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stem cell mis-regulation

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. He said the factual issue to be tried is whether what was removed was the same thing that was put back in. Framed in that fashion, it seemed clear that the defendants were going to win the case, and nothing about the judge’s actions or demeanor during the trial suggests otherwise. He does not seem super engaged by either side, and while he is listening politely, my sense is that he’s done, and just wants it over as quickly as possible so he can get about his business of writing the decision. Viewed another way, I don’t get the sense that the judge feels anything he is hearing on either side is particularly helpful.

2. It is obvious that the government doesn’t try many of these cases. The two FDA female doctors (one M.D. and one Ph.D.) were extremely knowledgable but between the defense counsel’s objections and cross-examination, the judge’s rulings, on what would be admissible testimony and their obvious and admitted lack of experience testifying (the MD at least), they were kept on a very tight leash and didn’t get to testify about everything they had to say. The FDA doesn’t have to try many of these cases, as the defendants usually cave in or the courts rule against the defendants on summary judgment. Doing trials on these complicated regulatory issues is a lot different from having an FDA attorney prepare a declaration for an FDA expert employee.

3. On the third day, there was much testimony on what is the same surgical procedure, as there should have been. The MD FDA witness tried to explain the difference between a surgical procedure and what the defendants were doing which was using a surgical procedure to harvest a product/material as a treatment. She also talked about the purpose of the surgical procedure, but I don’t think the explanation was clear as testified or as received by the judge. My sense was that he felt surgery is surgery.

4. The Ph.D. witness barely got to testify since apparently, the bulk of her testimony was about the ultimate legal issue in the case, namely whether SVF is a new drug because it is more than minimally manipulated and whether what was taken out was what was put back in. The judge ruled that expert testimony on the ultimate issue was not permitted under the rules of evidence. The Government lawyer cited some case law to the contrary. The judge pivoted to saying that since these were stated elements of the government’s case, it was his decision to resolve and didn’t need factual testimony about it. I’m not sure about that, but as a general matter, there is only one expert on the law in a trial, and that would be the judge. So to the extent an FDA regulatory expert tries to testify about the application of FDA law to the facts of a case, I think he’s on solid ground. And even on general legal principles of FDA law, let’s remember that the courts no longer give judicial deference to agency interpretations of its own regulations absent a finding of ambiguity.

5. I admit that I am not a big fan of FDA regulators and especially their actions in the stem cell field, but I have to say, between defense counsel’s overaggressive badgering and the somewhat unskillful redirect (and direct) by the government lawyer, even a guy with my predilection (bias), felt bad for the two FDA witnesses. Let me just repeat that the judge kept a very tight leash on what these witnesses were allowed to say. I think that caused some major problems for the government in presenting its case through these two witnesses. Still, even a biased guy like me gives credit where credit is due. Both witnesses were quite knowledgeable, straightforward, sincere, and came off well (to me). I think they handled themselves very well especially because of the above challenges (as painful as it is for me to admit it, though actually, it isn’t, since they both seemed like decent, dedicated, and hard-working professionals doing their jobs on sort of a grey area where they did not have any direct experience, and that wouldn’t a bad impression for the defense if the judge also thinks that).

6. The defenses: The cross-examination of these two witnesses clearly revealed the defenses main arguments or defense tactics: Make the point that the FDA doesn’t usually get involved/inspect surgical facilities and has no expertise in that area and that goes for these two witnesses (though they both watched the same video about a cornea operation, which is sort of pathetic). Make the point over and over again that the FDA doesn’t regulate the practice of medicine. Make the point over and over again that patients get opened up and that is surgery. Make the point that SVF has a bunch of different things in it, and what is taken out is the same thing that is put back in.

7. What about the vaccine stuff (ACAM something or other)? The defense is that the government confiscated the product from some other entity so the defendants no longer have it, and I suppose they will argue that what’s the point of enjoining something that the defendants no longer have and can’t get anymore.

8. What about the defense to the use of expanded stell cell products which prior persuasive authority has held to be more than minimally manipulated? I’m not sure about that, maybe just argue that the change in the deference standard makes the Regenerative Science decision bad law now. That might be persuasive to this judge.

9. The one thing that might have bothered the judge: There was evidence on direct from the Ph.D. that the enzymes used just don’t stop working; that they keep on breaking down tissue even after the product is reinjected back into the patient in the absence of chemical neutralizing process (I am a little unclear on the process required). The implication being that the defendants’ inadequate processes are going to limit or eliminate any beneficial effect the material/treatment might have. In response, the defense took her through the defendants’ article which claimed that the three washings removed over 99 percent of the enzyme. The witness was skeptical. I didn’t get a read on the judge’s reaction. So this is just my reaction that if there is anything that might have caught the judge’s attention and could impact him against his prior inclination that the defendants’ activities are not FDA regulatable, this was it.

10. The Ph.D. witness made the point that irrespective of the 1271.15 same-day surgical inspection issue, the defendants still had to comply with the FDA’s cGMP requirements. I think the defense’s counter was general about how the FDA doesn’t regulate surgical practices or procedures. The FDA’s response was yea but we regulate products. The judge: Hey let’s use the word treatment and I’ll decide if it is a regulatable product, and there were many variations of that basic point-counterpoint and counter-counterpoint.

11. “Did I read this correctly?” Really?

The craziest thing I saw technically was the defense counsel’s repeated question “Did I read this correctly” after reading a cherry-picked supportive statement contained in a defense article supporting the safety or efficacy of stem cells. Obviously, the defense was just using the witness to read to the judge these positive statements about stem cells. But what he didn’t do was ask any follow-up questions. Rather, he just moved to the next positive statement from the article and then to the next article and so on for each of quite a few articles.

I don’t get the government’s failure to object after the first time defense counsel pulled that nonsense. He should have made a speaking objection pointing out that without a follow-up question to the witness about whether she agreed or disagreed with the statement, the question posed was irrelevant. There is no issue in the case about whether defense counsel can accurately read a statement from a written text. The government attorney could have offered to stipulate that defense counsel has that reading capability (ok, maybe too sarcastic). I just didn’t get the govenment’s nonreaction other than these guys don’t have to try many of these kinds of cases. Defense counsel got away with it. I wish I could get away with stuff like that. The government did do some redirect on the point, but I don’t think it was sufficient in light of the hammering the witness took and the reading of all those cherry-picked statements. Tactically, some hard pushback including more extensive redirect on why the FDA expert thought those statements were incorrect or misleading.

My bottom line from these two trial days is that I think the defendants should be feeling pretty good about the case. The government, not so much. And the defense hasn’t even put on its full defense yet, though it is pretty clear what the defense is via the cross. I think that speaks well for the defense counsel’s preparation and execution. Good on them.

Rick Jaffe.

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 and I advocate and litigate for greater access to unapproved treatments. (And that puts me at odds with many in vaccine concerned community on an issue like access to EUA vaccines, which I support one hundred percent, so long as it is not compulsory.) I think people should be allowed to get any treatment or medical intervention they can get their hands on regardless of the status, as long as there is proper informed consent (which raises issues as well, but I’ll leave that for another time).

One of the areas I work in is the stem cell field. I am following a bench trial on the FDA’s attempt to obtain an injunction against a clinic’s use of autologous (the person’s own) stem cells. I am listening to it on my iPad kind of like background music, and as I was writing this post on VAER’s I heard in the distance an FDA MD regulator being cross-examined on the fact that there were very few reported side effects from stem cell treatments.

Guess what the FDA regulator said in response? She said that everyone knows side effects of drugs are vastly underreported and thus side effects rates can’t be relied upon. It caused a momentary confusion in me and I thought I was having an auditory hallucination since I had spent so much time thinking about the underreporting of vaccine side effects. It reminded me of a cross-over episode in TV world (where the characters in one show appear in character in another show). Nothing more than life’s little strange ironies.

But on to the main topic. There is a great deal of media and social media attention about VAERS (Vaccine Adverse Event Reporting System), and my prior post on the Harvard Pilgrim study has engendered some interesting comments. I think it might be helpful to actually relate the basics about VAERS which might help avoid some confusion, for those who have not actually looked at the issue directly.

VAERS has its own website and it contains more than just the numbers of deaths and injuries from the COVID vaccines. It explains what it is and does, and at least by implication, what it does not do.

You can look it over yourself. Here is the link. https://vaers.hhs.gov/about.html

VAERS was created in 1990 to monitor adverse events from vaccines. (I am pretty sure as part of the vaccine compensation act).

You all know that it created a reporting system for vaccine adverse events/effects

So what’s an adverse event?

Here is as good a definition as any (not taken from the VAERS web site).

Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.” [International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.]

As everyone knows, (but few acknowledge when discussing the dangers of vaccines) an adverse event report filed with VAERS is a just report of an adverse event occurring after a vaccine injection. No single or group of VAERS report about a vaccine establishes a causal connection. It is not the purpose of VAERS to make, investigate or establish the scientific connection/causation or lack thereof between the administration of the vaccine and an adverse event. The VAERS database is just the database of all adverse events which meet the VAERS criteria, where each filing was by some person or entity, presumably with knowledge about something bad that happened to a person within some specified time period after receiving a vaccine.

More specific on the purpose of VAERS (from the website):

“(VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.”

What are the objectives of VAERS?

Here they are from the website:

“The primary objectives of VAERS are to:

Detect new, unusual, or rare vaccine adverse events;
Monitor increases in known adverse events;
Identify potential patient risk factors for particular types of adverse events;
Assess the safety of newly licensed vaccines;
Determine and address possible reporting clusters (e.g., suspected localized [temporally or geographically] or product-/batch-/lot-specific adverse event reporting);
Recognize persistent safe-use problems and administration errors;
Provide a national safety monitoring system that extends to the entire general population for response to public health emergencies, such as a large-scale pandemic influenza vaccination program.”

And of course, it is a self-reporting and uncurated system, meaning anyone can report an AE temporally associated with the vaccine, but presumably, only people with direct knowledge of the untoward event should do the reporting (unless it is the person’s job to make that report, I presume).

So what is considered the temporal relationship and what kind of things can be reported?

Well, that’s easy, the website has a downloadable pdf of the reportable events and how long after the vaccine shot, an AE should be reported (i.e. the maximum time limit after the shot and the time limit is shorter than you would think).
Here is the PDF: VAERS_Table_of_Reportable_Events_Following_Vaccination(2)

As you can see, the event has to have occurred anywhere between 7 and 42 days after the shot, depending on the vaccine and the event. e.g., 7 days max for the DTaP and others, up to 42 days after the shot for arthritis associated with the rubella shot.
In reviewing the chart, it seems to me that the only localized event reportable is shoulder injury from the shots.

For grins, I looked over the screen for reporting an AE because I wanted to see if anyone could file an AE about anyone. I wanted to see if I could file one for say Hank Aaron. FYI: here is the screen. https://vaers.hhs.gov/esub/index.jsp. I suppose you could, but you’d have to make up a lot of his information. And at the bottom, there is a notice that providing false information is a crime.
But basically, you have to give the date and type of vaccine and when the event started and other such information, and presumably, there is some kind of internal edit that wouldn’t process an entry if it is outside of the temporal association limits.

So the bottom line is that a VAERS report is just a description of some bad thing (including death) that happened to a person after receiving a vaccine within a certain period of time after receiving the shot, and that time or window depends on which shot and the kind of every, but the outside window or temporal connection is anywhere between 7 and 42 days.

That much you can glean from the VAERS website. What happens with the information once it gets posted?

And there we have the limits of my knowledge and investigations. Presumably, the CDC and perhaps the FDA look at all these reports. There were only six reported blood clotting problems with the J&J vaccine but that was enough for the FDA to put the vaccine on clinical hold for a week or so. Some criticized the action as being unnecessarily cautious. I assume they quickly picked up on the blood clot issue because of a similar issue with the Asta Zenaca vaccine in Europe and the common ingredient/method used both.

