Biologics

ISCT Criticizes Ruling in Cell, Gene Therapy Case

The International Society for Cell & Gene Therapy (ISCT) says a recent California federal court ruling in favor of the California Stem Cell Treatment Center and against FDA “is flawed and has inserted regulatory uncertainty into the cell and gene therapy market, creating opportunities for clinics offering purported treatments that are scientifically unproven and potentially dangerous to patients.” An ISCT statement says the ruling that FDA has no jurisdiction over the California Stem Cell Treatment Center’s products contains scientific inaccuracies that may have affected the judge’s ruling.

The ISCT Committee on the Ethics of Cell and Gene Therapy says examples of statements in the decisions that are problematic and unfounded are:

statements about stromal vascular fraction that are both inaccurate and unsupported by current scientific knowledge;
the assertion that the clinical networks involved in the suit use FDA-authorized devices to produce autologous stem cell-based interventions does not recognize that the devices in question may not have been authorized by FDA or authorized for other purposes and have not been designed for the production of stem cell therapies; and
the statement that culture-expanded mesenchymal stem cells should not be regulated as drugs conflicts with scientific evidence, which “opens the door to unchecked administration of poorly characterized and non-standardized cell preparations with unknown safety and efficacy and may pose significant risks to patients.”

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