Is FDA Heading for A Consistent Fat Stem Cell Approach?
Recent FDA enforcement actions in two cases in California and Florida relating to use of fat/adipose stem cells are raising the question of whether the agency is changing its approach to the notion of such cells as unapproved biological drugs. That’s the view of Paul Knoepfler in a Knoepfler Lab Stem Cell Blog post.
After describing agency actions against StemImmune and the California Stem Cell Treatment Center and US Stem Cell Clinic, Inc., followed by a statement from FDA commissioner Scott Gottlieb indicating active oversight of the commercial operations of stem cell clinics, Knoepfler asks, “If the agency wants to be consistent, doesn’t it need to do something related to the hundreds of other clinics selling fat stem cell products for a medical dictionary’s worth of health problems? On the other hand, does FDA have the will and the resources to take such large-scale action? Does anyone recall the agency ever taking action on hundreds of businesses at once in any field of foods or drugs? Even scores or dozens?”
According to Knoepfler, the agency and specifically CBER didn’t seem to be keeping up with the growing stem cell clinic industry. “In the past couple years under Obama,” he writes, “FDA and CBER took near zero apparent action on an industry built selling stem cells without FDA approval and one proliferating at a rapid pace. Now the agency under the new administration seems to be signaling a major change in course on stem cell clinics and a willingness to be bold.”
He suggests a number of possible agency actions now, ranging from inspections of each of the businesses, likely followed by a large number of Warning Letters, to issuance of Warning Letters based on marketing rather than on inspections, to issuing a small number of Warning Letters in hopes that other companies will work toward becoming compliant. Other possibilities, he says, involve FDA including a strong message in an upcoming guidance that fat stem cell products cannot be marketed without approval. Or it could back off the notion of widely classifying adipose stem cells as biological drugs, leaving the industry free to continue business as usual when it comes to adipose stem cell marketing.
Knoepfler referred his questions to Georgia State University College of Law professor Patricia Zettler, a former FDA associate chief counsel, who agreed that “FDA almost certainly does not have the resources to immediately inspect and issue Warning Letters to the hundreds of stem cell clinics that may be illegally marketing therapies. But the hope, I think, would be that sending Warning Letters to some may bring both the recipients into compliance as well as deter some others from marketing illegal therapies.”
Zettler said another possible approach would be for the agency to communicate with companies its observation that it appears that the stem cell therapy being marketed is an unapproved drug, and inviting companies to respond with their basis for why agency approval is not required. She said that is the approach the agency took in 2010 with genetic testing companies such as 23andMe. “This might be a way for the agency to get more information about what products are being offered while at the same time signaling to stem cell clinics that they are at risk of a Warning Letter or other enforcement action if they do not come into compliance,” she said.
Knoepfler concludes that “it is not entirely clear how FDA will approach the stem cell clinic industry overall or the adipose segment, but there is an expectation in the wider community of more FDA action and clearer guidances to come soon.”