America’s Blood Centers (ABC) submitted a letter this week to the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regarding the draft guidance titled “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry.” The letter addressed to CBER Director Peter Marks, MD, PhD and Nicole Verdun, MD, director of the Office of Blood Research and Review with CBER, asks the agency to “finalize” the draft guidance with the announcement regarding the Administration’s intention to end the COVID-19 public health emergency (PHE) in the U.S. in May, “[i]f this guidance is not finalized before the expiration of the PHE on May 11th, blood centers will be forced to again modify their systems to revert to the previous requirements. Such a change will require blood center resources, including staff time, be[ing] dedicated to this over other priorities, only to have to again make modifications when the guidance is finalized. This additional burden has the potential to interfere with blood centers’ ability to efficiently implement other changes that would need to be made, including the change required to adopt the draft Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.”
Additionally, the letter references joint comments submitted by the blood community in July 2022. “We believe the requirement to report annually the number and type of donations released under the conditions of the draft guidance is overly burdensome and may actually be an inadvertent deterrent to releasing units — which is counter to the intent to increase available units for the blood supply…[B]lood centers maintain processes to record, track and trend deviations, as well as thresholds for process improvement. As an alternative to the annual reporting requirement, we recommend that FDA allow the review and monitoring of error rates and corrective actions to be conducted by FDA investigators during the inspection process.” The letter also thanked FDA for its efforts to help blood centers “maintain a safe and robust blood supply” throughout the COVID-19 pandemic [with] the issuance of several [FDA] guidances in April 2020, including “Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency” (Alternative Procedures Guideline). [ABC] appreciates FDA’s issuance of guidance documents to extend many of these changes after the expiration of the PHE.” ABC will continue to provide updates to member blood centers as they become available.