December 4, 2017Regulatory
According to FDA, 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. At the FDA, is remaining 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.
Over the last few weeks, FDA has been addressing the IV saline products shortage, which was exacerbated by Hurricane Maria. FDA has been closely working with one supplier, Baxter, to help them restore production operations in their Puerto Rico facilities. FDA 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, FDA now believes that the shortage situation related to IV saline products will improve by the end of 2017. While FDA has made progress on this front, unfortunately there continue to be drug shortage issues that are of serious concern to the agency. In addition to FDA's ongoing concerns related to IV saline products, FDA is 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.
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 U.S. 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. FDA is 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. 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 the needs of patients -- to prevent potential shortages of medically important products where possible, and help ensure that any shortages that do occur are mitigated as quickly as possible. FDA does understand the burden and stress drug shortages have on patients, health care providers and hospitals. FDA is monitoring approximately 90 medical products manufactured on Puerto Rico (which includes biologics, devices and drugs) that are important to patients. Mitigating medical product shortages will require a sustained effort by industry, the agency and other partners as we work with manufacturers to return to production levels that adequately meet the needs of patients.