Regulatory Focus™ > News Articles > More Than 100 Days After Hurricane Maria, Drug Shortages Situation Expected to Improve

More Than 100 Days After Hurricane Maria, Drug Shortages Situation Expected to Improve

Posted 04 January 2018 | By Zachary Brennan 

More Than 100 Days After Hurricane Maria, Drug Shortages Situation Expected to Improve

The US Food and Drug Administration (FDA) on Thursday announced that shortages of IV saline are expected to improve early this year as Baxter – a leading producer of IV saline fluids – has said all its facilities on Puerto Rico have now returned to the commercial power grid.

The good news on Baxter comes as the agency said all other companies that were on an initial list of drugs considered at risk of potential shortages – because the drugs were largely or entirely manufactured on the island – are now also on the power grid.

"The return of power to all of Baxter’s facilities also means that the shortage situation for pediatric and adult formulations of IV amino acids, a product of critical need for patients who are not able to eat and need to receive their nutrition intravenously, also is anticipated to continue to improve in the coming weeks," FDA said in a statement. "In addition, one of the firms that previously manufactured IV amino acids, ICU Medical, is planning to return to the market early this year."

Back in October, Baxter began importing sodium chloride and glucose intravenous infusion products from Ireland and Australia to address shortages because of Hurricane Maria.

Baxter spokesman Bill Rader confirmed to Focus that all of the company's facilities have been re-connected to the power grid and that "all facilities will continue to have backup diesel generation in case of power interruptions, which still occur intermittently.

"Baxter activated targeted recovery strategies across our global manufacturing network, including working with the FDA to secure regulatory discretion for the temporary special importation of certain products from Baxter facilities in Ireland, Australia, Canada, Mexico, England and Italy. These imported products began reaching healthcare providers in late October and product continues to enter the supply pipeline...Overall, we expect to return to more normal supply levels for products made in Puerto Rico in the coming weeks," Rader said.

FDA added that it’s looking to increase supplies of IV saline while product availability concerns remain, including via the approval of IV saline products from companies like Fresenius Kabi and Laboratorios Grifols.

"We continue to take additional steps to identify other supply sources for saline and encourage companies to submit data to extend expiration dates for these critical drugs," FDA said. "We understand that some product that remains at the hospital level is nearing expiry and could continue to be used if the expiration dates can be safely extended. All new information, including new supply sources and extensions of expiration dating, will be posted on the FDA’s drug shortage website as soon as it’s available."


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