Biologics

Change FDA Sepsis Screening Strategy: Dingell and McCormick

Reps. Debbie Dingell (D-MI) and Rich McCormick (R-GA) are calling on FDA to adopt a more effective strategy for identifying sepsis in human tissue donors. In a 5/26 letter to acting commissioner Kyle Diamantas, Dingell and McCormick say they have learned from talking with experts that screening for systemic infection (meaning evidence of an active, disseminated infection with the potential for communicable disease transmission), rather than a sepsis diagnosis, may be a more effective strategy for mitigating disease transmission. They ask the agency to consider adopting such an approach before finalizing a draft guidance on recommendations to reduce the risk of transmission of disease agents associated with sepsis by human cells, tissues, and cellular and tissue-based products.

“When FDA finalized its most recent guidance on donor eligibility in 2007,” the two write, “it was reasonable to classify sepsis as a relevant communicable disease agent or disease as a surrogate measure for infection risk. However, given the evolution of sepsis in clinical practice since the 2007 donor eligibility guidance, a sepsis diagnosis is not a scientifically valid surrogate for communicable disease risk in tissue donation. As detailed below, reliance on sepsis as a surrogate may both unnecessarily exclude otherwise eligible donors and potentially fail to identify donors with true potential for disease transmission.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome