In the United States, the FDA is actively warning to stem cell clinic, for example; https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies

However, many stemcell clinics are still open for business. As far as I know, any FDA's warning does not include a statement to prohibit the stem cell clinics.

My question;

How do American stemcell clinics legally justify themselves?

Although not a US domestic law, the 2013 Declaration of Helsinki contains the following language


Unproven Interventions in Clinical Practice
37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

In other words, my question is.

If you want to legally run a stem cell clinic in the US, what advice would a legal practitioner give you? However, if the regenerative medicine is to be performed that is not approved by the FDA.

At the very least, I think the advice would come that a qualified doctor should treat the patient. What else could it be?

I think the question converges on whether or not the doctor's authority includes the power to "practice medicine with unapproved drugs".

In Japan, stem cell clinics can justify themselves by undergoing a review under the Safety Assurance Act. Details are given below. In the past, there was no such scheme, but it seems to have used the logic that "doctors can perform unapproved therapeutic acts at the request of their patients". How does this work in the US?

In Japan, most of stemcell clinics get the legal justification using the Act on the Safety of Regenerative Medicine. Class 2 or class 3 regenerative medicine can be provided to patients as long as it is reviewed by the "Certified Special Committee for Regenerative Medicine", regardless of the result of the review; class 2 and class 3 are classified by the Act on the Safety of Regenerative Medicine. These classes includes most of autologous transplantation of the stem cells.

For the legal framework of regenerative medicine in Japan, the following will be helpful.

Note. I asked this question first in the medical stack, but was advised that the legal stack was preferable, so I decided to ask the same question here.

  • I've not read the links in any great detail, but if there is no legal prohibition on operating a clinic why should a clinic legally justify itself?
    – Rick
    Nov 26 '20 at 7:07
  • @ Rick Ape Thank you for your comment. The FDA says "May be illegal", although they have not declared it illegal. Perhaps these clinics are at least in a grey area.  Conversely, what is the basis for "no legal prohibition"? Nov 26 '20 at 7:13
  • Under general principles of legality, an action is legal unless there is a law which declares it to be illegal. That is, there is no need (or, generally, ability!) to justify an action as legal, only to defend against a specific claim that it violates some specific law. What specific law(s) do you suspect that these clinics might violate?
    – Sneftel
    Nov 26 '20 at 13:00
  • @sneftel1 Thank you for your comment. I don't have any specific basis for claiming excepting FDA's video I mentioned earlier; it says "may be illegal." In Japan, doctors have "the authority to use unapproved methods for treatment". If such authority were available to US doctors, it would probably be basically legal. Nov 26 '20 at 14:21
  • 3
    I’m voting to close this question because there is no legal question here; it's a question of semantics and a definition of "may" for a personal or political agenda. Nov 26 '20 at 16:07

They are not required to "justify" themselves in advance, in the US. They are required to comply with the law. It is possible that some such clinic is not in compliance with the law, and it is possible that the FDA will take legal action against some clinic. If they do, the clinic may have to go to court to defend its actions, showing that they are in compliance with the law, then the court will decide whether the FDA's hypothetical future position is correct, or is the clinic's position correct?

A therapy may or may not need to be approved by the FDA: that is a medical question. Crucial to the approval procedure is a medical question, and not a legal question: does a particular therapy work. The FDA is legally empowered to regulate "new therapies", therefore they have a technical review process that asks "does this work, is it harmful?". If this is a new therapy and if the therapy is subject to FDA approval, but the therapy has not been approved, then a clinic in the US is not complying with the law if it offers the treatment. The technical identity of a therapy is a medical question, so you would need to find detailed specifications of a putative therapy, and someone with medical knowledge who can make sense of the FDA database to see if it is approved and for what use.

  • Thanks for the answer. One of the harvest from your answer is to know that (Japan has a pre-justification process,) but the US does not. Right now I'm focusing on regenerative medicine that the FDA has not yet approved. If US doctors had the "authority to provide unapproved, unprohibited medical treatment at the request of a patient," then the practice would be legal? So do US doctors have that authority? And who has the power to impose a ban? I think it's a matter of law. Nov 26 '20 at 19:44

Not the answer you're looking for? Browse other questions tagged or ask your own question.