FDA Initiates Response Efforts Post Hurricane FlorenceBy
The US Food and Drug Administration (FDA) has taken action to support recovery from Hurricane Florence, particularly to prevent drug shortages from pharmaceutical companies manufacturing important drugs. The hurricane struck North Carolina, South Carolina, and Virginia earlier this month (September 2018).
“As part of our efforts to help prevent any medical product shortages as a result of Hurricane Florence’s impact, our team has been in ongoing, close contact with approximately 30 firms that manufacture critically important medical drugs,” said FDA Commissioner Scott Gottlieb in a September 19, 2018 agency statement. “Fortunately, at this time, we do not anticipate any critical shortages of medical products, but we recognize we are not out of the clear and there continues to be threats of rapid flooding. If needed, we will not hesitate to tap into any of the measures available to us to help mitigate potential shortages. We are committed to working with states and other partners to assess the storm’s impacts over the coming weeks and take all steps possible to ensure the safety of the products we regulate, including medicines, medical devices, food, and the blood supply.”
The FDA has identified and tracked over 7,000 FDA-regulated facilities, including nearly 3,000 medical product firms as the hurricane approached. Along with the 30 firms that the FDA has been in contact with that manufacture critically important medical drugs, the FDA also continues to monitor 10 firms that manufacture critically important biological products and/or devices. After Virginia, North Carolina, and South Carolina were hit by multiple tornadoes in the wake of Hurricane Florence, the FDA worked to identify approximately 60 FDA-regulated facilities near those areas and has begun assessing potential impacts.