More oversight of donated tissue products urgently needed, say experts and Michigan policymakers

Certain therapeutics, such as human cells and tissues, are only minimally regulated by the U.S. Food and Drug Administration

May 3, 2024 11:21 AM

Author | Kelly Malcom

Jacob Dwyer, Justine Ross, Michigan Medicine

A JAMA viewpoint outlines the tragic story of Shandra Eisenga, a patient who received spine surgery for back pain only to inexplicably contract tuberculosis.

She eventually died as a result of the disease.

The case was all too familiar to University of Michigan’s Robert Dickson, M.D., the medical director of the Washtenaw County Tuberculosis Program, who connected the outbreak to a previous one in 2021.

That outbreak was linked to cadaveric bone material infected with TB and subsequently implanted in some 113 patients.

Alarmed, Dickson reached out to Representative Deborah Dingell of Michigan to enlist her help in understanding how these products could fall through the regulatory cracks.

Bone graft material, the piece explains, falls within a category of therapeutics called human cells, tissues, and cellular and tissue-based products that are only minimally regulated for safety or efficacy by the FDA, unlike pharmaceuticals, blood products and organs for transplantation.

Since Eisenga’s death, Dickson and Dingell have sought to close the loophole that allows these products to go inadequately screened for TB, to raise physician and patient awareness about the risks of such products and to impose penalties for manufacturers whose tissue products result in infectious disease outbreaks.

Citation: "Urgent Need for Regulatory Oversight of Human Cells, Tissues and Cellular and Tissue-Based Products,” JAMA. DOI:10.1001/jama.2024.6834

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