FDA Provides Updates on Certain Drug ShortagesBy
Douglas Throckmorton, the Deputy Director for Regulatory Programs for the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA), provided an update on how the FDA is addressing drug shortages for what it considers “critical” products, including saline, opioid analgesics (pain medications), and EpiPen, Mylan’s self-injectable epinephrine products used for emergency-care situations.
“As Commissioner Gottlieb recently explained and we detailed last week in our 2017 annual report to Congress on drug shortages, the FDA does everything possible within our statutory authority to help address drug shortages,” Throckmorton said in a June 20, 2018 agency statement. “For example, using a range of available tools, the FDA’s Center for Drug Evaluation and Research worked with manufacturers to prevent 145 drug shortages in 2017. Still, there were 39 new shortages that occurred during 2017, and although this number is far lower than the peak of 251 new shortages in 2011, we recognize that many of these shortages have been for critical drug products and that they are having a tangible impact on patients.”
Throckmorton noted that many of Puerto Rico’s drug and device manufacturers were impacted during the 2017 hurricane season. One affected manufacturer was Baxter Healthcare, which is a manufacturer of sodium chloride-based (saline) and dextrose-based fluids for IV infusion, which are used for mixing drugs for use in healthcare settings and to keep patients hydrated. The FDA partnered with Baxter and other manufacturers to mitigate the shortage, which led to the temporary import of IV fluids from other countries and expedited review of product applications from other manufacturers.
“After much work and a great deal of collaboration with a wide range of stakeholders, these IV fluid shortages are beginning to improve,” Throckmorton said in his statement. “Baxter is now producing at significantly higher levels. Other companies, including ICU Medical, B. Braun Medical, Laboratorios Grifols and Fresenius Kabi, are also producing critically needed saline, many of which received expedited FDA reviews of their applications and supplements to add capacity and additional supply. In addition, six different manufacturing sites continue to temporarily import saline, which is helping to meet patient needs until the shortage completely resolves and approved IV fluid products can meet all demand.”
Throckmorton continued to address the supply of injectable opioid analgesic shortages, which saw a manufacturing-related shortage in 2017, according to information from the FDA. Shortages of these drugs were caused by production delays at a Pfizer facility in Kansas due to issues related to manufacturing quality, changes, and upgrades, according to information from the FDA. “While Pfizer currently expects that delays will continue until 2019, we are working with them to increase supplies before then,” Throckmorton said in his June statement. “One of the actions taken to help mitigate the impact of the shortage was that Pfizer recently coordinated with the agency to release some of the products that were on hold due to potential quality issues to distribute them with instructions for the safe handling and use to help mitigate any risks to patients. We are also working with other companies that manufacture FDA-approved injectable analgesics, which have agreed to increase their production, including Akorn Pharmaceuticals, Fresenius Kabi USA and West-Ward Pharmaceuticals.”
Another recent product supply issue that Throckmorton says has been of particular concern involves EpiPen (epinephrine injection). “Multiple factors, including regional supply disruptions and manufacturer issues, have contributed to EpiPen’s limited availability in certain areas in the U.S.,” Throckmorton said in his statement. “The FDA has been working closely with Mylan regarding the status of EpiPen production supply and has been in contact with the other manufacturers of epinephrine auto-injectors regarding their supply status.” Based on Mylan’s information, Throckmorton says the FDA anticipates the issue to be short-term.
The Deputy Director’s update followed a letter dated June 15, 2018 by a group of bipartisan senators to US FDA Commissioner Scott Gottlieb to ask the agency for a report and recommendations to Congress on how the agency is addressing drug shortages. The senators asked the agency to convene the Drug Shortage Task Force to develop the report and recommendations by no later than the end of 2019.