Are the several thousand reported deaths reported to VAERS being investigated? I don’t know, but I hope so.

Another Key Term: Background rate

Another important term in all this is background rate, meaning the rate that a percentage of the population will experience that particular event, say a blood clotting problem. There is a known number for that, and from what I read, the authorities determined that the 6 cases were within the background rate. A background rate above the reported adverse event rate doesn’t necessarily disprove that the AE was caused by the vaccine, but I think it is fair to say that public health authorities are looking for AE’s significantly greater than the background rate, in part because resources are limited. It seems to me that death in terms of the background rate is particularly tricky, obviously because it is an event that everyone eventually experiences and you would expect the background rate of death to have a straight relationship to age.

That brings up another point; early on, a disproportionate number of older people were dying of COVID than younger people. There was a lot of speculation as to why, and many in the vaccine community rejected these statistics basically claiming that the old were dying of co-morbidities (or had co-morbidities) so they don’t count as COVID deaths. (I think that is an erroneous argument). In terms of background rate, I guess the argument is that old people die a lot more than younger people; ie the background rate is higher because of age and more of them have co-morbidities. But I also hear that the old are dying at a much lower rate now, and the big difference is that the older got the vaccine first, and the purpose of the vaccine/the only benefit found/ was to stop people from dying of COVID, (and not necessarily prevent infection or transmission). I guess my saying that again puts me at odds with most of the vaccine concerned.

Now some hard truths and maybe a practical strategic suggestion that could help

The core mantra of the public health establishment is that vaccines are safe and effective and side effects are rare and of course, this is being repeated in the COVID vaccination world. But it is now a lot harder to sell that message during a pandemic where the world’s attention is on the disease and the focus has shifted to vaccines. AE’s and deaths are being reported in social media which is impacting decision-making both in individuals and in the public health policy context. The hard truth is that even if all or a significant percentage of the 3-5k VAERS reported deaths were caused by the vaccines, that would be one hundred times less than the reported number of deaths and orders of magnitude less than the death rate from the disease. I know that many of you don’t accept the COVID death numbers or the death rate, but that really doesn’t matter because those are the numbers upon which public health decisions will be made, and specifically, the decision about full approval/biological licensure of the COVID vaccine.

All medical interventions have risk, and some have a risk of death (I recall when bone marrow and stem cell transplants were done for advanced cancer, it carried something like a 2-4 percent fatality rate from the procedure). The COVID vaccines are going to be approved/biologically licensed despite the relatively small percentage of serious adverse events and even deaths, and I have no problem with that, given my background and many many years of fighting for access to treatment and allowing people to make up their own minds about their health care options. Of course, that makes the key issue mandates upon full biological licensure. And as you all know or fear, mandates are coming. Institutions have already told you all that. And of course, there will be many challenges to these mandates, but odds are they will fail under the expected process. The solution may be to change the expected process.

While drugs and vaccines are approved even if there is a measurable risk of mortality, the FDA has special conditions and warnings, the most severe of which is a black box warning on the labeling. If a very small but measurable adverse event is the possibility of death, that might warrant a black box or other lesser warning. I would propose as a strategic goal a nationwide effort to raise the issue of a black box warning on all COVID vaccines, after a public and thorough review of the VAERS report of deaths.

In order to convince the public of the safety of vaccines, each step of this process would have to be transparent and subject to public comment. You know what they say about light being the best disinfectant, and let the chips fall where they may.

This is something that many groups could adopt. It could become a national thing. It is likely to be something that could enlarge the base. It involves tactics that are relatively known and simple, i.e., contacting your federal legislators and maybe some direct campaigning of the FDA. If you think this has any merit, share this post or at least this last part, and let’s see if it gets any traction.

Having a black box or another type of labeled warning of death from the COVID vaccines could do all kinds of interesting things to the COVID mandatory vaccine debate, and even the public discussion of this technical regulatory issue would be enlightening and worthwhile (and hint, that would be an understatement).

#covidvaccineblackboxwarning

Rick Jaffe, Esq.

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. No detectable bias. He moved things along well but politely and had a nice touch of humor, but low keyed. No ego. No bombast. (No Judge Ito) He was barely there, but ever-present. Masterful and an absolute pleasure to see him work.

2. The government presented the compliance officers who did the inspections. Very cut and dried. They were as you would expect them to be on direct. Factual with a narrow focus.

3. The cross-examination was very competent. The main points as you would expect were 1. none of the inspectors have any competence or experience investigating or inspecting a surgical facility. 2. That the defendants and their operations were fully compliant with the applicable surgical requirements in terms of good surgical practices, safety, and sterility, or at least these government agents don’t know anything about the requirements and have no information that that is not the case. 3. None of them even have ever inspected such a place, though they did see some video of some cornea operation. (and they all had recently stayed in a Holiday Inn). The cross was effective on that point. 4. Defense Counsel kept correcting the witnesses for using the word product instead of treatment, which the judge endorsed, saying that was the issue in the case, whether SVF was, in fact, a product. I am sure the defendants were happy to hear that and smiled every time defense counsel made that objection and smiled again, every time the judge agreed and once again, every time the government witness had to apologize, and that happened often.

4. The case involves more than SVF same-day surgical procedures. Some patients received this vaccina stuff (smallpox vaccine or something like that) which complicates things for the defense. Also, some patients had their cells expanded by American Cryogenics, who also received a warning letter. That’s a tough fact for the defense since there is case law on the expansion of stem cells via the Regenerative Sciences case which is a federal circuit court authority. My guess is that the defense will (or should at least) try to use the change in the judicial deference standard to argue that the case would be decided differently today (to the extent that the opinion deferred to the FDA). But you try the case you have, not the one you wish you had.

