Is FDA Warning a Precursor to More Stem Cell Regulation?


Two stem cell clinics, one in California and the other in Florida, were on the receiving end of action taken by the FDA this past summer. In addressing the action, FDA Commissioner Scott Gottlieb promised further action against clinics offering experimental stem cell treatments that go above and beyond the “same basic function” standard the FDA has already set for such procedures. Now the question is this: is the FDA warning a precursor to more stem cell regulation?

Attorney and research professional Dr. A. Rahman Ford, a proponent of personal stem cell therapies, wrote an excellent piece for the Pain News Network published shortly after the FDA action and Gottlieb’s remarks. In it, he offered hope for the future of stem cell therapies based on some of the things Gottlieb said. But Dr. Ford was also admittedly circumspect.

Ford recognizes that the FDA has a long and checkered history of implementing regulations that place unnecessary burdens on doctors, researchers, and companies that create new and innovative treatments. He worries, based on that history, that the FDA is getting ready to begin flexing its muscle to curtail the growth of regenerative medicine – and stem cell therapy, in particular. Ford and others believe this would be a terrible mistake.

The Good News

The good news we can glean from Gottlieb’s remarks did not escape Dr. Ford. For example, Ford mentioned Gottlieb’s acknowledgment that stem cells offer “significant promise for transformative and potentially curative treatments” for certain chronic conditions, including chronic pain. The fact that the government officially recognizes such promise gives stem cell proponents hope that the FDA might encourage regenerative medicine therapies rather than trying to restrict them.

Second, Gottlieb acknowledged the current environment of legal uncertainty surrounding practitioners who offer unproven and potentially risky treatments for things like cancer and macular degeneration. Ford agrees with the concept that some regulation may be necessary to rein in that small percentage of doctors who practice medicine unscrupulously.

Finally, Ford was heartened by Gottlieb’s acknowledgment of the existing distinction between medical products and the principle of the ‘practice of medicine’. Even though that distinction can be blurred from time to time, it still exists.

Under current FDA standards, autologous stem cell therapies (those therapies that use material donated by the patient being treated) fall under the general practice of medicine because nothing foreign is being introduced to the patient during treatment. The patient’s own cells are harvested, processed, and returned through an injection at the treatment site. To reclassify autologous stem cells as medical products would open the door to significant and restrictive FDA control.

Let’s Hope for the Best

Ford is correct in his assessment that the FDA’s history is not one that instills a lot of confidence in doctors and researchers. Therefore, proponents of stem cell therapy and other regenerative medicine procedures can only continue what they are doing and hope for the best.

At Advanced Regenerative Medicine Institute (ARMI) in Utah, continuing with current practices involves training doctors to safely and correctly administer PRP and stem cell therapies. ARMI has already trained hundreds of doctors at sites around the country. The hope is that they will be able to continue doing so without the burden of unnecessary FDA regulations.

In the meantime, we all sincerely hope that clinics that would otherwise follow in the footsteps of the California and Florida clinics targeted by the FDA change their ways. Hopefully they will make the decision to stop putting the entire field of regenerative medicine at risk simply for their own gain. We shall see.

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