FDA’s Gottlieb updates on IV bag shortages after Hurricane Maria

FDA commissioner Dr. Scott Gottlieb expects that the shortage of IV fluids caused by Hurricane Maria in Puerto Rico will improve in the coming weeks and months, according to a statement issued by the agency yesterday.

The regulatory chief said that the FDA is working with manufacturers like Baxter (NYSE:BAX) and B. Braun to import products from foreign facilities into the U.S., as well as helping to get their Puerto Rico-based facilities operating at full capacity.

Gottlieb added that the agency has approved IV saline products from both Fresenius Kabi (NYSE:FMS) and Grifols (NSDQ:GRFS) to quickly increase product supply in the U.S. market.

The shortage of IV saline bags has been exacerbated by a flu season that is worse than usual, heightening the demand for products that keep patients hydrated.

The FDA commissioner asked that companies submit data regarding the expiration dates for IV saline products so the agency can evaluate if the expiration dates can be extended.

“If expiration dates can be safety extended, it would allow some near-expiry product that remains at the hospital level to be used,” he explained.

“Despite these steps, it may still take more time for new product supply to diffuse across the marketplace and have a noticeable impact on product availability. Because of the generally tight product supply, even when certain volumes of IV saline are not technically in shortage, there could be individual institutions that have a hard time obtaining adequate stock. We’ve heard from institutions that only have a few days’ worth of supply on hand; as well as institutions that have to ration diminished stores of these products. We believe that as more supply enters the market these challenges will start to diminish.”

He added that the demand for empty IV containers has spiked as hospitals are turning toward the empty containers as an alternative to filled bags. The empty containers are regulated by the FDA as Class II medical devices and are made by many of the same companies that manufacture the filled bags.

“We understand that, with the shortage of filled bags, hospitals and other health care providers are turning to the repackaging or compounding of IV saline fluids and utilizing empty IV containers. This is resulting in diminished supplies of these containers and concerns that supplies of empty bags could tighten further,” Gottlieb wrote.

The FDA is working directly with manufacturers, distributors, hospitals and other groups to mitigate any potential shortage of the empty IV containers.

“The dynamics of all shortages are challenging. This situation is no different. We recognize that these challenges have created hardships and, in some cases, have had an impact on patients,” Gottlieb said. “We’re deeply concerned by this situation. Resolving it remains one of my highest priorities. We’re actively monitoring the situation and taking actions to address this shortage. We also will continue to communicate with the public about any possible new shortages that could occur as a consequence of the IV saline solution shortage as the agency receives additional information from manufacturers and distributors.”

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