5. Paul Knoepfler was a government witness. I missed the direct, but from what I know, I think his only connection to the case was an exchange of communications with Mark Berman about his treatment and clinic. The cross tried to show bias. Something I didn’t know was that his lab received 2 million bucks from the California Stem Cell program. Having read his posts about Berman et al, and knowing their interaction, and understanding the issues in the case as I do, I’m going with his testimony won’t move the needle either way. It is pretty clear that he has a very specific point of view, but it’s the judge, not Professor Knoepfler who gets to decide if SVF is a new drug or part of a surgical procedure beyond the jurisdiction of FDA regulation, and that brings up two important points.

6. A big (and of course expected) part of the cross was trying to establish the limits of the FDA jurisdiction. The witnesses conceded that the FDA didn’t have jurisdiction over “the practice of medicine” in the abstract. There was a lot of back and forth on cross with the government witnesses on this point. But of course, the issue was the SVF and the key buzz concepts of more than minimal manipulation and homologous use, with ample defense references to 1271.15 (the same-day surgical procedure exemption.)

7. Another point briefly inquired on in cross was the cGMP requirements and jurisdiction to enforce them under the chapter (21 CFR 1271). The FDA’s current position is that regardless of 1271.15 (same day surgical exception) and even if SVF is held not to be a new drug, the place still has to comply with cGMP and good tissue practices which it didn’t. The defense is going to dispute that and the judge is going to have to decide the issue. As the guy who wrote probably wrote the first opinion clearing autologous MSC’s, I can tell you that wasn’t the FDA’s opinion back when the issue first came up in the early to mid-2000s. The FDA’s position was that no jurisdiction meant no jurisdiction because it was the practice of medicine and it was a state law matter. But things change I suppose. It will be interesting to see how the judge handles that matter.

8. Finally, all the lawyers were perfectly competent and quite good. The direct case on a technical case like this is not much of a test for a lawyer. The cross is where a lawyer can show her stuff. And she was quite good, very methodical, though perhaps a touch too scripted. It was obvious that she had a template for questioning all of the same kind of witnesses and I think by the third one, people following the examination could say her lines before she said them (you’re not a medical doctor, you didn’t go to medical school, you don’t have any training in medicine). The judge is a smart guy, and I’m guessing he would appreciate it if she shortens the script, because he gets the point.

The judge knows the issues cold. He has already written an extensive summary judgment opinion on the case, and if the defense was really clever, they’d make sure that every question they asked was geared to essentially reinforcing what the judge already said previously. Apart from the new (and somewhat thorny) issues, it’s their case to lose because they’ve already done a hell of a job so far.

Rick Jaffe, Esq.

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 the past) cajoling the agency to start taking more aggressive action about what he now thinks are around 1,000 of these illegal operations. Here is that post: https://ipscell.com/2021/04/fda-to-end-grace-period-on-stem-cell-clinics-agency-should-go-big-on-continued-offenders/

To show that it has not been just sitting on its thumbs, the FDA is reminding the stem cell community that it has issued 350 letters (warning and other lesser letters) to those businesses it feels are in violation of the law as the FDA sees, which view is stated in the final guidance documents issued at the end of 2017. Here is my post about the final guidance documents in case there is someone out there who can’t recite it chapter and verse by heart: https://wp.me/p7pwQD-bB.

The 1000 illicit stem business estimate is an interesting number because it is almost double the number of these illegal operations from when the widely publicized study of these illegal stem cell clinics was first reported in 2016 by the big dog and Leigh Turner. Here is that study/report.
https://www.cell.com/cell-stem-cell/fulltext/S1934-5909(16)30157-6.

By the metric of the estimated number of businesses, it doesn’t seem unfair to say that if the government has been attempting to eradicate what it thinks is the illicit stem cell business, it has not succeeded and is moving in the wrong direction.

True, three and a half years were under the grace period. However, there are a few “howevers”. First, the FDA hasn’t been the only player trying to stop these businesses. With great fanfare, the FTC announced a multimillion-dollar settlement with a California stem cell clinic. And to my knowledge, that’s the end of the FTC’s published involvement in the field. Another well-known California stem cell clinic filed bankruptcy but that was probably in large part because of a highly publicized class action suit. (full disclosure, I represented that clinic on matters unrelated to that civil lawsuit). States have filed or threatened to file consumer protection suits for false advertising (including against one or more of my clients). And that certainly has gotten the attention of those targets/defendants. (When I wrote this, I got an image of the whack-a-mole game, for some reason.)

I think (ok, I know) that other state agencies are nosing around the field trying out different jurisdictional ways to regulate/shut these places down, and yet the numbers continue to increase. And yet the numbers of these clinics continue to grow, which is what I have been saying for the past few years in response to each of the many, many times which the members of the institutional opposition to the private stem cell clinics have reported each bad thing that happened to a clinic or the FDA’s attempts to stop them.

I have an image in my mind which sums up my feeling that despite the FDA’s talk about the end of the grace period, and the predictions of demise by the stem cell constitutionalists, it might not go as planned. Anyone remember the Mad Magazine cartoon showing a police officer hammering a sign which reads “30 miles per hour speed limit, radar enforced”. A guy next to him says “all that radar equipment must have been very expensive.” to which the cop responds. “Naw, it was 20 bucks for the sign.”

Of course, the FDA has tons of people and billions of dollars in its budget, but nonetheless, its resources are limited and most of its enforcement efforts seem to focus on letters that have no actual binding legal effect (according to the FDA’s (and other federal agencies’) position it takes in court which has been accepted by the judiciary), but that another story.

But apart from the lack of FDA’s resources to deal with 500 plus but now 1,000 plus of these businesses (and let’s not forget that we’re in a pandemic and the FDA is going has bigger and more important priorities), there is one gigantic possible impediment to the announcement/prediction/wishful thinking that the FDA is going to file a bunch of lawsuits and shut these 1000 plus clinics down.

Maybe the FDA is wrong!

