The Food and Drug Administration (FDA) recently issued a warning letter to a clinic for misleading patients regarding stem cell procedures.
In a related press release, Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb, M.D stated that “[s]tem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk[.]” According to the FDA’s website, it has not approved any stem cell-based products for use other than cord blood-derived cells.
It is well settled that the FDA does not have any control over a physician’s ability to prescribe “off-label” or conduct “experimental use” of a drug. However, physicians taking such action are subjected to the oversight of their medical boards.