Biologics

FDA Loses California Stem Cell Treatment Case

A California federal judge has ruled that a stem cell treatment firm is exempt from FDA regulation. The Los Angeles Times reports the judge declined to block California Stem Cell Treatment Center from continuing to offer its treatments to customers. It says the 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.

The Times story says FDA filed suit against the California clinic and one in Florida 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.

In the Florida case, the newspaper says, a federal district judge ruled against the clinic and the decision was upheld by a three-judge 11th Circuit Court of Appeals panel that held that the clinic’s claim of exemption from FDA regulation on grounds similar to those raised by the California center did not apply. “No reasonable fact-finder could disagree,” the appeals court judges said.

The Times says the California judge ruled that the “defendants are engaged in the practice of medicine, not the manufacture of pharmaceuticals.” It then points 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.”

The article quotes University of California Davis stem cell biologist Paul Knoepfler saying the “language of the ruling sounded almost like it was written by the defendants. The ruling will not be a good thing for careful oversight of stem cell clinic practices. It’s concerning to think about more people being put at risk.”

Knoepfler said FDA would likely feel duty-bound to appeal the ruling to protect its regulatory campaign and because it conflicts with the decision in the Florida case. The agency officially informed the Times that it was reviewing the ruling and had no further comment.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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