SILVER SPRING, Md., Sept. 28, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is dedicated to supporting the U.S. response to the devastating hurricanes that have significantly damaged parts of our nation. As part of the hurricane response, the FDA has an important role to play with respect to ensuring the safety of the products we regulate, including medicines, medical devices, food, and the blood supply. The agency's hurricane relief efforts include priority actions such as providing recommendations on how to handle food and medical products that may have been impacted by the storms, working with industry to assess damage and impact to facilities, to avoid–where possible–food and crop loss, and coordinating with federal and local partners to help identify solutions to prevent shortages of life-saving therapies.
"As we continue our concerted effort to provide needed assistance to citizens in Puerto Rico and the U.S. Virgin Islands, we're also diligently working to prevent–whenever possible--medical product shortages as a result of Hurricane Maria. Additionally, the agency is committed to help these facilities, which are vital to these local economies, get back to full operation. Our emergency operations team is taking the lead in FDA's efforts on multiple fronts, from direct work with citizens to efforts to prevent medical product shortages," said FDA Commissioner Scott Gottlieb, M.D.
"Shortages have traditionally been handled by individual centers, but the unique logistical challenges in Puerto Rico require creative solutions and the ability to prioritize our efforts. By focusing our efforts through an expanded capacity we created as part of our emergency operations staff, we're able to leverage their expertise and cross-cutting perspective to address and prioritize the potential for medical product shortages and work towards solutions more effectively with federal partners and industry."
The following is an update on FDA's hurricane response efforts:
| Snapshots |
By the Numbers (as of 9/27) |
| Overall Hurricane Response
- All FDA staff are accounted for in Texas, Florida, and Georgia.
- There are currently no drug shortages resulting directly from the impact of the storms. This information is constantly evolving as companies assess the hurricane damage to Puerto Rico.
- In partnership with the AABB Interorganizational Task Force (ITF), FDA is working to ensure that there is an adequate blood supply in the continental U.S. and U.S. territories.
- FDA shared information about potential impacts on crops in impacted areas and continues to work closely with the U.S. Department of Agriculture and other partners to coordinate and reduce crop impacts whenever possible.
- FDA field teams continue to work alongside state partners in assessing damage to FDA regulated facilities.
Hurricane Maria Response
- The majority of FDA staff in Puerto Rico have been accounted for and FDA continues to work to reach remaining employees located in areas with more severe communications challenges.
- FDA is working closely with the Departments of Health and Human Services and Homeland Security, as well as local agencies, to find solutions to help prevent or limit any potential drug shortages that may or may not be directly related to the hurricane impacts.
- FDA, with federal partners, is coordinating with health care service companies working to ensure that Puerto Ricans have access to medical products.
- FDA is working in partnership with the AABB ITF, to ensure the people of Puerto Rico have access to safe blood products.
- FDA employees are preparing to deploy as part of USPHS for a variety of missions, including staffing mobile medical units, in areas impacted by Hurricane Maria.
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Overall Hurricane Response
- Only 2 of FDA's 30 facilities impacted by the storms remain closed.
- Approximately 9,000 firms in the path of the storms were identified for follow-up by FDA.
- Calls have been placed to nearly 5,000 firms to assess the impact of the storms; the agency has reached 60 percent of those firms and more than 200 site visits are planned.
- More than 200 of FDA's U.S. Public Health Service (USPHS) officers have been deployed to impacted areas, and there are approximately 150 more are on alert who could be called to deploy at any time.
- 150 FDA civilian staff have volunteered to join the Federal Emergency Management Agency's response to impacted U.S. regions.
Hurricane Maria Response
- There are more than 500 medical product facilities in Puerto Rico.
- More than 20 firms were identified as having medically important FDA regulated products.
- More than 40 high-priority drugs have been identified--their continued availability is essential and short-term disruptions could lead to shortages, but FDA is working to mitigate any potential disruptions that could occur.
- FDA is currently working with at least five companies impacted by the hurricane to prevent critical shortages of medical products in Puerto Rico and across the U.S. Assistance includes coordinating transport of certain critical drugs out of Puerto Rico. This number could increase in coming weeks.
- More than 700 food facilities have been identified in Puerto Rico and we will be working there to assess these operations.
- Nearly 100 FDA regulated facilities were identified in the U.S. Virgin Islands.
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For more information on these and other FDA hurricane response efforts and advice:
Hurricane Safety Resources Page
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricanes Harvey and Irma
Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA's work with farmers affected by the storms
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.
Media Inquiries: Megan McSeveney, 240-402-4514, [email protected]; Jennifer Dooren, 301-796-2983, [email protected]
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
Related Links
http://www.fda.gov
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