FDA Addresses Drug Shortages Due to Manufacturing Disruptions in Puerto Rico

The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb updated the agency’s efforts to address drug shortages resulting from manufacturing disruptions following the damage caused by recent hurricanes in Puerto Rico.

“While Puerto Rico is making progress in its effort to recover from the devastation left by the hurricanes, it remains a long process and there’s a lot of work left to do,” said Gottlieb in a November 30, 2017 statement. “At the FDA, we’re vigilant about helping address the challenges that remain. Power is being restored across the island and, importantly, some major medical product manufacturing facilities are coming back online and stabilizing their production. However, until the grid is reliably restored, 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.”

Gottlieb further addressed how the agency is addressing saline drug shortages resulting from manufacturing disruptions caused by the hurricane damage. Gottlieb had addressed the saline drug shortage earlier in a November 17, 2017 statement. He said hospitals across the country were reporting shortages of IV fluids, particularly sodium chloride 0.9% injection bags. Saline IV fluids, which are used to inject drugs intravenously in hospital and outpatient settings, have been intermittently in shortage dating back to 2014, according to the FDA. These products are on the list of approximately 90 medical products (which includes biologics, devices and drugs) that the FDA has been monitoring since the storms hit.

The FDA says it is taking several steps in conjunction with manufacturers of these products, which include: (1) temporarily allowing the importation of IV saline products from facilities outside of the US; (2) encouraging the expansion of production at existing facilities to meet shortfalls; and (3) expediting the review of new product applications that will help address the shortage.

“We have been closely working with one supplier, Baxter, to help them restore production operations in their Puerto Rico facilities,” he said in the November 30, 2017 statement. “We also approved IV solution products from Fresenius Kabi and Laboratorios Grifols to mitigate the shortage, and both of those companies have been working to increase production of saline products. Thanks to steps like these, we now believe that the shortage situation related to IV saline products will improve by the end of 2017.”

Gottlieb also pointed to other shortages, specifically amino acids for injection used in nutritional formulations. “While we’ve made progress on this front, unfortunately there continue to be drug shortage issues that are of serious concern to the agency,” he said in the November 30, 2017 statement.” In addition to our ongoing concerns related to IV saline products, we also are particularly focused on the shortage of amino acids for injection. This product is of critical need for patients, including children and infants, who are not able to eat and need to receive their nutrition intravenously. Like with saline, an ongoing amino acid short supply situation was worsened by Hurricane Maria’s impact on Puerto Rican drug manufacturing facilities that manufacture this product.“

Gottlieb continued to say, “Most notably, the hurricane disrupted Baxter’s amino acids production facilities in Puerto Rico; Baxter is one of the largest manufacturers of this product serving the US market. In order to help mitigate this shortage, the FDA has worked with Baxter to facilitate the temporary importation of amino acids for pediatric and adult formulations of IV amino acids from Baxter facilities in the United Kingdom and Italy. We’re also working with other manufacturers of amino acids to increase supplies to address the shortage, including ICU Medical and B. Braun. ICU Medical had experienced manufacturing delays, but now plans to return to the market soon, which will further help address the shortage.”

Gottlieb added that the FDA continues to work closely with federal and Puerto Rican authorities to address the needs of manufacturers on the island for power and other resources. “These efforts have been focused on preventing potential shortages of medically important products where possible, and to help ensure that any shortages that do occur are mitigated as quickly as possible, he said in the November 30 statement.

Editor’s note: This article was updated on December 1, 2017 to include further information from the FDA issued on November 30, 2017. 

Source: FDA (November 17, 2017 statement) and FDA (November 30, 2017 statement)

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