Placental “Stem Cells” and The State of Utah vs the FDA
There’s a battle brewing based on a new stem cell law that looks likely to pass in Utah. You can bet that this will result in the FDA getting involved and ignoring this new state law. It’s also reasonable to assume that this law will get quoted as the main ammunition to support that Utah physicians should be able to use placental-derived stem cells. Let’s dig in.
The New Utah State Law
Utah Senate Bill 199 was sent to me by a colleague this past week. It’s an interesting blend of other state laws requiring patient disclosure of the use of stem cell therapy and a law that pits the state of Utah against the federal government. Let me explain.
First, there’s a curious definition of stem cell therapy as:
“(c) (i) “Stem cell therapy” means a treatment involving the use of afterbirth placental perinatal stem cells or human cells, tissues, or cellular or tissue-based products.”
Hmmm…. Nothing about the other sources of stem cells like autologous bone marrow or fat. Is that included in “human cells, tissues, or cellular or tissue-based products”? Interestingly, the current version of this bill states:
” A health care provider whose scope of practice includes the use of stem cell therapy may perform a stem cell therapy that is not approved by the United States Food and Drug Administration, if the health care provider provides the patient with the following written notice before performing the therapy…”
So the bill comes out swinging by stating that the state of Utah allows stem cell therapies that would be deemed illegal by the US FDA as long as a disclaimer is used. Then there is this:
“…a health care provider who performs a stem cell therapy under an employment or other contract on behalf of an institution certified by any of the following:
(i) the Foundation for the Accreditation of Cellular Therapy;
(ii) the Blood and Marrow Transplant Clinical Trials Network;
(iii) the Association for the Advancement of Blood and Biotherapies
(iv) an entity with expertise regarding stem cell therapy as determined by the division.”
What’s bizarre here is that FACT doesn’t have a certification for delivering non-FDA-approved stem cell therapies. Niether does AABB or the Blood and Marrow Transplant network. What’s also fascinating is what I would call the “back door” opened by allowing any entity that the division determines has expertise in stem cell therapy to issue an exception to this law’s minimal requirements.
What Does the FDA Say About Using Placental Stem Cell Therapy?
The above language becomes far more problematic when you realize what the FDA has already weighed in on this topic:
The 2020 FDA public warning above was primarily about providers using birth tissue-derived “stem cells.” Here are untitled and warning letters sent to providers about the illegality of using birth tissue derived stem cell therapies:
So there is little doubt that the FDA considers the use of birth tissue derived stem cell therapies without a full drug approval illegal.
State vs Federal
Since our nation’s founding, there has been this give-and-take between the powers reserved for the states and those reserved for the federal government. In fact, the Federalist papers written in 1788 by Madison deal with this topic. He and others believed that for the new United States to take its place on the world stage, it would need a strong federal government. As a compromise necessary to ensure ratification of the newly minted constitution, Federalists agreed to the Bill of Rights and the Tenth Amendment, which states that “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.”
Today the biggest state versus federal battle we all know well is the state by state legalization of Marijuana. While this drug is still illegal federally, this works because the feds have decided not to enforce the law (regulatory discretion). The same has never been true with the regulation of stem cells.
Multiple groups have claimed that the state-regulated practice of medicine trumps the assertion that the FDA can regulate autologous stem cells as a drug. For example, the FDA has already fought three of these cases in the courts and is 2/3:
- The agency won the Regenerative Sciences case at the district and appeal levels on culture-expanded stem cells.
- The FDA won the US Stem Cell adipose SVF case at the district and appeal levels.
- The FDA lost the Cell Surgical Network Adipose SVF case at the district level and is currently appealing.
Hence, the FDA is clearly NOT engaging in regulatory discretion on this topic. In addition, that’s when the patient’s own cells are used, not when the cells are from a donor, which is what’s proposed with this new law.
Who Could Be Behind This New Push in Utah?
I have previously blogged on two players in Utah who could be behind this new law:
There could obviously be others who are behind it.
My Prediction
The FDA will send a Warning Letter to at least one Utah company or clinic that begins operating under this new law that will ignore the new law’s existence. That will begin a legal battle where attorneys for that clinic try to cite this new law, setting up yet another state versus federal battle on stem cell regulation. The FDA will ultimately win that battle.
The Bizzare Aspect of This New Law
As I have blogged on before, no tissue products in the US that use birth tissues have live and functional stem cells. When we and other labs tested these products, they all had dead and dying cells. Hence, these are not stem cell therapies.
The upshot? This new Utah law is a shot across the bow of the FDA. IMHO, the agency should take note. However, only time will tell if this is the next big showdown between the feds and doctors.
After this blog was published, two more detailed analyses of this crazy new law were published that may be of interest:
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