March 2, 2020

FDA just added a new drug to its shortage list—and the coronavirus is to blame

Daily Briefing

    FDA on Tuesday announced that it added an unnamed drug to its shortage list after a manufacturer alerted the agency to issues at a site affected by the coronavirus outbreak.

    Our analysis: The 'recurring themes' of disease outbreaks

    About the shortage

    FDA said the manufacturer told the agency that it's experiencing an issue "related to a site affected by coronavirus" that manufactures an active ingredient used in the drug.

    FDA said it is working with the manufacturer to "mitigate the shortage." FDA Commissioner Stephen Hahn said, in the meantime, there are "other alternatives" to the unnamed drug that patients can use.

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    According to CNN, the drug shortage is the first that FDA has attributed to the coronavirus.

    FDA monitoring more potential drug shortages

    However, officials have raised concerns that the United States could experience additional drug shortages tied to the coronavirus epidemic. According to FDA, China in 2018 was the second-largest exporter of drugs and biologics to the United States and the largest exporter of medical devices.

    FDA spokesperson Stephanie Caccomo said the agency has identified 20 drugs that either are solely produced in China or are made from active pharmaceutical ingredients that solely come from China and has contacted the manufacturers to determine whether they might face "any drug shortage risks due to the outbreak."

    Caccomo said FDA also has reminded more than 180 other pharmaceutical manufacturers that they are required to notify the agency of any supply disruptions or shortages.

    In addition, Hahn said the agency has been "closely monitoring" the United States' supply of medical products "with the expectation" that the coronavirus epidemic could lead to shortages.

    Trump admin considers using special powers to expand US manufacturing of protective gear

    Meanwhile, two U.S. officials last week told Reuters that the Trump administration is considering using special powers under the Defense Production Act (DPA) to expand U.S. manufacturing of masks and clothing that can be used to protect individuals from contracting the coronavirus.

    DPA permits the president to order manufacturing expansions of products or materials needed for specific reasons, including national security.

    HHS Secretary Alex Azar last week told lawmakers that the United States could need 300 million N95 face masks to help protect health care workers against the virus, but the country currently has just 30 million stockpiled.

    A Department of Homeland Security (DHS)official told Rueters that, during an interagency call on Wednesday, HHS and DHS officials discussed potentially invoking the president's powers under DPA to increase manufacturing of personal protective equipment that can be used to prevent coronavirus infection.

    According to Reuters, a White House official confirmed that the administration is considering such a move. The official, who spoke to Reuters on a condition of anonymity, explained, "Let's say 'Company A' makes a multitude of respiratory masks but they spend 80% of their assembly lines on masks that painters wear and only 20% on the N95. We will have the ability to tell corporations, 'No, you change your production line so it is now 80% of the N95 masks and 20% of the other.'"

    HHS declined to comment on the matter and DHS did not immediately respond to a request for comment, Reuters reports (Christensen, CNN, 2/28; FDA release, 2/27; Winsor/Schumaker, ABC News, 2/28; Erman, Reuters, 2/25; Hesson/Alper, Reuters, 2/27).

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