FDA Acknowledges First Drug Shortage Caused by COVID-19

In a recent statement, the FDA announced that one drug is in short supply due to the COVID-19 (coronavirus) outbreak. However, the agency did not disclose the name of the drug, its manufacturer, or where the product or its raw ingredients come from because U.S. law protects companies from having such confidential information disclosed.

The agency has previously said it was bracing for possible drug shortages as the virus disrupts the medical product supply chain in China.

FDA commissioner Stephen Hahn, MD, said the drug, which was already on the agency’s shortage list, is in short supply “due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug.” He noted that patients can access alternatives while the FDA works to address the shortage. The agency currently is monitoring about 20 products produced or sourced in China, but Dr. Hahn says these are considered “noncritical drugs.”

In The New York Times, pharmacists and other health-care stakeholders welcomed the government’s transparency. “Full transparency on issues like this is important to maintain public trust, and any hints that the government is hiding important information will sow distrust,” said Michael Carome, MD, director of consumer advocacy organization Public Citizen’s Health Research Group.

“Pharmacists want transparency, they want to be able to have the information that’s needed so they can better care for their patients,” Ilisa Bernstein, PharmD, JD, senior vice president at the American Pharmacists Association and former compliance official at the FDA, said. “But behind the scenes, I know the FDA is working hard to figure out what the impact will be on the availability of that product.”

Sources: The New York Times, February 29, 2020; FDA drug shortages list; FDA statement, February 27, 2020.