Great Lakes Wire

Congressman Moolenaar and a group of bipartisan lawmakers are demanding action from FDA Commissioner Califf following the tragic death of Shandra Eisenga, who contracted tuberculosis (TB) from an infected bone graft. The lawmakers have written a letter to Commissioner Califf, calling for the development of guidelines or regulations to ensure patient safety and accountability in human tissue transplant products. They highlight the recent TB outbreaks caused by infected tissue supplied by Azyio Biologics, which resulted in 36 patients being affected across seven states, with eight deaths reported in a similar incident in 2021. The lawmakers stress the FDA's authority to address such issues under the Public Health Service Act and reference recommendations from the American Association of Tissue Banks.

The lawmakers express their concerns about the recent outbreak of TB in bone graft material, leading to serious health complications and deaths. They cite the case of a patient who suffered severe health complications after receiving an infected bone matrix material and passed away due to the TB infection. The letter points out that this is not the first incident involving Azyio Biologics, as a similar outbreak occurred in 2021, resulting in the contamination of bone grafts in up to 100 patients and eight deaths. The lawmakers emphasize that patients should be able to rely on the integrity of these products, which are meant to improve their health and well-being.

The lawmakers highlight the FDA's authority under the Public Health Service Act to determine the parameters of tested communicable diseases, including TB. They argue that the prevalence and devastating impacts of these outbreaks warrant prompt action from the FDA. They also reference Bulletin 23-6 released by the American Association of Tissue Banks, which outlines donor eligibility criteria and recommendations for reducing the risk of TB transmission. The lawmakers urge the FDA to consider these recommendations and promptly issue guidance or regulations based on sound science to protect patients and increase accountability in the transplant industry.

In conclusion, Congressman Moolenaar and other lawmakers are urging FDA Commissioner Califf to take immediate action to prevent future outbreaks of TB through infected bone grafts. They emphasize the need to protect patients and uphold the integrity of transplant products, calling for the issuance of guidelines or regulations grounded in solid scientific principles. The lawmakers reference the recent TB outbreaks caused by Azyio Biologics as evidence of the urgency of the situation and urge the FDA to consider recommendations from the American Association of Tissue Banks. They express their appreciation for the FDA's dedication to ensuring the health and safety of communities and look forward to a response and potential collaboration to prevent future outbreaks.