FDA on watch for drug shortages, fraudulent claims

Stephen Hahn, nominee to be commissioner of the Food and Drug Administration, testifies during his confirmation hearing in the Senate Health, Education, Labor and Pensions Committee on Wednesday, Nov. 20, 2019.

Bill Clark | CQ-Roll Call, Inc. | Getty Images

The U.S. Food and Drug Administration said Tuesday the agency is monitoring the market for potential drug shortages and fraudulent treatment claims as the coronavirus outbreak places a pause on its product inspections in China. 

The FDA has identified about 20 drug products that either solely source their active ingredients or produce finished drug products in China and has contacted their manufacturers to see if they have experienced any supply issues, FDA spokesperson Stephanie Caccomo said in a statement.

“None of these firms has reported any shortage to date,” Caccomo said. “We will continue to remain in contact with the manufacturers so that we can best help mitigate any potential issues in the future.”

Since Jan. 24, the FDA has also reached out to over 180 manufacturers to remind them of their requirement to notify the FDA of any anticipated supply disruptions, Caccomo said. The FDA also asked them to evaluate their entire supply chains, including ingredients and other components manufactured in China, although no firm has reported a shortage as of now. 

In a statement Monday, the FDA said it has yet to conduct inspections in China since the State Department issued a travel advisory. However, the agency maintains it has continued to conduct inspections using other methods, which includes using its authority to request records from companies in lieu of drug surveillance inspections. 

At this time, over 60% of FDA-regulated products imported from China are medical devices and 20% are housewares, the FDA said. The FDA added that there’s no evidence suggesting increased health risk from imported products. 

“As noted, this remains a dynamic situation and we will continue to assess, and update guidance as needed,” FDA commissioner Stephen Hahn said in the statement. 

The FDA also said it is aggressively monitoring the market for any products that make fraudulent coronavirus prevention and treatment claims, which it plans to enforce using “warning letters, seizures, or injunctions against products on the market that are not in compliance with the law.” 

The FDA’s warning comes after Amazon said it would remove listings from its online marketplace that claim to help stop the spread of the coronavirus. 

As of Tuesday, there were more than 80,200 confirmed cases of coronavirus and at least 2,700 deaths.

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