Here are four ways the FDA is addressing the shortage.
1. Allowing importation of IV saline products from outside the U.S. The FDA is working with Baxter International, the biggest supplier of large saline bags, to import IV saline products from its facilities in Ireland and Australia.
2. Working with Puerto Rican authorities and manufactures. The FDA is helping saline manufacturing plants gain access to generators and fuel after Hurricane Maria knocked out power at the facilities. In addition, the FDA is helping to connect companies to local government to help clear roads and secure transportation to collect the raw ingredients needed for the saline bags.
3. Encouraging the expansion of production at existing facilities. The agency is encouraging all companies with FDA-approved saline products to increase capacity to meet demand.
4. Expediting review of new product applications to meet demand. The FDA recently approved IV solution products from Fresenius Kabi, a German pharmaceutical company and Laboratorios Grifols, a pharmaceutical company based in Spain. Dr. Gottlieb said the agency remains committed to approving safe and effective products to improve the shortage.
“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,” Dr. Gottlieb wrote.
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