Biologics

FDA Stem Cell Regulation Court Ruling Analyzed

Four Ropes & Gray attorneys say the 9/27 9th Circuit Court of Appeals decision backing FDA regulation of stem cell treatment, which followed a 2021 similar ruling by the 11th Circuit, will make it harder for other clinics to argue that their procedures are exempt from agency oversight. Writing in a Litigation Update, the attorneys say the 9th Circuit held that the stem cell clinic’s treatment was not covered by the “same surgical procedure” exception.

“Although this 9th Circuit ruling reinforced FDA’s authority to regulate stem cell therapies and other human cells, tissues, and cellular and tissue-based products (HCT/Ps),” the analysis says, “the incoming administration may choose not to prioritize enforcement in this area. Additionally, recent jurisprudential trends may increase the likelihood of future administrative law challenges to the underlying FDA regulations.”

The attorneys discuss these two points from the decision:

defendants do not qualify for the same surgical procedure exception because the implanted stromal vascular fraction derived from a patient’s adipose tissue is not the same as the removed adipose tissue; and
the defendants’ stromal vascular fraction is a drug and FDA’s regulation of the product does not intrude upon the practice of medicine, as the clinic had claimed.

In a section on implications for oversight and enforcement of HCT/Ps, the attorneys say the decision may lay the groundwork for future criminal prosecutions involving unapproved clinician-created stem cell therapies. Such prosecutions they say, would be more likely when the government can present evidence of fraud on patients and patient harm.

They note that the Federal Trade Commission also has acted against false and misleading advertising practices for stem cell products.

Unsure at this time, the attorneys write, is the potential for future Administrative Procedure Act challenges to FDA statutory and regulatory interpretations based on the Supreme Court’s ruling this year eliminating the so-called Chevron deference and saying that courts should decide for themselves whether FDA’s interpretation of an unclear law is correct.

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