Lawmakers urge FDA to tighten bone graft guidance


A group of lawmakers wrote a letter to Robert Califf, MD, the U.S. FDA commissioner, pushing for stricter guidance for bone grafts in light of a recent spate of tuberculosis linked to orthopedic products.

The Aug. 29 letter from Debbie Stabenow D-Mich., Gary Peters D-Mich., John Moolenaar R-Mich. and Debbie Dingell D-Mich. homes in on Azyio Biologics, which was involved in 2021 and 2023 recalls of its bone graft products. In both instances, bone graft products were found to be tainted by tuberculosis, and the infected lots came from a single donor.

The lawmakers recommend the FDA consider guidelines from the American Association of Tissue Banks' bulletin, which outlines donor ineligibility criteria including TB exposure, infection, travel history and age.

"While Azyio took proactive testing precautions after the 2021 incident, these precautions were not sufficient to prevent an outbreak two years later," the letter said. "Under the Public Health Service Act, the FDA has authority to determine the parameters of tested communicable diseases …. As TB incidence is lower compared to the aforementioned diseases, the prevalence and devastating impacts of these outbreaks calls for prompt action from the FDA."

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