涅狄格州的克里斯·墨菲（Chris Murphy）和佛罗里达州的马可·鲁比奥（Marco Rubio）已经要求FDA专员斯蒂芬·哈恩（Stephen Hahn）确保从中国进口的医疗器械和药物在冠状病毒爆发期间是安全的。尽管病毒不太可能通过这些产品传播，但参议员们表示担心，疫情可能会影响该机构监测遵约情况的能力，比如在美国要求非必要人员离开中国后进行检查。

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

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.

* 本文原出处为CSCMP中国认证总网站。