testing updates:
- As of today, 320 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 238 molecular tests and sample collection devices, 69 antibody tests, and 13 antigen tests. There are 33 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
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