The FDA Takes Action
On January 16, FDA Commissioner Scott Gottlieb stated that his agency is working with IV fluid manufacturers in Puerto Rico to get them back to full capacity. In the meantime, the FDA is allowing Baxter and B. Braun to import product into the U.S. from foreign facilities including Baxter’s Brazilian facility.
The agency also fast-tracked approvals for IV saline products from Fresenius Kabi and Laboratorios Grifols.
The FDA also asked companies to submit data to extend expiration dates for these products. If expiration dates can be safety extended, it would allow some near-expiry product that remains at the hospital level to be used.
Even so, Commissioner Gottlieb is asking for patience. “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.”
Black-Market of Saline Bags?
A market for saline bags has sprung up as a result of these shortages. Empty containers are regulated by the FDA as class II medical devices.
With the shortage of filled bags, numerous hospitals and other health care providers are turning to the repackaging or compounding of IV saline fluids and utilizing empty IV containers.
And that, in turn, is creating yet another shortage. This time, empty containers.
Exacerbating the situation is this year’s severe flu season—which increases demand for saline.
In a final note to healthcare providers, the FDA said: “Individual providers may find that they’re not able to order excess supply, above the volumes they’ve purchased in the past, until there is more product in the supply chain. We’ll continue to pursue efforts to increase supplies of IV saline while product availability concerns remain, as well as monitor the impact of mitigation strategies on the supply chain.”
