Thursday, July 26, 2012
FDA 1. RSI 0. Regenerative Sciences (Regenexx) vs FDA (2012)
As followers of this blog will know I've been blogging about Regenerative Sciences and predicting their eventual run-in with the FDA since my first post in September 2008 (Cell Therapy is Not the Practice of Medicine) and again in February 2009 (Regenexx vs the FDA 2009). When the FDA finally proceeded with an injunction against RSI in August 2010,I helped spread the news (here).
I've watched the development of the fight between RSI and the FDA with interest. In September 2001 I posted a rather lengthy commentary about the potential impact of the case (Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy.
Since then I have welcomed other bloggers and commentators who are now following and commenting on the case much more closely and frequently than I including @LeighGTurner (on Twitter) and Paul Knoepfler (@PKnoepfler on Twitter and his Knoeplfer Lab Stem Cell Blog). Recently I enjoyed being interviewed by Paul on the issue of unregulated stem cell activity and touched on the case for his blog.
Consequently I read with interest yesterday's federal court ruling upholding the FDA's injunction against RSI and the immediate commentary from the New Scientist, Stanford's Scope Blog and Knopfler's multiple posts (here and here). As a long-term follower of this case, I've been asked to comment. Here is my brief reaction:
This is a case that was always destined for the appellate courts regardless of which way the initial court ruled. The fact the federal court ruled in the FDA's favor certainly now sets the onus on RSI and what is anticipated to be a gamut of intervenors but taking this case to the appellate courts is what the legal team have anticipated and legal arguments designed for all along.
This is just the beginning of what will be a long and interesting battle. The ruling was nothing more than the granting of an injunction in response to the government's motion for summary judgement. In granting the injunction the court agreed with the government's position that it was acting under the authority given it under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) but it provided little-to-no rationale for its ruling.
The court chose, in its wisdom, not to address the bulk of the RSI's legal arguments which are largely jurisdictional in nature. These are the kinds of arguments which the lower courts prefer be dealt with by appellate courts and frankly the judge did us all a favor by ruling quickly, succinctly and punting the case where we all knew it was inevitably headed.
In my opinion, other than chalking one up in the government's win column there is little to be gleaned from this ruling in terms of how RSI's arguments will be received in appellate court. The interesting day is yet to come.
In terms of a short-term practical impact, frankly I see very little. RSI has already ceased distributing Regenexx within the US so there will be little-to-no impact there. As for the potential impact on other companies or clinics who might be operating on the fringes of FDA regulation within the US, I suspect it will be business as usual.
Most of the clinics/companies offering cell-based treatments/products which are arguably in contravention of FDA regulation are operating under the clear knowledge of what they are doing and where the FDA stands with respect to the treatments/products they offer and yet they persist and continue.
For the truly fraudulent there is the risk of criminal charges and/or litigation but for those companies or practitioners who are operating in this shade of grey which are not shady (and they do exist), the risks associated with this practice are barely higher than in the routine practice of medicine.
In reality, with the exception of the most fraudulent examples, it takes a fair long-time for the FDA to catch up with these folks and there is good money to be made in the interim. When they get caught, they will stop. If they've recouped their initial investment (which is nominal and the margins are high) there is very little penalty to this course of action. Perhaps they set up shot elsewhere or simply enjoy the proceeds. I doubt we will see much of a slow-down of this kind of activity. Indeed it may strengthen the resolve of those committed to the cause.
In my opinion yesterday's ruling was in interesting and important milestone in a continuing evolution in the debate of how best to regulate the use of cells in treating people but I'm not sure it's the seminal pivot point that some believe. I suspect we will not see any radical shift in terms of FDA or industry activity until (if then) the appellate courts rule.
Just my two cents....