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…
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…
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,…
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…
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…
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…
The Washington Times reported today that the FDA has filed permanent injunction lawsuits against the two most high profile U.S. stem cell clinics. Here is the article: https://www.washingtontimes.com/news/2018/may/9/doj-moves-shut-down-two-stem-cell-clinics/ Both of these clinics received FDA warning letters last year indicating that their operation violated federal law. Today’s action by the FDA in the logical and inevitable conclusion of the FDA’s multi-year effort to eradicate stem cell clinics using autologous stem cell treatments. See my end of year post, laying out what…
The original version of this Post incorrectly stated that IFM’s CME status was revoked by the ACCME. THAT WAS INCORRECT! Sorry about that. However, the highly respected Institute for Functional Medicine (IFM) has had some issues with its CME course accreditation, via the Family Practice physicians’ group. It’s complicated, so see my post at: http://wp.me/p7pwQD-d3 Previously, the ACCME had initiated revocation proceedings against other organizations. See:http://wp.me/p7pwQD-9q The ACCME has taken on the other big dog in the IM (Integrative Medicine)…
I’ve previously discussed the ongoing efforts by the AACME (the main CME accrediting agency) to revoke the CME granting status of various unnamed integrative medical groups. See post at: http://wp.me/p7pwQD-9q But the ACCME isn’t the only organization which grants CAM groups CME course accreditation. The AAFP (American Association of Family Practitioners) does also. The AAFP used to give the Institute for Functional Medicine (IFM) CME status for all its courses. But that changed in 2014 when its CME status was…
We’re now beginning the second month of 2018, and we are a few months past the FDA’s issuance of the final stem cell guidance documents which are intended to dramatically limit the availability of stem cell treatments outside of FDA approved clinical trials. See my prior post at: http://wp.me/p7pwQD-bB So what’s going on so far in 2018? FDA Inspections? Rumor has it that there already have been several facility inspections this year. What I can say is that it’s more…