FDA’s Gottlieb updates on Puerto Rico and medical product shortages

FDA commissioner Dr. Scott Gottlieb provided an update today to the work that the agency is doing to help medical device manufacturers in Puerto Rico in the weeks following Hurricanes Irma and Maria.

The FDA chief noted that even though some major medical product manufacturers have regained power, many firms continue to run on generator power and their production levels cannot return to baseline levels.

The shortage of IV saline products is slated to improve by the end of 2017, Gottlieb reported, as the FDA has helped restore production to one of Baxter‘s (NYSE:BAX) facilities on the island. The agency has also approved IV solution products from Fresenius Kabi and Laboratorios Grifols to help mitigate the shortage.

Although the situation with IV saline products has progressed positively since the hurricanes devastated Puerto Rico, there are still other drugs in short supply that have the FDA concerned.

“In addition to our ongoing concerns related to IV saline products, we also are particularly focused on the shortage of amino acids for injection,” Gottlieb said in prepared remarks. “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.”

Baxter is one of the largest manufacturers of amino acids for the U.S. market. The company is working with the FDA to temporarily import amino acids from Baxter’s U.K.- and Italy-based facilities.

“We’re also working with other manufacturers of amino acids to increase supplies to address the shortage, including ICU Medical and B. Braun,” Gottlieb added. “ICU Medical had experienced manufacturing delays, but now plans to return to the market soon, which will further help address the shortage.”

The commissioner added that the agency is monitoring approximately 90 medical products manufactured in Puerto Rico, including biologics drugs and devices.

“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,” he said. “We at the FDA are committed to seeing the hurricane response through to the island’s recovery and doing all we can to address these shortages.”

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