FDA coronavirus update
Actions taken in response effort amid pandemic
SAN JUAN — The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of the U.S. food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The agency announced the following actions taken this week in its ongoing response effort to the COVID-19 pandemic:
- The FDA took important actions to help accelerate the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers conducting work in this area. These guidance documents aim to make the process for submitting applications to initiate studies for new drugs and biological products more efficient by outlining recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19.
- The FDA provided an update on surveillance inspections during the COVID-19 pandemic. In the update, the agency stated it will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections. This will continue as local, national and international conditions warrant, with the exception of certain mission critical inspections.
- The FDA issued a warning letter to one company that was selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Fusion Health and Vitality LLC, recently offered products, including “CORE” and “IMMUNE SHOT,” for sale in the U.S. with claims that misleadingly represented the products as safe and/or effective for the prevention and treatment of COVID-19. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- To date, the FDA has posted 48 COVID-19 related warning letters.
- The FDA posted updated information for blood establishments regarding COVID-19, which aligns with the agency’s guidance on convalescent plasma to allow donation 14 days after complete resolution of symptoms. The posting also provides updated information blood establishments may wish to consider when evaluating prospective blood donors.
- Yesterday, the FDA issued an Emergency Use Authorization (EUA) for the Ascom teleCARE IP Nurse Call System for use by healthcare providers and patients in healthcare environments, including temporary hospital facilities, to facilitate remote communication between patients and healthcare providers. The remote communication and monitoring capabilities of the teleCARE IP Nurse Call System may reduce the amount of contact by healthcare providers with patients who are in isolation rooms, thereby reducing healthcare provider risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
- Yesterday, FDA issued an EUA for the emergency use of the Eko electrocardiogram (ECG) Low Ejection Fraction Tool (“ELEFT”) to be used by healthcare professionals to provide an assessment of Left Ventricular Ejection Fraction as a diagnostic aid to screen for potential cardiac complications associated with COVID-19 or underlying cardiac conditions that may affect clinical management of COVID-19, in adult patients having or suspected of having COVID-19. The EUA was issued to Manatt, Phelps & Philips.
- Testing updates to date:
- During the COVID-19 pandemic, the FDA has worked with more than 500 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
- To date, FDA has authorized 93 tests under EUAs, which includes 12 antibody tests and 1 antigen test.
- The FDA issued an Emergency Use Authorization (EUA) for emergency use of the Fresenius Propoven 2% Emulsion to maintain sedation via continuous infusion in patients older than 16 who require mechanical ventilation in an ICU during the COVID-19 public health emergency. Fresenius Propoven 2% Emulsion has important differences in its formulation compared to FDA-approved propofol drugs; providers should consult the Health Care Provider Fact Sheet for more information before administering it.
- The virus that causes COVID-19 has led to an increased number of people with severe respiratory illness. As a result, there is a shortage of FDA-approved drugs such as propofol that are used for sedation of mechanically ventilated patients.
- The FDA issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- The first seller warned in a letter issued jointly with The Federal Trade Commission (FTC) , Seanjari Preeti Womb Healing, L.L.C., offers a honey product for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
- The second seller warned, Plum Dragon Herbs, Inc., offers traditional Chinese medicine products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention of COVID-19.
- To date, the FDA has posted 46 COVID-19 related warning letters.
- Today, the FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance includes new content with considerations for using alternate laboratories or imaging centers, holding trial participant visits via video conference, and conducting required postmarketing clinical trials. The guidance also includes updated information about managing protocol deviations and amendments to ongoing trials, and about consulting with the FDA regarding administering investigational product infusions at home rather than at the clinical trial site.
- The FDA approved two Abbreviated New Drug Applications:
- Cisatracurium besylate injection USP 20 mg/10 mL is indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of cisatracurium include bradycardia, hypotension, flushing, bronchospasm, and rash.
- Azithromycin Tablets USP, 600 mg, is indicated for mild to moderate infections caused by designated, susceptible bacteria that cause certain sexually transmitted diseases and mycobacterial infections. Side effects of azithromycin tablets include hypersensitivity, QT prolongation, diarrhea, nausea, abdominal pain, and vomiting.
- Both ANDAs are relevant to COVID-19, and both medicines are listed in the FDA Drug Shortage Database. FDA recognizes the increased demand for certain products during the novel coronavirus pandemic and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
- Diagnostics update to date:
- On Friday, the FDA issued the first EUA for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. The EUA was issued to Quidel Corporation for the Sofia 2 SARS Antigen FIA test.
- Today, the FDA updated the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. The update includes EUA submission templates for molecular, antigen, and serology tests. Developers may choose to use these templates to facilitate the preparation, submission, and authorization of an EUA for various types of COVID-19 tests.
- During the COVID-19 pandemic, the FDA has worked with more than 385 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
- To date, the FDA has issued 92 EUAs, which includes 12 antibody tests and 1 antigen test.
- The FDA has been notified that more than 245 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
- The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.