The U.S. has its first case of a coronavirus-related drug shortage, the FDA said Feb. 27.
The FDA didn't release the name of the drug in shortage or the manufacturer. The agency told Becker's Hospital Review that the information is confidential commercial information and that while drugmakers have to report drug supply interruptions to the FDA, they aren't legally required to provide detailed information.
The drugmaker told the FDA the shortage was caused by an issue with manufacturing an active pharmaceutical ingredient used in the drug. Thirteen percent of APIs used in U.S. drugs are manufactured in China, where the coronavirus outbreak started.
The FDA said Feb. 26 that it is tracking 20 drugs that either solely source their APIs from China or make finished drug products in China for potential shortages. It said it is in contact with 180 drugmakers to remind them they are required to report any anticipated shortages to the agency and asked them to evaluate their supply chains.
The FDA said it is working with the drugmaker on a solution and said there are alternative versions of the drug in shortage still available to U.S. consumers.
The agency added that there are still no known medical device shortages, but devicemakers aren't required to report when they anticipate shortages.
The agency also said that there are four proposals in the president's budget that would better equip it to prevent or mitigate medical product shortages, including lengthening drug expiration dates where possible, requiring risk management plans, improving supply chain data and establishing reporting requirements for medical devicemakers.
Read the full news release here