FDA anticipates disruptions, shortages as China outbreak plays out

The FDA is bracing for drug and medical supply shortages in the U.S. as the COVID-19 outbreak from China continues to spread globally. The agency has contacted hundreds of drug and devicemakers, and, so far, the links of the supply chain have held but will take all available measures if disruptions appear.

The agency also has halted all plant inspections in China for now but says it can rely on facilities' compliance history and other information to determine whether drugs are safe for import. 

“We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.,” FDA Commissioner Stephen Hahn said in a statement late Friday. 

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He said the agency is speaking with regulators globally and has added resources to quickly spot “potential disruptions or shortages.”

“It’s worth noting that there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China,” Hahn said. “Raw materials used in manufacturing do come from China and other locations in Southeast Asia and we are in contact with biologics manufacturers to gauge any supply concerns regarding raw materials.”

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Other governments also are taking stock. EU Health Commissioner Stella Kyriakides last week said her group has a task force monitoring supplies, and, for now, no shortages are in evidence. In India, which produces about 40% of the generic drugs used by U.S. patients, a survey determined that manufacturers generally have about a two-month supply of ingredients from China on hand.  

Because of the State Department warning against travel to and from China, inspections have been put on hold, Hahn said. The FDA estimates that only about 10% of pending inspections are for cause. Those, as well as routine inspections, have been postponed. Hahn said the agency can rely on its “risk-based model” to alert the agency to any serious concern that would require the agency to change its approach. He said the FDA has the authority to take actions, like seizing products already on the market, if they pose a danger to the public. 

“(T)his is a dynamic situation that we are closely monitoring and will remain vigilant in this critical work," Hahn said.