FDA Reports Coronavirus-caused Drug Shortage
FDA says an unidentified drug manufacturer has alerted the agency about a drug shortage related to a manufacturing site affected by the coronavirus. “The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug,” FDA commissioner Stephen Hahn says. “It is important to note that there are other alternatives that can be used by patients,” he says. “We are working with the manufacturer as well as other manufacturers to mitigate the shortage.”
Since January, FDA has been closely watching about 20 drug products that are solely sourced from China. The agency say it has also “been reaching out to over 180 manufacturers and reminding them of their requirement to notify FDA of any anticipated supply disruptions. In addition, we have asked them to evaluate their entire supply chain, including active pharmaceutical ingredients and other components manufactured in China.”
For medical devices, Hahn says the agency is aware of 63 manufacturers which represent 72 facilities in China that produce essential medical devices. “We are aware that several of these facilities in China are adversely affected by COVID-19, citing workforce challenges, including the necessary quarantine of workers,” Hahn says. “While the FDA continues to assess whether manufacturing disruptions will affect overall market availability of these products, there are currently no reported shortages for these types of medical devices within the U.S. market.”
Personal protective equipment — surgical gowns, gloves, masks, respirator protective devices, etc. — have seen increased market demand and supply challenges, Hahn says. “However, the FDA is currently not aware of specific widespread shortages of medical devices, but we are aware of reports from CDC and other U.S. partners of increased ordering of a range of human medical products through distributors as some healthcare facilities in the U.S. are preparing for potential needs if the outbreak becomes severe,” he says.
Hahn noted that there are four specific proposals included in the President’s budget request that would aid FDA in preventing or mitigating medical product shortages. They are:
1. Lengthen Expiration Dates to Mitigate Critical Human Drug Shortages: By expanding FDA’s authority to require, when likely to help prevent or mitigate a shortage, that an applicant evaluate, submit studies to the FDA, and label a product with the longest possible expiration date that the agency agrees is scientifically justified.
2. Improve Critical Infrastructure by Requiring Risk Management Plans: Enabling FDA to require drug makers to conduct periodic risk assessments to identify the vulnerabilities in their manufacturing supply chain (inclusive of contract manufacturing facilities), and develop plans to mitigate the risks associated with the identified vulnerabilities.
3. Improve Critical Infrastructure through Improved Data Sharing and Require More Accurate Supply Chain Information: Allowing FDA to require information to assess critical infrastructure, as well as manufacturing quality and capacity, would facilitate more accurate and timely supply chain monitoring and improve its ability to recognize shortage signals.
4. Establish Reporting Requirements for Device Manufacturers: FDA currently does not have the same authorities for medical device shortages as it does for drugs and biological products. FDA seeks authority to require medical device manufacturers to notify it when they become aware of a circumstance that could lead to a device shortage or meaningful disruption in the supply of that device in the U.S.