FDA Fast Facts: Hurricane Michael Response Efforts

For Immediate Release: October 11, 2018
Media Inquiries: Megan McSeveney, 240-402-4514, [email protected]
Consumer Inquiries: 888-INFO-FDA

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On October 9, U.S. Department of Health and Human Services Secretary Alex Azar declared a public health emergency in Florida in advance of Hurricane Michael. The department continues to closely monitor the storm, which made landfall yesterday as a category 4 hurricane and continues to move across the Southeastern U.S. The U.S. Food and Drug Administration is actively involved in the emergency response efforts coordinated by HHS and FEMA. Our current priority is to focus on emergency response and lifesaving actions, especially in support of those in the hurricane’s path. We have identified more than 3,000 FDA-regulated facilities in the path of the storm and are closely monitoring the impact, as well as continuously updating the status of these facilities.

“Hurricane Michael continues to create dangerous conditions throughout large areas of the U.S. Gulf Coast and Southeastern U.S. Our thoughts are with those in the impacted areas, including Florida, Georgia and Alabama. Extensive damages from storm surges, flooding and high winds, as well as widespread power outages have been reported. At the FDA, we are working diligently to provide resources to residents in the region and to help ensure the safety of the products we regulate, including medicines, medical devices, food and the blood supply,” said FDA Commissioner Scott Gottlieb, M.D. “We have been closely collaborating with state and federal partners to provide technical assistance and support and we will continue to do so over the coming weeks as we will continue to assess the damage from this dangerous storm. We already have taken initial steps to identify FDA-regulated facilities in areas in the storm’s path and are closely monitoring its impact. Our Emergency Operations Center has been activated and FDA staff are working diligently to assess facilities that produce critically important medical products to help ensure that there are no shortages of those products. We are also providing information to farmers whose crops or animal food may be impacted, and we stand ready to assist any food or veterinary medicine facilities that may experience damage and have questions on how to safely restore their operations.”

The following is an update on the FDA’s current response efforts:

Snapshots	By the Numbers (as of 10/11/2018)
The FDA is monitoring firms that manufacture critically important medical products and is closely coordinating with them to ensure that we quickly address any potential shortage issues through measures, such as using temporary alternate facilities until storm impacts can be mitigated or allowing temporary importations. The FDA is identifying food facilities and food crops that may be impacted by the storm and may need technical assistance to safely restore their operations. We are providing state partners and farmers Resources for Food Producers in Flooded Areas Due To Hurricane Michael and Resources for Animal Food Producers in Flooded Areas of Gulf Coast At this time, blood supply needs appear to be met in impacted areas. The FDA and other members of the AABB Task Force are monitoring the situation closely and stand ready to provide assistance if needed.	The FDA has identified and begun assessing more than 3,000 FDA-regulated facilities, including more than 1,200 medical product firms as the hurricane continues to track across the Southeastern U.S. As part of our efforts to help prevent any medical product shortages from the hurricane, the FDA has identified and continues to monitor closely: 9 firms that manufacture critically important medical drugs; 11 firms that manufacture critically important medical devices; and 2 firms that manufacture critically important animal drugs. Several of the FDA’s Public Health Service Commissioned Corps officers are preparing to deploy to assist HHS response efforts, including pharmacists, nurses, physicians, engineers and veterinarians. The FDA has activated its Emergency Operations Center with support from 6 FDA Centers, the Office of Regulatory Affairs and multiple other offices. Approximately 50 FDA employees live in areas of concern in FL, GA, and AL.

For more information:

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.