Weekly FDA COVID-19 update
While COVID-19 continues to take its toll around the globe, the US Food and Drug Administration (FDA) has continued its efforts to monitor development of therapies, diagnostics and preventative measures for the virus.
Remdesivir EUA
The agency issued an emergency use authorization (EUA) for using investigational antiviral remdesivir in treating severe COVID-19 patients. While the industry has only assembled limited information about the drug’s safety and efficacy in treating patients with the virus, in a National Institutes of Health (NIH) clinical trial the drug showed promise in shortening the recovery time in some patients.
Department of Health and Human Services (HHS) secretary Alex Azar said the EUA—coming two days after the NIH reported its results—is a step forward in the battle against COVID-19.
“NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19,” he said. “The seamless cooperation between government and private industry under the President’s all-of-America approach to COVID-19 is getting treatment options to patients in record time.”
The EUA enables remdesivir to be distributed and administered intravenously by health care providers, to treat suspected or laboratory-confirmed COVID-19 in patients hospitalized with severe disease. “Severe disease” is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support, including such as a mechanical ventilator.
Antibody test
The agency issued its first authorization for an antibody test. The validation testing was performed at the Frederick National Laboratory for Cancer Research (FNLCR), a federally funded R&D center sponsored by the NIH’s National Cancer Institute.
The results are among the first to emerge from a collaborative effort by the FDA, NIH, Centers for Disease Control and Prevention (CDC), and Biomedical Advanced Research and Development Authority (BARDA) to evaluate certain serological tests.
Essential samples and materials used in the evaluation were provided by the NIH National Institute of Allergy and Infectious Diseases (NIAID), the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, including members of the Departments of Microbiology and Pathology, and the Vitalant Research Institute.
Diagnostic update
Since the COVID-19 pandemic hit, the agency has:
- Worked with more than 385 test developers who reported plans to submit EUA requests to the FDA for tests that detect the virus.
- Issued 60 individual EUAs for test kit manufacturers and laboratories.
- Added 25 authorized tests to the EUA letter of authorization for high-complexity molecular-based laboratory developed test.
- Received notification that more than 240 laboratories have kicked off testing under the FDA’s COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019.
Fraudulent treatments
While currently there are no FDA-approved therapies to prevent or treat COVID-19, that hasn’t stopped numerous manufacturers from distributing products that promise quick cures. The agency has kept busy issuing warning letters to companies offering false, ineffective products to treat the virus.
As part of the agency’s Operation Quack Hack effort to block potentially dangerous COVID-19 tests, treatments, preventions and other items, it has issued 42 warning letters to date. Recipients include the following:
- Two websites -- www.antroids.com and www.foxroids.com -- were warned to stop offering untested COVID-19 treatments to unwary consumers online.
- Honey Colony LLC was ordered to stop hawking a number of silver-based products, including Jigsaw Magnesium With SRT and Silver Excelsior Serum.
- Dr. Dhole’s Sushanti Homeopathy Clinic received a warning to stop selling its Homeopathic Genus Epidemicus virus prevention product.
- One seller offering chlorine dioxide products essentially equivalent to industrial bleach, referred to as “Miracle Mineral Solution”
