FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and supporting emergency efforts to diagnose and treat the disease. In addition, FDA is addressing safety concerns with its own workforce. In this three-part article, we explain FDA’s efforts in each of these three areas and highlight the impact on different sectors of the healthcare industry impacted by the coronavirus and also FDA’s focused efforts.
The current outbreak of respiratory disease caused by the novel coronavirus first detected in 2019 in Wuhan City, Hubei Province, China has now been detected in more than 60 locations internationally, including cases in the United States. The virus has been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). SARS-CoV-2 has demonstrated the capability to rapidly spread, leading to significant impact on healthcare systems and causing disruption throughout our society. As of March 2nd, the state of Washington confirmed six deaths relating to COVID-19, and confirmed or presumptive cases were investigated in California, Florida, New Jersey, Rhode Island and New York.
FDA’s focus on product safety is a two-pronged approach: leveraging the full breadth of FDA’s available public health tools, including enforcement tools to stop fraudulent activity in product promotion and marketing in the United States, while simultaneously engaging in a number of efforts to ensure the safety and quality of FDA-regulated products for patients and consumers.
Importantly, at this point in time, there are no drugs, OTC products or medical devices (such as hand or surface sanitizers, dietary supplements, or face masks) that have FDA authorization to make claims of treatment or prevention against COVID-19. FDA has formed a cross-agency task force to review and address fraudulent activities in this regard and reiterated that FDA will use available enforcement tools against entities or individuals who are “bad actors” taking “advantage of a crisis to deceive the public.” FDA is reaching out to major retailers, requesting removal of dozens of such fraudulent products from their online listings and has requested cooperation in monitoring for, and preventing, coronavirus claims on health and wellness products. Therefore, retailers should be vigilant about monitoring for product claims that could cause consumer confusion or deception, and product manufacturers and distributors should exercise caution in changing their product labels or claims without FDA review and approval. In Part III we will discuss the specific processes that FDA has made available for expedited review and emergency access to products designed to address the COVID-19 outbreak.
FDA is focusing on products imported from China. Presently, 60% of FDA-regulated products imported from China are medical devices and 20% are housewares (like food packaging). FDA has not seen the impacts of this outbreak resulting in an increased public health risk for U.S. 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. FDA uses its inspectional authority to inspect regulated products in an effort to provide post-market surveillance and assure ongoing product safety. FDA typically uses a risk-based model to approach inspections. On average, FDA conducts approximately 500 inspections per year in China with the majority of these inspections being for drugs, foods and medical devices, and 90% of those being routine surveillance (as opposed to for-cause inspection). On February 14, 2020, FDA confirmed that it is no longer conducting inspections in China, consistent with the State Department travel warnings. Scheduled inspections were either postponed or, for drug facility inspections, 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. FDA hopes that the increased reliance on record-request-based inspectional activities will reduce a presumed backlog of inspections in the future and help FDA prioritize future site inspections.
Firms in China manufacturing FDA-regulated products should be operating at heightened awareness, as FDA ultimately holds firms and individuals who manufacture and sell FDA-regulated products 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, including those offering adulterated or misbranded products.
FDA is also relying heavily on its collaboration with U.S. Customs and Border Protection to target products intended for importation into the United States that violate applicable legal requirements for FDA-regulated products. FDA has the ability, through a risk-based import screening tool called PREDICT, to focus import examinations and sample collections based on heightened concerns about specific products entering U.S. commerce. The PREDICT screening will adjust risk scores as necessary throughout the COVID-19 outbreak. FDA has reiterated that the combination of these risk-based tools are providing a comprehensive approach to product safety. Firms importing FDA-regulated products into the U.S., regardless of origin, should be aware of the increased utilization of import controls as a mechanism for product safety evaluation during the COVID-19 outbreak.
Finally, it’s worth noting that there are no vaccines, gene therapies or blood derivatives licensed by FDA that are manufactured in China. The potential for transmission of COVID-19 by blood and blood components is unknown at this time; however, respiratory viruses, according to FDA and CDC, are not known to be transmitted by blood transfusion. There have been no reported cases of transfusion-transmitted COVID-19. Thus, this class of products is not a central focus of FDA’s product safety efforts, although FDA is aware that certain human cells, tissues, or cellular or tissue-based products (HCT/Ps) establishments are revising donor screening criteria to account for risk factors associated with COVID-19, including recent travel or familial exposure.