Florida stem cell bill is part of state trend to sidestep FDA

A new Florida stem cell bill directly challenges the FDA and its CBER branch.

If passed, which seems relatively likely, the Florida bill would become of state trend.  A Utah stem cell law and a broader Nevada biologics law legally okay non-FDA approved biologics. These and other pending state efforts pose major risks to FDA authority and the public.

This comes at a particularly bad time too. The FDA has lost key leadership like Dr. Peter Marks. RFK Jr. seems ready to weaken FDA oversight of unproven cell therapies and maybe other iffy biologics like regenerative peptides.

What’s going on with the Florida stem cell bill? First, some quick background on the other state stem cell and biologics laws.

States challenge the FDA on stem cells and other biologics

The Utah and Nevada laws explicitly say non-FDA-approved biologics and related products are permissible at the state level. See:

• Another state challenges FDA on biologics as Nevada OKs risky, unproven oligo, gene, & other therapies
• Utah stem cell law OKs non-FDA approved placental cell drug therapies likely sparking conflict

The Utah stem cell law focuses on placental cells, while the Nevada law legalizes non-FDA-approved gene therapies and possibly many other things. The scope of the Nevada law might even include so-called SOT or supportive oligonucleotide therapy. Note that SOT appears to be undergoing a rebrand to “Q-REstrain therapy”. The Nevada biologics law is also vague enough to probably include stem cells and other kinds of cells.

How does the new Florida bill compare?

Florida stem cell bill

There are actually two Florida bills, but they are similar enough that we can consider them functionally one bill.

The Florida stem cell bills were covered here by Florida Politics: Jay Trumbull, James Buchanan file bills to make stem cell therapy more available. Sen. Jay Trumbull and Rep. James Buchanan, both Republicans, seem to have coordinated on their bills (SB 1768, HB 1617).

The summary of the first bill says: “Stem Cell Therapy; Authorizing health care providers to perform stem cell therapy not approved by the United States Food and Drug Administration under certain circumstances; requiring health care providers to provide a specified written notice to patients before performing any stem cell therapy; requiring health care providers to obtain written consent from the patient or his or her representative before performing the therapy, etc.”

It appears limited to orthopedics, wound care, or pain management. The production facility must be registered with the FDA. It needs some kind of clearance from at least one of four listed industry groups too. Written notice of the cells being non-FDA-approved is also required. These provisions are positive, but not enough. Some unproven stem cell clinics and suppliers will take advance of this to sell risky cells if it becomes the law.

Promoting perinatal cells over others?

The second bill also specifically would legalize, at least at the state level, going around the FDA. It has many of the same provisions as the first but mentions placental cells.

It stands out that both bills seem to exclude minimally manipulated bone marrow. Minimally manipulated bone marrow used for orthopedic conditions is relatively low risk. In that particular context, it is also not a drug. At least so far it has not been treated as one. So why go out of your way in a bill to exclude it? Is there some ideological or specific corporate interest here too? Probably. Potentially fitting with that, the bills also apparently exclude adipose MSCs. Such products including SVF are drugs.

These bills and the Utah stem cell law seem intended to promote perinatal stem cells above most other cell types.

Stay tuned for more state laws

Can states just say FDA approval is not needed for biological drugs?

Federal law takes precedence over state law. For that reason, the Utah and Nevada laws, as well as this potential Florida stem cell law and bills that may come up soon in other states, cannot override the requirements of the FDA.  Even so, things are not so simple.

These laws can cause many problems, put patients at risk, and further weaken the FDA.

Some experts that I’ve talked to also are concerned that these state laws are laying the foundation for a potentially harmful federal law. The state laws also could lead to federal court cases challenging the FDA, where the agency could lose one or more key cases.

Remember also that the Cell Surgical Network lawsuit could end up before SCOTUS. That case relates to SVF.

Will the FDA take a step back on oversight?

There’s another level to this situation that could make some of the potential legal drama here unnecessary but do more harm.

It’s possible under RFK Jr. at HHS that the FDA may become much more passive on biologics like stem cells.

The agency may be forced from within HHS to soften its own approach to enforcement actions. This weakening would be especially likely to manifest on oversight of certain kinds of adult stem cells like those mentioned in the state laws/bills. The makeup and tone of the recent Kennedy regenerative roundtable suggested that some adult cell injections may not be carefully regulated anymore. As I wrote earlier, new FDA Commissioner Marty Makary also brought on an assistant, Dr. Tracy Hoeg, who has marketed unproven regenerative therapies at a clinic. I don’t know that that will be her focus in the FDA as she could work on vaccine policy, but it’s still notable.

Many things are happening almost all at once related to biologics regulations.

Broader trends point to more harm

Practically speaking, what is this confluence of events going to lead to here in the U.S.?

We can think of it as akin to an equation like A+B =C.

(A) We have state laws challenging the FDA on stem cells plus (B) an FDA seemingly poised to be far more passive anyway in this area equals (C) likely more harm to both the public and the legitimate stem cell research field. That seems totally inconsistent with making America healthier.

Throw in probably far less NIH funding for research in general including on cell therapies and possible bans on funding of human ESC research, and we’re heading toward a huge collective step backwards. I just wrote over at STAT about promising new U.S. and Japanese clinical trial research on stem cells for Parkinson’s. The future may bring less of such steps forward on cell therapies.

Notes

• The Florida bill checks off one of my 25 predictions for the stem cell and regenerative medicine field for this year. A few of the other predictions have already come to pass as well.
• I’m often using the term “stem cells” in this article, but in many cases the cells (while being called “stem cells” by some proponents) are not actual stem cells. Perinatal “stem cell” products often have no living cells of any kind and when live cells are present, they do not appear to be stem cells. Some other adult cell products like MSCs as made and used by unproven clinics are also generally not stem cells. The MSC products might only be true stem cells if sorted and validated in vigorous ways, rarely done or attempted by clinics. MSCs are most often heterologous products with mostly stromal or fibroblast-like cells, blood vessel cells, etc. They could still potentially be helpful for some conditions, but the sponsor has to prove safety and efficacy with careful clinical trials.