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In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.
On Nov. 30, 2017, FDA Commissioner Scott Gottlieb released a statement warning of a supply shortage of amino acids for injection due to a disruption at Baxter’s amino acids production facilities in Puerto Rico in the wake of Hurricane Maria, which hit the island in September 2017.
“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 said in an FDA press statement.
FDA has been working with Baxter, one of the largest manufacturers of amino acids that serves the US market, to facilitate temporary importation of amino acids for pediatric and adult formulations of intravenous amino acids from Baxter’s facilities in the United Kingdom and Italy. The agency is also working with other amino acids manufacturers, including ICU Medical and B. Braun, to increase supplies to address the shortage. According to the agency, ICU Medical had experienced manufacturing delays, but plans to return to the market soon to further help address the shortage.
“We continue 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. We understand the burden and stress drug shortages have on patients, health care providers and hospitals,” Gottlieb said in the press statement.
The agency is monitoring approximately 90 medical products manufactured in Puerto Rico, including biologics, devices, and drugs, that are vital to patients. The agency cautions that mitigating medical product shortages will require a sustained effort by industry, FDA, and other partners as the agency continues to work with manufacturers to return to production levels that adequately meet patients’ needs.
Earlier in October 2017, FDA had issued a statement from Gottlieb regarding the agency’s work to help prevent a shortage of Baxter’s sodium chloride 0.9% injection bags (saline solution), which are manufactured in Puerto Rico. Supply of this product, whose availability was already lacking prior to the impact of Hurricanes Irma and Maria, was further threatened by the destruction caused by these hurricanes.
In his Nov. 30, 2017 statement, Gottlieb gave an update on the progress of the Baxter saline supply shortage.
“Over the last few weeks, I’ve talked about the [intravenous (IV)] saline products shortage, which was exacerbated by Hurricane Maria. We have been closely working with one supplier, Baxter, to help them restore production operations in their Puerto Rico facilities. 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 said in the statement.
He also noted that, while Puerto Rico is making progress in its effort to recover from the hurricanes, recovery remains a long process and much work is still left to do. “At [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 said in the statement.