[11/14/2017] The U.S. Food and Drug Administration is actively working with drug manufacturers to address critical shortages of IV fluids aggravated by Hurricane Maria’s impact on Puerto Rican drug manufacturing facilities.
Because the hurricane disrupted Baxter International’s IV fluid production facilities in Puerto Rico, FDA has not objected to the temporary import from Baxter facilities in Ireland, Australia, Mexico and Canada and from B. Braun in Germany. B. Braun recently announced they were slowing production. It is important to note that when FDA exercises regulatory discretion with respect to importation of a medically necessary drug from another country, the agency evaluates the foreign firms and drug products to ensure they are of adequate quality and do not pose undo risks to patients. A letter from the company explaining that the drug is being imported to address a shortage is posted on the FDA Drug Shortages webpage and accompanies the drug when it is shipped.
In addition to the temporary imports, FDA continues to expedite review of drug applications that may help relieve shortages. The agency recently approved Fresenius Kabi and Laboratorios Grifols saline products and anticipates that availability of these products will help address the shortage.
Although Hurricane Maria affected Baxter’s facilities in Puerto Rico, there have been limited supplies of IV fluids since 2014. Since that time, the approved manufacturers Pfizer/Hospira and now ICU Medical, Baxter and B. Braun, have worked with FDA to meet steadily increasing demand for IV fluids.
Since 2014, FDA has encouraged the firms with FDA-approved saline products to add capacity to meet increased U.S. demand and has searched for additional manufacturers to help prevent future shortages. The agency anticipates this situation will improve over time and will continue to address this shortage.
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