FDA Finally Announces it is Clamping Down on Illegal Stem Cell Clinics
(Thursday, June 11, 2021)
FDA’s self-imposed deadline to remove “enforcement discretion” on stem cell clinics ended last week, with prompt release of consumer announcement and blogs by FDA’s top regulators. However, the exact nature of the removal of enforcement discretion was not made clear. During the enforcement discretion period over the last 3-4 years, FDA issued 400 letters to individuals and companies offering stem cell treatments, issued 24 untitled letters and 14 Warning Letters citing specific violations. In two cases, FDA fought legal challenges from stem cell clinics, both egregious violators, winning in one case, and still litigating in the second. So, how does this period of “regular enforcement” differ from the enforcement so far. Would FDA start walking into doctors’ offices to close down stem cell operations, would it primarily go after companies that sell such products, would it increase warnings to consumers, would it pass new rules? Specifics have not been announced but likely FDA would do all of the above. In the two public announcements since 1 June, one is addressed to the consumers asking them to complain to the FDA about any providers of illegal stem cell treatments, and the other addressed to the industry stating that providers of such illegal products, “do so at their own risk and may be subject to an enforcement action.” But to anyone who was listening, this is not news. FDA has been very clear in its interpretation of the requirements, and consumers mostly have been aware that such treatments are not approved by FDA, not covered by their insurance providers, and carry risk. Human Cell and Tissues based products, called the HCT/Ps, form an important component of the treatments offered to patients. There are many legal HCT/Ps sold in the US for the last two decades. It is a sub-section of the HCT/Ps that FDA objects to and for the consumers it is not possible to distinguish between legal and illegal treatments. Besides, patients generally trust their doctors more than the FDA. So, will the stem cell clinics simply go underground where patients do what their doctors tell them to and FDA does not find out? The biggest challenge to the FDA has been consumer education. After more than two decades of being offered stem cell therapies by their physicians, patients may not care for the new FDA policies. It is not helped by the fact that despite FDA’s assertion to the contrary, a very small fraction of patients getting the so-called illegal stem cell therapies have reported serious adverse events associated with these treatments, these treatments are legally available in many countries including those in Europe, that path to formal approval via clinical trials is prolonged and nuanced. This policy may backfire if it simply pushes an important treatment option to patients, to back channels. Unless FDA offers a middle ground where it acknowledges the low-risk stem cell treatments, and focuses on the most egregious violators, FDA has picked a tough fight.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC