FDA statement on response to ongoing drug shortages for critical products

FDA reports it continues to work with manufacturers to help address and mitigate drug shortages of medically necessary products used to prevent or treat a serious or life-threatening disease or medical condition.

FDA reports it continues to work with manufacturers to help address and mitigate drug shortages of medically necessary products used to prevent or treat a serious or life-threatening disease or medical condition. In the wake of the 2017 hurricane season's impact on Puerto Rico, many hospitals throughout the United States and overseas experienced serious shortfalls of essential products such as I.V. fluids, opioid analgesics, and EpiPen. After collaboration with a wide range of stakeholders, these I.V. fluid shortages are beginning to improve. Baxter is now producing at significantly higher levels. Other companies are also producing critically-needed saline, many of which received expedited FDA reviews of their applications and supplements to add capacity and additional supply. 2017 also saw a manufacturing-related shortage of injectable opioid analgesics. Shortages of these particular drugs were caused by production delays due to a number of changes and upgrades at a Pfizer facility in Kansas. While Pfizer currently expects that delays will continue until 2019, FDA is working with them to increase supplies before then. Multiple factors, including regional supply disruptions and manufacturer issues, have contributed to EpiPen’s limited availability in some places. FDA has been working closely with Mylan regarding the status of EpiPen production supply and has been in with the other manufacturers of epinephrine auto-injectors regarding their supply status. FDA anticipates the issue to be short-term.