The U.S. Food and Drug Administration (FDA) said on Feb. 25 that although there are currently no reported drug shortages due to the coronavirus outbreak, it anticipates the medical supply chain will likely be affected.
Stephen Hahn, commissioner of the FDA, told reporters Tuesday the agency has been proactively reaching out to hundreds of medical product manufacturers to gauge potential disruptions to critical medical products in the United States, and none have yet reported anticipated shortages.
“FDA is keenly aware that the outbreak will likely affect the medical product supply chain, including potential disruptions to suppliers [and] shortages of critical medical products in the U.S.,” Hahn said.
“It’s important to note that FDA is not aware of any medical product shortages at this time,” Hahn continued, adding that the agency is monitoring several products that might be at risk, in particular shortages of medical products.
Hahn later elaborated and said that the United States could see shortages of personal protective equipment such as masks and gowns.
“There’s no question that there’s pressure on the demand side here,” he told reporters. “We’re keeping a very close eye on this and a forward-leaning approach, because we may in fact see some effect on the supply chain there.”
Ninety-six percent of pharmacists in the country said they’re selling surgical masks faster than they can restock and nearly 4 out of 10 said they can’t get enough respirator masks, according to a survey earlier this month from the National Community Pharmacists Association. Many reported shortages of hand sanitizers, surface sanitizers, and gloves.
The Centers for Disease Control and Prevention said this month that some partners were alerting agency officials to higher than usual demand for face masks and N-95 respirators. The agency doesn’t recommend people wear masks unless they are around known cases or they have the virus, or are under investigation for possibly having the virus and are around other people.
Hahn’s comments came after an FDA spokeswoman on Monday said the agency had contacted producers of about 20 drugs that either source all of their main ingredients from or are finished in China to gauge if they will face shortages due to the coronavirus outbreak.
None of the companies reported that a shortage is expected for their drugs due to the outbreak, FDA spokeswoman Stephanie Caccomo said.
“We have been in contact with those firms to understand if they face any drug shortage risks due to the outbreak,” Caccomo said in a statement late Monday. “None of these firms has reported any shortage to date.”
Caccomo did not identify any of the drugs or the companies.
She said the FDA has also reached out to more than 180 manufacturers to remind them of their requirement to notify the regulator of any expected supply disruptions.
U.S. officials raised concerns this week about the security of the U.S. drug supply chain in the wake of the coronavirus outbreak in China, where a significant portion of the ingredients used to make prescription drugs are manufactured.
Around 88 percent of the active pharmaceutical ingredients used in drugs for the U.S. market were manufactured overseas in 2018, according to the FDA. About 14 percent of the active pharmaceutical ingredients for U.S. drugs in that year were produced in China, the FDA said.
It had been reported that there could be an upcoming shortage of about 150 prescription drugs, sparking concern as the number of confirmed coronavirus in the United States rose to 57 on Tuesday.
“Please be assured if a potential shortage or disruption of medical products is identified by the FDA, we will use all of our available tools to react swiftly and mitigate the impact to U.S. patients and health care professionals, and we will take steps to quickly share that information with the public,” Hahn added.
Zachary Stieber and Reuters contributed to this report.