The US Food and Drug Administration (FDA) has suspended inspections in China and warned Americans that there could soon be a shortage of “critical” medical products due to the corona virus outbreak.
Inspectors were pulled out of the country after the US Department of Foreign Affairs issued a warning on January 30 not to go to China.
Although the news means that the agency is lagging behind in conducting quality controls of medicines and Chinese factories where medical devices are made, Commissioner Dr. Stephen Hahn said the FDA has other tools to check Chinese products.
“The robust and layered compliance process at the FDA helps protect US patients and consumers, although we cannot currently conduct inspections in China,” he said in a statement.
It comes when officials reach nearly 200 drug manufacturers and warn them that they should tell the FDA if they have a failure to market their products on the US market.
The FDA has stopped drug and factory inspections in China since the US Department of Foreign Affairs advice warned travelers not to go to China. Pictured: FDA commissioner Dr. Stephen Hahn at a press conference
No safety and quality controls have been carried out on site since December and have been suspended at least in March. Pictured: A medical store employee organizes masks
According to the FDA data, since December 20, 2019, no inspections have been carried out from Chinese factories.
In addition to random checks, factories are also inspected after they have asked permission to send medicines or drug ingredients to the US.
TODAY USA reports that officials will not carry out on-site safety and quality checks until at least March.
Hahn states that 90 percent of the inspections planned for February were routine surveillance and not officials who investigated potential security issues.
He added that these inspections were postponed or that the FDA “used other information to make decisions that would allow the products to enter our US market.”
Hahn did not explain why no inspections were carried out in January.
Until the inspections are resumed, the FDA intends to use tools such as import screening, investigations and sampling, and to rely on a company’s earlier compliance history.
“We will continue to monitor the situation in China closely so that as the situation improves we are prepared to resume routine inspections,” Hahn said
“The FDA is well aware that the outbreak is likely to have consequences for the supply chain of medical products, including potential disruptions at suppliers [and] shortage of critical medical products in the US. “
Currently, more than 60 percent of products imported from China are regulated by the FDA medical devices and about 20 percent are household items.
But the FDA says there is no evidence that there is a health risk to the public from the imported products.
Officials have informed 180 drug manufacturers to alert the FDA if they expect delays in getting their products to the US. Depicted: Passengers on a metro in Milan wear masks, 26 February
The FDA says it also oversees the market for anyone making fraudulent claims about the prevention or cure of coronavirus. Pictured: a medic checks the temperature of a woman in Syria, 26 February
More than 81,000 people worldwide have been infected with coronavirus and more than 2,700 people have died
On Monday, the agency said it had contacted 180 drug manufacturers to remind them that they are required to notify the FDA if they think they will ship supplies to the US too late, or cannot.
About 20 medicines are exclusively from China, which means that the active ingredients come from the country or that the medicines undergo final production there.
“We have been in contact with these companies to understand if they are facing drug outbreaks,” FDA spokesperson Stephanie Caccomo said in a statement.
“None of these companies has reported a deficit so far. “We keep in touch with the manufacturers so that we can best help solve potential problems in the future.”
The agency says it is currently also monitoring the market for anyone making fraudulent claims about the prevention or cure of the new virus.
“The FDA can and will use any authority at our disposal to protect consumers from bad actors abusing a crisis to mislead the public,” a statement said.
From Wednesday, more than 80,000 people worldwide have been infected with the corona virus and more than 2,700 have died.