Why FDA Should Refer Babesia Policy Discussion to the ACBTSA
The Food and Drug Administration's Blood Products Advisory Committee (BPAC), rejecting recommendations from the blood community, endorsed nationwideserological testing for Babesia microti, combined with nucleic acid testing (NAT) of donations collected in high-risk states (see AABB statement). This means testing millions of donors with virtually no infection risk, consuming limited resources that might be better used elsewhere in pursuit of patient safety. The model presented to BPAC by the agency on the impact of testing is based on unvalidated diagnoses of babesiosis derived from Centers for Medicare & Medicaid Services (CMS) claims data in a population (elderly Medicare beneficiaries) that does not reflect donors (see BPAC issue summary). This is in contrast to direct evidence from prospectiveBabesiascreening by the American Red Cross, suggesting that much more limited testing is just as protective as extended screening and more cost effective.
Does BPAC miss the context in which their recommendation is made? Pursuit of zero risk goes beyond FDA approval of safe, effective screening assays, and enters the arenas of diverse priorities competing for limited patient safety resources and societal risk tolerance. However, the agency is prohibited from addressing cost and cost-effectiveness, and should not annex decision-making where these critical issues will not be accorded due consideration. Do BPAC and FDA properly reflect the breadth of stakeholders who should dictate patient safety policy? Absent robust, formal representation from patients, physicians outside transfusion medicine, healthcare epidemiologists and risk managers, hospital administrators, third party payers, and bioethicists - we think not.
The fiscal asymmetry of BPAC's recommendation is problematic for our centers in endemic areas. Our CEOs in those areas are gravely concerned because hospitals/hospital systems faced with an upcharge of ≈ $20 forBabesiaNAT-negative components could look to suppliers in non-endemic states, destabilizing blood systems where there is babesiosis risk. The committee has not addressed this concern or its mitigation.
We need a new model, facing, as we do, complex decisions about a wide spectrum of safety concerns like financing the implementation of pathogen reduction. Blood safety should not be considered from the FDA-blood community silo alone, our historic vantage point. Transfusion-transmitted babesiosis warrants mitigation. This requires testing, and the assays under consideration by the agency have appropriate performance characteristics. Those are the two issues that BPAC should have addressed. For the broader decision-making task, viewed from the societal perspective, ABC asks that BPAC and the agency refer the policy discussion to the HHS Advisory Committee on Blood and Tissue Safety and Availability, a group charged with evaluating these larger issues. The Alliance of Blood Operator's Risk Based Decision Making Framework is an appropriate template for the new model.
Susan Rossmann, MD, PhD, Board President; firstname.lastname@example.org