4 Steps The FDA Is Taking In Response To The Coronavirus Outbreak

Although at this time the majority of the coronavirus outbreak (COVID-19) is in mainland China, there are at least 29 cases in the U.S. Several U.S. companies, such as AbbVie, Gilead Sciences, and Johnson & Johnson, are running clinical trials in China to determine if their antiviral drugs may be effective in treating the disease. In the U.S., Moderna is working with the U.S. National Institutes of Health (NIH) on developing a vaccine, as are other companies.

The U.S. Food and Drug Administration (FDA) issued a statement on Friday outlining what the agency is doing at home and abroad in response to the outbreak, which has infected more than 73,000 people worldwide.

“The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts,” Stephen M. Hahn, Commissioner of Food and Drugs, FDA, wrote.

The agency is taking four major steps. First, active supply chain surveillance. “We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages,” Hahn wrote.

Secondly, the agency is inspecting and monitoring compliance of FDA products manufactured overseas. Hahn notes that “FDA inspections are used as part of our commitment to the supply chain and are currently continuing as normal except in China consistent with the State Department Travel Warning. Any travel to China which is deemed to be mission-critical is being assessed on a case-by-case basis in close coordination with HHS and the State Department.”

The agency notes it runs about 500 inspections annually in China with most being for drugs, foods and medical devices. They are not currently running any because of the State Department warning.

Third, the agency oversees the safety of consumer products that come into the U.S. from other countries. They are all subject to the regulatory requirement U.S. Customs and Border Protection (CBP), which then refers FDA-regulated products to the FDA for review. If anything is considered higher risk or the paperwork is incomplete or inaccurate, it is flagged for manual review by the FDA.

“Again,” Hahn wrote, “we want to reassure the public that at this time there is no evidence that food or food packaging have been associated with transmission and no reason to be concerned. Further, there is no evidence to support transmission of COVID-19 associated with imported goods, including food and drugs for humans and pets, and there have not been any cases of COVID-19 in the U.S. associated with imported goods.”

And fourth, the FDA is working to diagnose, treat and prevent the disease. Last week the FDA issued an emergency use authorization (EUA) to allow immediate use of a diagnostic assay developed by the U.S. Centers for Disease Control and Prevention (CDC), which will make it easier for CDC-qualified labs to use the test. The agency has also developed an EUA review template for tests for the virus, which outlines the data requirements for a Pre-EUA package that assay developers can request. So far, more than 50 companies have expressed interest in the EUA review template.

And finally, Hahn notes that the FDA “is closely monitoring the outbreak and collaborating with our interagency partners, international partners, and medical product developers and manufacturers to help advance response efforts to combat this virus.-Bio Space