FDA moves to ensure protections against Novel Coronavirus

As part of the response to the ongoing novel coronavirus (COVID-19) outbreak worldwide, the U.S. Food and Drug Administration (FDA) last week outlined its efforts to facilitate diagnosis, treatment, and prevention of the disease, keep an eye on the medical product supply chain and maximize the potential of public health tools.

The organization’s statement, released by FDA Commissioner Stephen Hahn, labeled it likely that the outbreak will impact the medical product supply chain, causing disruptions or shortages of critical medical products in the United States. The organization is moving to reduce its effects by reaching out to manufacturers and trying to stay ahead of any shortages. Additional resources have been put toward the review and coordination of data to identify potential vulnerabilities in the medical product sector, and regular contact has been maintained with manufacturers and global regulators.

“It’s worth noting that there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China,” Hahn said. “Raw materials used in manufacturing do come from China and other locations in Southeast Asia, and we are in contact with biologics manufacturers to gauge any supply concerns regarding raw materials. This remains an evolving and very dynamic situation with respect to potential shortages.”

Increased ordering of some essential medical devices have been tracked, but so far, no shortages have emerged.

Meanwhile, the FDA reported that its inspections are continuing as normal everywhere except China, where many personnel were evacuated. The FDA conducts approximately 500 inspections per year in China, the majority of them being for drugs, food, and medical devices. These have been halted due to the State Department warning advising against travel to China. The administration is instead either postponing inspections or using other information to determine whether to allow Chinese products.

“While the outbreak is impacting our ability to conduct inspections in China, it’s important to underscore that the FDA’s regular risk-based process of surveillance testing of imported products, including those from China, which is based on a number of factors, continues,” Hahn said. “Fortunately, at this time, we are not seeing the impacts of this outbreak resulting in an increased risk for American consumers from imported products. Furthermore, the FDA Fraud Team monitors on-line products promoted with claims to prevent, treat, mitigate or cure 19-nCoV (or coronavirus, in general).”

Additionally, the FDA continues to review products referred to it by Customs and Border Protection. Those found to meet the same standards as domestic products are allowed through — no additional measures have been put in place for Chinese products, as no evidence has shown that COVID-19 transmits via imported goods.

Beyond this, the FDA is working to expedite the development and availability of medical products for the disease and is offering regulatory advice, guidance, and technical assistance to advance the development of vaccines, therapies, and diagnostic tests for COVID-19. To date, the administration’s emergency use authorization review template has been given to more than 50 developers with interest in creating COVID-19 diagnostics.