- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The National Institutes of Health (NIH) and the Foundation for the NIH announced a public-private partnership with the FDA and others to speed the development of COVID-19 vaccine and treatment options. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership also includes the U.S. Centers for Disease Control and Prevention, the European Medicines Agency, the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, as well as more than a dozen biopharmaceutical companies. The ACTIV partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.
- A federal court has entered a temporary injunction against the Genesis II Church of Health and Healing (Genesis) and four individuals associated with the entity requiring them to immediately stop distributing its “Miracle Mineral Solution” (MMS), an unproven and potentially harmful treatment offered for sale to treat Coronavirus, which includes Coronavirus Disease 2019 (COVID-19) and many other diseases. The FDA, jointly with the Federal Trade Commission (FTC), previously issued a warning letter to Genesis and the FDA has warned consumers numerous times over the past decade not to purchase or drink chlorine dioxide products such as MMS sold as medical treatments. The FDA and FTC requested that the company respond within 48 hours describing the specific steps it has taken to correct the violations. In response to the warning letter, the defendants made clear that they had no intention of taking corrective action and would continue to sell MMS in violation of the law.
- The FDA and 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, Nova Botanix LTD DBA CanaBD, sells unapproved and misbranded cannabidiol (CBD) products 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. 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.
- Yesterday, FDA announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose. As part of this effort, U.S. Cotton, the largest manufacturer of cotton swabs and a subsidiary of Parkdale-Mills, developed a polyester-based Q-tip-type swab that is fully synthetic for compatibility with COVID-19 testing. Harnessing its large-scale U.S.-based manufacturing capabilities, U.S. Cotton plans to produce these new polyester swabs in large quantities to help meet the needs for coronavirus diagnostic testing.
- The FDA issued a new emergency use authorization (EUA) for Extracorporeal Blood Purification (EBP) to ExThera Medical Corporation for emergency use of the Seraph 100 Microbind Affinity Blood Filter device to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit with confirmed or imminent respiratory failure to reduce pathogens and inflammatory mediators from the bloodstream. The Seraph 100 Microbind Affinity Blood Filter device is an extracorporeal broad-spectrum sorbent hemoperfusion device that is designed to reduce bacteria, viruses, toxins, cytokines and other inflammatory mediators from whole blood. The Seraph 100 Microbind Affinity Blood Filter device is designed to share a form factor very similar to other blood filters, such as hemodialyzers or hemoperfusion filters, and therefore is compatible with hemodialysis systems that use industry standard bloodline connectors for ease of operation, training, and utility.
- Diagnostics update to date:
- During the COVID-19 pandemic, the FDA has worked with more than 320 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
- To date, the FDA has issued 39 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 16 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- 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 FAQ up to date.
The 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 our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Molly Block