IV saline product stock improving, but hurricane-caused drug shortages remain — 3 insights

Eric Oliver - Print  |

FDA Commissioner Scott Gottlieb released an update on hurricane-caused drug shortages, saying while IV saline product inventory is improving, production capacity issues remain throughout Puerto Rico.

Here's what you should know know:

1. Dr. Gottlieb said power is being restored at manufacturing plants across Puerto Rico, but he anticipates that many plants will continue to run on generators and will not return to baseline production levels for some time.

2. Concerning IV saline product shortages, the FDA worked with Baxter to restore operations in the company's Puerto Rico facility. The FDA also approved IV solutions from Fresenius Kabi and Laboratorios Grifols to help mitigate the shortage. Both newly-approved companies are ramping up production. Dr. Gottlieb said, "We now believe that the shortage situation related to IV saline products will improve by the end of 2017."

3. Despite the efforts to mitigate saline shortages, the FDA is now concerned about amino acids for injections shortages. Puerto Rico-based manufacturers have been unable to return to baseline production levels for amino acids as well. The FDA is working with Baxter to import amino acids from Baxter's United Kingdom-based facilities. ICT Medical is expected to return to market soon as well.

Dr. Gottlieb concluded, "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." He reaffirmed the agency's efforts to prevent medical supply shortages.

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