This is not a crazy thought (even though a couple of years ago, I thought it was) for two reasons. First, as I have related many times, Judge Bernal’s summary judgment decision in the California Stem Cell case said that SVF does not appear to be a new drug, or at least that is the implication of his decision. See one of several of my earlier posts about that https://rickjaffeesq.com/2021/01/24/for-the-same-surgical-procedure-autologous-stem-cell-transplant-crowd-big-decisions-are-a-coming/?preview_id=3334&preview_nonce=32c880d320&post_format=standard&_thumbnail_id=-1&preview=true

And FYI, I guess a buried the lead because the California Stem Cell remote trial is now underway. Today, May 5th is the second day of what is expected to be an 8-day trial. It is remotely viewable. Here is Court’s calendar for today with contains the log-in information.
may5calendar

Figure around 60 days for the judge to make his decision. Between the trial briefs and the proposed findings of fact and conclusions of law and the work he did on the summary judgment motion, it should not be that big a deal. (the preparation of the trial transcript might push this time frame back a bit, unless one of the parties is ordering daily copies).

Second, as I also pointed out previously, one month after the Florida district court judge granted summary judgment to the FDA in an almost identical case, the Supreme Court limited judicial defense which federal judges can accord to an administrative agency’s interpretation of its laws (statutes and regulations) to cases where the statute/regulation is ambiguous. The Florida district appeared to defer to the FDA’s interpretation of its laws via the Court’s reference to the stem cell guidance documents which are the FDA’s written current interpretation of its laws. (My above post talks about this as well). So the question is whether the statute and regulation (21 CFR 1271) is/are ambiguous. If the Eleventh holds that it is, then presumably the Florida District Court properly relied on the guidance document. If it isn’t, then the case should get reversed and sent back. And then there is the California stem cell ongoing trial.

If either the Eleventh reverses or Judge Bernal rules against the FDA and or just holds that SVF is not a new drug, the FDA can kiss its intimidation PR enforcement campaign goodbye, and the cajoling for criminal prosecutions will fall on deaf ears. I can tell you from my personal experience that the federal prosecutors do not like ambiguity in the law and they surely don’t take cases where a federal judge has decided against the FDA position if that is the theory of the intended prosecution.

And finally, as I have repeatedly said, parts of the adipose stem cell business have already moved on to other products like bone marrow, and that product is not more than minimally manipulated and some uses are likely homologous even to the FDA. For other products, the FDA might have a clearer path to the FDA designation of illicit new drug status, but even with them, the FDA’s battle begins anew, one company at a time.

In my view, market forces driven by ineffective conventional treatments for chronic conditions which have strong anecdotal evidence of efficacy and little evidence of harm are just as strong and certain as the ocean washing on to the shore. Trying to stop that force will most likely have the same result as King Canute. I love the King Canute picture, so here it is again:

Best of luck to the California Stem Cell folks and their legal team, (in case you had any doubt about where I stand).

Rick Jaffe, Esq.

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 unapproved treatment for COVID. Nothing will get you in trouble with the feds faster than that, and even if your product is natural like a bunch of herbs.

Second, she was promoting a “stem cell” treatment even though the product she was administering had no stem cells. (It was some kind of amniotic mixture made by the University of Utah for commercial distribution, and that’s another story for another day).

Worse for her, she was actually told that by the University of Utah that the product had no stem cells (or any other kind of cells for that matter). That means she knowingly falsely represented over the internet and TV the product she was administering. The feds take a dim view of that and call it “wire fraud” (because of the use of the internet and TV transmission lines).

Then there was the fact that she was writing prescriptions for controlled substances for patients she had not seen (she was DEA registered) because she was the only physician’s assistant at the clinics to be DEA registered. In addition to being charged criminally for that, I am sure that the DEA will move to revoke her registration certificate.

So what’s the lesson for the regenerative medicine community from the case?

For starters, don’t promote stem cell treatments for COVID and don’t lie about what is in your product.

Beyond that, I actually don’t think this case means much for most of the regenerative medicine community because this individual (allegedly) did so much wrong.

The folks who maybe should be worried are those of you who are marketing stem cell products with dead stem cells, and there are many reports about that happening in the community, especially amongst the non MD stem cell providers.

If you are one of these folks, you might be taking some solace in the fact that you don’t know or don’t believe the stem cells in what you are selling are dead/not viable.

Wasn’t the Missouri woman’s problem that she was told by the manufacturer that the product has no cells?

Yes, that is true, but let me introduce you to a nasty tool in the federal prosecutors’ toolbox and it’s called the deliberate ignorance jury charge. Basically, you can’t stick your head in the sand like an ostrich and claim you didn’t know. The deliberate ignorance charge supplies the element of knowledge in the absence of proof of direct knowledge in a federal felony charge which requires knowledge as an element of the offense. It is especially applicable in the health practitioner setting since there is a duty to know. For health practitioners and their defense counsel, it’s a tough one..

Still and all, the federal criminal apparatus has heretofore not been a major player in the stem cell field. The criminal boys and girls (meaning the US Attorneys Offices’ Criminal Division and the FDA’s Office of Criminal Investigations) have mostly left it to the federal civil apparatus.

Mostly I say, because you only hear about the cases which result in indictments. FDA criminal attorneys handle investigations which don’t result in indictments, and that’s not something which gets talked about much for obvious reasons, but there have been such investigations in the past, and I suspect it is still on the the criminal boys’ radar screen, as they continue to watch for egregious cases like this Missouri one.

Also, I don’t think this case will have much if any impact on the autologous crowd and especially for the utilizers of bone marrow. For those folks, it is all about the advertising claims and the recent action is more from the state AG’s offices than the feds.

Or so I see it.

Rick Jaffe, Esq.

 

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 trial will not go forward until the pandemic is fully in control, and no one thinks that is going to happen by May.

However, according to media reports, that won’t happen until the country hits herd immunity through vaccination, and that’s not expected to happen until the late summer or fall (and that assumes the as yet untested notion that the current vaccines will be at least 50% effective against the new COVID strains). So, in short, expect another delay in May, with a rescheduled September ish date, and then it’s probably 50-50, one more delay (at least). Another data point to follow is when the federal courts allow jury trials. You would think when they allow potential jurors into courts, they’ll allow attorneys, paralegals, and witnesses to do live bench trials.

