Newest FDA actions and alerts on COVID-19

By Jenni Spinner

- Last updated on GMT

(Nuthawut Somsuk/iStock via Getty Images Plus)
(Nuthawut Somsuk/iStock via Getty Images Plus)

Related tags Fda COVID-19 Coronavirus

The federal agency continues to monitor as the virus impacts the pharma and clinical trials industries, offering advice and taking action where necessary.

While the acceleration of new cases is slowing in some states, the news on the pandemic is not all rosy. The number of cases in America hit 1.8m this week, other states are seeing scores of new cases, and widespread civil unrest has thrown a wrench in testing and tracking efforts.

In the face of these developments, the US Food and Drug Administration (FDA) has continued to keep tabs on the situation. Below are some of the guidance documents, consumer updates and actions from the past week.

Clinical trials app

FDA is making its previously developed FDA MyStudies app available to investigators as a free platform, so that they can use the app to securely obtain patients’ informed consent for eligible clinical trials, The app also has been renamed COVID MyStudies​.

The application is designed to be used in cases when face-to-face contact is not feasible or practical because of COVID-19 control measures. It can be downloaded at no cost from the Apple App and Google Play stores.

COVID-19 and cancer

On Friday May 29, the FDA issued another title in its FDA Voices informational series. Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic​. The writing, by commissioner Stephen Hahn, outlines the agency’s role in helping bring new medical products to market and evaluate their safety.

In the blog-format document, Hahn talks about how the industry continues to pursue therapies for cancer, COVID-19 and other ailments, even as the pandemic continues to make healthcare workers’ work difficult. He also explains emergency use authorizations (EUA) and investigational drugs like hydroxychloroquine.

Connecting with concerned consumers

The agency issued a consumer update entitled Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19​. The resource talks about researchers and their work to develop coronavirus preventatives and treatments.

One intention for the document, according to the agency, is to help clear up confusion the language and terminology used when talking about COVID-19 can bring about. The document focuses especially on regulatory terminology and what it might mean for future developments.

Home tests

In a move designed to support development of COVID-19 tests for at-home self-collection, the agency put on its website a template that can be used to facilitate submission of requests for EUAs for at-home sample collection kits. The template is designed to reflect the agency’s current position on the data and information developers should submit to facilitate the EUA process.

The agency template includes recommendations geared toward laboratories and commercial manufacturers to harness during the preparation and submission of an EUA request. Developers can offer a COVID-19 test for at-home self-collection where specifically authorized under an EUA or as part of an Institutional Review Board (IRB)-approved study.

Sketchy COVID-19 cures

To date, the FDA has not approved any consumer products for the prevention or treatment of COVID-19. In order to prevent fraudulent and potentially harmful items from getting into the public’s hands, it has issued dozens of warning letters ordering manufacturers and sellers of such products to cease:

  • Quadrant Sales & Marketing has been offering non-alcohol-based hand sanitizer products for sale, claiming they block the virus for up to 24 hours.
  • StayWell Copper products has een selling copper-based Germ Stopper products, claiming they can prevent COVID-19 infection.

Diagnostic development update

During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus. To date, the FDA has authorized 119 tests under EUAs, which include 103 molecular tests, 15 antibody tests, and one antigen test.

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