A hurricane due to hit southeastern states in the US this week has prompted President Trump to declare an emergency in the state of North Carolina. Earlier this week, President Trump reported, “The places that are in the way and in the most jeopardy would be Virginia, North Carolina [and] South Carolina.”
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb expressed concern for the life sciences industry via social media, announcing plans to assist pharmaceutical companies where required, to mitigate the threat of drug shortages.
#FDA closely monitoring for potential shortages related to Hurricanes #Florence & #Olivia. We've offered assistance to firms in impacted areas to help prevent shortage risks of critical products, such as temporarily using alternate facilities until storm impacts are mitigated. pic.twitter.com/i3d84pNBLj— Scott Gottlieb, M.D. (@SGottliebFDA) September 12, 2018
Major pharmaceutical companies with facilities on the southeastern coast have planned site closures, evacuations, and logistics operations to avoid drug shortages, in preparation for Hurricane Florence.
Pfizer has a gene therapy manufacturing facility in Sanford, North Carolina, and owns a laboratory in Richmond, Virginia; its subsidiary Hospira also has a manufacturing facility in Rocky Mount, where the firm makes and supplies products, such as anesthetics, for hospital use.
Pfizer spokesperson Steven Danehy told us the firm is “monitoring the situation…as of now we plan to suspend operations on Thursday at both of our facilities in North Carolina.”
“Only essential emergency, utility, and monitoring personnel will be onsite during the storm,” he added.
In order to ensure uninterrupted supply of medicines, Danehy told us the firm has contingency plans in place to “mitigate interruptions during natural disasters”.
Merck & Co. (known as MSD outside of North America) also has operations in North Carolina, including a vaccine manufacturing plant in Durham and corporate offices in Charlotte. Merck also has a plant in Elkton, Virginia, which houses vaccine operations.
“The manufacturing facilities in North Carolina and Virginia are shutting down,” confirmed the firm in an emailed statement.
“Crisis management plans are being executed – shipments in and out of the facilities have been adjusted and additional power generators have been acquired in case they are needed. Continuity of supply of our medicines and vaccines is one of our highest priorities. We will continue to closely monitor the situation and the impact the storm may have,” we were told.
Along with Pfizer and Merck, Novartis told us its primary focus is to ensure the health and safety of its associates, as well as business continuity. The firm has a presence in North Carolina, as well as sites in Philadelphia – which borders Virginia.
“We have communicated safety preparations to approximately 2,700 associates and contractors in the storm’s path, including the closure of the Wilson, North Carolina site from Wednesday evening through Sunday evening, and we expect to resume production on Monday,” company spokesperson Sofina Mirza-Reid told us.
In addition, the firm is shifting product out of “potentially impacted areas” in order to maintain drug supply, we were told.
Catalent’s Morrisville site in North Carolina, which houses development and analytical operations, is currently the only facility in the contract manufacturing organisation’s (CMO) network that could potentially be affected.
“The safety of Catalent’s employees is paramount and the situation is being closely monitored,” Catalent’s strategic marketing director for oral drug delivery, Elizabeth Hickman, told us.
“Catalent has completed a thorough risk assessment of all likely scenarios and, if necessary, is prepared to temporarily close the Morrisville facility.
“Comprehensive plans are in place to ensure reliable supply of product to customers, including back up stocks, cloud-based storage of essential information, and alternative power supplies and manufacturing processes, which will minimize any potential impact on product supply,” we were told.
Germany-headquartered Bayer also told us it has facilities “in the storm’s path,” however confirmed that none of these potentially affected sites will impact its manufacturing or anticipated ability to meet customer demands.
“We have provided guidance to employees in the forecasted path of the storm and have taken steps to ensure their awareness and preparedness. We will be coordinating any response plans to ensure their well-being after the storm,” a Bayer spokesperson told us.
In addition, the pharma giant has donated $100,000 (€85,453) toward the American National Red Cross Disaster Preparedness Programme, and is working with Animal Search and Rescue to provide needed products to those caring for animals who have been displaced, injured, or have become ill during the hurricane.