Current FDA COVID-19 updates and actions

By Jenni Spinner contact

- Last updated on GMT

(ChakisAtelier/iStock via Getty Images Plus)
(ChakisAtelier/iStock via Getty Images Plus)

Related tags: Fda, Drug development, Clinical trials, COVID-19, Coronavirus

The agency continues to offer advice related to drug development and clinical research during the pandemic, and take action against those falling out of line.

In the months since the spread of COVID-19 was officially declared a pandemic, the US Food and Drug Administration (FDA) has offered numerous resources, given advice, and taken action related to the virus. Read below for the most recent updates.

Drug distribution

The agency issued a guidance, “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency​.” The guidance addresses questions the FDA has received concerning prescription drug sample distribution under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency.

The document explains that, on a temporary basis, the agency has no intention to raise objections to the delivery of prescription drug samples to patients’ homes if requested by their licensed health care professional. Additionally, the guidance describes current FDA policy regarding the signature required at time of delivery of drug samples, to promote public health.

Public virus information

FDA has published two new web pages to help the public access information: Innovation to Respond to COVID-19​ and Educational Resources

Innovation to Respond to COVID-19 delivers an overview of FDA’s approaches to respond to COVID-19 as quickly and safely as possible. Educational Resources provides links to FDA-produced COVID-19-related resources that help explain FDA’s work regarding the pandemic.

Consumer COVID-19 video

The FDA issued a new video​ that outlines the differences between diagnostic and antibody COVID-19 tests. The consumer-forward video is designed to help people outside the life-sciences industry understand the characteristics and benefits of both tools, and assist medical professionals in explaining to their patients.

The resource explains diagnostic tests can tell if someone is infected currently. Antibody or serology tests detect antibodies in the blood, which would indicate the person was previously infected.

Testing updates

The agency reports that during the COVID-19 pandemic, it has worked with more than 400 test developers who have already submitted, or said they will be submitting, emergency use authorization (EUA) requests to the FDA for tests that detect the virus or antibodies to the virus.

To date, the FDA has authorized 124 tests under EUAs. These reportedly include 106 molecular tests, 17 antibody tests, and one antigen test.

Sketchy COVID-19 products

There currently are no FDA-approved drugs or other products to prevent or treat COVID-19. The agency continues to issue warning letters to companies unscrupulously claiming to offer items that can block or cure the virus:

This week, the agency issued warnings to operators of four websites. The sites www.roidsmall.net, www.emedkit.com, www.4nrx.md and www.chloroquineonline.com all had been marketing various unapproved and misbranded COVID-19 products.

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