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Category: Stem cells regulation

stem cell mis-regulation

Surprise, Surprise: The FDA is Losing Big Time the War against Unregulated Stem Cell Clinics

Surprise, Surprise: The FDA is Losing Big Time the War against Unregulated Stem Cell Clinics

Since stem cells and other HCT/P’s have come into clinical use in the early 2000s, (starting with one of my maverick doctor clients in the South), the FDA has attempted to regulate the field. Early on, the FDA adopted HCT/P regulations, that would be 21 CRF 1271. These regs made clear that allogeneic and expanded/cultured stem cells were regulated as new drugs. HOwever, there was one giant hole in the regulations, that being autologous, same surgical procedures. That hole in…

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Update on the FDA’s California Stem Cell Case: So is SVF (i.e., sort of stem cells) a New Drug? That is the question

Update on the FDA’s California Stem Cell Case: So is SVF (i.e., sort of stem cells) a New Drug? That is the question

Here is where the case stands as of September 13, 2021: Closing arguments were held on August 20th. The Judge set a short post-closing briefing schedule and both sides did briefs and replies, mostly on the definition of HCT/P’s. The reply briefs were submitted, per the judge’s order, on September 1st, as of which day the case was submitted and is now sub judice (legalese for pending decision by the court). One interesting note: Of course, the Government submitted to…

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The United States vs Your Own Stem Cells: Trial days Three and Four

The United States vs Your Own Stem Cells: Trial days Three and Four

The FDA’s case against the California Stem Cell network went forward last Thursday and Friday for the third and fourth days. Yesterday, Monday was an off day. The trial resumes today at 8:30 PDT. Very briefly, (I hope because I have a lot on my plate today) here are my main observations: 1. The judge has already made up his mind about the case. In a sense that is an obvious implication of his decision denying the government summary judgment….

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My Crossover Moment Between Stem Cells and the Vaccine Issue, some basic facts about VAERS and maybe an interesting strategic suggestion (so please read this to the end)

My Crossover Moment Between Stem Cells and the Vaccine Issue, some basic facts about VAERS and maybe an interesting strategic suggestion (so please read this to the end)

Although many, many of my posts lately have been about the vaccine issue, I view myself as a health care attorney who focuses on novel and unconventional treatments and technologies. The legal contexts may be different, i.e., medical board work, civil litigation, or federal criminal cases (FDA and health care insurance issues) but the overarching commonality is constant, unconventional health care and ensuring the broadest possible access to it. In my FDA-related work, that basically pits me against the government…

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Some Quick Takes on the Second Day of the California Stem Cell Treatment Trial

Some Quick Takes on the Second Day of the California Stem Cell Treatment Trial

While working yesterday, I had the zoom California stem cell trial playing sort of as background music. Here are some of my quick takeaways. 1. My strongest impression was of the Judge. As a lawyer who does trial work, he was wonderful to watch. He is very, very sharp, but he’s also very laconic. Lawyers object. He thinks about it for a second, then gives a short response, usually 1 word. I think he was on the money every time….

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Where are we Really on the on the Adipose/Fat Stem Cell and other private Stem Cell Business

Where are we Really on the on the Adipose/Fat Stem Cell and other private Stem Cell Business

There have been recent reports about the FDA’s impending forced closure of the autologous adipose stem cell business because the three-year grace period (to come into compliance with the FDA’s view of the law) is expiring soon. (The three-year grace period was extended for six months because of the pandemic.) The big dog has dutifully reported the FDA’s pronouncement about the end of the adipose and other non-FDA compliant business model and he is (as he has often done in…

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The Missouri Feds Indict a physician’s assistant/clinic operator (and recently elected State Rep) for Stem Cell fraud (and other things). Should the Private Stem Cell Crowd be worried?

The Missouri Feds Indict a physician’s assistant/clinic operator (and recently elected State Rep) for Stem Cell fraud (and other things). Should the Private Stem Cell Crowd be worried?

Earlier the week, it was widely reported that the feds indicted a woman operating a couple of regenerative medicine clinics for all kinds of fraudulent and illegal conduct. Here is an article about it. fraudindictmentarticle If you want to go deeper, here is the indictment. derges_indictment_0 It seems like she was way off the reservation for many reasons. First and foremost, she did what I think is the riskiest thing for any health care practitioner to do, namely promote an…

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California FDA Stem Cell Case Adjourned Again

California FDA Stem Cell Case Adjourned Again

Although the Pacer docket does not reflect it yet, I have heard from a client who is in communications with one of the parties that the FDA’s case against the Cell Surgical Network and Drs. Berman and Lander has been adjourned again, this time until early May. I have lost count of how many times it has been adjourned, but it’s been at least three and maybe four or even 5 times.  It is certainly starting to look like the…

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For the Same Surgical Procedure Autologous Stem Cell Transplant Crowd, Big Decisions are a-coming

For the Same Surgical Procedure Autologous Stem Cell Transplant Crowd, Big Decisions are a-coming

If you are in the business of providing autologous stem cell transplants during the same surgical procedure for therapeutic purposes, the next couple of months are going to be very consequential for you because of the decisions in the two big cases in the field. The appeal of the US Stem cell case is now under consideration by the appellate court. Oral argument was held on January 13th. By some accounts, the judges gave the government a hard time. But…

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Stem Cell End of the Year Legal Update

Stem Cell End of the Year Legal Update

As those in the field remember, in the fall of 2017,  with greatest of largesse, the FDA proclaimed that it would exercise its enforcement discretion and give all but the most egregious/dangerous private stem cell clinics three years to come into compliance with its view that autologous based stem cells, even if administered during the “same surgical procedure” were in violation of the FDA’s revised interpretation of its 21 CFR 1271 regulations. The FDA’s reimaged view of its power to…

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