For Immediate Release: February 24, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Leadership Role Associate Commissioner for Regulatory Affairs - Office of Regulatory Affairs Judith A. McMeekin Pharm.D.

Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak: COVID-19. We continue to take a multi-pronged approach to this public health emergency, including 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, including enforcement tools to stop fraudulent activity as we oversee the safety and quality of FDA-regulated products for American patients and consumers.

Today, we are providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by this outbreak. While we are not able to conduct inspections in China right now, this is not hindering our efforts to monitor medical products and food safety. We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue monitoring the global drug supply chain by prioritizing risk-based inspections in other parts of the world. The FDA is not currently conducting inspections in China in response to the U.S. Department of State’s Travel Advisory to not travel to China due to the novel coronavirus outbreak. We will continue to closely monitor the situation in China so that, when the travel advisory is changed, we will be prepared to resume routine inspections as soon as feasible.

We already use other tools to help complement our inspections, including import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and we use information from foreign governments as part of mutual recognition agreements. Thus, at this time, we can rely on these other tools to give us comprehensive oversight of FDA-regulated products entering this country. This is all part of our agency’s risk-based approach to ensuring quality, as well as compliance with applicable FDA requirements.

It is important to reiterate that 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. A wide variety of FDA-regulated products are imported from China, which makes it important to assure the public of the quality of these products. At this time, over 60% of FDA-regulated products imported from China are medical devices and 20% are housewares (like food packaging).

In response to the COVID-19 outbreak, the FDA will utilize, where appropriate, our authority to request records from firms “in advance or in lieu of” drug surveillance inspections in China. The Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act (FDASIA) of 2012, gives the FDA authority to request records “in advance of or in lieu of” on-site drug inspections. Congress enacted this provision to improve the effectiveness and efficiency of inspections, given the increasing globalization of drug production. Along with other FDASIA provisions, this inspection record request authority was viewed as a way to “level the playing field” between foreign and domestic drug inspections by allowing the FDA to review records ahead of time and take a more risk-based approach to conducting both domestic and foreign inspections. These records will help the agency when we resume drug inspections in China. By applying the use of paper records in our risk-based inspection framework, we can prioritize our early inspections on those deemed most needed, based on the records . By doing so, we hope to rapidly assess what could become a backlog number of on-the-ground surveillance inspections this fiscal year if travel restrictions persist.

In addition to records requests, the FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law. FDA has the ability through our risk-based import screening tool (PREDICT) to focus our examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak. We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements.

Fortunately, currently, we are not seeing the impacts of this outbreak resulting in an increased public health risk for American consumers from imported products. There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. As noted, this remains a dynamic situation and we will continue to assess, and update guidance as needed.

We also continue to aggressively monitor the market for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA can and will use every authority at our disposal to protect consumers from bad actors who would take advantage of a crisis to deceive the public, including pursuing 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.

We know the public may have questions or concerns for the FDA as a result of this outbreak, including you and your family’s risk of exposure, or whether your critical medical products are safe and will continue to be available in the future. We assure you that the FDA is working around the clock to monitor and mitigate emerging coronavirus issues through collaborative efforts with U.S. regulators, international partners, and medical product developers and manufacturers to help advance response efforts to combat the COVID-19 outbreak.

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.

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Source: U.S. Food and Drug Administration (FDA.gov)