The US Food and Drug Administration (FDA) continues to have its hands full with various actions and advisements related to development of tests and treatments for COVID-19. Virus-related announcements include measures to help fast-forward developments of therapies, research partnerships, and actions to stop fraudulent cures from harming consumers.
The agency issued “The Path Forward: Coronavirus Treatment Acceleration Program,” a resource describing a new program that aims to move treatments to patients as soon as possible, and determine their safety and effectiveness.
To date, 72 clinical trials of potential COVID-19 therapies have been launched, with FDA oversight. The agency also reported it has streamlined its review and advice process to get studies started as quickly as possible.
The agency is joining forces with the National Institutes of Health (NIH) and the Foundation for the NIH in a plan to speed development of treatments and vaccines for the virus. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership also includes the Centers for Disease Control and Prevention, the European Medicines Agency, the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, and various biopharmaceutical companies.
According to the FDA, the ACTIV partnership aims to develop a framework for prioritizing vaccine and drug candidates. It also will tackle streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.
At-home sample collection
The FDA has authorized the first diagnostic test with a home collection option for COVID-19. The agency reissued an emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
The molecular test enables the patient to collect a nasal-swab sample, then mail it to a lab for analysis. The company plans to make the test available to consumers in the coming weeks.
Since the onset of the pandemic, the FDA has worked with more than 360 test developers who have reported they will be submitting EUA requests for tests that detect the virus. To date, the agency has:
- Issued 43 individual EUAs for test kit manufacturers and laboratories
- Added 17 tests to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- Received notification that more than 215 laboratories have begun testing under the policies set forth by the agency.
- Continually updated its COVID-19 Diagnostics FAQ.
Fake COVID-19 cures
The agency maintains that to date, no FDA-approved products to prevent or treat COVID-19 exist. However, that has not stopped several companies from creating, producing and promoting fraudulent treatments to the public.
One of the entities shut down for offering untested cures is the Genesis II Church of Health and Healing (Genesis). The FDA issued an injunction to halt production and sale of Miracle Mineral Solution, an untested and potentially deadly cure that, when activated, has a chlorine dioxide content equivalent to industrial-strength bleach.