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Update on the FDA’s Stem Cell Injunction Cases

Update on the FDA’s Stem Cell Injunction Cases

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Watching a federal civil case progress is usually about as interesting as watching grass grow, except that grass grows faster. It’s been around three months since the FDA filed permanent injunction actions against the country’s two most notorious stem cell clinics/networks, California Stem Cell Treatment Center/Cell Surgical Network and US Stem Cell Clinic and network. The most interesting thing about the cases so far is what hasn’t happened. The FDA has not filed a motion for a preliminary injunction in…

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It’s Surprisingly Quiet on the California Vaccine Front

It’s Surprisingly Quiet on the California Vaccine Front

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It has now been two years since California rescinded the PBE (Personal Belief Exemption) for vaccinating school kids (SB 277). Let’s take a quick look back and see what can be learned from what has and hasn’t happened. 1. The Legal Challenges to the law were a complete bust From the get-go, I was extremely critical of the lawsuits challenging the law. (See my earliest posts in the SB 277 section of this web site). The bottom line was/is that…

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Can a doctor recommend medical marijuana for a five-year-old in California?

Can a doctor recommend medical marijuana for a five-year-old in California?

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That’s the question that will be answered in a California medical board case I am trying this week in downtown Los Angeles. Back in 1996, California became the first state to allow for a doctor to recommend medical marijuana for patients with serious medical conditions. There was a lot of confusion initially as to what was required to issue the recommendation without getting into board trouble. The California law (called prop 215) by its terms granted physicians immunity from prosecution…

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Is CBD Oil Legal?

Is CBD Oil Legal?

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The CBD oil business has exploded in the last couple of years. I was at an integrative medical conference in New York City back in February and I asked a few CBD oil vendors whether their product was legal. They all assured me that their product was legal, some claiming that it was legal because it contained less than 0.3 percent THC, while others said it was legal because it contained no THC. That didn’t sound right to me. I…

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Federal “right to try” is law! Now what?

Federal “right to try” is law! Now what?

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Last week, Pres. Trump signed the federal right to try law. So what happens next? Meaning, who is it going to affect and how big of a difference is it going to make in the lives of the terminally ill and those without any other therapeutic option. Why a federal law was needed? As most of you know, a majority of states have already passed a right to try law. The problem with just having the law on a state…

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Criminal prosecution was not a concern or consideration in Regenerative Sciences’ decision to stop treating patients in its case way back then

Criminal prosecution was not a concern or consideration in Regenerative Sciences’ decision to stop treating patients in its case way back then

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In an earlier post discussing the decision making facing the US Stem Cells and California Stem Cell Treatment Center folks, I discussed the Regenerative Sciences case in which the district court granted the government’s summary judgement motion to bar the company from providing its expanded stem cells to patients (which decision was affirmed by the Court of Appeals.) I related that the company agreed to stop treating patients with the contested procedurevery early on, pending the outcome of the injunction…

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Further thoughts on the defendants in the FDA’s stem cell injunction actions

Further thoughts on the defendants in the FDA’s stem cell injunction actions

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My post about considerations facing the defendants in the FDA’s injunction cases, http://rickjaffeesq.com/2018/05/17/hard-choices-stem-cell- defendants-fdas-injunction-cases/ was discussed yesterday in the stem cell field’s big dog, the Niche, by Paul Knoepfler. https://ipscell.com/2018/05/when-the-fat-stem-cells-hit-the-fire-will-clinics-sued-by-fda-opt-to-stop-soon/. After reading it, a follow-up is in order. A correction and follow up: In my post, I said that both US Stem Cell and California Stem Cell Treatment Center had received warning letters. Knoepfler correctly pointed out that the California company had not received a warning letter from the FDA,…

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Hard choices for the stem cell defendants in the FDA’s injunction cases

Hard choices for the stem cell defendants in the FDA’s injunction cases

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As recently reported, the FDA filed permanent injunction actions against the two highest profile stem cell clinic/operators, US Stem Cells Clinic and Cell Surgical Network/California Stem Cell Treatment. See my post at http://wp.me/p7pwQD-dz As an FDA attorney who has worked on civil and criminal stem cell investigations and cases, I can tell you that these defendants are facing a major decision: whether to stop treating patients during the pendency of the permanent injunction action. Here’s what I believe to be…

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Texas Medical Board to patients needing stem cells (and the Texas legislature): Drop Dead!

Texas Medical Board to patients needing stem cells (and the Texas legislature): Drop Dead!

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Last year, the Texas legislature passed landmark stem cell legislation (HB 810). The law didn’t open the floodgates for every physician who wanted to inject patients with stem cells. However, it did allow patients to access their own stem cells (as well as other people’s stem cells), under controlled circumstances, namely the procedure had to be performed in a high level facility (an ambulatory surgical center or hospital), and it required university type IRB (institutional Review Board) approval. Here is…

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The FDA’s injunction complaints against US Stem Cell Clinic and California Stem Cell Treatment Center

The FDA’s injunction complaints against US Stem Cell Clinic and California Stem Cell Treatment Center

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Yesterday, May, 9th the FDA filed complaints seeking permanent injunctions in Florida and California federal courts against the two highest visibility U.S. stem cell operations. For the interested, here are the complaints. comella bermancomplaint What’s in the complaints? It’s pretty much as I said in yesterday’s post. The two complaints are substantially identical and no doubt prepared in Washington, primarily by the FDA with input from Main Justice (or vice versa). Both entities were inspected by the FDA, after which…

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