Coronavirus: Senators Call on FDA to Ensure Supply of Products From China is Safe

Regulatory NewsRegulatory News | 06 February 2020 |  By 

As the number of infections and deaths from the novel coronavirus (2019-nCoV) outbreak in China continue to rise, US Sens. Marco Rubio (R-FL) and Chris Murphy (D-CT) on Thursday called on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to ensure the safety of the drugs and medical devices imported from China.
In a letter to Hahn, the senators point out that the US imported more than $12 billion in food, drugs and medical devices from China in 2018 and that China is one of the largest producers of active pharmaceutical ingredients.
“While the Centers for Disease Control and Prevention [CDC] stated it’s unlikely the 2019-nCoV will spread to the United States from these products, we are concerned that the pandemic could impact the FDA’s ability to monitor compliance with good manufacturing standards and the ability for Chinese manufacturers to maintain supplies to meet demand in the United States and the growing demands in China,” the senators write.
They also ask Hahn whether FDA has the resources to ensure the 2019-nCoV outbreak does not impact the US supply of food, drugs and devices.
The senators further ask the commissioner how many FDA personnel are still in China to conduct inspections, as the US has ordered nonessential personnel to leave the country, and whether the outbreak has affected the agency’s inspection schedule.
Some FDA staff have already left the country and are back in the US. William Sutton, assistant country director of FDA’s China office, said on LinkedIn that he’s back in Bethesda, MD, on self-quarantine for 14 days.
Additionally, the senators ask what steps the agency has taken to ensure there are no shortages of drugs or devices due to manufacturing disruptions in China stemming from the outbreak.
Just days before the letter, FDA issued the first emergency use authorization (EUA) for a diagnostic developed by the CDC, which will allow labs across the country to use it.


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