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 the Texas law:
As the bill was winding its way through the Texas legislature, a few Texas senators (probably doing the bidding of the Texas Medical Association and/or the Texas Medical Board (“TMB”) tried to kill the bill by adding requirement that the procedure had to be FDA approved, i.e., part of a clinical trial.
(I pointed this and other flaws in the bill in a post. See: http://wp.me/p7pwQD-a )
Let’s just say that my comments were not appreciated.
The whole point of the law was to allow people to receive stem cells even if they were not part of clinical trials or under FDA approved special exception. Obviously, by re-imposing the clinical trial/FDA approval requirement, the law would be meaningless. Fortunately, the clinical trial requirement was dropped from the final bill.
There was one other provision in the bill that was particularly worrisome to me: that the TMB was given carte blanc to promulgate rules implementing the stem cell statute.
I’ve been litigating cases before the TMB for 30 years and have interacted with dozens of board members. They are very conservative medically, and most don’t believe in physicians practicing beyond established clinical guidelines. So I was very concerned when the Texas legislature gave the TMB unfettered discretion to set-up rules for stem cells. I said so publicly, subtly in my past posts(see the end of this post, http://wp.me/p7pwQD-ab) and much more bluntly in private conversations with the patient advocates shepherding the bill through the legislature. Let’s just say my concerns were not well-received.
But my long (and hard-fought) experience with the board members and the Board’s legal staff was telling me that the Board was going to be very reluctant to implement the statute as the legislature intended. In fact, the relative ease in which the opposing Senators gave up the FDA clinical trial requirement made me suspect that they simply decided to pass the bill knowing that the Board would kill it, or at least never let it be implemented as the rest of the legislature intended.
So what’s in the Board rule?
On March 26, 2018, the TMB published its proposed rule on HB 810, the stem cell law as well as regulations implementing the Texas “right to try” law (I’ll deal with the right to try regulations in a separate post).
Here is a link to the entire revised rule on investigational treatments:
Here is a pdf of just the stem cell part of the proposed rule.
But it’s a statute and thus pretty boring, so I’ll just relate the part which kills the stem cell law:
“(d) Stem cell treatments which are under investigation in a clinical trial and being administered to human participants:
(1) may be administered or provided to eligible patients with qualifying terminal illnesses or severe chronic diseases as defined by the executive commissioner of the Health and Human Services Commission; and
(2) must be done in compliance with applicable law.
(e) In order for a patient to be eligible to receive treatment with investigational stem cells, the eligible patient must:
(1) be enrolled in a clinical trial investigating the use of adult stem cells in humans;”
As previously stated, the whole point of HB 810 was to make stem cells available to patients outside of clinical trials. There is no need for a law that says patients can enroll in clinical trials, because that’s already the law. The point is to allow clinicians not doing clinical trials to administer stem cells outside of clinical trials.
Well why can’t a clinician just start a clinic trial and administer stem cells to his/her patients?
The answer: because it’s illegal (or so says the FDA). Physicians can’t give non-FDA approved drugs (which the board rule calls “investigational drugs”) to patients except in an FDA approved clinical trial. If they do, they are violating the FDA’s trifecta of introducing an unapproved drug into interstate commerce, and providing a misbranded and adulterated drug to patients. That’s the thrust of the recent injunction actions that I wrote about in my last two posts. (And it’s a nonstarter for the average clinician to do a clinical trial; it’s a quantum level more work and money than any clinician or clinic can do (unless your name is Burzynski).
And remember, the TMB’s proposed rule states that the stem cells being administered to patients in clinical trials must be done so “in compliance with applicable law.” There’s no more applicable law than the FDA law and regulations on clinical trials.
I think there are other problems with the TMB rule regarding IRBs which will make compliance practically impossible for university level IRBs, but that’s secondary to the fact that the proposed TMB rule limits stem cell access to patients on clinical trials performed “in compliance with applicable law,” which was exactly the law before Texas legislature passed SB 810!
Way to go TMB! The stem cell Mafioso is breathing a sigh of relief.
The good news, if there’s any, is that that this is just the TMB’s proposed rule. Public comments are allowed. Here is the number for more information:
There might be a public hearing sometime in the future. To state the obvious, there’s more work to be done by the folks who are advocating for access to stem cells outside of clinical trials.
Rick Jaffe, Esq.