The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA provided an update on one potential treatment called convalescent plasma and is encouraging those who have recovered from COVID-19 to donate plasma to help others fight this disease. Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus. The agency launched a new webpage to guide recovered COVID-19 patients to local blood or plasma collection centers to discuss their eligibility and potentially schedule an appointment to donate. The webpage also includes information for those interested in participating in the expanded access protocol, conducting clinical trials, or submitting single patient emergency investigational new drug applications.
- The FDA issued warning letters to Fishman Chemical of North Carolina, LLC., and Dr. G’s Marine Aquaculture, which distribute chloroquine phosphate products intended to treat disease in aquarium fish. Chloroquine phosphate intended to treat disease in aquarium fish has not been approved, conditionally approved, or indexed. Although neither product identified in today’s warning letters made claims about use in people, the agency is concerned that consumers may mistake unapproved chloroquine phosphate animal drugs for the human drug chloroquine phosphate, which is currently under study as a potential treatment for COVID-19. People should not take any form of chloroquine unless it has been prescribed by a licensed health care provider.
- The FDA and Federal Trade Commission (FTC) issued a warning letter to a seller of fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, The Art of Cure, offers homeopathic drug products for sale in the U.S. that are unapproved and misbranded with misleading claims the products are 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.
- The FDA posted tips on Shopping for Food During the COVID-19 Pandemic - Information for Consumers and a downloadable PDF. These materials reassure consumers that there is currently no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19.
- In an interview posted on the FDA’s webpage, Deputy Commissioner for Food Policy and Response Frank Yiannas talks about the state of the U.S. food supply, both now and beyond this public health crisis. The topics he covers include food safety and food availability, as well as an update on implementation of the FDA Food Safety Modernization Act and plans to release a blueprint for the New Era of Smarter Food Safety initiative.
- The FDA issued a guidance for immediate implementation setting forth a temporary policy for outsourcing facilities to compound certain human drugs for hospitalized patients during the COVID-19 public health emergency. This guidance is being issued to provide patient access to treatment options for COVID-19 when hospitals experience difficulties accessing certain FDA-approved drugs. FDA does not intend to take action against outsourcing facilities that prepare certain compounded drugs, as described in the guidance, for hospitals that treat patients with COVID-19.
- 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 on conducting remote clinician-reported outcome or performance outcome assessments; remote site monitoring; electronic common technical document requirements; investigational product administration by a local health care provider who is not a sub-investigator; and information for sponsors on who they should contact at the FDA regarding certain changes to ongoing trials. There is also updated information about obtaining informed consent from a patient who is unable to travel to the clinical trial site due to COVID-19 illness or travel restrictions, in situations where electronic informed consent is not an option.
- The FDA issued guidance to help expand the availability of telethermographic systems used for body temperature measurements for triage use for the duration of the public health emergency. The advantage of these systems for initial temperature assessment for triage use is the potential use in high throughput areas (such as airports, businesses, warehouses, and factories) and in settings where other temperature assessment products may be in short supply.
- Diagnostics update:
- During the COVID-19 pandemic, the FDA has worked with more than 315 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for COVID-19 tests.
- To date, 37 emergency use authorizations have been issued for COVID-19 tests.
- The FDA has been notified that more than 190 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 FAQs up to date.