On Monday, October 2, 2017, Gov. Jerry Brown signed into law SB 512, which requires what I call the practice of medicine stem cell clinics to notify their patients that the use of stem cells by the clinic is not FDA approved. And that’s it!
Here is the link to the law:
The law should be a welcome relief to the hundred plus California clinics that provide stem cell treatments to patients, because it does not affect their businesses at all. Any prospective patient who knows enough about his/her condition or disease to consider stem cells, knows that the therapeutic use stem cells is not FDA approved, and has probably failed conventional treatment, so lack of FDA approval is not a concern.
But even beyond that, most clinics (and all of the clinics I represent) already inform patients about the non-FDA’s approval status of their treatments, and provide much more information to secure and document informed consent. Thus my conclusion that SB 512 won’t have any meaningful effect on these clinics. Nor will the law provide most stem cell patients with information that has heretofore been lacking.
The law also gets the California Medical Board into the picture, sort of. The board will have to separately identify complaints received and disciplinary/administrative actions taken against licensees who administer stem cell therapies. I suppose that may provide some useful information down the road, but I don’t think any of the California stem cell clinics will give this provision a second thought.
So in my view, the California stem cell clinics have nothing to worry about, so long as they post the required notice and give the patient the required form.
The institutional stem cell mafia (which is against the practice of medicine stem cell clinics) is likely to be wholly unsatisfied by the law because it does not restrict these clinics, and because the Mafioso doesn’t believe that non FDA stem cell treatment should be available outside of clinical trials, even with complete informed consent.
The real problem the practice of medicine stem cell clinics have is, of course, the recent spate of activity by the FDA and the likely content of the FDA’s four final guidance documents on autologous stem cell therapies. See my prior post at:
I’m still expecting the issuance of these documents soon, but we’ll see.
Richard Jaffe, Esq.