'There is a surge in cases and a shortage of masks, but the United States rejects China's kn95 masks'. The US News website buzzfeed reported on March 29 that kn95 masks are a Chinese substitute for N95 masks, but the US Food and Drug Administration (FDA) refused to allow them to enter the United States. The article questioned that there were 'political reasons' behind the FDA's decision.
Novel coronavirus pneumonia is banned by the United States government when it is looking for N95 masks to protect medical staff from new crown pneumonia patients. Buzzfeed reported that the U.S. Centers for Disease Control (CDC) said that the effectiveness of kn95 mask is the same as that of N95, and it is one of many 'suitable substitutes' of' N95 mask in short supply '. According to 3m, the world's largest mask manufacturer, kn95 and N95 masks are 'equivalent' and 'it can be expected that their functions are very similar'. However, according to the law, masks and most medical devices cannot be sold in the U.S. market without FDA approval. On March 28, in order to alleviate the shortage of medical protective equipment in China, FDA urgently approved non-n95 masks certified by the European Union and five countries (Australia, Brazil, Japan, South Korea and Mexico), but kn95 masks were not urgently authorized. " Without FDA approval, importers will hesitate to order kn95 masks because they are worried that they will be detained by customs. Many hospitals refuse to accept these donations, even if they are free, because they are worried that if medical staff get sick while using unauthorized equipment, they will bear legal responsibility. "
The FDA did not respond to requests for comment, the report said. Most of all masks, including N95 and kn95, are made in China. Now the United States must compete with dozens of countries desperately buying masks. American importer Bob & middot; Tilton said, 'it's easier to buy kn95 masks now, but N95 is hard to buy. But I don't want to risk losing $500000 or $1 million to ship masks. " Buzzfeed said that under normal circumstances, N95 masks are about $1 per piece in U.S. stores, and the wholesale price is as low as 35 cents. " However, in just two months, the epidemic exhausted the world's supply and formed a gray market. The price of each N95 mask reached US $12 or even higher. This has also opened the door to some illegal actors. "
According to the above report, some people believe that the 'omission' of the FDA may be due to the intensification of tensions between China and the United States. Byron & middot, who operates e-commerce; Walker said, 'this seems to have happened for political reasons'. But Vanessa middot, a lawyer who studies FDA law; Pollard said she knew that some medical supplies suppliers were asking the FDA about Approving the import of kn95 masks. 'I believe the FDA is considering allowing the import of kn95.' This is based on science and I don't think it has any political significance. " Karen & middot, senior executive of GHX, an American pharmaceutical supply chain platform; Conway said that in view of the extreme shortage of masks, 'the most important thing is to let medical workers get what they need.' The report said that although some hospitals followed the advice of lawyers and refused any kn95 masks, some doctors and nurses received donations because of their urgent needs. Kn95 masks have also begun to appear in U.S. retail stores.
Li Haidong, a professor of the foreign affairs school, told the global times on the 31st that there is no political consideration for the US FDA to do so? There is no doubt that it exists. The U.S. government, especially the military, recently made it clear that it should use the process of the U.S. response to the epidemic to get rid of its dependence on Chinese medical materials and equipment, and even get rid of its dependence on China. This view undoubtedly shows that there are political, security and other factors in American policy. Some people believe that even if the United States has some loose measures due to the emergency of the epidemic, it is difficult to be 100% honest. Source: cover news