The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb.
It already took some action too on clinics in Florida and in California. So today we heard about both a bold statement of vision on how the FDA will deal with stem cell clinics and also it took real action. For instance, the FDA issued a warning letter to Kristin Comella of US Stem Cell Clinic (a subsidiary of US Stem Cell Inc) in Florida, an organization linked to negative outcomes in patients including blindness. It also apparently raided a stem cell business in San Diego, StemImmune Inc.
This taken together is a very big deal. For me as someone who has been following and trying to make a difference about the stem cell clinic problem for more than 7 years, I find today very encouraging. Better late than never?
The FDA also indicated today and has suggested before in a blog post by Gottlieb, that it may soften some regulations of stem cell treatments. We’ll have to wait and see how that plays out and what impact it has.
Overall, what does this all mean and what happens next? This story is still breaking so there’s a lot to think about, but on my first run through of it I’ve got 6 major thoughts and questions on today’s development.
- How much further will the FDA go with actual enforcement actions? What we heard about today is a major positive step, but it’s just one step out of many needed along the path toward reining in the out of control stem cell clinic industry. With around 600 stem cell clinics in the U.S., FDA action on just 2 is positive but not enough. More to come?
- Will the FDA define fat stem cells as a drug (or not) in upcoming guidances? If yes, how will it handle the fact that there are hundreds of clinics using fat stem cells without proper licensing and approval of the product/treatment as a drug? If not and fat stem cells are viewed as not necessarily drug products, will the FDA then narrow the scope of permitted applications of fat stem cells used not as a drug to only include homologous use? I.e., “fat stem cells are drugs if used on non-fat-related health problems”? May there be exceptions to that limitation?
- How will the FDA handle non-homologous use of bone marrow cells in the commercial sector? This kind of use is pretty common out there too by clinics. To be clear, some clinics use bone marrow cells in a homologous fashion and without more than minimal manipulation, but I’m not referring here to those.
- Amniotics? Will the FDA work to deal with the growing problem of unapproved, amniotic stem cell offerings? If so, what steps will it take?
- What about networks of stem cell businesses? How will the new FDA under Gottlieb view networks of stem cell businesses such as Cell Surgical Network? This comes to mind because the FDA in its PR mentioned key member of that network as where StemImmune’s unapproved product was administered to patients: “California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. ” The founders of Cell Surgical Network are listed on its own website as part of the StemImmune Inc. leadership team.
- Will other entities like state medical boards use this FDA action as a spring-board to get off the sidelines and take positive action too? After all, some of the providers at stem cell clinics I’ve talked to over the years often recite a similar mantra that it isn’t the FDA that regulates them, but rather state medical boards. So, state medical boards and other governmental bodies, are you watching and willing to do something? So far state medical boards have mainly stood on the sidelines on the stem cell clinic problem, but that may be changing.