The US Food and Drug Administration (FDA) Commissioner Stephen Hahn outlined the agency’s supply-chain surveillance plan in the wake of the coronavirus (COVID-19) outbreak in China, including the steps the agency is taking to mitigate potential shortages and supply disruptions of  products from China and how the agency is handling inspections of manufacturing facilities in China.

“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 US,” said US Food and Drug Administration Commissioner Stephen M. Hahn, in a February 14, 2020 statement. “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. The FDA has dedicated additional resources to review and coordinate data to better identify any potential vulnerabilities to the US medical product sector, specifically from this outbreak.”

Hahn outlined that the FDA has been “in contact with hundreds” of manufacturers of human and animal drugs and medical devices, as well as syncing up with global regulators, like the European Medicines Agency, to assess and monitor for indications and early warning signs of potential manufacturing discontinuances or interruptions due to the outbreak,” he said in his statement.  

He added that there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China, but that raw materials used in manufacturing do come from China and other locations in Southeast Asia. He said that the FDA is in contact with biologics manufacturers to gauge any supply concerns regarding raw materials. He added that the agency is tracking reports of increased ordering of some essential medical devices through distributors, such as personal protective equipment (e.g. respirators and surgical gowns, gloves and masks).

“If a potential shortage or disruption of medical products is identified by the FDA, we will use all available tools to react swiftly and mitigate the impact to US patients and healthcare professionals,” he said in his statement. “These tools include closely working with manufacturers and expediting review of alternate supply to prevent shortages, among other measures, with the common goal of minimizing any negative impact to public health in America.”

Update on manufacturing inspections in China

Hahn said that FDA inspections are currently continuing as normal except in China consistent with the US 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 [US Department of Health and Human Services] and the State Department,” he said in his statement. “We will revisit this approach and adjust as necessary as this outbreak continues to unfold.”

In general, the FDA conducts approximately 500 inspections per year in China with the majority of these inspections being for drugs, foods and medical devices, according to information from the FDA. The FDA says it is not currently conducting inspections in China due to the US State Department warning advising against travel to China.

For the month of February, the FDA said it identified all scheduled inspections in China, and they were either postponed or the agency was able to utilize other information to inform decisions allowing the products to enter the US market. Of these inspections, approximately 90% were routine surveillance inspections in China and the remaining for-cause inspections scheduled for February were able to be postponed after reviewing all available information and analyzing on a case-by-case basis. Routine surveillance inspections have a different public-health consideration than a for-cause inspection in which a serious concern has been identified, which require more timely follow-up by the agency, and the timing of these inspections is further determined on a case-by-case basis as informed by the risks the issue poses.

Hahn said that the majority of routine surveillance inspections in China scheduled for March are for medical products, and at this time are expected to be conducted at a later date. “We will continue to closely monitor the situation in China so that as the situation improves, we will be prepared to resume routine inspections as soon as feasible,” said Hahn in his statement.

Surveillance testing of imported products from China

Hahn emphasized that although the current outbreak in China is impacting the FDA’s inspection of facilities, the agency continues with surveillance testing of imported 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,” said Hahn in his statement. “Fortunately, at this time, we are not seeing the impacts of this outbreak resulting in an increased risk for American consumers from imported products…We will continue to assess the need for additional examinations or analytical testing on FDA-regulated products from China as a result of the outbreak, and we will continue to look at inspections on a case-by-case basis.”

lmported shipments of FDA-regulated products, including those from China, are then reviewed by the FDA and must comply with the same standards as domestic products. During the entry review process, the imported products must be held and may not be distributed into US commerce until the FDA has determined their admissibility.

The FDA says that it continues to review products imported from China using its routine entry-review process and that it has not determined that additional measures are needed to protect public health. All products offered for entry into the US, including items for personal use, are subject to regulatory requirements under the US Customs and Border Protection (CBP). CBP refers FDA-regulated products to the FDA for review. Products considered higher-risk and entry submissions with incomplete or inaccurate information are flagged for manual review by the FDA to determine the admissibility of the product.

Hahn emphasized that 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 US associated with imported goods.

Fraudulent products; products with false claims

Hahn added that the FDA has established a cross-agency task force dedicated to closely monitoring for fraudulent products and false product claims related to COVID-19, and it has already reached out to major retailers to ask for their help in monitoring their online marketplaces for fraudulent products with coronavirus and other pathogen claims. He said that products sold are subject to FDA investigation and potential enforcement action if they claim to prevent, treat, or cure COVID-19 and have not been evaluated by the agency for that intended use. He added that the task force has already worked with retailers to remove more than a dozen of these types of product listings online and that several have already responded that they plan to monitor for coronavirus claims.

Next steps

In sum, Hahn said: “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.”

Source: US Food and Drug Administration