Biologics

Appeals Court Gives FDA a Win on Stem Cells

The U.S. 9th Circuit Court of Appeals in San Francisco has reversed an 8/2022 California lower court decision (see earlier story) that ruled a stem cell treatment firm was exempt from FDA regulations. The lower court had declined to block California Stem Cell Treatment Center from continuing to offer its treatments to customers after a judge accepted the center’s contention that its treatments qualify for an exception from FDA regulations in part because they were tantamount to surgical procedures.

In reversing the lower court’s decision, the appeals court ruled FDA’s determination that processed stem cells are considered a “drug” was correct, according to an Los Angeles Times article. The court also accepted the agency’s position that it has the authority to regulate clinics offering purported stem cell treatments, the article says.

The Times story says FDA filed suit against the California clinic to target the widespread practice in which fat cells are extracted from a patient by liposuction. The extraction is treated to produce a fluid said to be rich in stem cells, known as a stromal vascular fraction, that is injected back into the same patient.

The lower court had ruled that the “defendants are engaged in the practice of medicine, not the manufacture of pharmaceuticals,” according to the Times. It also pointed out that FDA regulations define drugs much more broadly than the “manufacture of pharmaceuticals,” saying they are any article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”

In its ruling, the appeals court found that the stem cell mixture “fits comfortably within the Food, Drug & Cosmetic Act (FDCA) because it is sold and administered to patients for therapeutic purposes, and there is no reason to think that Congress intended it to be outside the FDCA’s scope. In fact, recent legislation suggests that Congress presupposes that the FDA regulates stem cell therapies.”

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