The US Food and Drug Administration (FDA) warns that the emergence of the novel coronavirus disease 2019 (COVID-19) in China and its rapid spread will likely affect the medical product supply chain and potentially disrupt the flow of “critical medical products” to the US.
China is a major supplier of ingredients used to make pharmaceuticals, as well as medical devices and other medical products, including personal protective equipment, such as respirators, gowns, gloves, and masks. The FDA is “keenly aware” that the outbreak will likely affect the medical product supply chain in the US, FDA Commissioner Stephen Hahn, MD, noted in a statement. He said the agency was proactively contacting drug and device makers to identify shortages rather than waiting for manufacturers to report such problems to the FDA.
“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,” Hahn said.
“The FDA will continue to closely monitor the domestic and global supply chain during this evolving situation,” he said. He noted the agency is tracking reports of increased ordering through distributors of some essential medical devices, such as personal protective equipment.
Hahn said that although no FDA-licensed vaccines, gene therapies, or blood derivatives are manufactured in China, facilities there and in other locations in Southeast Asia supply raw materials used in pharmaceutical manufacturing. “We are in contact with biologics manufacturers to gauge any supply concerns regarding raw materials,” he said.
If the FDA learns of a potential shortage of or disruption in the supply chain for medical products, the agency will take steps to limit the effect on patients and clinicians in the US, Hahn said, including “closely working with manufacturers and expediting review of alternate supply to prevent shortages, among other measures.”
The FDA has also halted inspections of Chinese drug and device factories in response to the US State Department’s warning against travel to China because of the COVID-19 epidemic. The agency typically conducts about 500 inspections annually in China, mostly of facilities that produce drugs, foods, and medical devices.
“Any travel to China which is deemed to be mission-critical is being assessed on a case-by-case basis in close coordination with [Health and Human Services] and the State Department,” Hahn said. “We will revisit this approach and adjust as necessary as this outbreak continues to unfold.”
The COVID-19 epidemic highlights existing concerns about the US’s reliance on China and other countries as sources of active ingredients for pharmaceuticals. At an October 2019 hearing on safeguarding pharmaceutical supply chains in a global economy, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, testified that the reliance on foreign suppliers “creates vulnerabilities in the US drug supply.”
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Stephenson J. FDA Warns Coronavirus Outbreak May Disrupt Supply of Critical Medical Products. JAMA Health Forum. 2020;1(2):e200222. doi:10.1001/jamahealthforum.2020.0222