FDA monitors Covid-19 and its impact on the healthcare supply chain

Feb. 18, 2020

The Food and Drug Administration (FDA) is partnering in the novel coronavirus disease (COVID-19) response, working closely with the U.S. government and public health partners as well as international counterparts.

Their work focuses on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of public health tools to oversee the safety and quality of FDA-regulated products for American patients and consumers.

The FDA is 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. They are not waiting for drug and device manufacturers to report shortages to us—they are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages. Further, they have dedicated additional resources to review and coordinate data to better identify any potential vulnerabilities to the U.S. medical product sector, specifically from this outbreak.

The agency 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. There are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China. 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. They are tracking reports of increased ordering of some essential medical devices through distributors, such as personal protective equipment (PPE) (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 U.S. patients and health care professionals. 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.

The FDA will continue to closely monitor the domestic and global supply chain during this evolving situation. Should the agency be alerted to a potential shortage of a critical medical product, they will be as transparent as possible in sharing updates as they develop. Protecting the safety and security of the medical product supply chain is one of the FDA’s highest priorities. 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. They will revisit this approach and adjust as necessary as this outbreak continues to unfold.

Under the authorities Congress has given the Agency, we implement a risk-based model to identify firms for inspection. The FDA prioritizes for inspection facilities deemed as higher risk based on specific, defined criteria. These criteria can include inherent product risk. For example, a manufacturing facility that makes sterile injectable drug products will have a higher inherent product risk than a facility that makes oral capsules. As part of our risk-based model, we also consider patient exposure, as the more products a facility manufactures, the more likely a patient is to encounter products made at the facility. They also weigh factors in inspection history, a facility that has not met established quality standards when previously inspected is considered higher risk than those that have met standards in the past. In addition, we will consider signals and events of concern, such as product recalls or manufacturer or patient reports of quality problems associated with a facility, which increase the risk score when compared with facilities that have fewer or no such signals or events.

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. The agency is not currently conducting inspections in China due to the State Department warning advising against travel to China. For the month of February, the FDA 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 our U.S. 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.

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. Fortunately, at this time, they 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 COVID-19 (or coronavirus, in general). The agency 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.

All products offered for entry into the U.S., including items for personal use, are subject to the regulatory requirement U.S. Customs and Border Protection. 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.

Again, the FDA wants 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.

The agency has established a cross-agency task force dedicated to closely monitoring for fraudulent products and false product claims related to COVID-19 and we have 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. 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. The task force has already worked with retailers to remove more than a dozen of these types of product listings online. Several have already responded that they plan to monitor for coronavirus claims. The agency is committed to taking action to prevent unscrupulous actors from marketing unlawful products related to this outbreak.

A key focus area for the FDA is helping to expedite the development and availability of medical products needed to diagnose, treat and prevent this disease. We’re committed to help foster the development of safe and effective medical countermeasures as quickly as possible to protect public health, and are providing regulatory advice, guidance, and technical assistance to advance the development and availability of vaccines, therapies, and diagnostic tests for this novel virus. The agency issued an emergency use authorization (EUA) to enable immediate use of a diagnostic test developed by the Centers for Disease Control and Prevention (CDC), facilitating the ability for this test to be used in CDC-qualified labs. They have also developed an EUA review template for tests to detect the virus, which outlines the data requirements for a Pre-EUA package, that is available to developers upon request. To date, they have shared the EUA review template with more than 50 developers who have expressed interest in developing diagnostics for this virus.

FDA has the announcement

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