Court Rules Autologous Stem Cell Therapy Legal in a Rebuke to the FDA
(Thursday, September 1, 2022)
In a stunning decision against the FDA, the United States District Court for the Central District of California ruled this week that autologous fat stem cell products cannot be regulated as new drugs. The ruling contains several comments by the court that upend about two decades of FDA’s regulatory decisions and several guidance documents, that would have a seismic impact on the FDA regulation of stem cell therapy clinics in the US. FDA has maintained through public presentations and Guidance Documents that Human Cells, Tissues and Cellular or Tissue-based products (HCT/Ps) that involve any manipulations such as enzymatic processing for separation or expansion in growth media are regulated as drugs and require a formal FDA approval to be marketed. FDA had issued hundreds of warning letters to clinics offering stem cell therapies that breached the above tenet. Under the same practice, FDA filed a complaint for permanent injunction against California Stem Cell Treatment Center (CSCTC), Cell Surgical Network (CSN), and two physicians who owned those businesses, in the California CD court. Unlike previous cases, where courts sided with FDA’s interpretation of the laws, this court indicated early on that it will not defer to FDA’s version of the regulations. And in its final ruling, the court took a diametrically opposite opinion about the regulatory definitions for HCT/Ps. In its ruling, the court concluded that separation of cells from tissue using enzymes, expanding cells in culture media, and storing cells in frozen cryovials for extended periods of time and using them for future implantation, does not alter their characteristics and are not major manipulations, as interpreted by the FDA. The court also ruled a broader definition of the same surgical procedure (SSP) exception. The court sided with the defendants in all the claims giving a decisive blow to FDA’s established practices for regulating autologous stem cell treatments. With this court decision, it does not need a legal expert to conclude that it would be hard for FDA to continue its current policies for other similar autologous stem cell treatments. While the decision would give a boost to the stem cell clinics, it is not in favor of patients. Stem cell clinics make egregious claims for the therapeutic potential of these treatments with scant evidence. These treatments are not covered by almost all health insurance plans and cost the patients tens of thousands of dollars. In the recent past, state regulators and FTC have tried to regulate these clinics, but without FDA’s support, the clinics would have a field day. This ruling should force FDA to rethink its regulatory regimen for stem cell clinics. There is need for reform at the FDA to force the regulators to take a more pragmatic approach to regulating such clinical practices which balances the patient’s perspective with real-world scientific evidence. Most patients who use these treatments are desperate to find alternate treatment options as the FDA approved ones don’t seem to work for them. So far, FDA took a one-size-fits-all approach to the treatments offered at stem cell clinics. The stem cell therapies need to be regulated but this court showed the flaw in FDA’s approach which relied on legal deference allotted to it by most courts in the past, rather than scientific jurisprudence to create regulatory policies. FDA assumed no court would question its interpretation of the law. Hope, this court decision will jolt FDA out of its slumber.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC