Moolenaar, Mich. Democrats call on FDA to fight TB outbreaks in bone graft material

U.S. Rep. John Moolenaar (R-MI) joined a bipartisan, bicameral group of Michigan lawmakers in urging the Food and Drug Administration (FDA) to ramp up efforts toward stopping the rising threat of bone grafts being tainted by tuberculosis (TB).

Rep. Moolenaar and his colleagues in a letter called on FDA Commissioner Robert Califf to work with them on preventing future outbreaks of TB in bone graft material, which the Centers for Disease Control and Prevention (CDC) reports has caused the deaths of at least two people who died after contaminated bone tissue from the same deceased donor was used in 36 patients earlier this year. A similar outbreak in 2021 killed eight people. 

The lawmakers’ request was spurred by the Aug. 10 death of Shandra Eisenga, a Marion, Mich., resident who died from complications of TB, which she contracted through a bone graft from an infected donor. The infected tissue used in Eisenga’s procedure was supplied by Maryland-based Azyio Biologics, according to the lawmakers’ letter.

“No patient should suffer such devastating health outcomes from a transplant product,” wrote Rep. Moolenaar and his colleagues, U.S. Sens. Gary Peters (D-MI) and Debbie Stabenow (D-MI) and U.S. Rep. Debbie Dingell (D-MI). “Our patients should rely on the integrity of their products, as they are used to improve their health and well-being.”

The American Association of Tissue Banks (AATB), the top accreditor of bone and tissue transplant banks, on Aug. 7 released a bulletin outlining donor ineligibility criteria, including TB exposure, infection, travel history, and age, according to their letter.

“We urge the FDA to consider these recommendations and promptly issue guidance or regulations based on sound science to protect patients and increase accountability for human tissue transplant products,” wrote Rep. Moolenaar and his colleagues.

“The tragic loss of Shandra Eisenga must be a call to action for Commissioner Califf and the FDA so that no family goes through something like this again,” Rep. Moolenaar said in a statement issued on Tuesday. “It is clear that the precautions taken after the 2021 TB outbreak have not been enough and that the FDA must do more to protect patients. Commissioner Califf should act urgently to prevent more outbreaks like this one from happening in the future.”