By Stephen M. Hahn, M.D, FDA Commissioner
SILVER SPRING, Md., Feb. 14, 2020 — The FDA plays an essential role in overseeing our Nation’s medical products as part of our vital mission to protect and promote public health, including during public health emergencies. 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. Our work is multifaceted, focusing 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 our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.
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. The FDA has 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.
We have 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. It’s worth noting that 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. We 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, we will be as transparent as possible in sharing updates as they develop.
FDA Inspections and Monitoring Compliance of FDA Products Manufactured Overseas
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. We 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. We 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 FDA 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. Routine surveillance inspections have a different public health consideration than a for-cause inspection in which a serious concern has been identified requiring 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 to American patients and consumers. I can also share 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.
The robust and multi-layered compliance process at the FDA is helping to protect American patients and consumers even though we are not able to conduct inspections in China at this time. It’s important to note that the FDA is operating in an elevated status to swiftly respond to any new data that may require adjustments to our current risk model. And, as we have noted, along with our U.S. government partners – this is a dynamic situation that we are closely monitoring and will remain vigilant in this critical work.
The FDA’s risk-based framework is integral in helping the agency to make data-driven decisions and provides our inspection and compliance programs with the flexibility needed to help ensure that they are able to prioritize any facilities in the U.S. or abroad that are identified as having a higher risk profile. Congress had the foresight of adopting risk-based inspections for the agency as part of efforts to modernize the FDA’s framework for inspections, including enhancements that were enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act.
Inspections are one of many tools that the Agency uses to inform our risk strategy for imported FDA-regulated products and to help prevent products that do not meet the FDA’s standards from entering the U.S. market. Others tools include: import alerts, increased import sampling and screening, requesting records, in advance or in lieu of an inspection – firms may elect to provide this voluntarily to allow the FDA to make approval decisions, evaluation of previous FDA inspections history to determine if this information would suffice in lieu of an inspection, as well as relying on a firm’s previous compliance history and information from foreign governments with which we have mutual recognition agreements as part of our Agency’s risk-based approach to ensuring quality, as well as compliance with applicable FDA requirements. This process has a number of layers in place and is not solely reliant upon on boots on-the-ground inspections. Firms and individuals who manufacture and sell FDA-regulated products are responsible for ensuring the quality of their products. The FDA can pursue regulatory and enforcement action, such as warning letters, seizures, or injunctions, against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
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, 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). 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.
The Safety of Consumer Products
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.
All imported 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 U.S. commerce until the FDA has determined their admissibility. At this time, the FDA continues to review products imported from China using our routine process and has not determined that additional measures are needed to protect public health. If necessary, the agency can utilize the tools noted above, including increased import screening. Again, 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.
We have 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.
Efforts to Diagnose, Treat and Prevent the Disease
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.
Last week, the FDA issued an emergency use authorization (EUA) to enable immediate use of a diagnostic test developed by the Centers for Disease Control and Prevention, facilitating the ability for this test to be used in CDC-qualified labs. We 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, we have shared the EUA review template with more than 50 developers who have expressed interest in developing diagnostics for this virus.
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.
As the world responds to this public health emergency, I am grateful to the FDA staff who are working around the clock, in addition to our other mission-critical work at the Agency, to help mitigate this outbreak as swiftly as possible. You have my commitment that we will continue to stay vigilant on all fronts to protect the public health—at home and abroad–during this critical time. We are committed to continuing to update the public as we have further updates on the FDA’s vital work in this area.
- FDA: Emergency Use Authorization
- FDA: Novel coronavirus (2019-nCOV)
- News Release: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures
Media Contact: Megan McSeveney (240) 402-4514
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: U.S. Food and Drug Administration (FDA)