in my layman (non medical, legal) terms :-)
#1
FDA sues USRM stem cell procedure is illegal as the extraction of cells qualify it as drug, so get approval by proving safety first
#2
FL court sided with FDA as we know and bans USRM.
may be partly ‘cus USRM has presented conflicting arguments by saying “same day” on one end to show it comparable to other bone marrow procedures etc while also saying it’s safe as we have done so many procedures and see patients banked their stem cells with trust. well “banked” one imply your intent was to use them at a later day or might even use in other patients too?
#3
USRM can only argue it’s not a “drug” so FDA doesn’t have authority but they just need to comply with medical boards and prove it’s safety.. and continue. stick to its “autologous” nature of its business and safety track and FDA can’t argue ‘cus you’d have no authority on that subject. FDA position is weak on double standard here..
recent development to isolate the stem cell banking issue from core case may be indicative that defense is now clearer about how theirs is same as current marrow/transfusion procedures. FDA may recognize overstepping and try to settle by a compromise than appearing like a total failure so let USRM with their “analogous same day procedures” with a guidance to get their approval for other use cases? just guidance is not legally mandatory.. just like RMAT etc! and differences in court perceptions in CA, FL cases may have resulted due to the nature of defense.. IMO that cross learning is key! if you agree to “drug” definition, you already lost the argument.. just focus on that aspect and your business is safe until some national level legislation is defined!
(apologies for poor use of English)
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