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FDA Statement

Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages

For Immediate Release

January 4, 2018

Summary

Update on the continued efforts to mitigate the IV saline and amino acids for injection shortages exacerbated by Hurricane Maria

Statement

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As we enter the new year and pass the 100-day mark from when Hurricane Maria made landfall in Puerto Rico, we want to provide an update on the current recovery efforts, the state of existing drug shortages that resulted from the impact of the storm and our continued commitment to help the island fully recover.

A key area of focus for the FDA remains addressing the IV saline shortage, which has impacted patients, health care providers and hospitals. Based on the information we’re receiving from the companies, we expect that the shortage of IV saline fluids will improve in early 2018, with continuing improvements in the weeks ahead. Just before the holidays, Baxter – a leading producer of IV saline fluids – announced that all their facilities on the island have returned to the commercial power grid.

Moreover, all the other companies that manufacture products that were on our initial list of drugs that we considered critical and at risk of potential shortages – because the drugs were largely or entirely manufactured in Puerto Rico – are now on the power grid. 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.

Our drug shortage website remains the best source of information the agency has regarding product availability. The website includes a list of manufacturers with products in shortage, and the current availability and estimated shortage duration for the products. In most cases, the manufacturers, based on historical need, are allocating IV saline products to health care providers until supply is improved. We also continue to encourage 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 recently released guidance Small-Volume Parenteral Solutions Shortages provides an outline for potential actions for organizations and health care professionals to consider in managing the shortage. Further, we are continuing to pursue efforts to increase supplies of IV saline while product availability concerns remain. This includes our approval of IV saline products from additional 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. 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.

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. In addition, one of the firms that previously manufactured IV amino acids, ICU Medical, is planning to return to the market early this year. This step will further help increase supplies of these products. The FDA will continue to take all possible steps to continue to address this critical shortage as well.

The FDA also has been in frequent communication with hospitals, health care providers and health system organizations about the burden the shortages of these drugs have placed on them and the efforts they have taken to mitigate them. We will continue to engage with them and provide information to support their management of the shortages.

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. 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. I’ve said from the beginning that the FDA is in this for the long run. We’re fully committed to Puerto Rico’s recovery and its return as a vital and robust base for the skilled manufacturing of medical products. Based on the progress made so far and what we expect to see in the coming weeks, I’m confident we’ll continue to make progress toward that goal in the new year.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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