FDA Still Addressing Drug Shortages Resulting from Manufacturing Disruptions in Puerto Rico

The agency’s focus remains on the IV saline shortage.

In an update on efforts by the US Food and Drug Administration (FDA) to address manufacturing issues in Puerto Rico following Hurricanes Irma and Maria, agency Commissioner Scott Gottlieb noted that FDA remains focused on addressing the IV saline shortage.

The January update follows an earlier update issued in November 2017. The saline shortage was an issue at that time as well. Currently, most manufacturers in Puerto Rico are reporting that they are now on the power grid. The commercial power grid does remain unstable, however. Despite these concerns, Gottlieb noted that because producers are at least connected to the grid, there is reduced risk that future shortages should result from the impact of the storm on the island’s manufacturing sector.

Most notably, Gottlieb said that Baxter, “a leading producer of IV saline fluids,” announced toward the end of December that all of its facilities in Puerto Rico were connected to the commercial power grid. “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,” Gottlieb said. He also noted that Baxter’s access to power should also ameliorate the shortage situation for pediatric and adult formulations of IV amino acids. The shortage of amino acids for injection used in nutritional formulations has been a second area of focus for FDA.

“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,” Gottlieb stated. “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.”


Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.