FDA Commissioner Gottlieb Gives Update on Saline and Amino Acid Shortages

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.
Jan 05, 2018
By BioPharm International Editors

FDA Commissioner Scott Gottlieb, MD, released a statement on Jan. 4, 2018 giving an update on recovery efforts in Puerto Rico to mitigate the intravenous (IV) saline and amino acids for injection shortages that had been exacerbated by Hurricane Maria in September 2017.

Based on information the agency has been receiving from the drug companies impacted by the hurricane, the agency expects that the shortage of IV saline fluids will improve in early 2018, with continuing improvement in the coming weeks. Similarly, the shortage situation for pediatric and adult formulations of IV amino acids is also anticipated to continue to improve in the coming weeks.

“Given the improvements we’ve seen over the last few weeks, I’m optimistic that supplies of IV saline and amino acids will increase over the next few weeks, and the stress of the shortage will begin to abate, even if the shortages will not be fully resolved immediately,” said Gottlieb in his statement.

“That said, the production situation in Puerto Rico remains fragile. As many risks and challenges remain and there are still shortages affecting patient care, we’ll continue to take all possible steps to help improve shortage situations. The cautious progress I’m able to report is the result of a sustained effort by industry, and by the dedication of the agency’s professional staff and other partners,” he added.

Baxter, a major producer of IV saline fluids with three manufacturing sites in Puerto Rico, announced just before the holidays that all its facilities on the island have returned to the commercial power grid.

“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. 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 [FDA’s] drug shortage website as soon as it’s available,” Gottlieb said.

The return of power to all of Baxter’s facilities also bodes well for the company’s pediatric and adult formulations of IV amino acids, which is critically needed for patients not able to eat and who need to receive nutrition intravenously. Supply of the product is expected to improve over the coming weeks. In addition to Baxter’s recovery, another firm that previously manufactured IV amino acids, ICU Medical, is planning to return to the market early this year, according to Gottlieb.

“This step will further help increase supplies of these products. [FDA] will continue to take all possible steps to continue to address this critical shortage as well,” he said.

In addition to manufacturers, FDA has also been in frequent communication with hospitals, healthcare providers, and health system organizations. The agency has addressed the burden that was placed on these organizations due to the drug shortages and the efforts that have been taken to mitigate the situation. The agency will continue to engage with these organizations and provide information to support the management of the shortages.

In addition, all the other companies that manufacture products largely or entirely in Puerto Rico and that were on FDA’s initial list of drugs considered critical and at risk of potential shortages are now back on the power grid, Gottlieb asserted. “Many of these companies report to us that their production is increasing. While there are still many challenges that remain—for instance, the commercial power grid remains unstable in places—these developments reduce the risk of any future shortages resulting from the impact of the storm on the island’s manufacturing sector,” he said.

Further information on drug shortages, current product availability, and estimate shortage duration can be found on FDA’s drug shortage website. Gottlieb noted that, in most cases, manufacturers, based on historical need, are allocating IV saline products to healthcare providers until supply is improved. The agency is encouraging hospitals to consider clinical recommendations for managing the shortage of these IV fluids, including recommendations issued by the American Society of Health-System Pharmacists (ASHP) and the University of Utah.

The guidance, Small-Volume Parenteral Solutions Shortages, recently released by ASHP provides an outline for potential actions that organizations and healthcare professionals can consider in managing the shortage. FDA is continuing to pursue efforts to increase supplies of IV saline while there still remains concern over product availability. The agency’s efforts include approval of IV saline products from additional sources, such as Fresenius Kabi and Laboratorios Grifols.

Source: FDA

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