What that means is that the Eleventh Circuit’s decision in the Florida US Stem Cell case will come down before California District Judge Bernal issues his decision (if he ever does). Technically, federal appellate decisions are only binding on the district courts in that circuit, but they are considered persuasive authority for other district courts in other circuits, meaning district courts in other circuits have some leeway to distinguish or not follow it for other considerations.

So the wait continues for the first post-limitation on federal judicial deference to the FDA’s interpretation of its own regulations case.

Rick Jaffe, Esq.

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 you can judge for yourself. Here is a link to the 30-minute oral argument.

https://www.ca11.uscourts.gov/oral-argument-recordings?page=1 (its on page 2)

I have always thought that the FDA was in the wrong on the basic issue of whether under its regulations, MSC or SVF same surgical procedures were regulatable under the FDA’s new drug. And that’s for a pretty simple reason. I asked the FDA several times when I was pondering whether to issue what I think might have been the first opinion letter for a facility back in the early 2000s. I was assured a couple of times by different FDA personnel that as long as it was all done in the same surgical procedure (which precluded meaningful expansion/culturing of the cells), the FDA had no jurisdiction over the procedure.

But alas, things changed with the proliferation of these clinics and the increasingly shall I say aggressive advertising engaged by some. The FDA tried to reinterpret its position and tried to amend the regulations with a clever one-word change which it argued made it all subject to the New Drug laws. Since that time, there have been numerous warning letters, and of course, the final FDA’s guidance documents explaining why when a doctor removes a body part and reimplants it, somehow that body part gets transformed into an FDA regulatable drug which cannot be put back into you unless and until the FDA approves testing with other people whose more or less similar body parts are safe to put back into those other persons and does something helpful.  I felt that could only make sense to a regulator, bench scientists, or people who can’t see the forest for the trees.  But that’s just my opinion.

On the other hand, the feds and the states have what I consider to be a nasty doctrine called judicial deference to administrative agencies. It is what it sounds like, and it is a big reason why many complain about the power of the administrative state. To lawyers like me who practice before administrative agencies and/or challenge administrative findings in court, it is always an uphill and frustrating battle. Frankly, it is not a fair fight. And thus, despite believing that the FDA was wrong, under judicial deference to administrative agencies’ determination of the meaning of their own regulations, I thought the FDA would prevail in the US Stem Cell case and in the California case as well.

However, in the last few years, the increasingly conservative Supreme Court has taken notice of the issue, and slowly, a few judges starting writing dissents complaining about it. One or two of them have started to call for the elimination of the whole deference to administrative agency program (and here like in pandemic law, Justice Gorsuch is leading the charge).  But in the summer of 2019, the Supremes limited judicial deference to an agency’s interpretation of its own regulation to cases where the regulation is ambiguous. That’s a start but didn’t go far enough for the vocal minority.

That decision came a month after the district court in the US Stem Cell case issued its summary judgment ruling granting the FDA’s request for a permanent injunction on the grounds that the FDA law and regulations make SVF (stromal vascular fraction) a drug, and that was in part based on the fact that the FDA said so in its Guidance documents, in other words, judicial deference to the all-knowing (or at least all-powerful) FDA.

You all know by now that California District Judge Jessie Bernal took a different view and held that as long as the SVF removed was the same SVF reimplanted that it would not be subject to FDA oversight under the SSP (same surgical procedure) exemption under 21 CFR 1271.15, or at least so he thought and expressed in his opinion denying summary judgment.

Well folks, on Tuesday, January 26, 2021, the FDA’s injunction trial will start against Cell Surgical Network. All the pre-trial paperwork has been on file for many months.  It seems like the trial will take place by Zoom, but that’s more of an assumption on my part since I have not seen anything official about that in the docket. Since the paperwork is already on file (including the parties’ proposed findings of fact and conclusions of law), and because the judge has already ruled on the core issue, I wouldn’t expect him to take too long to issue his decision. I would say inside of 30 days, maybe 45 at the latest.

There is another factor that might propel the judge to issue a quick decision, namely the fact that the Eleventh Circuit Court of Appeals will be issuing its decision on the US stem cell case in the next couple of months. District Judge Bernal may want to give his views on this core issue before the appellate court does and might prefer that the appellate court reacts to his decision, rather than the other way around, given the fact that his is the “inferior” court.

If one of the two court cases resolve in favor of the stem cell transplanters, of course, look to a resurgence of these facilities offering and further aggressively advertising of these services.  That will lead to further action by the state AG’s against these facilities under state consumer protection laws, and possibly by the FTC, though it has not been a significant player in the space. I would guess the FTC is allowing the FDA to clean-up the field via the warning letters.  If both stem cell transplanters lose, then the field will just stick to the new HCT/P’s being used like bone marrow and other more exotic products which are a half step ahead of the FDA (for now).  Either way, I do not see any major restriction on the field, in the short to medium term, and as suggested, I think things could open-up big time if one or both decisions hold that these same surgical procedures are not regulatable by the FDA, But (and there is usually a but), even if that happens, that might just switch the battle to the medical boards, which is probably where the fight should have always been.   And on and on it will go.

Rick Jaffe, Esq.

 

 

 

 

 

 

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 regulate surgical procedures transmogrified these clinics from 1271.15 exempt from FDA drug regulation into dangerous and evil promoters of unapproved, misbranded, and adulterated drugs, subject to warning letters and civil injunction actions.

The elegance of the transformation was that the FDA only had to change one word in the stem cell regulations. The fact that the FDA may not have had to power to revise its governing regulations, has not yet been litigated, but it will be, most likely next year with the trial of the FDA’s case against the Cell Surgical Network and its founders Mark Berman and Elliot Lander.

But this trial will be very different from the summary judgment disposition in the US Stem cell case in large part because we no longer live in a world of Chevron deference to an administrative agency’s interpretation of its own regulations. It is now a fair fight in terms of judges analyzing and interpreting FDA law and regulations. and that is most unwelcome news for the FDA.

