Nine weeks after hurricanes Maria and Irma brought devastation to Puerto Rico, FDA commissioner Dr. Scott Gottlieb says hospitals across the U.S. are reporting shortages of IV fluids – medical products that are often sourced from Puerto Rico.
Hospitals are specifically noting that 0.9% injection bags of saline, used to inject drugs intravenously, are of short supply. Gottlieb said in a prepared statement that despite the agency’s best efforts, the damage to Puerto Rico’s infrastructure has “greatly exacerbated this supply issue.”
To help address the shortage, the FDA is temporarily permitting the importation of IV saline products from outside the U.S., encouraging existing facilities to expand their production capabilities and speeding up the agency’s review of promising new product applications.
The FDA pointed to its work with Baxter (NYSE:BAX) as an example, reporting that they are helping the supplier restore operations in its Puerto Rico facility and get critical products onto and off the island.
The agency is also working with local and federal authorities to address issues with the island’s basic infrastructure. The FDA is helping production facilities access fuel or generators, as well as roads and transportation to import raw ingredients.
“As part of our efforts to reduce the risk of further shortages, the FDA has been working with federal and local government partners to prioritize a small number of critical facilities based on public health needs, including those plants that manufacture IV saline bags, for consideration or prioritization to gain earlier access to the electrical grid,” Gottlieb said in prepared remarks.
Federal and local authorities have been very responsive to these requests. We’re hopeful that these companies manufacturing medically important products will see their power needs addressed on an accelerated basis. The FDA continues to encourage the companies with FDA-approved saline products to add capacity to meet U.S. demand. We’re also working to identify additional potential manufacturers.
That said, this shortage will require a sustained effort by industry, the agency and other partners to return to production levels that adequately meet the needs of patients. For our part, the FDA will continue to do all we can to address this shortage. We also want to discourage hoarding of products by some healthcare providers. We’re concerned that shortages of some products may be exacerbated in part because of hoarding behavior.”