California Does What FDA Can’t: Require Unapproved Stem Cell Clinics to Inform Patients
​​[Posted on: Thursday, October 5, 2017]

California passed a law this week that requires physicians providing unapproved stem cell therapies to prominently display at multiple locations within the clinic that the stem cell therapy provided by them is not approved by FDA. The intent of the new law is to assure that patients are aware of the unapproved status of the so-called treatment, and can make educated decisions. The law does not ban such treatments or ask the physicians to provide any further disclaimers about the therapy, so the physicians can still make dubious claims to their patients about the effectiveness and safety of such therapies. This is in contrast to Texas that last month legalized most stem cell therapies, although the Texas law requires that such treatments be provided under clinical trials. Together Texas and California, two of the largest states in the country, show the impatience States feel due to the slow response from FDA. FDA announced that it plans to create new policies to regulate unapproved stem cell therapies later this year. Past experience has shown that FDA faces intense resistance from the stem cell clinics to create any laws that would have a tangible impact on these businesses due to lack of FDA-approved stem cell therapies. FDA has so far taken a hands-off approach to not enforce the current laws on the providers of unapproved stem cell therapies despite numerous concerns from the Agency scientists. So, the states are starting to step in to fill the void. But the California law would likely have little impact in curtailing such stem cell clinics. Past experience has shown that patients try such treatments despite knowing that they are unapproved by FDA based on trust in their physicians. A sign in the practitioner’s office could have limited impact on the patient’s decision to use such therapies. More desperate or unhappy a given patient is with their FDA-approved options; the more likely they are to try such unproven but legally available therapies. Studies have shown that desperate patients are mostly willing to try any new treatment options. We just hope that FDA makes true on its announcement to rein in unproven therapies quickly otherwise states will start making diverse rules and create even more confusion to the patients.