Speaking of the Cell Surgical Network case, as you know, it has already been put off twice (at least).  It had been set for November but was adjourned for the same pandemic reason as it was previously adjourned. Right now, it is set for later in January, with a pre-trial conference in early January. Here is the judge’s November order putting the case off.  031134257294.

The trial will obviously not go forward live and in-person in three weeks, so the only question is whether the defense can convince the court to hold a videoconference trial. I have it on good authority that the defendants are anxious (if not giddy) about getting on with the trial, as well they should be given the judge’s decision denying the FDA summary judgment. While I don’t think the defendants will necessarily be completely exonerated, given the judge’s summary judgment decision, as long as he doesn’t change his mind, I expect the judge to exonerate them on the principle charge and hold that SVF is an exempt surgical procedure under 21 CFR 1271.15, and deny the FDA’s request for a permanent injunction stopping them from administering the treatment, so long as it doesn’t include anything else in it.

So far, the judge has been reluctant to hold a video trial. I don’t see why he would abandon that reluctance now and hold a video hearing in January, given what is happening with increased cases, hospitalizations, and deaths. So, for the reasons I didn’t think the case would go forward in November, I’m going with that it’s not going to go forward in late January either.

Beyond that case, the FDA continues to send out warning letters, and the clinics keep on finding more exotic tissue products to administer to keep one step ahead of the FDA’s enforcement actions. I am not aware of any newly filed injunction actions. Given the pandemic, it wouldn’t shock me if 2021 turns out to be quiet on the FDA front save for the relatively cost effective warning and untitled FDA letters.

This is playing out pretty much as I have expected. As I have often previously said, the FDA does not have the resources to eradicate the private stem cell field. There are market forces at play that are far more powerful than one overtaxed federal agency. The demand for these services is just too great. More importantly, apart from one spectacularly stupid clinic, the safety profile of the treatments doesn’t lend itself to the FDA amassing broad public support for its efforts. The longer these clinics (including major hospitals) use these treatments, the more people will continue to use their own body parts for conditions refractory to other forms of treatment, regardless of what the FDA tries to do. (and, for understandable reasons, it doesn’t seem to be trying all that hard now.)

I think this will continue throughout 2021. By late 2022, I think we’ll have some appellate court authority to resolve what I expect to be the conflicting decisions between Florida and California courts (again, assuming the California federal judge does not change his mind). I hear that the Ninth Circuit (which is where the California stem cell case will be heard on appeal) now has a conservative majority, because of all the federal appellate judges Trump has appointed. Conservative judges are typically more pro personal freedom over one’s own body, (at least as long it does not involve a fetus).

Between the lessening impact of Chevon deference to administrative agencies, and the fact that the FDA probably did not have the authority to amend its regulations, there is a fairly good chance that the California judge’s approach will prevail on appeal. If the California case reaches the Supreme Court, I expect and predict the six conservative justices, and in particular, Alito and Gorsuch to be strong advocates for a person’s freedom to use his/her own body parts without government interference. Look to Gorsuch to write the majority or a separate concurring opinion, and it will be strong and clearly draw a line in the sand of where the Government cannot go.

In short, expect more of the same in 2021, with the California case pushing back on the FDA’s current view on autologous same-day surgical procedures for the above reasons.

Beyond the Feds

Lately, chiropractors are getting into the stem cell space, ownership wise. I think that is unfortunate, at least for public perception reasons. Plus, I hear a lot of talk about dead cells in these chiro-owned operations, and that is very disturbing. I have considerable experience in the MD/DC format. I could have made a ton of money setting up these chiro owned stem cell clinics. However, it is just too easy for these operations to run afoul of state and federal criminal statutes, so I stay away from the MD/DC legal set-up business.  I give them all the same answer: “Stay in your own lane.” As evidenced by how popular these chiro/MD stem cell clinics have become, other attorneys have made a different decision.

In 2020, we have had some state attorney general action against private stem cell clinics in the form of consumer protection/deceptive trade practices cases against clinics.  That will surely continue, somewhat, but we live in difficult times and they will have their hands full and the pandemic will probably slow things down, at least in terms of new cases.

I think the big issue in 2021 will be whether states can use the FTC’s adequate substantiation requirement under the FTCA as a grounds for liability in a state consumer protection case, in the absence of a statute which does not specifically allow adequate substantiation as a basis of liability under a consumer protection law. I don’t think they can, and more to the point, that is the position I will be taking in my New York stem case filed by Leticia James. By April, I should have some indication of whether I am right or wrong.  So, stayed tuned.

LIke all of you are thinking, let’s hope for a better next year.

Rick Jaffe, Esq.

 

 

 

 

 

 

 

 

The FDA’s California stem cell case has a new trial date, sort of

The FDA’s California stem cell case has a new trial date, sort of

When last I reported on the FDA’s injunction action against the California stem cell treatment operation, the judge had adjourned the July trial date because of the recent alarming uptick in COVID-19 cases in the area. The court ordered the parties to confer and come up with a new proposed date in November or thereafter.

The defense’s response to the order was unusual. It attempted to seek an earlier remote video trial. The judge was not prepared to do that just yet, but after further discussions, a few days ago, he issued an order setting a new trial date for November 10, 2020. HOWEVER, the judge ordered a telephone conference on October 19, 2020, to determine whether “1) [the] trial . . . can safely be conducted in-person, consistent with public health guidance; and/or 2) trial can fairly and reliably be conducted through remote appearances by witnesses and counsel.” Meaning, it is not at all clear that the trial will go forward on November 10th.

We already know that the Defendants want to go forward with a remote video trial. My guess is that the FDA might be reluctant. Based on the judge’s decision denying the FDA summary judgement, (the details of which I explained in a previous post, and here is that post: https://rickjaffeesq.com/2020/01/28/stem-cell-shocker-cali-federal-judge-denies-the-fda-summary-judgement-and-orders-a-trial-in-the-cell-surgical-network-case/ )
the judge agrees with the defense’s position that the procedure removes and reimplants the same thing, namely SVF. Hence the procedure is covered by the same day surgery exception. Therefore, it is not subject to the FDA’s regulatory authority. In short, the FDA is going to have to change the judge’s mind. I would speculate that the feds think they have a better chance of doing that in a live trial. If so, that would suggest that the feds will hold out for a live trial.

