My comment had nothing to do with where laws originate. I am aware of the legislative process. The FDA enforces the law.
The FDA has authorized stem cell treatments for certain procedures. But USRM was operating outside those established guidelines. Without approval USRM was in violation of FDA policy meant to ensure public safety.
I work in medicine and have experienced the process of obtaining FDA approval for a procedure that involves a medical device (surgical implant). I have first hand knowledge. Without FDA approval you are in violation of the law - like it or not.
The FDA has changed their position numerous times in an attempt to maintain control. There is no need to rehash their arbitrary interpretation of law as it pertains to tissue transplants and SSP's. If you have read my previous posts you will see where I challenge the FDA.
It is up to the appellate court to determine whether summary judgment was justified. The injunction was the outcome. I find it hard to believe the appellate court would be willing to go beyond remanding the case back to the state supreme court. I would expect the injunction to remain until a final ruling is made as that would be most prudent.
My focus is on winning the appeal. If the injunction is lifted temporarily that would be great. But what USRM really needs is their day in court.
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