The US Food and Drug Administration (FDA) has put inspections in China on hold and warned Americans there could soon be shortages of ‘critical’ medical products due the coronavirus outbreak.
Inspectors were pulled from the country after the US State Department issued an advisory warning travelers not to China on January 30.
While the news means the agency is falling behind on performing quality checks of drugs and Chinese factories where medical devices are made, Commissioner Dr Stephen Hahn said the FDA has other tools to monitor Chinese products.
‘The robust and multi-layered compliance process at the FDA is helping to protect American patients and consumers even though we are not able to conduct inspections in China at this time,’ he said in a statement.
It comes as officials reached out to nearly 200 drug manufacturers and warned them they are required to tell the FDA if they foresee a disruption in getting their products on the US market.
The FDA has halted inspections of drugs and factories in China since the US State Department advisory that warned travelers not to go to China. Pictured: FDA Commissioner Dr Stephen Hahn at a press conference
No on-site safety and quality checks have been conducted since December and they are suspended at least March. Pictured: A worker at a medical supply store organizes masks
According to FDA data, no inspections have been conducted of Chinese factories since December 20, 2019.
In addition to random surveillance checks, factories also undergo inspection after they ask for approval to send drugs or drug ingredients to the US.
USA TODAY reports that officials will not be conducting on-site safety and quality checks until at least March.
Hahn states that 90 percent of the inspections scheduled for February were routine surveillance and not officials investigating possible safety problems.
He added that these inspections have either been postponed or the FDA used ‘other information to inform decisions allowing the products to enter our US market.’
Hahn did not explain why no inspections had been conducted in January.
Until inspections resume, the FDA plan to use tools such as import screening, examinations, and sampling as well as relying on a firm’s previous compliance history.
‘We will continue to closely monitor the situation in China so that as the situation improves, we will be prepared to resume routine inspections,’ Hahn said
‘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 US.’
Currently, more than 60 percent of products imported from China that are regulated by the FDA are medical devices and about 20 percent are homegoods.
But the FDA says there is no evidence that there is a health risk to the public from the imported products.
Officials have notified 180 drug manufacturers to warn the FDA if they anticipate delays in getting their products to the US. Pictured: Passengers on a subway in Milan wear masks, February 26
The FDA says it is also monitoring the market for anyone making fraudulent claims about preventing or curing coronavirus. Pictured: A medic checks the temperature of a woman in Syria, February 26
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 reached out to 180 drug manufacturers to remind them that they are required to notify the FDA if they believe they will be late sending supplies to the US, or unable to.
About 20 drug products are solely sourced from China, meaning the active ingredients are from the country or the drugs undergo final production there.
‘We have been in contact with those firms to understand if they face any drug shortage risks due to the outbreak,’ FDA spokesperson Stephanie Caccomo said in a statement.
‘None of these firms has reported any shortage to date. ‘We will continue to remain in contact with the manufacturers so that we can best help mitigate any potential issues in the future.’
The agency says it is also currently monitoring the market for anyone making fraudulent claims about preventing or curing the new virus.
‘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,’ a statement read.
As of Wednesday, more than 80,000 people worldwide have been infected with coronavirus and more than 2,700 have died.
