A big update in the stem cell industry last week as a California judge issued a favorable order on behalf of a California based stem cell treatment provider. California Stem Cell Treatment Center, Inc., is a California based medical company offering SVF surgical procedure and MSC Surgical procedures. A few years ago, the Food and Drug Administration (“FDA”) sought an injunction against the Company to prevent them from performing these procedures because the FDA claimed that the procedures included the adulteration of drugs which were then re-injected into the patient and thus were classified as “drugs” and therefore under the FDA purview. The Company argued, however, that the SVF procedure and MSC procedure are not “drugs” as defined by the FDA and there that the procedures don’t fall under the FDA’s definition/prohibition regarding adulteration and misbranding of products. The Court allowed the trial to move forward, and the Company provided support of their position which ultimately was successful. The Judge agreed that the procedures and the subsequent cells were not “drugs” and went on to further state that the SVF procedure qualifies for the “Same Surgical Exception” under the Food Drug and cosmetics Act (“FDCA”) even so.
The ruling in this case reinforces the Florida based company, US Stem Cell, position and is contrary to the ruling made in its case back in 2019. The Court also made it clear that the FDA does not have the ability to interfere with the practice of medicine of physicians, as limited by Congress and the FDCA. The Court, through its ruling, removed some of the power of the FDA in these types of cases, essentially saying that they do not have oversight on surgical procedures (which the Court believes these procedures constitute).
So, what does this mean? It certainly pushed back on the FDA and its reach big time. It means the FDA will either take a step back from stem cell regulation and allow these clinics to operate with less scrutiny, or it means the FDA will work with Congress to update their governing statutes and expand their purview. For the time being, it keeps the FDA at bay.