Addressing Shortages; An Update from the FACT Professional Relations Committee on Fludarabine and Cord Blood Processing Device Shortages
Drug and supply shortages have been frequently plaguing cellular therapy programs. Current shortages include, but are likely not limited to, Fludarabine, Albumin, marrow collection kits, and apheresis circuits. Such shortages have been topics of discussion by the FACT Professional Relations Committee. Professional societies and registries advocate for solutions to the operational, regulatory, and quality challenges these shortages cause.
The American Society for Transplantation and Cellular Therapy (ASTCT) and the National Marrow Donor Program (NMDP)/Be the Match have been reporting their efforts to the FACT Professional Relations Committee regarding the Fludarabine Phosphate Injection shortage in the United States. This shortage is forcing centers to use non-FDA approved lymphodepleting regimens that may negatively influence the outcome of blood and marrow transplantation and CAR-T cell therapy. In June 2022, the two organizations submitted a letter to the U.S. Food and Drug Administration (FDA) outlining the issue, the negative impact on patients, and potential solutions. ASTCT and NMDP/Be the Match are continuing to advocate for solutions and work with the FDA to alleviate the issue. During the most recent committee meeting in October 2022, updates included reports of current availability from Teva Pharmaceuticals and expected availability from Fresenius Kabi and Areva Pharmaceuticals in late October.
Preparative regimens must be documented within Standard Operating Procedures or clinical guidelines per FACT Standards. If Fludarabine is specifically used as part of a preparative regimen but other drugs must be used due to the shortage, then this is a deviation and must comply with established deviation processes as outlined in an accredited organization’s Quality Management Plan. For ongoing situations such as Fludarabine shortages, guidelines could also include alternative protocols when the main protocol is not possible due to shortages. Since this would be an established and approved approach to handling shortages, then it would not be a deviation every time one occurs.
An additional shortage of processing technology that is impacting cell processing at cord blood banks and transplant programs results from the exit of Cytiva (formerly GE/BioSafe) from the medical device market. Banks and programs must identify new processing technology and, if applicable, submit pre-approval supplements to the FDA. Collaboration among cord blood banks to share validation protocols could ease the burden on individual banks and result in standardized processes. For more information on how you can help, please reach out to Donna Regan at firstname.lastname@example.org.