US Stem Cell Inc (USRM)

[Dragon Lady]

Attorney article..he says BAD FOR USCC/Comella:

Great law blog article by a very experienced FDA law attorney - and according to him, and he cites prior case law etc, he thinks it don't look good for USCC/Comella and USRM in general....thinks they're essentially gonna get bulldozed by the FDA....yepper....that's what his article is telling me...and the dude knows what he's talking about and has the credentials, background, resume and experience in the courtroom to back it all up...every statement he makes....

http://rickjaffeesq.com/

Columbia law...the dude is no sluff..and he's got a resume that looks like a small phone book if you ask me...he's litigated a LOT....

http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/#comments

FASCINATING ARTICLE, and the guy is very experienced and obviously knows what the H he's talking about IMO.

Key parts, as it's long:

QUOTE:
"
THE SLEEPING GIANT AWAKENS: THE FDA STARTS ITS FINAL PUSH TO ELIMINATE PRACTICE OF MEDICINE STEM CELL CLINICS

Richard Jaffe, Esquire, lawyer

And then the sleeping giant awoke

In late August, the FDA made three dramatic pronouncements, which have the same underlying message: the FDA is going after the POM clinics. Here they are:

1. Warning Letter to Kristina Comella and the US Stem Cell Clinic in Sunrise, Florida
On August 24, 2017, the FDA issued a warning letter to US Stem Cell Clinic in Sunrise, Florida and its head, Kristina Comella.
Here it is:
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm

Ms. Comella and her clinic had become infamous after an anti-POM clinic New York Times story reported that several patients had gone partially or totally blind as a result of the clinic’s nurse practitioner (NP) injecting the patients’ eyeballs with stem cells (actually a stromal vascular fraction derived from adipose tissue) for therapeutic purposes (macular degeneration). Given these seemingly egregious facts, it was just a matter of time until the feds went after the clinic.

The warning letter had several parts. First, in line with the draft guidance documents, the FDA said that the clinic’s SVF (stromal vascular fraction) was a drug and not exempt from regulation under 21 CFR 1271.15 (see my prior discussions on this regulation listed above).

The FDA’s drug determination had two bases: First, the SVF product was more than minimally manipulated because it altered the relevant characteristics of the adipose tissue (i.e. fat). Second, the use of the fat derived product was “non-homologous” since it was used to treat an eye condition, which is not a homologous use of fat. Thus, the FDA’s conclusion that the product was an unapproved new drug, and not something which is exempt from the FDA’s new drug laws.

The FDA’s other disconcerting finding was that that the clinic was deficient in terms of its CGMP (Current Good Manufacturing Practices) and CGTP (Current Good Tissue Practices) standards, compliance of which is presumably required under federal law. The FDA cited fourteen areas of CGMP and/or CGTP deficiencies.

Based on my experience, it is going to be very hard for a regular medical clinic to be fully CGMP and CGTP compliant. Further, I can’t think of any other examples of types of clinics in which such rigorous standards are applied by the FDA to medical clinics. Also, I have firsthand experience that early on, the FDA took the position that if the 21 CFR 1271.15 exemption criteria are met, the FDA did not have jurisdiction over the procedure or the clinic because it was the practice of medicine. Obviously, the FDA has changed its view.

The warning letter documented the clinic’s impeding the FDA’s inspection, which is never a good idea, since as the FDA pointed out in the warning letter, such actions can administratively transform approved drugs into adulterated ones.

The warning letter acknowledged the clinic’s prior response to these violations (presumably noted in the 483 (i.e. the inspection report issued by FDA inspectors at the conclusion of the inspection)). The clinic argued that it was engaged in the practice of medicine and hence exempt from all FDA drug and inspection requirements. The warning letter rejected the clinic’s contention.

This was the same argument used by the Regenerative Science clinic in Colorado a few years back when it tried to argue that the culturing/expansion of autologous stem cells was the practice of medicine and exempt from federal regulation. Regrettably, the federal court rejected the argument which surely emboldened the FDA in its current mission.

And that brings up an annoying point: Bad Cases Make Bad Law

The Regenerative Science case was a bad case in the sense that under current regulations culturing stem cells seems like more than minimal manipulation. The decision fed the beast, which from my perspective was a bad thing.

The problem with the FDA’s choice of using this particular Florida stem cell clinic is that the case involves nasty, and almost inexplicable facts. A nurse practitioner injecting tissue products into people’s eyeballs! What genius thought that was a good idea, legal though it may be under the Florida scope of practice laws. So when patients were harmed by the NP, the FDA could not have found a better poster child to show the dangers of these unregulated and “illegal” clinics.

My guess is the Florida clinic is not going to roll-over, and will either sue the FDA first (and that case will be dismissed) or wait for the FDA to sue the clinic. It’s going to be a tough job defending the clinic on those facts. If the clinic loses (and there’s a very excellent chance it will), that will be another nail in the coffin in the POM stem cell clinics."

END QUOTE.....

HOLY COW what a fascinating article....WOWZA....case law and all....

...that's the jest of the entire longer blog/article by this very experienced attorney....his conclusion is that IF USCC/Comella even "tried to sue" they'd most likely LOSE.

Pretty cut-n-dry if you ask me....gonna be fascinating....I doubt they even get that far personally, they don't IMO have the money to sue, and this attorney may not realize that.

Why else are they already begging for "legal defense fund" money, LOL ! If they had this "in the bag" and/or could afford to take on the Federal govt. in Federal court, which this attorney describes as having almost "unlimited resources", then how is lil ole Comella and USCC gonna do it- when she said in her "reply" that the cost or printer ink and printer paper was "harming their little biz" and she "asked for more, but was not given it", LOL !! Freaking buying printer ink can put um out of biz... so what's the tab on a Federal govt lawsuit gonna do to um ????


It don't look good here in my totally amateur opinion...but that dude above, he's a experienced attorney...and he concludes it "don't look good" in his opinion...so I'm going with those facts and opinions....