The U.S. Supreme Court could soon have a historic opportunity to limit the scope of FDA stem cell oversight. A large stem cell clinic firm now says it plans to ask SCOTUS to review a case it recently lost on appeal to the FDA.
If SCOTUS takes the case, the FDA could find its powers to regulate biologics sharply curtailed.
FDA stem cell clinic oversight
While stem cells and related biological therapies have great promise, highlighted by the FDA’s approval of two new stem cell-based sickle cell treatments last year, the agency has been struggling to oversee unproven clinics in this space. More than a thousand stem cell clinics sell scientifically unproven biologics like stem cells now across the U.S. The number could even be around 2,000 clinics.
While some of these clinics are not technically violating FDA regulations, others clearly are non-compliant. At just a few clinics, dozens of patients have been harmed including some who were blinded.
Other clinics operate in a kind of regulatory grey area that the FDA has been slow to address. The courts also can play a role in resolving gray areas such as related to what types of biologics are drugs or not.
SCOTUS and FDA stem cell oversight
The FDA recently got better footing in this overall cell therapy area, issuing more than a dozen warning letters related to unproven cell therapies last year, which was unprecedented. However, this momentum may be short-lived. Should SCOTUS accept the case in question and ultimately rule against the FDA, its oversight of hundreds of regenerative clinics could essentially end.
How’d we get to this point?
The agency is currently seeking an injunction against a group of more than one hundred stem cell clinics called Cell Surgical Network. This situation ended up in a federal district court here in California. While these clinics won the initial case, the 9th Circuit Court recently overturned that and ruled in favor of the FDA, potentially setting the stage to move toward an injunction that would stop the clinics.
Now the defendants requested in a new filing that the 9th Circuit Court delay moving forward toward an injunction. The reason is that they plan to ask SCOTUS to look at key aspects of this case. It revolves around how the FDA defines certain unproven cell therapies as drugs and potential exceptions to those rules.
Will SCOTUS take it?
The 9th Circuit Court ruling aligned well with an earlier 11th Circuit Court ruling in a similar case. That case was against a different stem cell clinic firm in Florida. In both cases, the firms marketed an unproven therapy consisting of adipose cells that the FDA has defined as a drug. The clinics argue that the patients’ own fat cells should not be regulated as drugs. They’ve also asserted that an exception should apply. These issues may sound legalistic, but they are important in practical ways. For example, if biologics are not defined as drugs then FDA oversight is more minimal. In that case, I see risks as being higher.
I asked Stanford Law Professor Hank Greely for his thoughts on a potential role for SCOTUS in this case:
“Normally a question about an interpretation of the meaning of a statute that has been adopted by the only two circuits to consider it would not be expected to have much chance of getting accepted by the Court. This one seems to me a little different because four (or, ultimately, five) justices might see it as a good vehicle for further delineating the meaning of the overruling of Chevron. It seems a little early after Chevron for the Court to be doing that…often they give the lower courts a few years to grapple with a major change. But maybe. The right’s pro- (selling unproven and illegal but highly profitable) stem cell tilt might have some effect on a few justices. I’d wonder whether any of them actually have gotten stem cell “treatments”, especially the older ones.”
So, in theory, it doesn’t seem that probable as there is no circuit court split here. In theory.
Why SCOTUS might take the case
But Hank also rightly alluded to reasons why the high court might weigh in here.
Another more specific factor potentially favoring SCOTUS jumping in is that conservative politicians and operatives seem increasingly interested in both limiting FDA authority and, in particular, reducing its oversight of cell therapies including stem cells. During Trump’s first term, Republicans like Rudy Giuliani, Rick Perry, and even Roger Stone advocated for or were linked to unproven stem cells.
States have also begun to challenge the FDA on stem cells and related materials. Both Nevada and Utah recently passed laws explicitly allowing the marketing of non-FDA-approved biologics. Other states appear interested in following suit. I believe some of these state efforts are driven by conservative activists.
RFK Jr., Trump’s choice for HHS Secretary, recently claimed that the FDA is suppressing stem cells. My sense is that Kennedy meant unproven stem cells, perhaps of the type sold by clinics. Should he be confirmed, Kennedy would oversee the FDA, where he could be a powerful ally to the unproven clinics. Here are my thoughts on RFK Jr. and stem cells.
Further, as Hank alluded to in the quote above, with SCOTUS recently ending the Chevron deference of courts to agencies like the FDA, some conservative justices may be sympathetic to the defendants’ arguments and more likely to hear the case. In that scenario, I believe the stem cell clinics are likely to prevail and the FDA could find itself seriously weakened.
Looking ahead
As a result, we could see more negative outcomes at clinics.
I believe that a politically-empowered stem cell clinic industry would also be harmful to the overall stem cell research field.
We are at a critical juncture. In the next five-to-ten years, I envision several additional FDA approvals of rigorously-proven stem cell therapies. These could include proven treatments for type one diabetes, at least one type of muscular dystrophy, spina bifida, and epilepsy.
At the same time, a boosted unproven stem cell clinic industry could cause major uncertainty for the field.
The 9th and 11th Circuit Courts got their rulings just right. As a result, there is no need for SCOTUS to step in here. However, the wheels could already be in motion for the conservative majority to use this case as a way to weaken the FDA.
The possibility noted by Hank of some of the aging justices having received unproven stem cells or other biologics is interesting and could factor in as well.