As the COVID-19 (coronavirus) outbreak continues to spread, the FDA is preparing for drug and medical supply shortages.
The agency has temporarily halted all plant inspections in China and plans to rely on the facilities’ compliance histories 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, MD, said in a statement.
“It’s worth noting that there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China,” Dr. Hahn added. “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.”
In addition, the European task force monitoring supplies has not reported any shortages. India, which produces about 40% of U.S. generic drugs, keeps a roughly 2-month supply of ingredients from China on hand.
The epidemic has also stalled research by Chinese contract research organizations (CROs), which are often staffed with scientists trained in American labs.