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Impact News Service
December 6, 2017 Wednesday
319 words
FDA commissioner updates on Puerto Rico-related medical product shortages

Washington, DC: American Pharmacists Association has issued the following news release:  

In an update on the status of medical product shortages after Hurricane Maria hit Puerto Rico earlier this year, FDA Commissioner Scott Gottlieb said that progress is being made, but more still needs to be done. As power is being restored across the island, some major medical product manufacturing facilities are coming back online and stabilizing their production. 'Until the grid is reliably restored,' Gottlieb said, 'many firms will continue to run on generator power or require generators as a backup and production levels will not return to their baseline levels.'

He said FDA is working with Baxter, a supplier of I.V saline products, to help them restore their production operations in their Puerto Rican facilities. Additionally, FDA has approved I.V solution products from Fresenius Kabi and Laboratorios Grifols to mitigate the shortage. Both companies have been working to increase production of saline products. As a result, Gottlieb said the I.V saline product shortage is expected to improve by year-end. Another big concern is the shortage of amino acids for injection. FDA is working with Baxter, one of the largest manufacturers of this product serving the U.S market, on the temporary importation of amino acids for pediatric and adult formulations of I.V amino acids from U.K and Italian Baxter facilities. FDA is also working with other manufacturers of amino acids to boost supplies in light of the shortage. Gottlieb said the agency is monitoring some 90 medical products manufactured in Puerto Rico—including biologics, devices, and drugs—that are important to patients. He noted, 'Mitigating medical product shortages will require a sustained effort by industry, the agency, and other partners as we work with manufacturers to return to production levels that adequately meet the needs of patients.'
December 7, 2017
      
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