There might be another reason for the feds trying to delay the trial. Right now, there is a giant storm cloud over SVF and the California Stem Cell operation. I do not have any direct knowledge, but my experience tells me that kind of cloud is very bad for business. Since the FDA can read the tea leaves, it knows it has an uphill battle with this judge, and it will take the agency at least a year to get an appellate review of the district court’s decision. In the meantime, the FDA is continuing with its PR campaign on the illegality of this and other stem cell products and procedures. So, delaying this case might appear to the agency to have some benefit. But that is all speculation on my part. All we know for sure is that there is a new trial date, but in these uncertain times, it cannot be said that the case will actually be tried on that date.

Rick Jaffe, Esq.

Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Yesterday, California federal district court judge Jesus G. Bernal on his own adjourned the the FDA’s trial against Cell Surgical Network (“CSN”) and their owners Mark Berman and Elliot Lander. The parties were ordered to meet and confer about a new trial date to take place after November, 2020. The trial had been scheduled to commence on July 28th. Because of my deep interest in the case, I have been checking the Riverside Ca. Covid-19 numbers and once the numbers started to rise, and based on what has been happening in California in general (which is another area of interest and which I write about), I was pretty sure the the judge would have to knock the case off the docket. This is too big and too important to do via Zoom, and the judge really had no choice. Too bad, as this is for sure the most important stem cell case in the country right now, and in general, and for reasons having to do with my stem cell work, I was really hoping to get some clarity, or more specifically, another ruling similiar to the judge’s seminal summary judgement decision.

For my own needs, I have recently reviewed some of the pre-trial filings in the case, and in particular the proposed findings of facts and conclusions of law filed by the parties. (Findings of fact and conclusions of law are the main documents filed in a bench trial. In a jury trial, the parties would file proposed jury instructions. But in a bench trial, the findings of fact and conclusions of law are what the parties expect to show fact wise, and what they argue how the law applies to the facts, and of course, present the proposed outcome. In case you were wondering, there is no federal (7th Amendment) right to a jury trial in cases in which the relief is equitable, like injunctions and declaratory judgments).

CSN’s findings and conclusions, prepared by Venerable’s LA office’s team headed by Celeste Brecht are about the best I have ever seen in an FDA case (or maybe in any case). They clearly lay out CSN’s position in the case. If you want to understand exactly what the defendants did and why they think all of it is legal, and how the FDA improperly used industry guidance procedures to substantively change the law without going through the proper and required procedure, then read this document. (I know I am being alittle redundant, but I just love saying how the government acted improperly; it’s a defense lawyer’s thing, and spoiler alert, I’m not done yet!) Here it is.

csnproposedfindings

This document also cogently and succinctly lays out the evolution of the same day surgical procedure exception, from whence MSC/SVF procedures were considered 21 CFR 1271.15 EXEMPT, to the FDA’s illegal transformation of the procedure and a person’s body part into an illegal, unapproved, adulterated and misbranded drug.

In all my years doing this law thing, this one action, (and did I mention that it was illegal and improper?) is the single stupidest thing I’ve ever seen. Your body part removed and reimplanted during the same surgical procedure is a drug! In my opinion, this is perhaps the most extreme case of over regulation and lack of common sense that I have ever seen in the field.

For a long time, I thought the FDA would get away with its improper transformation, and that this case would reach a similiar result as the US Stem Cell case in Florida, because of the deference federal courts are required to give federal agencies like the FDA when it interprets its own regulations. However, in 2019, (after a few Justices gave some heart warming hints), the Supreme Court came out with a couple decisions which limit deference to laws and regulations which were ambiguous. This might well prove to be the death-knell of the FDA’s decade plus effort to (improperly) rewrite the the same day surgical exception.

So getting back to Venerable’s findings of fact and their succinct history of the FDA’s regulation of this issue, here it is:

“Regulatory History of the SSP Exception
6. Until 1997, the FDA exerted little to no control over human cellular and tissue-based products.
7. In 1997, the FDA introduced Guidance providing that:
the agency would not assert any regulatory control over cells or tissues that are removed from a patient and transplanted back into that patient during a single surgical procedure. The communicable disease risks, as well as the safety and effectiveness risks, would generally be no different than those typically associated with surgery.
(Ex. 88 (emphasis added).)
8. In 2001, the FDA then promulgated the Same Surgical Procedure Exception (“SSP Exception”) based on the 1997 Guidance.
9. The SSP Exception exempts from any FDA regulation:
[A]n establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure.
21 C.F.R. § 1271.15(b).
10. The FDA has not amended the SSP Exception since its promulgation.
11. HCT/Ps are defined as “articles containing or consisting of human cells or tissue that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” 21 C.F.R. § 1271.15(b).
12. In 2014, the FDA released a draft guidance that sought to create ambiguity in the SSP Exception. (Ex. 89.)
13. The draft guidance proposed substantive changes that interpret the SSP Exception to exclude surgical procedures that would otherwise qualify for exemption by requiring that the patient’s transplanted HCT/P be implanted in its
“original form,” which is very narrowly defined and otherwise limits the types of surgical procedures that would fall within the SSP Exception. (Id.)
14. The “original form” language is not included anywhere in the regulation, see 21 C.F.R. § 1271.15(b). Instead, the SSP Exception unambiguously states that a tissue or human cell is not a drug if it is removed from an individual and then re-implanted in the same individual.
15. The FDA adopted the draft guidance, which was improperly signed by Ana Abrams, in December 2017. (Ex. 87.)”

Ahh, this is music to my ears and will be to many in the stem cell field (on this side of the fence anyway). Only thing that’s needed is the judge’s signature. But alas, that can’t/won’t happen until sometime after November. We’ll all have to stay tuned until then.

Rick Jaffe, Esq.