Drugs

FDA Monitoring for Shortages Under Virus Plan

FDA says it is keeping a close eye on the medical product supply chain during the current coronavirus outbreak. “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 says in 2/14 virus update. “We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages.” Additional resources have been directed to coordinate data to better identify any potential vulnerabilities to the U.S. medical product sectorm he says.

FDA has been in contact with global regulators and hundreds of medical product manufacturers to assess and monitor for indications and early warning signs of potential manufacturing discontinuances or interruptions due to the outbreak. “It’s worth noting that there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China,” Hahn says. “We are tracking reports of increased ordering of some essential medical devices through distributors, such as personal protective equipment (e.g. respirators and surgical gowns, gloves and masks),” he says.

If a potential shortage or disruption of medical products is identified by FDA, Hahn says the agency will use all available tools to react swiftly and mitigate the impact to U.S. patients and health care professionals. These tools include closely working with manufacturers and expediting review of alternate supply to prevent shortages, he says.

While FDA conducts about 500 inspections per year in China, the agency continues to maintain an inspection hold on these due to a State Department warning advising against travel to the country. “For the month of February, the FDA identified all scheduled inspections in China, and they were either postponed or the agency was able to utilize other information to inform decisions allowing the products to enter our U.S. market,” Hahn says. Of these 90% were routine surveillance inspections and the remaining for-cause inspections scheduled for February were able to be postponed after reviewing all available information, he says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome