The U.S. Food and Drug Administration (FDA) is not currently conducting inspections in China due to the novel coronavirus outbreak and current travel restrictions.
FDA Commisioner Stephen M. Hahn M.D. and Judith A. McMeekin Pharm.D., Associate Commissioner for Regulatory Affairs, addressed concerns about supply chain oversight on Feb. 24.
“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. 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.”
Import screening, examinations, sampling, import alerts, relying on a firm’s previous compliance history, and information from foreign governments as part of mutual recognition agreements round out the tools at the FDA’s disposal for assessing products entering this country.
Over 60% of FDA-regulated products imported from China are medical devices and 20% are housewares (like food packaging).
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 also help the agency when drug inspections in China are resumed
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 the risk-based import screening tool (PREDICT) to focus 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,” said FDA officials.
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.
