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Friday, April 26th, 2024

Sens. Murphy, Rubio encourage FDA to secure imports from China due to novel coronavirus outbreak

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Fearing for the pharmaceuticals, food, and medical supplies coming from China amid the novel coronavirus, U.S. Sens. Chris Murphy (D-CN) and Marco Rubio (R-FL) implored the Food and Drug Administration (FDA) to take action this week.

In a letter to FDA Commissioner Stephen Hahn, the senators said they hoped to ensure the FDA has the necessary tools to ensure safety and supply. After all, in 2018 alone, the United States imported more than $12.7 billion of pharmaceutical and antibiotics, medical devices, and food from China, as well as numerous organic chemicals used to create pharmaceutical products. It’s a major source of a wide number of products for the U.S., even accounting for nearly 10 percent of medical devices used in-country.

“While the Centers for Disease Control and Prevention 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 wrote.

The novel coronavirus, which was officially renamed COVID-19 by the World Health Organization (WHO) this week, has infected more than 42,000 people since its debut in Wuhan, China, in December 2019. The number of dead has also reached more than 1,000. Over the weekend, WHO Director-General Adhanom Ghebreyesus tweeted that the latest figures may only be the tip of the iceberg.

“There are also widespread reports of shortages of medical supplies, hospital beds, and testing kits in China to confirm potentially more cases of 2019-nCoV,” the senators wrote. “Additionally, the pandemic has forced schools and businesses throughout China to close. These closures, combined with the possibility of infected workers, could limit the ability of Chinese manufacturers to maintain the production capacity needed to keep pace with global demand. Given the strain this virus has placed on China’s healthcare system, we are concerned there could be reduced resources available to U.S. healthcare providers that rely on products manufactured in China.”

The senators also request answers to several questions by February 18, including whether the FDA has the resources needed to guarantee COVID-19 does not impact imports and what they might need to do so, how many FDA personnel are still in China to conduct inspections of supplies the United States relies on, how the FDA’s inspection schedule has been impacted, how the FDA is coordinating with companies to monitor products manufactured in China and what moves the FDA has made to ensure no shortage of essential pharmaceuticals or medical supplies from China is experienced.